Implementation of the US EPA Strategic Plan for New Approach Methodologies and the New Chemicals Program

Transcription

1 Implementation of the US EPA Strategic Plan for New Approach Methodologies and the New Chemicals Program Louis Scarano, US EPA (Presented by Anna Lowit, US EPA) SOT RASS October 10, 2018 Webinar

2 Topics Covered TSCA Mandate Strategic Plan: Brief Overview Progress on Strategic Plan SOT RASS Oct.10, 2018 Webinar 2

3 Statutory Mandate - Background The Toxics Substances Control Act (TSCA) was originally enacted in In 2016, TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act: New requirements and deadlines for actions related to the regulation of new and existing chemical substances. New subsection under Section 4 (Testing of Chemical Substances and Mixtures); specifically, Section 4 (h) entitled Reduction of Testing on Vertebrates 3

4 Statutory Mandate: Section 4(h) Reduction of Testing on Vertebrates Section 4(h)1 General Section 4(h)2 Develop Strategic Plan Section 4(h)3 Voluntary Testing SOT RASS Oct.10, 2018 Webinar 4

5 Statutory Mandate: Section 4(h)(1) Prior to requesting testing using vertebrates: Consider reasonably available existing information, and Encourage and facilitate (Section 4(h)(1)(B)(I, ii and iii): Scientifically valid test methods and strategies that reduce or replace use of vertebrate animals while providing information of equivalent or better scientific quality and relevance that will support regulatory decisions; The grouping of 2 or more chemical substances into scientifically appropriate categories ; and The formation of industry consortia to jointly conduct testing 5 to avoid unnecessary duplication of tests

6 Statutory Mandate: Section 4(h)2 4(h)(2) - Implementation of Alternative Testing Methods To promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals, the Administrator shall 4(h)(2)(A) - not later than 2 years after the date of enactment.develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing 6

7 Statutory Mandate: Section 4(h)2 Strategic Plan Published June 22, SOT RASS Oct.10, 2018 Webinar 7

8 Statutory Mandate Section 4(h)(3)(A) Submitting Information Voluntarily* Any person developing information for submission shall first attempt to develop the information by means of an alternative test method or strategy *Or, information not requested by the Agency SOT RASS Oct.10, 2018 Webinar 8

9 Overview of Strategic Plan Three Main Parts: Identify, develop and integrate NAMs Establish relevance, reliability and confidence Training, education and collaboration EPA views the term New Approach Methodologies (NAMs) as equivalent to alternative test methods and strategies (the language in the statute) 9

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11 Use of NAMs for TSCA Decision Context/Fit for Purpose New chemicals program Has been using NAMs for years: ECOSAR, OncoLogic, EPISuite, New Chemical Categories Document, SAR/QSAR/Read-Across New use of NAMs in 2018: publication of interim science policy on use of NAMs for skin sensitization (April, 2018) Existing chemicals program Screening candidates for prioritization Prioritization Risk evaluation 11

12 Implementation: Near-Term (Next Three Years) Building a TSCA NAM Foundation 1. Continue to Implement NAMs to Evaluate Hazard, Exposure and Environmental Fate for New and Existing Chemicals 2. Maintain and Regularly Update a List of NAMs First list published on June 22, 2018 to be updated at least once a year. Four tables: OECD accepted TGs for health-effects testing; OECD accepted TGs for environmental-effects testing; new policies (skin sensitization); and EPA-Specific NAMs for use under TSCA (examples ECOSAR, EpiSuite, etc.) 12

13 Implementation: Near-Term (Next Three Years) Building a TSCA NAM Foundation 2. Maintain and Regularly Update a List of NAMs, cont d Review other existing NAMs according to initial criteria provided in Chapter 5 Process/procedure to be worked out with TSCA NAM Team (TNT) SOT RASS Oct.10, 2018 Webinar 13

14 Implementation: Near-Term (Next Three Years) Building a TSCA NAM Foundation 3. Identify and Maintain a List of Most Requested/Needed Studies for New and Existing Chemicals Under TSCA Retrospective Analysis UPDATE Work Beginning 4. Identify and Curate Available Existing TSCA Information on NAMs (and Traditional Test Data) CBI; TSCA In-House Inventory Analysis UPDATE Work Beginning 14

15 Implementation: Near-Term (Next Three Years) Building a TSCA NAM Foundation 5. Use of NAMs to Identify Candidates for Prioritizing Existing Chemicals for TSCA Risk Evaluation Ongoing 6. Begin Development of Scientific Information Technology (IT) Platform Ongoing SOT RASS Oct.10, 2018 Webinar 15

16 Implementation: Near-Term (Next Three Years) Building a TSCA NAM Foundation 7. Collaborate with Partners and Stakeholders to Identify NAMs for Further Development Increase EPA-OPPT participation in collaborative efforts Develop a regular series of webinars (both for internal education/training and with stakeholders) Establishing webinar series with PETA/PCRM (Fall, 2018) Become more active in ICCVAM and OECD activities/workgroups Actively seek out and visit/host academic, industry and stakeholder experts/facilities to exchange ideas Development and communicating TSCA-specific Case Studies 16

