ICCVAM Agency Activities
News Published Since Last Biennial Report
This page contains ICCVAM agency activities announced in NICEATM News, an email list that distributes announcements of interest to those developing alternatives to animal use for chemical safety testing. Subscribe to NICEATM News
ICCVAM agency activities occurring since the last ICCVAM Biennial Report are listed below. Most activities that occurred more than two years ago will be described in the most recent ICCVAM Biennial Report.
FDA to Present Update on Predictive Toxicology Roadmap September 18
On Wednesday, September 18, FDA will host a free public meeting to provide updates on implementation of its Predictive Toxicology Roadmap. Speakers from seven FDA centers will describe how predictive toxicology methods are being advanced towards application to safety and risk assessments. The meeting, to be held at FDA’s White Oak campus in Silver Spring, MD, will also be webcast. Information about registration and a preliminary agenda are available on the FDA website. Those interested in attending or viewing the webcast should register by Monday, September 16.
OSHA and DOT Request Public Input in Advance of International Meetings
The Occupational Safety and Health Administration (OSHA) and the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration plan to hold separate public meetings on Thursday, June 20, in advance of July meetings of:
The purpose of the June 20 public meetings is to discuss proposals and receive input for the July meetings. Both June 20 meetings will be held at the DOT Headquarters Conference Center in Washington, DC. They are open to the public and remote access is available.
Small Business Grants Available from HHS; Webinar May 29
The Department of Health and Human Services (HHS) has released the 2019 Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Omnibus Grant Solicitations. These solicitations will be used by the National Institutes of Health and other offices within HHS to fund researcher-initiated projects in health, medicine, and life sciences.
Projects being funded by NIEHS under this solicitation include development of short-term assays to reduce or replace existing regulatory animal studies for acute toxicity, reproductive or developmental toxicity, carcinogenicity, or ocular toxicity. NIEHS will also fund projects to develop computational tools for integrating toxicity data, including in vivo and in vitro data, to analyze and visualize data across different screening systems. The first deadline for applications under this announcement is September 5.
A May 29 webinar will provide a brief overview of SBIR/STTR funding and instructions for applying.
Free Workshop on Artificial Intelligence and Machine Learning June 6-7
The National Academies of Sciences, Engineering, and Medicine will hold a workshop on “Algorithms, Air Pollution, and Adverse Outcome Pathways: Leveraging Artificial Intelligence and Machine Learning to Advance Environmental Health Research and Decisions.” The workshop is June 6-7 at the National Academy of Sciences in Washington, DC, and will also be webcast. Registration is free.
Approaches such as machine learning and artificial intelligence are being applied to environmental health to characterize pollution, predict chemical toxicity, estimate human exposures, and identify health outcomes. Participants in this workshop will discuss issues of data availability, quality, bias, transparency, and uncertainty in the data used to develop machine learning algorithms that need to be addressed to apply these tools to inform environmental health research and decision making.
The workshop is sponsored by the National Institute of Environmental Health Sciences (NIEHS), and NICEATM Deputy Director Nicole Kleinstreuer is on the organizing committee.
Postdoctoral Opportunity at NIST
The National Academies of Sciences, Engineering, and Medicine is supporting a postdoctoral fellow opportunity at the National Institute of Standards and Technology (NIST). The successful candidate will comprehensively examine in vitro assays to improve the repeatability and interlaboratory agreement of the assay results. Candidates must have a Ph.D. in biology, chemistry, engineering or a related area and be a U.S. citizen. Work will be done at NIST in Gaithersburg, MD, outside Washington, DC. The closing date for applications is August 1. For more information contact Elijah Petersen at Elijah.Petersen@nist.gov.
May 9 Webinar to Discuss EPA Computational Tools
A free webinar titled “New Computational Tools from EPA” will be presented on Thursday, May 9, at 10:00 a.m. Eastern Daylight Time. Antony Williams and Grace Patlewicz of the U.S. Environmental Protection Agency (EPA) will provide overviews of the CompTox Chemicals Dashboard and the EPA’s generalized read-across (GenRA) application.
The webinar is being presented by the American Society for Cellular and Computational Toxicology (ASCCT) and the European Society for Toxicology In Vitro. Videos of past ASCCT webinars are available for viewing by society members.
FDA Webinar May 2 to Review Non-animal Cosmetic Safety Testing
The U.S. Food and Drug Administration (FDA) will host a webinar, “Decision-making in Non-animal Cosmetic Safety Assessment,” on Thursday, May 2, from 12 noon-1:00 p.m. Eastern Daylight Time. The webinar will introduce a new collaboration, Non-Animal Cosmetic Safety Assessment Globally, formed among stakeholder groups with the goal of globally implementing non-animal cosmetic safety assessment by 2023. Webinar speakers will discuss how next-generation risk assessment principles will be applied to this goal and consider case studies from Unilever, Procter & Gamble, and Estee Lauder.
