ICCVAM Agency Activities
NIEHS/EPA: Workshop Examines Use of New Data Streams in Decision Making (November 2017)
The National Academies of Science, Engineering, and Medicine will present a workshop on Understanding Pathways to a Paradigm Shift in Toxicity Testing and Decision Making on November 20-21 in Washington, DC.
Technological advances have led to new approaches to understanding the toxicity of chemicals in humans. However, many questions remain about whether and how to make the shift to using new data streams as the basis for the wide array of research, policy, and regulatory decisions. This workshop will explore key factors that influence how scientists, policymakers, risk assessors, and regulators incorporate new science into their decisions. John Bucher, Ph.D, Associate Director of the National Toxicology Program and Stanley Barone, Ph.D., Acting Director, Environmental Protection Agency Office of Science Coordination and Policy served on the workshop organizing committee.
The workshop is free and will be webcast. More information and a link to registration are available on the National Academies website.
NIEHS: Webinar Series on Adverse Outcome Pathways (November 2017)
The Superfund Research Program of the National Institute of Environmental Health Sciences (NIEHS) is presenting a webinar series on adverse outcome pathways (AOPs), structured ways to represent biological events leading to adverse health effects. The second webinar in the series will be presented November 29. Presenters will discuss the development of AOPs and how they may be used to support hazard and risk assessment.
- Carole Yauk of Health Canada will present an overview of AOP development.
- Ed Perkins of the U.S. Army Engineer Research and Development Center will discuss how an AOP framework can be integrated with in vitro and in vivo data to support hazard and risk assessment.
- Justin Teeguarden of the Pacific Northwest National Laboratory will discuss approaches to exposure assessment.
The webinar will be hosted on the EPA Contaminated Site Clean-Up Information website; registration is free. More information about the webinar series is available on the NIEHS website. This page has a link to a recording of the first webinar in the series, which introduced the AOP concept.
The webinar series provides background information for an April 2018 workshop on Understanding the Combined Effects of Environmental Chemical and Non-Chemical Stressors: Atherosclerosis as a Model. The workshop is being planned and public comments are welcomed: please visit the NIEHS website for details.
FDA: Draft Guidance for Reproductive Toxicity Testing (November 2017)
The U.S. Food and Drug Administration (FDA) has requested comment on draft guidance ICH S5(R3), “Detection of Toxicity to Reproduction for Human Pharmaceuticals.” This document clarifies the qualification and potential use of alternative assays to assess reproductive risk and includes a list of compounds suggested for qualification of assays. FDA recognizes that this list is not complete and is requesting information on potential additional compounds to be added to the list.
The draft guidance ICH S5(R3) is available on the FDA website. An announcement in the November 13 Federal Register includes instructions on submitting comments on the draft guidance. To ensure consideration as the guidance is finalized, comments should be received by February 12, 2018.
EPA: Public Meeting on EPA Plan to Promote Alternative Tests November 2 (October 2017)
The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended Section 4(h) of the Toxic Substances Control Act (TSCA) to require the U.S. Environmental Protection Agency (EPA) to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing. The Act requires EPA to develop a Strategic Plan for this purpose by June 22, 2018.
EPA will hold a public meeting on November 2 to obtain input from interested parties and the public on the Agency's development of the Strategic Plan. EPA believes this early feedback will be important in developing a strong Plan. The Agency will consider input from the meeting and from written comments to develop a draft Plan that will be shared with the public for comment.
The meeting will be held from 9:00 a.m.-5:00 p.m. at the Porter Neuroscience Research Center, National Institutes of Health, Bethesda, Maryland. The meeting is open to the public with attendance restricted only by the space available, and will also be webcast. It is being co-organized by EPA and ICCVAM.
Goals and objectives to inform the Strategic Plan are available on the EPA website at and may be used for discussion and comment during the meeting. Interested parties may provide input about the draft Strategic Plan during the meeting. Written comments may be submitted to docket EPA-HQ-OPPT-2017-0559 at www.regulations.gov. The deadline for receipt of written comments is January 1, 2018.
EPA: EPA Seeks Input on Endocrine Panel Questions: Webinar November 6 (October 2017)
EPA will hold a virtual meeting on November 6 to get public input in advance of a November 28-30 meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). Both meetings will focus on the topic of “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.”
The FIFRA SAP will meet in person on November 28-30 to discuss high-throughput screens to determine endocrine disruption. The purpose of the November 6 virtual meeting is to get input from the panel and the public on the draft charge questions for the in-person meeting.
