US EPA CSS-HERA Board of Scientific Counselors Chemical Safety Subcommittee Meeting February 2-5, 2021 CSS-HERA Introduction Slides


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US EPA CSS-HERA
Board of
Scientific
Counselors
Chemical Safety
Subcommittee
Meeting

US EPA CSS-HERA BOSC Meeting - February 2-5, 2021

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The work presented within represents US EPA Office of Research and Development research
activities. Material includes both peer reviewed, published results and work-in-progress
research. Please do not cite or quote slides.

-------
Table of Contents

CSS NAMs Research and Development Portfolio (Jeff Frithsen)	3

HERA Advancing the Science and Practice of Risk Assessment (Samantha Jones)	15

Moving from the StRAPs to Implementation by ORD Investigators (Jill Franzosa)	26

Evolution of NAMs in EPA: From Research to Application (Rusty Thomas)	37

The work presented within represents US EPA Office of Research and Development research activities. Material
includes both peer reviewed, published results and work-in-progress research. Please do not cite or quote slides.

-------
e

Research and
Development

Chemical Safety for Sustainability (CSS)
National Research Program

Board of Scientific Counselors (BOSC)

Chemical Safety Subcommittee
Implementation Meeting

Jeffrey Frithsen National Program Director (NPD)

JoeTietge, Principal Associate NPD
Kathie Dionisio,Associate NPD
Heidi Bethel,Associate NPD

February 2,2021

-------
oEPA E=S= ^ Focus of this BOSC Meeting

•	CSS Focus:

•	Presentation of selected research demonstrating examples of
the development, testing and implementation of New Approach
Methods (NAMs);

•	Demonstration of selected tools.

•	HERA Focus:

•	Presentation of research related to applying NAMs in HERA
assessments;

•	Systematic review tools and approaches;

•	Dose-response analyses and models.

•	NAMs: Any technology, methodology, approach or combination
thereof that can be used to provide information on chemical hazard
and risk that avoids the use of intact animals.

2

-------
rnA Research and CSS Research Portfolio and NAMs S

#% Development	\\	NgFi J

\ \	\	LL

Topic

Research Areas

Outputs

Products

Presentations



High-Throughput Toxicology (HTT)

8

36

Sessions 1A; 1C;
ID; 2

Chemical Evaluation

Rapid Exposure Modeling and Dosimetry
(REMD)

8

50

Session IB; 2; 3



Emerging Materials and Technologies
(EMT)

2

13





Adverse Outcome Pathways (AOP)

8

42

Session 2

Complex Systems

Virtual Tissue Modeling (VTM)

3

16

Session ID

Science

Ecotoxicological Assessment and Modeling
(ETAM)

10

34

Session 1C

Solutions-Based
Translation and
Knowledge Delivery

Chemical Safety Analytics (CSA)

4

24

Session 3

Informatics, Synthesis, and Integration
(ISI)

5

29

Sessions 2; 3

CSS Research Areas that support work on NAMs.

3

-------
x>EPA

Meeting Date

Primary
Topic

HTT

REMD

EMT

AOP

VTM

ETAM

CSA

ISI

February 2021

IMAMS

XXX

XXX



XX

X

X

X

X

Summer 2021

PFAS

XXX

XXX



XXX



XXX

X

X

Fall 2021

Complex
Systems







XXX

XXX

XXX

X





Knowledge
Delivery





X

X



X

XX

XXX

BOSC Review of Other Parts

Research and
Development

4

-------
oEPA

Research and
Development

Planning

National Programs Lead
Strategic Focus
Resources allocated at
Research Area level

StRAP to Implementation to Delivery

RACTs

Implementation

Research Area
Implementation Plans

Center Lead
Tactical focus
Resources allocated for
specific products

Delivery

sot aai

Sequence Alignment to Predict Across Species
Susceptibility (SeqAPASS): A Web-Based Tool
Addressing the Challenges of Cross-Species
Extrapolation of Chemical Toxicity

Includes data, models,
methods, EPA and journal
publications

Joint activity of National
Programs and Centers

Chemical Safety
for Sustinablility

STRATEGIC RESEARCH ACTION PLAN

2019-2022

-------
oEPA

Research and
Development

Why NAMs?

Strong focus of the CSS Program for over a decade.