Webinar on New Approaches for Respiratory Sensitization April 24
A free webinar on “New Approaches for Respiratory Sensitization” will be presented on Wednesday, April 24, at 10:00 a.m. Eastern Daylight Time (EDT). Steve Enoch of Liverpool John Moores University will speak on “Chemistry-based Approaches for Identifying Respiratory Sensitizers” and Arno Gutleb of the Luxembourg Institute of Science and Technology will discuss “In Vitro Models to Identify Respiratory Sensitizers.”
This is the third in the “Webinar Series on the Use of New Approach Methodologies (NAMs) in Risk Assessment” co-organized by the PETA International Science Consortium (PISC), the U.S. Environmental Protection Agency (EPA), and the Physicians Committee for Responsible Medicine. Links to slides and video recordings from webinar 1, “Skin Sensitization Testing,” and webinar 2, “MMPD and CFD Modeling to Predict Dosimetry of Inhaled Substances,” are available on the PISC website.
Postdoctoral Opportunities at EPA NCCT, Other Offices
The EPA National Center for Computational Toxicology in Research Triangle Park, NC, has postdoctoral positions available for scientists with diverse expertise in computational and experimental laboratory research. These scientists will develop mathematical and computer models and new chemical testing technologies to help predict potential risk, and apply cellular, molecular, and systems biology to support better evaluations of potential health and environmental effects.
These are among 80 postdoctoral opportunities currently available throughout EPA’s Office of Research and Development. These are three-year federal positions with full benefits. Applicants must be U.S. citizens. Applications are being accepted now and are due by May 2.
Postdoctoral Opportunities at the U.S. Army Chemical Biological Center
The National Academies of Sciences, Engineering, and Medicine are supporting two postdoctoral positions at the U.S. Army Edgewood Chemical Biological Center in Maryland. Both positions are open to U.S. citizens only.
SOT FDA Colloquium on 3D Bioprinted Tissue Models: Tuesday, April 9
The Society of Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) will hold a workshop on “Alternative Methods for Predictive Safety Testing: 3D Bioprinted Tissue Models” on Tuesday, April 9, at the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland. This workshop is the latest in the series, “SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety.”
Human 3D bioprinted tissues represent a valuable in vitro approach for chemical, personal care product, cosmetic, and preclinical toxicity/safety testing. Bioprinting of skin, liver, and kidney is already appearing in toxicity testing applications for chemical exposures and disease modeling. The use of 3D bioprinted tissues and organs may provide future alternative approaches for testing that may more closely resemble and simulate intact human tissues to more accurately predict human responses to chemical and drug exposures.
Preregistration to attend the workshop in person has closed, and only federal employees may register on-site to attend. However, the workshop will also be webcast, for which registration is still open.
EPA OCSPP Biologist/Toxicologist Positions Available, Deadlines Next Week
The U.S. Environmental Protection Agency (EPA) has positions open for Biologists/Toxicologists in the Office of Chemical Safety and Pollution Prevention (OCSPP). Multiple positions are available for each of the following opportunities. The closing date for both announcements is Thursday, March 21.
Applicants will be evaluated in the following areas: experience in preparing and evaluating environmental hazard information and risk assessments; knowledge of risks and/or hazards associated with industrial chemicals, biological agents and nanomaterials; ability to work on a multi-disciplinary team of scientists; experience preparing hazard and risk characterizations; experience developing methodologies to improve environmental hazard information and risk assessments; written and oral communication skills; and data analysis skills.
All openings are in Washington, DC. Candidates for all opportunities must be U.S. citizens, and all positions may require one to five days of travel per month. Apply online at the USAJOBS.gov website. For more information about the opportunities, contact Sherron Gardner at 800-433-9633 or email@example.com
EPA Biologist/Toxicologist Positions Available, Deadlines Next Week
The U.S. Environmental Protection Agency (EPA) has positions open for biologists and related specialties in the Office of Pesticide Programs within the Office of Chemical Safety and Pollution Prevention. Multiple positions are available for each of the following opportunities. The closing date for both announcements is Monday, March 18.
Successful candidates for both positions will:
The announcement at https://www.usajobs.gov/GetJob/ViewDetails/526780800 describes permanent positions for candidates who have completed bachelor’s degrees in biology, toxicology, or related areas and have at least one year of full-time experience conducting statistical/scientific evaluations of laboratory research data or applying scientific concepts in analyzing, compiling, or computing data as it relates to chemicals.
The announcement at https://www.usajobs.gov/GetJob/ViewDetails/526609000 describes permanent positions for more experienced candidates who have completed bachelor’s degrees in biology, toxicology, or related areas and have at least one year of full-time experience reviewing statistical/scientific evaluations of laboratory or field research data pertaining to the use, benefits, and/or efficacy of chemicals; or reviewing the impacts chemicals have on human health. This position may require one to five days of travel per month.
