By Lynn L. Bergeson and Carla N. Hutton
On October 1, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives within the following strategic goals:
- Goal 1: Tackle the Climate Crisis;
- Goal 2: Take Decisive Action to Advance Environmental Justice and Civil Rights;
- Goal 3: Enforce Environmental Laws and Ensure Compliance;
- Goal 4: Ensure Clean and Healthy Air for All Communities;
- Goal 5: Ensure Clean and Safe Water for All Communities;
- Goal 6: Safeguard and Revitalize Communities; and
- Goal 7: Ensure Safety of Chemicals for People and the Environment.
Goal 7 includes two objectives. Objective 7.1, “Ensure Chemical and Pesticide Safety,” is intended to protect the health of families, communities, and ecosystems from the risks posed by chemicals and pesticides. It includes the following long-term goals:
- By September 30, 2026, complete at least eight High Priority Substance (HPS) Toxic Substances Control Act (TSCA) risk evaluations annually within statutory timelines compared with the fiscal year (FY) 2020 baseline of one;
- By September 30, 2026, review 90 percent of risk mitigation requirements for TSCA new chemical substances compared to the FY 2021 baseline of none;
- By September 30, 2026, renew 40 percent of expiring lead-based paint Renovation, Repair, and Painting (RRP) firm certifications within 30 days compared to the FY 2021 baseline of 36 percent;
- By September 30, 2026, complete 78 pesticide registration review cases;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species for new active ingredients in 90 percent of the risk assessments supporting pesticide registration decisions for new active ingredients compared to the FY 2020 baseline of 50 percent;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species in 50 percent of the risk assessments supporting pesticide registration review decisions compared to the FY 2020 baseline of 25 percent; and
- By September 30, 2026, support Agricultural Worker Protection Standard (WPS) pesticide safety training for 20,000 farmworkers annually compared with the FY 2018-2020 annual average baseline of 11,000.
Objective 7.2, “Promote Pollution Prevention,” is intended to encourage the adoption of pollution prevention and other stewardship practices that conserve natural resources, mitigate climate change, and promote environmental sustainability. It includes the following long-term goals:
- By September 30, 2026, reduce a total of 1.5 million metric tons of carbon dioxide equivalent released attributed to EPA pollution prevention grants; and
- By September 30, 2026, EPA’s Safer Choice program will certify a total of 2,300 products compared to the FY 2021 baseline of 1,950 total certified products.
According to the notice, EPA is seeking comment from individual citizens, states, tribes, local governments, industry, the academic community, non-governmental organizations (NGO), and all other interested parties. Comments are due November 12, 2021. EPA states that it “anticipates the final Strategic Plan will be submitted to Congress in February 2022.”
By Charles M. Auer, Oscar Hernandez, Ph.D., and Lynn L. Bergeson
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment. Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to the Toxic Substances Control Act (TSCA).
The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA. EPA describes alternative test methods and strategies as different descriptors that have a common goal. The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard. The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints.
Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM). The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.”
A much more detailed summary and analysis of this important issue is available in our memorandum.
By Lynn L. Bergeson and Margaret R. Graham
On March 7, 2018, the U.S. Environmental Protection Agency (EPA) released a draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods to reduce the use of vertebrate animals in chemical testing, fulfilling another milestone under the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA). Under amended TSCA, EPA is required to develop a strategy to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing by June 22, 2018. EPA states the draft document incorporates input from a November 2017 public meeting held on the development of the draft strategy, as well as written comments submitted after the meeting, and draws upon EPA research on test methods.
The draft strategy outlines EPA’s Strategic Plan for the reduction of testing in vertebrates for chemicals regulated under TSCA. The organizing framework for the EPA’s strategy to reduce vertebrate animal testing relies heavily on what have been termed new approach methodologies (NAM) -- a broadly descriptive reference to any nonanimal technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment. The strategy describes a multi-year process with incremental steps for adoption and integration of NAMs that are appropriate and fit-for-purpose for making TSCA decisions, and has three core components:
- Identifying, developing, and integrating NAMs for TSCA decisions;
- Building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions; and
- Implementing the reliable and relevant NAMs for TSCA decisions. The EPA has identified seven current/near-term (less that three years) needs and activities.
EPA states that completing these activities will result in moving towards four intermediate-term (three to five years) objectives and these time frames, needs, and activities provide the basis for developing NAMs, establishing reliability and relevance criteria for the NAMs, and implementing NAMs to inform decisions made under TSCA.
Comments on the draft strategy will be due 45 days after the notice of availability is published in the Federal Register. EPA has scheduled a public meeting to obtain input on the draft strategy for April 10, 2018, from 9:00 a.m. (EDT) to 5:00 p.m. (EDT) in Washington, D.C. Registration is available online and is requested by April 3, 2018.
By Lynn L. Bergeson and Margaret R. Graham
On October 26, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a public meeting on November 2, 2017, from 9:00 a.m. to 5:00 p.m. (EST) to obtain input from interested parties and the public on its development of a Strategic Plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing. EPA is required under Section 4(h) of the Toxic Substances Control Act (TSCA), as amended, to develop this Strategic Plan by June 22, 2018. EPA states that it “will consider input from the meeting and from written comments to develop a draft Strategic Plan that will be shared with the public for comment.”
EPA has posted materials for the meeting to inform the Strategic Plan and that can be used for discussion and comment on its website, including:
EPA is requesting input about the draft Strategic Plan to be shared during the meeting and in the form of written comments that may be submitted to Docket No. EPA-HQ-OPPT-2017-0559 on www.regulations.gov; comments must be received no later than 60 days following the meeting. Registration for the meeting and further information is available on EPA’s Alternative Test Methods webpage.