National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/807778

Announcements Sent to the NICEATM News List in 2017


These announcements were originally distributed via the NICEATM News email list. Subscribing to the NICEATM News email list will notify you directly of publication of NICEATM Federal Register notices, availability of ICCVAM reports, notices of upcoming meetings, requests for public comments or data, and other events of interest to our stakeholders.

May 3: ASCCT Meeting September 21-22; Abstract Submission Open

The 6th Annual Meeting of the American Society for Cellular and Computational Toxicology is scheduled for September 21-22, 2017, at the U.S. Food and Drug Administration (FDA) office in College Park, MD. The September 21 plenary session will focus on the advancement of alternatives for acute toxicity testing, and the September 22 plenary session will focus on the alternative methods requirements of the Lautenberg Chemical Safety Act and the use of in vitro and computational methods to address those requirements. The meeting will also include a poster session, mentoring and networking opportunities, and a reception and awards ceremony.

Abstracts for presentations at the meeting are due July 1. Abstracts relevant to the plenary session themes will be considered for oral presentations during these sessions. Submission of abstracts on all topics related to cellular and computational toxicology are also welcomed for oral and poster presentations. Authors will be notified of abstract acceptance August 1.

Details on the meeting and abstract submission are available on the ASCCT website; registration and a draft agenda will be available soon.

May 3: Registration Open for ICCVAM Public Forum

Registration is open to attend the ICCVAM public forum on May 23 at the National Institutes of Health in Bethesda, Maryland. ICCVAM holds annual public forums to share information and facilitate direct communication of ideas and suggestions from stakeholders. ICCVAM agencies will give presentation on their activities relevant to the ICCVAM mission. This year’s forum will also provide an opportunity for stakeholder input on an effort to establish a U.S. national strategy to explore new approaches for evaluating the safety of chemicals and medical products in the United States.

More information about the public forum and links to register to attend in person or view the webcast are available on the NICEATM website. Those planning to attend in person are encouraged to preregister by May 12.

May 3: NICEATM Deputy Director, Collaborators Comment on Progress Toward Animal Replacement

NICEATM Deputy Director Nicole Kleinstreuer and a number of NICEATM collaborators in academia, industry, and animal welfare organizations commented on progress toward replacing animals for chemical safety testing in the April 24 issue of Chemical and Engineering News. The article “Big Data, Big Deadlines Spur Change in Toxicity Testing” is available on the C&E News website.

May 3: FDA Reaches Food Safety Agreement with Australia

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.

April 20: FDA Partners with Industry to Develop Organs-on-Chips

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.

April 10: OECD Releases Update of QSAR Toolbox

The Organisation for Economic Co-operation and Development (OECD) has released version 4.0 of QSAR Toolbox. The QSAR Toolbox is a software application that governments, chemical industry, and other stakeholders can use to fill gaps in toxicity data needed for assessing the hazards of chemicals.

Version 4.0 of QSAR Toolbox features:

  • Automated and standardized workflows for skin sensitization and short-term toxicity to fish
  • Improved customizable reports
  • An updated software system
  • Expansion of databases with the introduction of reliability scores for alerts and databases
  • Enhanced ADME information and improved presentation

The QSAR Toolbox can be downloaded from the OECD website. This page includes detailed information about QSAR Toolbox and the new features in version 4.0.

March 24: OECD Releases Guidance Document on Integrated Approaches to Testing and Assessment

OECD recently released a “Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches for Testing and Assessment (IATA)”. This guidance document is intended to:

  • Provide a framework for developing and using IATA
  • Describe how IATA can be based on the adverse outcome pathway concept
  • Provide examples on how AOPs can be used in the development of IATA

IATA provide a means for combining the data from different testing methods, with the objective of predicting chemical toxicity more accurately than with any single test method.

The OECD Programme on Hazard Assessment addresses chemical hazards. One of the programme’s current efforts is on the development and application of IATA and the collation of comments on new hazard assessment methodologies.

More information on IATA can be found at the OECD website. The new guidance document can also be downloaded from this page.

March 3: New Agency Joins ICCVAM

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.

February 15: New Release of Effectopedia Site Available

Effectopedia is an open-knowledge and structured platform to display quantitative information on adverse outcome pathways (AOPs). This collaborative tool is designed to facilitate interdisciplinary efforts for delineating AOPs in an encyclopedic manner with greater predictive power.

The new release of Effectopedia features:

  • A stable and user-friendly experience, supported by online training material (videos, introduction tutorials)
  • Quantitative features that support entry of dose- and time-response data and can be used to derive response-to-response relationships
  • New functionalities for model development and interaction
  • Workflow support that allows users to create and save their AOPs locally or publicly
Explore the new Effectopedia features on the new Effectopedia website. Effectopedia is supported by the Organisation for Economic Co-operation and Development. More OECD resources supporting development of AOPs are available on the OECD website.

January 20: Advisory Committee Applications Due January 31

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) is recruiting new members for its Scientific Advisory Committee. The ESAC acts as a scientific peer-review body that provides EURL ECVAM with opinions on the adequacy and outcome of formal validation studies of alternative methods, typically in the context of regulatory safety assessment.

Eligible applicants must have a postgraduate university degree and at least 10 years of subsequent experience in relevant fields, have sufficient oral and written English fluency, and have not served on the ESAC since 2009. Applicants will be evaluated for their competence in scientific areas relevant to alternative methods development and their experience in regulatory and safety assessment of chemicals, validation practice, analyzing complex information, and providing scientific advice at a national or international level. Applications are due January 31. More information is available on the EURL ECVAM website.

January 20: Risk Assessment Training Opportunity for Young Scientists

The Joint Research Centre of the European Commission will hold a “Summer School on Alternative Approaches for Risk Assessment” on May 16-19. The Summer School will be hosted by the Centre’s Chemical Safety and Alternative Methods Unit in Ispra, Italy. Tailored for postgraduate students and young scientists, the Summer School aims to give insight into principles and methodologies of human health and environmental risk assessment from a scientific, regulatory, and industrial perspective with a focus on alternative (non-animal) methods.

Attendance is limited to students and scientists who have completed their Ph.D. or master’s degree within the last four years. Applicants must provide a letter of motivation, including one professional reference, and a poster abstract. Selection of participants (100 maximum) will be based on the clarity, relevance, and quality of the application and the relevance of the Summer School to current area of study or job. Preregistration for the Summer School is open until February 14. More information is available on the JRC website.

January 6: National Academies Report: Using 21st Century Science to Improve Risk-related Evaluations

A report released January 5 by the National Academies of Sciences, Engineering, and Medicine makes recommendations on the best ways to incorporate emerging science into risk-based evaluations of chemical safety. The report, “Using 21st Century Science to Improve Risk-related Evaluations”, was prepared at the request of the four Tox21 partner organizations: the U.S. Environmental Protection Agency, National Institute of Environmental Health Sciences, National Center for Advancing Translational Sciences, and the U.S. Food and Drug Administration. The new report discusses both the inherent opportunities and the challenges that will need to be met to achieve the vision described in two earlier National Research Council reports, “Toxicity Testing in the 21st Century” and “Exposure Science in the 21st Century.”

The new report can be read online or downloaded as a free PDF from the National Academies Press website. National Academies Press is also accepting pre-orders for purchase of the paperback edition.

January 4: EPA Launches Voluntary Pilot Program to Reduce Animal Testing

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.

More information about the pilot program and instructions for submitting data are available on the EPA website.

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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.