All openings are in Arlington, VA. Candidates for all opportunities must be U.S. citizens. Apply online at the USAJOBS.gov website. For more information about the opportunities, contact Marketa Evans at 800-433-9633 or firstname.lastname@example.org
April Workshop to Focus on Cancer Pathways; Poster Abstracts and Information Requested
NTP will present a workshop “Converging on Cancer” on April 29-30 at the William Jefferson Clinton East Building, U.S. Environmental Protection Agency, Washington, DC. The workshop will address using systems biology and knowledge of cancer pathways to better understand how environmental chemicals lead to cancer. Potential applications of this understanding include building a framework for incorporating mechanistic data into cancer risk assessment, developing effective screening tools to detect the carcinogenic potential of environmental chemicals (including mixtures), engineering safer products, and designing more effective therapeutics.
This free meeting is open to the public with attendance limited only by the space available. The meeting will consist of plenary sessions, breakout discussion sessions, and a poster session. The plenary sessions only will be webcast. Those wishing to attend in person must register by April 22; registration to view the plenary sessions by webcast is open through the end of the workshop on April 30.
A limited number of abstracts will be accepted for poster presentations at the meeting. Abstracts of 250 words or less on topics relevant to the meeting should be submitted by March 31; submitters will be notified of acceptance by April 8. More information about submitting abstracts >>
In support of the workshop, NTP requests information regarding assays and approaches for evaluating chemical effects on cancer pathways. Relevant information may include but is not limited to: systematic review approaches; assays associated with pathways and characteristics of carcinogens; assays that integrate across multiple cancer-related pathways; modeling approaches to assess the joint effects of multiple chemicals on carcinogenic potential; and input on types of data needed to address knowledge gaps and innovative technology and research approaches that could be used to generate these data. Information should be submitted by April 22.
FDA Announces Creation of Botanical Safety Consortium
In a February 11 press release, the U.S. Food and Drug Administration (FDA) announced policies aimed at modernizing the oversight and regulation of dietary supplements. Steps FDA will take to implement these policies include:
To support the final step, the FDA has established the Botanical Safety Consortium, a public-private partnership of industry, academia, and government that will promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness.
SOT FDA Colloquium on Redesigning the Rodent Bioassay: Wednesday, February 20
The Society of Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) will hold a “Colloquium on Redesigning the Rodent Bioassay for the 21st Century” on Wednesday, February 20, at the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland. This workshop is the latest in the series, “SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety.” The workshop is chaired by Suzanne Fitzpatrick, FDA principal representative to ICCVAM; NICEATM Director Warren Casey is co-chair.
In carrying out its mission to protect and promote public health, FDA must use the best scientific and technological information available to make decisions on the products it regulates. This workshop will consider how one important toxicology tool, the rodent chronic bioassay, should be redesigned to meet the needs of 21st century risk assessment. FDA envisions that this workshop will begin an ongoing dialogue between stakeholders on the utility of the chronic rodent bioassay for regulatory risk assessment.
The workshop is free and open to the public. Attendees who are not federal employees must preregister; federal employees may register on-site. The workshop will also be webcast.
Postdoctoral Opportunities Available at NTP
The U.S. Food and Drug Administration is accepting applications for postdoctoral fellows to develop human cell- and protein-based assays for assessing cardiotoxicity of new drugs. These projects are part of an initiative to design, build, and test new non-animal approaches to assess cardiotoxicity hazard. The initiative is supported jointly by NTP (Biomolecular Screening Branch and NICEATM), the FDA Center for Drug Evaluation and Research, and the Health and Environment Sciences Institute.
Candidates for these two postdoctoral positions should have received Ph.D. or equivalent degrees in computer sciences or life/health/medical sciences within the last five years and must have resided in the United States for at least three of the past five years. Work will be done at NIEHS in Research Triangle Park, NC.
Availability of the Collaborative Acute Toxicity Modeling Suite
NICEATM has released the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic chemicals for acute oral toxicity. CATMoS is implemented in v2.0 of the Open Structure-Activity/Property Relationship App (OPERA), a free and open-source quantitative structure-activity relationship (QSAR) tool. OPERA v2.0 can be downloaded from the NIEHS Github repository.
CATMoS is the result of a global collaboration to develop in silico models to predict acute oral toxicity. It is a suite of consensus models developed by combining the results of individual models contributed by participants in the April 2018 Workshop on Predictive Models for Acute Oral Systemic Toxicity (Kleinstreuer et al. 2018). The individual models were built using information on chemical structures and rat oral acute toxicity data for nearly 9000 chemicals, and tested using approximately 3000 chemicals.
CATMoS includes models for predicting five acute oral toxicity endpoints: very toxic, non-toxic, U.S. Environmental Protection Agency hazard classification, United Nations Globally Harmonized System of Classification and Labelling of Chemical (GHS) hazard classification, and LD50. Predictions generated by CATMoS may be useful to those developing or triaging new chemicals or for prioritizing existing chemicals for more detailed and rigorous toxicity assessments.
EPA Seeks Comments on TSCA Panel Nominees
EPA is requesting comment on nominees for ad hoc participation and possible membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). SACC nominees are experts in toxicology, environmental risk assessment, exposure assessment, and related fields. Nominees will constitute a pool of experts from which EPA can draw to assist with reviews of chemical substances addressed under TSCA.