Those wishing to make oral comments during the November 6 virtual meeting should register by noon on Wednesday, November 1. Those wishing to listen in on the meeting may register at any time. Written comments on the scope and clarity of the draft charge questions should be submitted to docket EPA-HQ-OPP-2017-0214 on www.regulations.gov by noon, November 1. More information about the virtual meeting and the FIFRA SAP are available on the EPA website.
FDA: SOT and FDA Present Free Webinar October 24 (September 2017)
The Society of Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition will present a colloquium on October 24 on In Vitro to In Vivo Concordance for Toxicity Prediction and Use in Safety Assessments. This program is the latest in the series SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety. The October 24 colloquium will feature expert reviews on state-of-the-art in vitro technologies for safety assessment and how they are being utilized.
The colloquium will be held from 8:30 a.m. to 1:00 p.m. at the FDA Wiley Federal Building in College Park, Maryland, and will also be webcast. Registration for either in-person attendance or webcast viewing is free. In-person attendance is available to U.S. federal employees only, and those planning to attend in person must register by October 10. More information is available on the SOT website.
NIEHS: NIEHS Offers Grants for Development of Culture Models (September 2017)
NIEHS is providing grants for development of novel in vitro systems using cells from experimental animal models typically used for toxicology testing. The intent is that these systems will replicate biological responses within the corresponding animal tissues or organs. When developed and validated, these systems will provide information needed to predict toxicity of chemical and drug candidates, enable comparisons with existing in vivo animal toxicity data, serve as newer assays for toxicology testing, and have the potential for reducing the numbers of animals used in toxicology testing.
These grants of up to $150,000 for Phase I awards and up to $1 million for Phase II awards are only available to U.S. small businesses. Applications will be accepted starting December 12, with an application due date of January 12, 2018. Applicants are encouraged to apply early to allow time before the due date to correct errors that may be found in the application. Details about the grants are available on the National Institutes of Health (NIH) website.
EPA: New Review Describes Use of AOPs in EPA Screening Program (September 2017)
A review in the September issue of the journal Environmental Health Perspectives describes how the U.S. Environmental Protection Agency (EPA) uses adverse outcome pathway (AOP) and toxicity pathway frameworks in its Endocrine Disruptor Screening Program. The review, co-authored by NICEATM Director Warren Casey, describes how these frameworks help to establish biologically plausible links between endocrine mechanisms and apical responses when those end points are not measured in the same assay.
NIEHS: NTP to Present Webinars on Genomic Dose-response Modeling (August 2017)
An ongoing NTP webinar series focuses on the use of genomic features to assess dose-related response to test article treatment. The first two webinars, presented August 30 and September 1, discuss approaches to genomic dose-response modeling being explored by NTP and the U.S. Army Engineer Research and Development Center, respectively. Webinars to be presented later in September will discuss methods developed at North Carolina State University and the National Center for Advancing Translational Sciences.
The webinars are free and open to the public. More information is available on the NTP website; recordings of past webinars will also be available on this page.
EPA: EPA Requests Comment on Candidates for Advisory Panel (August 2017)
The U.S. Environmental Protection Agency (EPA) will hold a meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) on November 28-30 in Arlington, Virginia. The FIFRA SAP provides scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. The November meeting will focus on “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.”
A list of ad hoc candidates to serve on the panel at the November meeting has been posted on the EPA website. EPA is accepting comments on the candidates through Thursday, September 7. Comments on panel nominees should be provided to the Designated Federal Official, Dr. Todd Peterson, via email at firstname.lastname@example.org or telephone at (202) 564-6428.
NIH: NIH to Hold Small Business Workshop (August 2017)
The National Institutes of Health (NIH) will hold a Multi-Institute Small Business Workshop September 7-8, in New Orleans. This event will inform attendees about the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs, which provide support for researchers developing new methods for testing of chemicals. The workshop will feature presentations from the National Institute of Environmental Health Sciences and other institutes, and provide detailed guidance for applying to these funding programs and successfully managing an award. Attendees will interact with SBIR/STTR program staff, investors, commercialization experts, and successful entrepreneurs.
USDA: Exemptions Help Reduce Live Animal Use in Leptospira Vaccine Potency Testing (July 2017)
Leptospirosis is a transmissible bacterial disease of animals and humans caused by infection with any of the pathogenic members of the genus Leptospira. The organism is shed in the urine and milk of infected animals and may cause symptoms of renal and hepatic disease, which could be fatal. Disease transmission to man and animals is reduced by the vaccination of cattle, swine, and dogs. In light of this, the potency of these vaccines must be tested by law.