Critical component of the CSS Program's long-term vision:

• Provide the information needed to inform Agency decisions
about chemicals;

• Accelerate the pace of chemical assessment and decision-
making;

• Replace, Reduce and Refine vertebrate animal testing;

• Provide scientific innovation and leadership to transform
chemical screening and assessment.

Supports Agency objectives, regulatory drivers, and the
needs of multiple partners and stakeholders.

T- ^

r i

Establish
scientific
confidence and
demonstrate
application

Develop NAMs
that fill critical
information
gaps

L. .U

New Approach
Methods Work Plan

Reducing we of animate In chemical testing

U5 Envuoanei«Ut Yrotsction Agency

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-------
Research and
Development

New or
Existing NAM

Identify,
Develop, &
Integrate

TSCA Strategic Plan for NAMs

Training and
Education

Implement

l!\S

Integrate

NAM

Additional

Data or Case

Studies to

Address

Uncertainties

Fit-for-Purpose: Developing and Using NAMs for TSCA Decisions

with
Stakeholders

(Public,

Private and

Government)

Meet TSCA
Section 4(h) to
Reduce, Refine,
or Replace
Vertebrate
Animal Testing

-------
oEPA

Research and
Development

CSS Partners for NAMs

External to ORD Partners

Internal to ORD Partners \

-------
oEPA V CSS Session I

* Presentations focus on examples of the development of
NAMs to address specific research needs and topics.

* Presentations align with CSS Charge Question I:

• Please provide specific sugg

improve approaches to adv

of NAMs conducted under

* Four concurrent sessions, each having three focused
presentations by ORD scientists.

-------
SERA V CSS Session 2

* Highlights research aimed at facilitating the application of
NAMs in decision-making.

* Presentations align with CSS Charge Question 2:

• Please comment on the ex

research activities have the appropriate approach, structure,

and components to increase

use of NAMs in Agency de

* Four presentations will be made.

-------
rOA Research and
V/uM Development

* Provides demonstrations of three selected CSS tools.

* Tools utilize the results of NAM research. However, these
tools have a broader focus.

* Presentations align with CSS Charge Question 3:

• Please provide suggestions

how these CSS products can be improved and best

implemented to serve EPA

stakeholders?

CSS Session 3

-------
*>EPA

Research and
Development

Final Comments:

* Presentations contain peer^reviewed published results,
works in press, and results from works in progress.

* ORD investigators welcome this opportunity to engage with
the BOSC and talk about our science.

* Have fun!

-------
Health and Environmental Risk Assessment (HERA)
National Research Program

Board of Scientific Counselors (BOSC)

CSS-HERA Subcommittee — Implementation Meeting

Samantha Jones, National Program Director (NPD)

Beth Owens, Principal Associate NPD

February 2,2021

-------
Research and
Development

Implementation of HERA
Research - Advancing the Science
and Practice of Risk Assessment

-------
oEPA

Research and
Development

ORD Implementation of Planned Research

Measure pollutant(s) in
the environment
(air, water,
land)

CEMM

Center for
Environmental
Measurement and
Modeling

Generate data/models
inform pollutant(s)

assessment

Center for
Environmental
Solutions &
Emergency Response

CESER

Center for Public
Health &
Environmental
Assessment

Develop
treatment
technologies to
remove pollutant(s)

CPHEA

Assess health
and ecological
effects of pollutant(s)
exposure

Organizational structure is designed to enhance
our scientific leadership, better integrate scientific
approaches to problems, support mission and
partner focused solutions, create communities of
practice, and align the size and structure to
optimize the use of our workforce.

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-------
rOA Research and
V/uM Development

Addressing Agency Priorities and Mandates

Clea

FAWT^FAl

rivii

Toxic Substances C

omprehensive Environmental Response, Compensation, and Liability
Act (CERCLA

ents a

niw

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Broad Input to Support

Agency and ORD Strategic Goals
Children's Health
Environmental Justice

-------
rOA Research and
V/uM Development

HERA Vision and Structure

To innovate and advance the
science and practice of
assessments

By developing a portfolio of fit-for-purpose
human health and environmental assessment
products and assessment research that meet
the needs and priorities of EPA programs and
regions, states, tribes, and external
stakeholders.

Topic

Research Area

Science
Assessments &
Translation

1. Science Assessment Development

2. Science Assessment Translation

Advancing the
Science and
Practice of Risk
Assessment

3. Emerging and Innovative Assessment
Methodologies

4. Essential Assessment and Infrastructure

Tools

-------
oEPA

Research and
Development

Delivering Assessment Products and Scientific
Advancements Research

Assessment products such as:

• Integrated Science Assessments (ISAs) for the health criteria for particulate
matter and ozone, and the ecological criteria for oxides of nitrogen, oxides of
sulfur, and particulate matter.