The request for comment was issued in a Federal Register notice published December 14. Comments on nominees are requested by January 14.
DOT Requests Comment on Harmonization Proposal
The DOT Pipeline and Hazardous Materials Safety Administration is requesting comment on proposed revisions to the Hazardous Materials Regulation to better align with international standards. Included in the proposal are criteria that would enable consideration of existing data on chemical properties as a non-testing alternative for classifying corrosive materials. This would be expected to reduce animal use for this testing. Comments on the proposal are requested by January 28, 2019. More information about the proposal is available in a November 27 Federal Register notice.
Positions Open for Researchers to Support the EPA EDSP
EPA is seeking candidates for three postgraduate research projects in its Endocrine Disruptor Screening Program (EDSP). These appointments are through the Oak Ridge Institute for Science and Education fellows program, a joint venture between EPA and the U.S. Department of Energy. They are one-year appointments with the opportunity for renewal. Positions are open to U.S. citizens only, and qualifying degrees should have been received within the past 60 months.
Upcoming EPA Advisory Panel Meetings
The next meeting of the Scientific Advisory Panel for the EPA Federal Insecticide, Fungicide, and Rodenticide Act will take place on December 4-7 at EPA's Potomac Yards site in Arlington, VA. The meeting topic is "Evaluation of a Proposed Approach to Refine Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology."
The case study focuses on use of a human tissue-based in vitro assay to characterize the hazard of the pesticide chlorothalonil and derive a point of departure (POD) for use in human health risk assessment. EPA is soliciting advice from the SAP on the derivation of the POD from the in vitro assay and the integration of the in vitro POD for calculation of human equivalent concentrations for inhalation risk assessment.
The meeting is open to the public and will be webcast via Adobe Connect. Preregistration is not required to attend the meeting or view the webcast. Visit the EPA website for more information about meeting logistics and additional information about the meeting.
DoD Environmental Research Program Invites Funding Proposals
The DoD Strategic Environmental Research and Development Program (SERDP) is seeking environmental research and development proposals for funding beginning in FY 2020. SERDP is DoD’s environmental science and technology program, planned and executed in partnership with the U.S. Department of Energy and the U.S. Environmental Protection Agency, with participation by numerous other federal and non-federal organizations. SERDP invests across a broad spectrum of basic and applied research, as well as advanced development.
Funded projects will be selected through a competitive process. The Core Solicitation provides funding opportunities for basic and applied research and advanced technology development. The SERDP Exploratory Development (SEED) Solicitation provides funding opportunities for work that will investigate innovative environmental approaches that entail high technical risk or require supporting data to provide proof of concept. SERDP Core pre-proposals are due January 8, 2019. SEED proposals are due March 5, 2019.
NIH Seeks Input on Data Sharing and Management Policy; Webinar Nov. 7
On October 10, NIH issued a Request for Information to solicit public input on proposed key provisions that could serve as the foundation for a future NIH policy for data management and sharing. Feedback will inform the development of a draft policy, which is expected to be released for an additional public comment period upon its development. Comments on the proposed key provisions will be accepted through December 10; a webform to submit comments is available on the NIH Office of Science Policy website.
To further engage stakeholders, NIH will be hosting a webinar on the proposed key provisions on November 7 from 11:30 a.m. – 1:00 p.m. EST. More information about the input request and the webinar is available on the NIH Office of Science Policy website.
NICHD Launches Placental Analysis Tool
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) recently launched the Placental Atlas Tool (PAT). PAT is a free resource incorporating placental data from publications and public databases into a reference tool for studying placental development and function throughout pregnancy. Investigators from all backgrounds can use PAT to generate new ideas and build models by analyzing differential gene expression and gene set enrichment and visualizing heat maps, pathways, and networks for hypothesis generation or testing. PAT is accessible on desktop, tablet, and mobile devices.
NCATS to Fund Tissue Chips to Model Opioid Use Disorders
NCATS has released a notice of intent to publish a funding opportunity announcement for tissue chips to model nociception, addiction, and overdose. This funding will support creation and testing of human-based microphysiological systems, also known as “tissue chips,” that can model the mechanisms or effects of nociception/pain-relevant signaling, addiction, or opioid use disorders.
The notice of intent is being provided in advance to allow potential applicants time to develop meaningful collaborations and responsive projects. The funding opportunity announcement is expected to be published in early December, with application due dates planned for February 2019. It is anticipated that institutions eligible for this funding will include public and private higher education institutions, nonprofits, small businesses, and U.S. state, local, and tribal governments.
FDA Requests Input for International Meeting on Drug Development
FDA will hold a joint public meeting with Health Canada on October 17 in advance of an international meeting in November. The October 17 meeting will provide information and solicit public input on activities of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
ICH brings together regulators and industry to increase efficiency of development and registration of new medical products without compromising safety or effectiveness. Several items currently under consideration by ICH have potential to reduce or replace animal use. One of these is a revision of guidance document “S5: Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals,” which explicitly mentions opportunities for potential reduction of animal use. Other topics include provisions for waivers of bioequivalence studies for biopharmaceuticals, microsampling for toxicokinetics, guidance for rodent carcinogenicity studies, and items concerning preclinical studies.