In April 2017, the U.S. Department of Agriculture–Animal and Plant Health Inspection Service–Center for Veterinary Biologics (USDA-APHIS-CVB) issued CVB Notice 17-06, “Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa.” This notice permits the removal of back-titration hamsters when potency testing vaccines containing L. pomona and L. grippotyphosa in accordance with 9 CFR 113 §101-104. This exemption to the codified test can reduce animal use up to 50% for these serogroups. CVB Notice 17-06 along with the 2015 CVB Notice 15-13, “Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae” are available on the USDA-APHIS website.
CVB Notice 17-06 is the latest action in a continuing effort by USDA, an ICCVAM member, to reduce the number of hamsters required for potency testing of leptospirosis vaccines. In 2013, APHIS issued Veterinary Services Memorandum No. 800.102, which permitted the use of the in vitro ELISA test developed by CVB as a complete alternative to live animal usage required under 9 CFR 113 §101-104. CVB provides supplemental assay methods for in vitro testing using the ELISA test. All of these documents are available on the NICEATM website.
NIEHS: Small Business Phase II Grants for Alternative Methods Development (June 2017)
The National Institute of Environmental Health Sciences is funding grants to U.S. small businesses for development of medium- to high-throughput assays. Assays developed under these grants should evaluate the effects of toxicants on pluripotent or induced pluripotent cells with respect to cell differentiation and the resulting differentiated cell populations. The ability to incorporate genetic diversity in these assays would be useful. Results from these assays should help identify mechanisms of chemically induced biological activity, prioritize chemicals for more extensive toxicological evaluation, and support more predictive models of in vivo biological response.
Letters of intent for this funding opportunity are due September 4, with applications due October 4.
Full funding announcement on NIH website (posted June 23)
NIEHS: Postdoctoral Fellow Opportunity in Computational Toxicology (June 2017)
A computational toxicology postdoctoral fellowship is available at NIEHS. The successful candidate will develop and apply computational methods, tools, and applications across projects in the areas of computational toxicology, bioinformatics, and computational biology. Candidates should have a Ph.D. in computational biology, computer science, biomedical engineering, bioinformatics, or a related discipline. Programming skills are required, ideally in R and/or Python. Experience in Bayesian modeling, deep belief networks, and the application of computational methods to high throughput screening data are highly desirable. Excellent verbal and written communication skills and the ability to simultaneously work on a variety of diverse projects are essential.
The position is in the Computational Toxicology group in the Biostatistics and Computational Biology Branch of the NIEHS Division of Intramural Research. The Computational Toxicology group is led by NICEATM Deputy Director Nicole Kleinstreuer. To apply, send curriculum vitae including publication list, brief summary of past/current research, and the names of three references to email@example.com.
NIEHS: Small Business Grants Available for Alternative Methods Development (June 2017)
The Department of Health and Human Services has released a new solicitation of Small Business Innovation Research and Small Business Technology Transfer applications for grants funded by the National Institutes of Health and other agencies. Included in this solicitation are funding opportunities for technologies to improve predictivity in toxicology testing offered by the National Institute of Environmental Health Sciences.
More information about the grant solicitation and other funding opportunities is available on the NICEATM website. An informational webinar about the 2017 HHS omnibus grant solicitation will be presented on Thursday, June 29, at 2:00 p.m. EDT.
EPA: EPA Announces Meetings, Requests Nominations of Panel Members (June 2017)
The Environmental Protection Agency will hold two meetings of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) in the coming months. Both meetings will be held at EPA in Arlington, Virginia. The FIFRA SAP provides scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues impacting health and environmental regulatory actions. EPA is requesting nominations for experts to serve as ad hoc members of the FIFRA SAP for each of these meetings. Nominations for either panel should be submitted by July 21.
The Oct. 24-27 FIFRA SAP meeting will consider and review physiologically based pharmacokinetic modeling to address pharmacokinetic differences between and within species. Nominees to serve on the expert panel for the meeting should have expertise in areas including physiologically based pharmacokinetic modeling, pharmacokinetics, pharmacodynamic modeling, in vitro to in vivo extrapolation, human health risk assessment, neurotoxicity, and exposure assessment.
Read the Federal Register notice containing the meeting announcement and request for nominees
The Nov. 28-30 FIFRA SAP meeting will consider and review the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” Nominees to serve on the expert panel for the meeting should have training and experience in computational model development, high-throughput assay development, biostatistics and performance-based validation, as well as general expertise in toxicology, physiology, biochemistry, endocrinology, and epidemiology.