• Integrated Risk Information System (IRIS) assessment materials for inorganic
mercury salts, methylmercury, and 5 PFAS.

• Provisional Peer-Reviewed Toxicity value (PPRTV) assessments for 2-ethylhexanol,
2-nitropropane, p-a,a,a-tetrachlorotoluene.

Models, databases, and software products such as:

• Advancements to Health and Environmental Research Online (HERO) and
Health Assessment Workplace Collaborative (HAWC) databases.

• Benchmark dose software (BMDS) and All Ages Lead model (AALM).

Integrated Science Assessment
for Oxides of Nitrogen. Oxides
of Sulfur and Particulate Matter-
Ecological Criteria

HAW#

HEALTH ASSESSMENT

WORKSPACE COLLABORATIVE

Dose (mg/kg-day HEP)

-------
rOA Research and
Development

Delivering Assessment Products and Scientific
Advancements Research

Arzuaga, X. et al. (2019). Use of the Adverse Outcome Pathway (AOP) framework to evaluate species
concordance and human relevance of Dibutyl Phthalate (DBP)-induced male reproductive toxicity.

Reproductive Toxicology.

Alman, B. et al. (2019). Associations between PM2.5 and risk of preterm birth among liveborn infants.Annals of
Epidemiology.

Kirrane, E. et al. (2019). A Systematic Review of Cardiovascular Responses Associated with Ambient Black
Carbon and Fine Particulate Matter. Environment International.

Radke-Farabaugh, E. et al. (2019). Development of outcome-specific criteria for study evaluation in systematic
reviews of epidemiology studies, Environment International.

Lizarraga, L.,J. Dean, J. Kaiser, S.WesselkamperJ. Lambert, and J. Zhao. (2019). A Case Study on the Application of An
Expert-driven Read-Across Approach in Support of Quantitative Risk Assessment of p,p'-
Dichlorodiphenyldichloroethane. Regulatory Toxicology and Pharmacology.

Reyes, J., and P. Price. (2018). Temporal Trends in Exposures to Six Phthalates from Biomonitoring Data
Implications for Cumulative Risk. Environmental Science & Technology.

-------
oEPA

Research and
Development

Topic 2 - Advancing the Science and Practice of Risk
Assessment

Participant selection -
\sure measurement
\e ascertainment
Confounding -
Analysis
Snsitivity

NormaW *ss'

lUmP«°n

V V.

0ose level

Advancing the Science and Practice of Risk Assessment

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-------
Implementation of Research under HERA RAs 3 and 4

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Emerging and Innovative Assessment Methodologies

• Focus on evaluating and optimizing the integration of
existing, new, and emerging data streams, techniques,
models, tools, or other methodologies for practical
implementation in assessing human and environmental
health.

Essential Assessment and Infrastructure Tools

• Delivering state-of-the-science assessment products
requires the use of software and database tools to
provide the necessary infrastructure.

• Enables the maintenance and development of new or
existing tools and databases used in the assessment
process and provides training on these resources and
applications.

• Anchored in assessment development.

• Improve the accuracy, efficiency, flexibility, and
utility of applications across the large landscape of
assessment activities served by the HERA

program.

-------
Research under Review

Advance, translate, and build confidence in the application of new approach methods (NAMs) and
data: As NAMs' science advances, risk assessors still encounter many chemicals with little-to-no
data that require assessment. Research is required to translate and build confidence in the application
of these NAMs in HERA science assessment contexts.

Advance methods for systematic review: Incorporating the principles of systematic review into the HERA
portfolio of assessment products has been a goal of the HERA program for the last several years. In order to
achieve this goal, the HERA program intends to advance the field of systematic review more broadly.

Advance methods in dose-response modeling and tools: Dose-response modeling is a critical step in
human health assessment. Existing methods have improved upon older methodologies; however, unresolved
issues, uncertainties, and complications remain that require targeted research. HERA has planned research
products that will result in dose-response methods that are more precise, robust, and meet varied needs.