The October 17 meeting will be held at the Sir Frederick Banting Research Centre in Ottawa, Canada and will also be webcast. An October 4 Federal Register notice provides instructions for submitting comments to FDA. Those planning to attend the October 17 meeting should register by October 12. Comments relevant to the meeting should be submitted to FDA by October 31.
DOT, OSHA Request Input for International Meetings on Chemical Safety
In preparation for upcoming United Nations meetings focused on chemical safety, DOT and OSHA will hold meetings on November 13 at DOT headquarters in Washington, DC.
An October 2 Federal Register notice announced the meetings. Remote participation will be available.
NIH to Build Cell Map of Human Body
NIH has issued its first set of research funding awards for the Human BioMolecular Atlas Program (HuBMAP). HuBMAP is an open, global framework that will support research community efforts to map the adult human body at the level of individual cells. The project is planning to award $54 million over the next four years to support:
Superfund Research Program Webinar Series Concludes October 1
The Superfund Research Program (SRP) Progress in Research webinar series concludes October 1 with presentations from centers at Boston University, Texas A&M University, and the University of California, Davis. The SRP Centers, funded by NIEHS, seek practical scientific solutions to protect health, the environment, and communities from exposure to hazardous substances, such as industrial solvents, arsenic, lead, and mercury. Approaches used include in vitro models and computational and statistical tools. The webinar will be presented on Monday, October 1, from 1:00-3:00 p.m. Eastern Daylight Time. Recordings of the previous webinars are available on the NIEHS website.
Postdoctoral Opportunities Available at NTP
FDA is accepting applications for postdoctoral fellows to develop human cell- and protein-based assays for assessing cardiotoxicity of new drugs. These projects are part of an initiative to design, build, and test new non-animal approaches to assess cardiotoxicity hazard. The initiative is supported jointly by NTP (Biomolecular Screening Branch and NICEATM), the FDA Center for Drug Evaluation and Research, and the Health and Environment Sciences Institute.
Candidates for these two postdoctoral positions should have received Ph.D. or equivalent degrees in computer sciences or life/health/medical sciences within the last five years. Work will be done at NIEHS in Research Triangle Park, NC. More information about the projects and instructions for applying >>
EPA Requests Nominees for TSCA Advisory Committee
EPA requests nominations of scientific experts for ad hoc participation and possible membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee for Chemicals (SACC). The SACC will be conducting peer reviews of EPA’s risk evaluations for the first 10 chemical substances addressed under TSCA. Nominations must be submitted by October 29.
Any person or organization may nominate qualified individuals, and interested individuals may self-nominate. Nominees should have expertise in one or more of the following areas: women’s health; children’s health; genetic variability; disproportionately exposed populations; aging; other susceptible populations; biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic modeling; pharmacology; ecological risk assessment; environmental fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; biostatistics; computational toxicology; fiber science; inhalation toxicology; volatile organics; and systematic review.
Update of ToxTutor Available
The National Library of Medicine has updated its online ToxTutor course. ToxTutor is a self-paced tutorial for users of NLM chemical and toxicology databases that covers the key principles of toxicology.
The August 2018 release of ToxTutor adds "The Microbiome" as a new topic, expands content on alternatives to animal testing and human-on-a-chip testing approaches, and includes induced pluripotent stem cells as an emerging approach for toxicity testing. The tutorial has also added more content on adverse outcome pathways and new sections on "Intuitive Toxicology and Risk Communication" (including content on uncertainty) and "Environmental Toxicology, Environmental Health, and One Health."
FIFRA Advisory Panel to Meet in December, Nominations Requested
The scientific advisory panel for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA SAP) will meet December 4-7 at EPA in Arlington, VA. The FIFRA SAP provides independent scientific advice, recommendations, and information to the EPA Administrator relating to the impact of pesticide regulatory actions on human health and the environment. The upcoming meeting will focus on "Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology." The meeting is open to the public and will be webcast.
EPA seeks nominees to serve as ad hoc members of the FIFRA SAP for this meeting, specifically nominees with expertise in development and implementation of new approach methodologies. Nominations should be submitted by September 7. More information is available in an August 8 Federal Register notice.
Funding Opportunity to Support Alternative Methods Development
EPA is funding research to promote the development and use of alternative test methods and strategies that reduce, refine, or replace vertebrate animal testing. Pertinent research includes approaches such as analog/read-across techniques, mathematical models, and tiered-testing approaches that integrate evidence from multiple sources to help accomplish these goals. Research activities should advance the science underpinning the use of non-vertebrate test methods and develop actionable alternative approaches for developmental toxicity, reproductive toxicity, or ecotoxicity testing.
This opportunity is expected to fund five grants of up to $850,000 each. Eligible institutions include U.S. state, local, and territory governments; federally recognized Indian tribal governments; and public and private nonprofits, hospitals, and academic institutions located in the U.S. Applications are due September 25.