Read the Federal Register notice containing the meeting announcement and request for nominees
FDA: FDA Reaches Food Safety Agreement with Australia (May 2017)
FDA has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing that their food safety systems are comparable. This recognition means that the FDA and Australian Department of Agriculture and Water Resources are confident that they can leverage each other’s science-based regulatory systems to ensure food safety, and establishes a framework for regulatory cooperation in a variety of areas ranging from scientific collaboration to outbreak response. FDA has similar agreements with New Zealand and Canada.
FDA: FDA Partners with Industry to Develop Organs-on-Chips (April 2017)
On April 11, the U.S. Food and Drug Administration (FDA) announced a multi-year research and development agreement with Emulate, Inc., to evaluate the company’s “Organs-on-Chips” technology in laboratories at the FDA’s Center for Food Safety and Applied Nutrition. The project will focus first on developing a liver chip, but the agreement may expand in the future to kidney, lung, and intestine models. The ultimate goal is to predict how specific organs will respond to potential chemical hazards found in foods, cosmetics, or dietary supplements more precisely than with current methods.
More details about the agreement are available in an FDA blog article by FDA ICCVAM representative Suzanne Fitzpatrick.
NIST: New Agency Joins ICCVAM (March 2017)
The National Institute of Standards and Technology has joined ICCVAM. NIST participation will provide ICCVAM with interest and experience in the study of process controls, measurement artifacts, and interlaboratory testing.
ICCVAM was established to facilitate and promote development and regulatory acceptance of new toxicological tests with the potential to replace, reduce, or refine animal use. The expertise within NIST will benefit ICCVAM, especially in the development of validation studies to assess the appropriateness of new test methods for specific purposes. In particular, NIST has experience with cell-based and small model organism assays, which are becoming increasingly important as alternatives for traditional animal tests. NIST also brings to ICCVAM additional expertise in experimental design and statistical analysis.
This event represents the first time ICCVAM has expanded its membership to include a new member agency since its inception in 2000. NIST, which is part of the U.S. Department of Commerce, has been interacting with ICCVAM since 2015. The agency submitted an official request to join ICCVAM in January 2017, which was approved in February by National Institute of Environmental Health Sciences Director Linda Birnbaum.
NIEHS: NICEATM and ICCVAM Activities at SOT (March 2017)
NICEATM and ICCVAM will be participating in two exhibitor-hosted sessions.
- “Developing an Implementation Strategy for Toxicity Testing in the 21st Century” will be Monday, March 13, at 12 noon in CC Room 340. This session will present a plan and seek stakeholder input on development of a U.S. roadmap to new approaches for toxicity testing.
- “ICCVAM Tools for Validation and Regulatory Application of Alternative Methods” will be Wednesday, March 15, at 1:30 in CC Room 337. Representatives from NICEATM, the U.S. Environmental Protection Agency, and the National Library of Medicine will present overview of online resources that support development and use of alternative methods.
In other SOT activities, ICCVAM representatives will serve as co-chairs for five platform sessions, NICEATM scientists are co-authors on 10 poster or platform presentations, and ICCVAM members are co-authors on 18 presentations. Visit the NICEATM webpage summarizing SOT 2017 activities.
NIEHS: NICEATM to Present Webinar Series on Zebrafish Screening (January 2017)
A NICEATM webinar series on “Using Informatics to Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish” begins on February 2. This three-part webinar series will consider the issues of protocol variability in zebrafish screening studies and how some of these issues might be addressed by implementation of standardized nomenclature systems.
The webinars are free and open to the public, although registration is required to attend. The webinar series is being organized by NICEATM in support of the National Toxicology Program’s Systematic Evaluation of the Application of Zebrafish in Toxicology (SEAZIT) program. A link to registration, details about all webinars, and more information about SEAZIT can be found on the NICEATM website.
EPA: Voluntary Pilot Program to Reduce Animal Testing (January 2017)
On December 20, 2016, the U.S. Environmental Protection Agency launched a voluntary pilot program to evaluate the usefulness and acceptability of a mathematical tool that estimates the toxicological classification of a chemical, and published guidance on how pesticide companies can submit data for the program. This program is another step toward EPA’s goal of reducing animal testing by adopting better testing methods, as described in the March 2016 Letter to Stakeholders issued by Office of Pesticide Programs Director Jack Housenger.
The mathematical tool, known as the GHS Mixtures Equation, is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Use of the GHS Mixtures Equation can reduce animal use for oral and inhalation toxicity studies of pesticide formulations.
To evaluate the GHS Mixtures Equation, EPA requests submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations. EPA expects that the pilot will run for approximately six months but will begin data analysis sooner if enough data is received.