-------
THANKYOU!

https://www.epa.gov/research/health-and-environmental-risk-
assessment-strategic-research-action-plan-2019-2022

-------
*»EPA

United States
Environmental Protection
Agency

Moving from the StRAPs to
Implementation byORD Investigators

Jill Franzosa, PhD

Office of Research and Development

Center for Computational Toxicology and Exposure

Disclaimer: The views expressed in this presentation are those of the author
and do not necessarily reflect the views or policies of the US EPA.

February 2, £021

-------
A EPA

United States
Environmental Protection

2019 - 2022 Strategic Research Action Plans

• StRAPs finalized and published on EPA
internet

• Focused on defining national program
structure and identifying specific outputs
to meet the needs of partners

• Informed design and planning of research
activities to fulfill the outputs

Chemical Safety
for Sustinablility

STRATEGIC RESEARCH ACTION PLAN
2019-2022

Health and Environmental
Risk Assessment

STRATEGIC RESEARCH ACTION PLAN
2019-2022

https://www.epa.gov/research/strategic-research-action-plans-2019-2022

-------
oE

United States
Environmental Protection
Agency

StRAP Implementation

Output is a body of work that addresses partner needs through delivery of one or more products

Products can be peer-reviewed journal articles, models, databases, software, methods, reports or assessments

Agency Research Needs

StRAP

Implementation

Program, Region, or
State Need

Research Area

Program, Region, or State Need

Program, Region, or
State Need

Product

Output

Product Product

NPD led

Center led

-------
SERA

United States
Environmental Protection
Agency

Research Area Coordination Team (RACT)

WMt-

Objective

• Expand involvement of partners

• Improve understanding what is needed

• Ensure proposed products are what is
needed by partners

Who

• Program Office representative(s)

• Regional Representative(s)

• State Representative

• NPD Representative

• ORD Scientists

Outcome

• Products responsive to outputs

• By-in from partners

• Collaboration with partners

Purpose: Define the products that ORD will develop to meet the objectives of the outputs

-------
SERA

United States
Environmental Protection
Agency

The Process for RACTs

Meet weekly/biweekly basis
from April - September

Balanced product proposals
with ORDs capacity to ensure
partner needs met

• Developed ideas for products
to meet the outputs

Delivered Research Area
Descriptions for products

-------
AEPA

United States

Environmental Protection | g ^ I m a •

Delivery of Research Area Descriptions

Program/Regional/State Needs:

• How this research will be applied to meet the needs of EPA programs/regions, states, tribes,
and/or other partners

• Key statutes and/or regulatory issues that the research will support

Output:

Output Description:

• What information is needed by the program, region, state, or tribal partner(s)

• How the products build on each other to form the Output

• Description of how the partner will use the Output
EPA Program/Regional or State/Tribal Partner(s)

Product:

Brief Description and Research Use:

• Description of research and how it will be used by the partner to address their identified
regulatory, policy, and/or other need(s).

EPA Program/Regional or State/Tribal Partner(s)

-------
SERA

United States
Environmental Protection
Agency

RACT Output Leads and Product Leads

Output Leads

• Nominated by Center management

• Provide scientific leadership

• Coordinate and communicate with Product Leads

• Include representation from across ORD Centers

Product Leads

• Develop research products and components to fulfill
objectives of the output

• Lead and coordinate product research teams

• Include representation from across ORD Centers

-------
oE

United States
Environmental Protection
Agency

CSS Example: Translating Partner Needs to Outputs

PARTNER NEED

RESEARCH
AREAS

OUTPUTS WITH DNT PRODUCTS

HTT

Develop, evaluate, apply, and interpret a
developmental neurotoxicity (DNT) battery of assays
to reduce uncertainties in chemical safety
evaluations

Developmental neurotoxicity (DNT): DNT is an

important risk assessment endpoint for chemical
assessments. However, currently available in vivo
methods are costly and do not fully represent
important mechanisms and pathways. Therefore,
there is a need for alternative approaches for
evaluating DNT, including valid in vitro methods and
modeling approaches. (OCSPP; OLEM; OCHP)

AOP

Develop and conduct strategic in vitro and in vivo
studies for high-priority AOPs to help establish
validity of NAMs approaches, support predictive
model development, and reduce vertebrate animal
testing through in vivo testing refinements for
decision-relevant endpoints

VTM

Integrate and evaluate phenotypic responses in
human cell based in vitro and virtual tissue model
systems to predict chemical hazard during growth
and development

*
O

VTM

Develop and apply in silico agent-based and
computational models to evaluate the effects of
chemicals on biological pathways critical for lifestage
endpoints