Funding Available for Tissue Chip Models
The National Center for Advancing Translational Sciences (NCATS) has issued funding opportunities to support development of tissue chip technologies.
FDA Webinar on In Silico Medicine August 9
FDA will present a webinar on “What We’re Doing to Advance In Silico Medicine at FDA.” Tina Morrison, Ph.D., chair of FDA’s Modeling and Simulation Working Group and Regulatory Advisor of Computational Modeling for FDA’s Office of Device Evaluation will give an overview of in silico modeling and simulation approaches used by FDA. Her presentation will highlight success stories with simulation and discuss the potential for in silico clinical trials for advancing medical products. The webinar will be presented on Thursday, August 9, from noon-1:00 p.m. EDT. Continuing education credit is available for viewing the webinar.
NICEATM/EPA Project Receives EPA Award
EPA annually recognizes outstanding scientific work of its employees with the Scientific Technological Achievement Awards (STAA). An EPA collaboration with NICEATM, “Using Novel Zebrafish Toxicity Assays to Evaluate a Predictive Model of Development Vascular Toxicity,” has received a Level III STAA, for projects accomplishing an unusually notable research or technological effort.
Small Business Funding Available for Assessing Nanomaterials Toxicity
The National Institute of Environmental Health Sciences (NIEHS) has issued a funding opportunity to support development of technologies to assess exposure of engineered nanomaterials and characterize their effects on biological systems. In particular, this funding opportunity supports development of mid- to high-throughput assays or high-content assays for characterizing the effects of specific nanomaterials on biological pathways, including cytotoxicity, cellular uptake, inflammatory pathways, and oxidative stress in target tissues.
NIEHS intends to fund four or five awards totaling $1 million in 2019. This funding opportunity is open only to U.S. small business concerns. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Letters of intent are due August 11, with applications due September 11. More information is available on the National Institutes of Health Grants website.
FDA Workshop on Dermal Safety Testing September 10
The U.S. Food and Drug Administration (FDA) is hosting a workshop on human dermal safety testing for topical drug products. Workshop participants will review current approaches to the collection of human data during clinical development of topical drug products. The workshop will also address the impact of human skin toxicity studies on drug labeling and consider alternative approaches to providing information about skin toxicity.
The workshop will be held on September 10 at the FDA White Oak Campus in Silver Spring, Maryland and will also be webcast. Those interested in attending in person or viewing the webcast should register by September 4. More information about the workshop is available on the FDA website. Information for visitors to the FDA White Oak Campus is also available on the FDA website.
FDA Public Hearing on Predictive Toxicology Roadmap September 12
The U.S. Food and Drug Administration (FDA) is holding a public hearing on Wednesday, September 12, 2018 on its Predictive Toxicology Roadmap. The Agency is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into regulatory review, as applicable.
The public hearing will be held at the FDA White Oak Campus in Silver Spring, Maryland, and will also be webcast. Those wishing to attend in person or view the webcast must register by Wednesday, August 29, 2018.
Read the June 30 Federal Register notice announcing the public hearing and providing instructions on submitting comments.
Physical Scientist Opportunity at Department of Defense
The Defense Threat Reduction Agency in the Department of Defense is seeking a Physical Scientist to plan, implement, and evaluate research and development programs in drug discovery, development, and safety. Applicants must be U.S. citizens and should have (1) experience in drug discovery and development research and (2) relevant knowledge in the areas of chemistry, biology, toxicology, and the U.S. Food and Drug Administration regulatory process. For more information and to apply, visit the USAJobs website. Applications must be submitted by Wednesday, July 4.
EPA Releases Strategic Plan to Promote Alternative Methods
The U.S. Environmental Protection Agency (EPA) has published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. The document describes how EPA will promote development and implementation of methods and strategies that reduce, refine, or replace vertebrate animal testing to provide chemical safety information required under the Toxic Substances Control Act (TSCA).
The core components of the plan are (1) identifying, developing, and integrating new approach methodologies (NAMs) for TSCA decisions; (2) building confidence that the NAMs are scientific reliable and relevant for TSCA decisions; and (3) implementing the reliable and relevant NAMs for TSCA decisions.
FDA Issues Guidance on Nonclinical Testing of Cancer Drugs
In a June 18 Federal Register notice, the FDA announced release of a Q&A to help stakeholders interpret international guidance on nonclinical evaluation of cancer drugs. The Q&A includes statements about reduction of animal use or use of in vitro alternatives in these studies. The Q&A is available on the FDA website.
EPA Biologist/Toxicologist Positions Available, Deadlines Next Week
The U.S. Environmental Protection Agency (EPA) has Biologist/Toxicologist positions open in the Risk Assessment Division of the Office of Pollution Prevention and Toxics within the Office of Chemical Safety and Pollution Prevention. Multiple positions are available for each of the following opportunities:
Report Available from BioMed21 Workshop
The June 2017 BioMed21 workshop, co-organized by NICEATM and the Human Toxicology Project Consortium, examined actions needed to implement a human systems-biology approach to understanding disease and improving interventions. The report from the workshop has been published in the journal Drug Discovery Today.