17 Implementation: Near-Term (Next Three Years) Building a TSCA NAM Foundation 8. Launch TSCA NAM Website Target date Third Quarter, 2018 (July-September) Updates to webpage in-process More elaborate website in the works SOT RASS Oct.10, 2018 Webinar 17

18 Implementation: Intermediate-Term Objectives (3-5 years) i. Review Retrospective and In-House Analyses to Identify Appropriate NAM Research Needs of Importance to TSCA ii. Progress Towards Use of NAMs for Prioritization, Risk Evaluation, and Other Risk-Based Decisions iii. Maintaining the Continual Expansion of the TSCA Section 4(h) List SOT RASS Oct.10, 2018 Webinar 18

19 Implementation: Intermediate-Term Objectives (3-5 years) iv. Developing and Maintaining Educational and Outreach Goals for Regulatory Scientists, Endusers and the Public v. Continue Collaboration with Partners and Stakeholders to Identify NAMs for Further Development SOT RASS Oct.10, 2018 Webinar 19

20 Implementation: Long-Term EPA s Long-Term Goal: To Reduce and Eventually Eliminate Vertebrate Animal Testing for TSCA. SOT RASS Oct.10, 2018 Webinar 20

21 Recent NAM Activities EPA-NCER Science to Achieve Results (STAR) Program: Advancing Actionable Alternatives to Vertebrate Animal Testing for Chemical Safety Assessment (now closed) New, Interim Skin Sensitization Policy Upcoming FIFRA Science Advisory Panel (SAP) Meeting on Refining Inhalation Risk Assessment Using NAMs: December 4-7, 2018 ( ) 21

22 EPA-NCER Science to Achieve Results (STAR) Program Advancing Actionable Alternatives to Vertebrate Animal Testing for Chemical Safety Assessment Research that will promote the development and use of alternative test methods and strategies that address the 3Rs of toxicity testing Develop actionable alternative approaches to: 1) developmental toxicity tests in humans; 2) reproductive toxicity tests in humans; and/or 3) ecotoxicity tests. 22

23 Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing Announced April 10, 2018 & describes the science that supports a policy to accept alternative (in vitro, in silico, in chemico) approaches for identifying skin sensitization hazard in place of animal studies. The interim policy is the result of collaboration between ICCVAM, NICEATM, EURL ECVAM, Health Canada (PMRA) 23

24 2 out of 3 Method Sequential Testing Strategy SOT RASS Oct.10, 2018 Webinar 24

25 Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing EPA will begin accepting these approaches immediately under certain conditions described in the interim policy. Existing OECD guidelines for determining hazard Pesticide active or inert ingredients (not formulations yet) and TSCA chemicals On-going work at NTP to evaluate use of OECD guidelines on formulations/mixtures Will revise policy in the future as appropriate Comments on the draft skin sensitization policy were solicited this summer however the comments are still being 25 evaluated

26 Case Study Using a NAM to Refine Inhalation Risk Assessment for Point of Contact Toxicity Upcoming FIFRA Science Advisory Panel (SAP) Meeting, December 4-7, Proposal developed by Syngenta Crop Protection, one of the registrants for products containing the contact irritant chlorothalonil Proposal for refining inhalation risk assessment using an in vitro model initially presented to EPA-OPP in 2014 Agency recognized the value of the proposal for chlorothalonil, as well as other respiratory contact irritants and encouraged further development Collaborated with NICEATM early in the process for review of the proposed approach 26

27 Upcoming FIFRA Scientific Advisory Panel Charge questions regarding: How the biological understanding informs the applicability of the in vitro testing Use of in vitro system (study design, methods, selected measurements, robustness of data, data reporting) Assumptions and calculations using computational fluid dynamics model to calculate cumulative deposition Calculation of human equivalent concentrations Strengths and limitations of using approach for other contact irritants, as well as potential for use with other chemicals that cause portal of entry respiratory tract effects 27

28 Education and Outreach Additional Points Attend internal training where possible (e.g., DART in OPP on Oct 3-4) Outreach this webinar as an example Recruitment of new technical staff with data science and other relevant experience Collaboration Lung project ACC and others SOT RASS Oct.10, 2018 Webinar 28

29 TNT TSCA NAM Team Office of Pesticide Programs (OPP) Anna Lowit Office of Science Coordination and Policy (OSCP) Kristan Markey, Seema Schappelle, Stan Barone Office of Research and Development (ORD) National Center for Computational Toxicology (NCCT) Rusty Thomas, John Cowden, Maureen Gwinn National Exposure Research Laboratory (NERL) Barbara Wetmore Immediate Office (IO) Jeff Frithsen Office of Pollution Prevention and Toxics (OPPT) Numerous Technical Staff (HazRatt* and EHATT* teams), Susanna Blair *Two technical teams within OPPT the Hazard and Risk Assessment Tech Team (HazRatt) and the Environmental Hazard Assessment Tech Team (EHATT) SOT RASS Oct.10, 2018 Webinar 29

30 THANK YOU! Anna Lowit Louis Scarano