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-------
oE

United States
Environmental Protection
Agency

CSS Example: Developing products to fulfill the Output

OUTPUT

-------
AEPA

United States
Environmental Protection

What We Developed

Topic

Research Areas

Outputs

Products

High-Throughput Toxicology (HTT)

Chemical Evaluation

Rapid Exposure Modeling and Dosimetry
(REMD)

Emerging Materials and Technologies
(EMT)

Adverse Outcome Pathways (AOP)

Complex Systems

Virtual Tissue Modeling (VTM)

Science

Ecotoxicological Assessment and
Modeling (ETAM)

Solutions-Based
Translation and
Knowledge Delivery

Chemical Safety Analytics (CSA)

Informatics, Synthesis, and Integration
(ISI)

-------
Thank you!
Comments/Questions.

Hi $ iif . t iii/ ti'L j >i

Hlliinli -:U W

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-------
Evolution of NAMs in EPA: From
Research to Application

CSS HERA Board of Scientific Counselors Meeting
February 2, 2020

Rusty Thomas
Director

Center for Computational Toxicology and Exposure

The views expressed in this presentation are those of the presenter and do not necessarily reflect the
views or policies of the U.S. EPA

-------
svEPA EPA Faces Multiple Challenges in Evaluating the

United States

Environmental Protection I ¦ 1 w— ¦ 4 a ¦—% a a m a m a

Human and Environmental Risks of Chemicals

Number of Substances

Amount of Data

Reliability/Relevance

60,000
40,000
20,000

Canadian DSL EU REACH EU REACH Pre- USEPATSCA
Registered Registered Non-Confidential

USEPATSCA
Non-Confidential
Active

% of Non-Confidential, Active TSCA
Inventory with Repeat Dose
Toxicity Studies

Yes
26%

*Data from ToxValDB
(Dec 2019)

Time

Chemical Assessment
for

Chemical X

Regulatory Organization Y
January 2020

Center for Computational
Toxicology & Exposure

$10,000,000

$1,000,000

$100,000

$10,000

Economics

$1,000

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-------
oEPA

United States
Environmental Protection
Agency

1980

1979
NHERL-Duluth
releases first
QSAR for BCF

111

To Address These Challenges ORD has a History in
Research on New Approach Methods (NAMs)

2000

2003
Strategic Plan for
CompTox Research
Program

2010

2012
ORD StRAP I

2020

2008
Tox21 MOU
Signed

2016
ORD StRAP II

2018
TSCA Alternatives
Strategic Plan

2020
EPA NAM
Workplan
Released

2019
ORD StRAP

Center for Computational
Toxicology & Exposure

-------
oEPA

United States
Environmental Protection
Agency

What is a New Approach Method?

Coined in ~2014, but the definition of a
New Approach Method (NAM) has evolved
over time

Currently, it is broadly descriptive reference
to any non-animal technology,
methodology, approach, or combination
thereof that can be used to provide
information on chemical hazard and risk
assessment

Functionally equivalent to "alternatives", but
can include exposure NAMs, eco NAMs,
toxicokinetic NAMs, etc.

A Strategic Roadmap for Establishing
New Approaches to Evaluate the Safety
of Chemicals arid Medical Products
in the United States

frupraffirrui update GfcAFT

Center for Computational
Toxicology & Exposure

-------
oEPA Despite this History, NAM Development and

United States

Environmental Protection jk mm 4 m m a m m m m m a bb j ¦ % *

Application is Still in its Formative Years...

limk

We are here

Center for Computational
Toxicology & Exposure

-------
s>EPA

United States
Environmental Protection
Agency

Directing NAM Research Through Formative Years
Involves an Integrated Strategy

Long Term

Research

Strategies

Four Year
Research Plans

wEPA

Research
Products

SOT Sag.

The Next Generation Blueprint ot Computational
Toxicology at the U.S. Environmental Protection Agency

Chemical Safety
for Sustainability

STRATEGIC RESEARCH ACTION PLAN

2019-2022

f Health and Environmental
Risk Assessment

STRATEGIC RESEARCH ACTION PLAN

2019-2022

Center for Computational
Toxicology & Exposure

-------
s>EPA

United States
Environmental Protection
Agency

There is a Significant Overlap Between Elements of
the EPA NAM Research Strategies...