Agenda and Registration Available for Workshop on Rabies Vaccine Testing
A preliminary agenda and registration are available for a workshop on Implementing Non-animal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond. The workshop will be held October 16-17 at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. It is co-organized by NICEATM and the International Alliance for Biological Standardization. The workshop is open to the public, there is no registration charge, and participants may attend in person or view a webcast.
Testing to ensure effectiveness and safety of vaccines often requires the use of large numbers of animals. However, technological advances have led to the development of methods that could reduce or eliminate the need for animal testing. This workshop will bring together scientific and regulatory leaders from government, academia, and industry to develop recommendations to advance alternative methods for human and veterinary rabies vaccine testing. Workshop sessions will also spotlight state-of-the-science animal alternatives for other antigens and future possibilities for advancing animal reduction and replacement initiatives.
NICEATM Requests Information on Technologies for Detection and Measurement of Botulinum Neurotoxin
NICEATM requests available data and information on approaches and/or technologies currently used for detection and measurement of botulinum neurotoxin (BoNT). Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to detect the presence of BoNT and measure potency of BoNT preparations.
Respondents to this request should provide information on any activities relevant to the development or validation of alternatives to in vivo test methods currently used by federal agencies for regulatory and other decision contexts. NICEATM also requests available data from in vivo BoNT tests used for similar applications as the proposed alternative, such as distinguishing between BoNT serotypes in biological matrix samples or measuring the potency of therapeutic BoNT preparations.
The deadline for receipt of the requested information is July 11. More information is available on the NICEATM website.
NIH Releases Strategic Plan for Data Science, Seeks Chief Data Strategist
Storing, managing, standardizing, and publishing the vast amounts of data produced by biomedical research is a critical NIH mission. In support of this effort, NIH has released its first Strategic Plan for Data Science, which provides a roadmap for modernizing the NIH-funded biomedical data science ecosystem.
The strategic plan calls for the appointment of a Chief Data Strategist. This person will guide the development and implementation of NIH’s data-science activities and provide leadership within the broader biomedical research data ecosystem. The vacancy announcement for the Chief Data Strategist is available on the NIH Jobs website. Applications will be reviewed starting July 9 and will be accepted until the position is filled.
FDA Final Guidance on Toxicokinetics Studies Available
In a May 10 Federal Register notice, the U.S. Food and Drug Administration (FDA) announced availability of final guidance on the benefits and limitations of the use of microsampling techniques in toxicokinetics studies. Benefits of these techniques include reducing the numbers of animals needed for these studies.
Workshop on Pyrogen Testing Methods September 18-19
NICEATM is co-organizing a workshop on September 18-19 with the PETA International Science Consortium to discuss non-animal approaches for pyrogen testing. The workshop will be held at NIH in Bethesda, Maryland, and will focus on the use of the monocyte activation test (MAT) as a standalone release test for medical devices. Registration and materials will be posted on the NICEATM website when available.
Pyrogens are substances such as bacteria, fungi, and viruses that can produce fever. Medical products for implantation or injection must be shown to be free of pyrogens before use. This workshop will bring together scientists and regulatory authorities from government and industry to review the MAT and discuss ongoing challenges such as identifying material-mediated and other non-endotoxin pyrogens. Participants will also describe industry experience and use of the MAT and identify any issues to be addressed to enable its implementation.
NICEATM Requests Information on Technologies for Identifying Developmental Toxicants
NICEATM requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring. The deadline for receipt of the requested information is June 15.
Respondents to this request should provide information on any activities relevant to the development or validation of alternatives to in vivo developmental toxicity test methods currently used by federal agencies for regulatory and other decision contexts. NICEATM also requests available data from in vivo developmental studies, human or animal studies, or accidental human exposures, using the same chemicals used to evaluate the alternative developmental toxicity test methods.
NIEHS Webinars to Discuss New Approaches and Methodologies for Chemical Safety Evaluation
The National Institute of Environmental Health Sciences (NIEHS) Superfund Research Program is hosting a webinar series highlighting research that may be useful as new approaches and methodologies for toxicity testing. This series coincides with recent initiatives found in the EPA draft strategic plan discussed above and the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.
Session 1, presented on May 14 at 1:00 p.m. EDT, will discuss “Toxicity Testing Strategies and Model Systems.” Speakers will provide an overview of toxicity testing strategies to advance the use of 21st-century science in chemical safety evaluation. Speakers will also describe the pros and cons of model systems such as zebrafish and cell-based assays in hazard identification.
Session 2, on May 23, will focus on “Tools for Assessing Exposure and Toxicity,” and a third session on May 31 will discuss “Modernizing Safety Testing.” More information and links to register for all three webinars are available on the NIEHS website.
Comments on EPA Draft Strategy Due May 11
Comments on a U.S. Environmental Protection Agency (EPA) draft strategy to reduce use of vertebrate animals in chemical testing are due Friday, May 11. The draft strategy and related documents are available at https://www.regulations.gov/ under docket EPA-HQ-OPPT-2017-0559. Comments received will be considered in the Agency's development of the final strategy. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act, mandated development of the strategy, which was released March 7. The announcement of the draft strategy release is available on the EPA website.
EPA Requests Comments on Draft Policy on Skin Sensitization Testing
On April 10, the U.S. Environmental Protection Agency (EPA) released a draft Science Policy to reduce animal use in testing strategies to evaluate chemicals for their ability to cause an allergic reaction, inflammation, or sensitization of the skin. “This draft policy is another step toward achieving EPA's goal of reducing the use of animals and increasing the use of cutting-edge science in chemical testing,” said EPA Administrator Scott Pruitt in an EPA Office of Pesticide Programs news release.
The draft policy is the result of national and international collaboration among ICCVAM, NICEATM, Cosmetics Europe, the European Union Reference Laboratory for Alternatives to Animal Testing, and Health Canada’s Pest Management Regulatory Agency.
SOT-FDA Colloquium on Testing of Food Mixtures March 27
Humans are routinely exposed simultaneously to numerous chemicals in food, yet risk assessments of chemicals in food rely on test data from individual chemicals. A March 27 colloquium sponsored by the Society of Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) will consider whether new testing approaches such as in vitro assays, in silico models, and non-mammalian in vivo models could be used to assess the potential health impacts of exposure to chemical mixtures in food.
“Can Alternatives Inform a Risk Assessment of Mixtures in Food?” will be held from 8:30 a.m. to 1:00 p.m. at the Wiley Auditorium, FDA Center for Food Safety and Applied Nutrition, College Park, Maryland. Preregistration to attend the colloquium in person has closed; walk-in registration is available to U.S. federal employees only. The colloquium will also be webcast.
NEI Sponsors Competition to Develop In Vitro Models
On February 13, the National Eye Institute (NEI), part of the National Institutes of Health, announced the 3-D Retina Organoid Challenge. This $1 million federal prize competition is designed to support development of lab-grown human retinas from stem cells. Organoids developed for the competition will mimic the structure, organization, and function of the human retina, the light-sensitive tissue in the back of the eye.
In the current phase of the challenge, NEI will award up to $100,000 each to as many as six teams whose models best address the challenge’s scientific criteria. Participating teams must designate a captain who is a U.S. citizen or permanent resident. Private entities participating must maintain a primary place of business in the United States. Federal offices or employees are not eligible to participate, and federal funds may not be used to develop submissions. Submission deadline is October 1; winners will be announced in December. Complete challenge details are available on the NEI website.
EPA Releases Strategic Plan
On February 12, the U.S. Environmental Protection Agency (EPA) released its 2018-2022 Strategic Plan. The Strategic Plan states as one of the EPA’s goals, to “Administer the law, as Congress intended, to refocus the Agency on its statutory obligations under the law.” One of the objectives under this goal is to “prioritize robust science”, which includes an intention to “Use ToxCast/Tox21 data to develop high-throughput risk assessments, particularly for chemicals for which adequate risk assessment information has been historically unavailable.”
NIH Requests Comments on Draft Strategic Plan for Data Science
To capitalize on the opportunities presented by advances in data science, the National Institutes of Health (NIH) is developing a Strategic Plan for Data Science. This plan describes NIH’s overarching goals, strategic objectives, and implementation tactics for promoting the modernization of the NIH-funded biomedical data science ecosystem.
NIH published a Request for Information that seeks input from stakeholders, including members of the scientific community, academic institutions, the private sector, health professionals, professional societies, advocacy groups, patient communities, as well as other interested members of the public. Comments in response to the request can be submitted via the NIH Grants website. To ensure consideration, comments must be submitted by April 2.
NIEHS Offers Funding to Small Businesses for Toxicity Screening, Testing, and Modeling
The National Institute of Environmental Health Sciences (NIEHS) is offering funding for small businesses developing technologies of interest to the Tox21 program. These technologies include improved or expanded testing methods for toxicity screening, computational approaches for predictive toxicology, and other technologies such as alternative or improved methods for fixing and preserving tissues. The funding is being offered as part of the 2018 Omnibus Solicitation of the National Institutes of Health (NIH), Centers for Disease Control, and Food and Drug Administration for small business grant applications to support development and commercialization of innovative technologies.
The next application deadline is March 5. Complete information about the grants is available on the NIH Grants website:
More information about these and other NIH grants is available on the NICEATM website.
USDA Issues Updated Guidance on Vaccine Testing Exemptions
The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics recently added Veterinary Services (VS) Memorandum 800.116 Target Animal Safety Testing Exemption to its website. View all USDA VS Memoranda
VS Memorandum No. 800.116, signed in August 2017, replaces an earlier version issued in July 2013. The memorandum provides guidance to licensed firms on requesting an exemption under title 9, Code of Federal Regulations (9 CFR), part 113.4, to target animal safety testing as required for testing of live and inactivated vaccines and antibody products. Such exemptions can reduce animal use in facilities that have documented consistency in manufacturing processes and product safety.