TSCA Alternatives Strategic Plan

Identify,
Develop, &
Integrate

H Evaluate H

Scientific

v ^

Reliability

and

/?¦ Relevance »

Pk A 1

DECISION

Ready for
Evaluation?

DECISION
Ready for
TSCA Decision
Context?

Training and
Education

Implement

Fit-for-Purpose: Developing and Using NAMs for TSCA Decisions

EPA CompTox Blueprint

Outreach &
Training

Meet TSCA

' c!

Section 4(h) to

Reduce, Refine,

and Replace

Vertebrate

-------
oEPA

United States
Environmental Protection
Agency

Highlights of the Research You Will Hearing About
Today

Establishing
Confidence

Outreach &
Training

Estimate toxicokinetic parameters for

hundreds of chemicals

Put in vitro testing concentrations in a dose

context

Broadly evaluate potential impacts of
chemicals across biological space and
species

Systematically address limitations in in vitro
test systems

Identify likely tissue, organ and organism
effects and susceptible populations

Throughput

Uncertainty
& Variability

Software &
Decision
Support Tools

Estimate chemical exposures with uncertainty
for thousands of chemicals
Put hazard in a risk context
Identify potential exposure pathways for
unknown chemicals

Establish consistency and confidence in non-
targeted methods

Center for Computational
Toxicology & Exposure

-------
s>EPA

United States
Environmental Protection
Agency

Highlights of the Research You Will Hearing About
Tomorrow and Thursday

Case studies and proof-of-concept
applications with State, Region, and Program
Partners

Incorporating metabolite similarity into read
across

Outreach &
Training

Establishing
Confidence

Throughput

Software &
Decision
Support Tools

Application of AOPs for evaluating mixtures

Uncertainty
& Variability

• Data extraction and curation for model training
and evaluation

• Data integration, data visualization, and
decision support tools

Center for Computational
Toxicology & Exposure

-------
<>EPA But, There are LOTS of Activities You Won't Hear

About This Time

United States
Environmental Protection
Agency

Center for Computational
Toxicology & Exposure

-------
s>EPA

United States
Environmental Protection
Agency

Working with Federal, State, and International
Collaborators to Develop, Evaluate, and Apply NAMs

APCRA Inter-Governmental
Consortium

Chemical

Research in

Toxicology

Accelerating the Pace of Chemical Risk Assessment

'Office ofReararch and Development,
:Haldiy Environment. and Coiumne;

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APCRA

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inimal le.Ung apptoaihe.. have lhown ptomttf to provide *e* • • at t " •

arge amount dau lo HI infarmiilon gap. to bolh h.«ani % * "if

ind tTo»n, In onto lo <»« spenence with the ne« • . .'35* . J* .1 .(V."
lata and lo advance the application. nf NANf data to evaluate * *

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laMStudki can be wed lo explore the domain.
-------
x^epa Outreach and Training

United States
Environmental Protection
Agency

• Ongoing development of EPA NAM
Training Program

• Collaboration with organizations with
interest and expertise in NAMs

• Active solicitation of feedback from
stakeholders through Agency NAM email
address, workshops, and communities of
practice

• Ongoing communications and outreach
via NAMs website, webinars, conferences
and social media

Center for Computational
Toxicology & Exposure

-------
v>EPA

United States
Environmental Protection
Agency

Center for Computational
Toxicology & Exposure

Questions?

fikU

Where we are going

-------
vvEPA

United States
Environmental Protection
Agency

• ECHA. (2016). New Approach Methodologies in Regulatory Science, Proceedings of a scientific workshop,
Helsinki, Apr 19-20, 2016.

• EPA. (2003). A framework for a computational toxicology research program. EPA 600/R-03/065.

• EPA. (2018). Strategic Plan to Promote the Development and Implementation of Alternative Test Methods
Within the TSCA Program. EPA-740-R1-8004.

• EPA. (2020). New Approach Methods Workplan: Reducing Use of Animals in Chemical Testing. EPA-
615B20001.

• ICCVAM. (2018). A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of
Chemicals and Medical Products in the United States.

• Kavlock RJ et al., Accelerating the Pace of Chemical Risk Assessment. Chem Res Toxicol. 31(5):287-290,
2018.

• Thomas RS et al., (2018). The US Federal Tox21 Program: A strategic and operational plan for continued
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• Thomas RS et al., (2019). The Next Generation Blueprint of Computational Toxicology at the U.S.
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References

Center for Computational
Toxicology & Exposure

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