ICCVAM Agency Activities: 2016

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NIEHS: National Toxicology Program Level of Concern Study Phase 2 Recruitment (December 2016)

The National Toxicology Program uses Level of Concern categories to communicate its opinion about whether an environmental substance might cause adverse effects in humans. This study aims to update the Level of Concern categories to better inform and protect public health. If you are a public health professional who is familiar with toxicological risk communication tools, please join this important study and share it with interested colleagues. Eligible participants will be individuals who have a M.S., Ph.D., M.D., or equivalent degree and at least three years of experience in toxicology, epidemiology, risk assessment, or a related field.

NICEATM Deputy Director Nicole Kleinstreuer is senior author on one article and co-author on a second article to be included in a special issue of Reproductive Toxicology focused on developmental angiogenesis. The articles describe collaborations among NICEATM, the U.S. Environmental Protection Agency, and other investigators to use transgenic zebrafish to test predictions made using adverse outcome pathways on how chemicals can disrupt blood vessel formation during development. Links to the articles by McCollum et al. and Tal et al. are available on the NICEATM publications page.

EPA: New Guidance for Testing Pesticides Will Reduce Animal Testing (December 2016)

On November 30, the U.S. Environmental Protection Agency (EPA) published "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations and Supporting Retrospective Analysis." The new guidance expands the potential for data waivers for acute dermal studies and includes a policy statement to waive all acute lethality dermal studies for formulated pesticide products. EPA expects this waiver guidance to reduce the use of laboratory animals, potentially up to 2,500 or more each year. The guidance document is available on the EPA website.

NIEHS and EPA: AR Pathway Article Named Editors’ Choice (December 2016)

NICEATM Deputy Director Nicole Kleinstreuer is the lead author on a paper describing an androgen receptor pathway model that incorporates 11 high throughput screening assays. “Development and Validation of a Computational Model for Androgen Receptor Activity,” which was published online on November 18 in Chemical Research in Toxicology, has been selected as an ACS Editor’s Choice Article. This selection was based on recommendations by the scientific editors of ACS journals around the world. With this designation, the article becomes open access, meaning it can viewed by anyone regardless of institutional affiliation or subscription status. The article is on the ACS Publications website.

NLM: NLM Requests Stakeholder Input for Strategic Plan (November 2016)

In a November 8 Request for Information, the National Library of Medicine announced that it is soliciting stakeholder input as part of its ongoing strategic planning process. The RFI and NLM’s planning process are organized around the role of NLM in these four areas:

  • Advancing data science, open science, and biomedical informatics
  • Advancing biomedical discovery and translational science
  • Supporting the public’s health: clinical systems, public health systems and services, and personal health
  • Building collections to support discovery and health in the 21st century

The November 8 RFI is intended to obtain public input on goals and priorities for NLM’s next strategic plan. Many NLM stakeholders replied to a similar RFI in 2015 in the context of NLM’s leadership transition and emerging NIH data science priorities. Input provided in 2015 is already under consideration and does not need to be re-submitted.

The deadline for responses to the November 8 RFI is January 9, 2017. More information about the RFI, including how to submit input, is available on the National Institutes of Health Grants website.

NIEHS: Kleinstreuer Receives Lush Cosmetics’ Young Researcher Prize (November 2016)

In a November 2 ceremony, NICEATM Deputy Director Nicole Kleinstreuer received the Lush Cosmetics’ Young Researcher Prize recognizing efforts to eliminate animal use for chemical safety testing. Five researchers in the Americas received the honors presented at Lush Cosmetics headquarters in Vancouver.

Kleinstreuer is the first U.S. federal government employee to receive a Lush Prize. She is also part of a group of U.S. federal employees named as finalists for the Science prize for advancing non-animal approaches to identify endocrine-active substances. Lush Prize winners in this and other categories will be announced later in November.

A list of the 2016 Young Researcher Prize winners from the Americas and more information about the Lush Prize are available on the Lush Prize website. Video summaries of the prize winners’ work are available on the Lush Cosmetics website.

NIEHS: NICEATM Requests Data on Zebrafish Embryo Chemical Screening (November 2016)

NICEATM requests available data and information on zebrafish embryo screening tests and protocol design, including pharmacokinetics measurements. 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 developmental effects in offspring. Respondents to this data request should provide information on any activities relevant to the development or validation of zebrafish embryo screening assays.

NICEATM specifically requests information on efforts to optimize zebrafish embryo screening tests and protocol design including comparisons of (1) zebrafish strains, (2) embryos with and without an intact chorion, and (3) static and static renewal exposures. NICEATM is also interested in developing a better understanding of pharmacokinetics in the zebrafish embryo model and requests available data on chemical uptake.

More information on this data request, including guidelines for data submission, is available on the NICEATM website.  The deadline for receipt of the requested information is December 30, 2016.

NLM: Resources From the National Library of Medicine: ToxTutor and ALTBIB (November 2016)

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 ToxTutor update incorporates recent advances in the science of toxicology, provides more information on alternatives to animal testing, and features responsive design to support use on mobile devices. ToxTutor is available on the NLM website.

A December 8 NLM webinar will introduce new users to the NLM database ALTBIB: Resources for Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing. The webinar will describe the history, purpose, and scope of ALTBIB, identify key people who work on ALTBIB, and demonstrate the features of the resource. Participants will gain hands-on experience with practice exercises and leave the webinar with a sense of what ALTBIB can and cannot do for animal alternative searches. The webinar is free and open to residents of the United States.

NIEHS: NTP Requests Data on Alternative Methods to Assess Inflammation or Exaggerated Immune Responses (October 2016)

The National Toxicology Program at the National Institute of Environmental Health Sciences requests available data and information on approaches and/or technologies currently used to identify substances with the potential to cause excessive inflammation or exaggerated immune responses leading to tissue injury when swallowed, inhaled, or absorbed through the skin. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that could be used to evaluate the potential of chemicals to induce inflammation and immune-related conditions.

View Federal Register notice announcing the data request
Submit data and information to the NTP website by December 12.

NIEHS: NICEATM Director Participates in Congressional Briefing (September 2016)

NICEATM Director Warren Casey was a panelist for a September 13 Congressional briefing on “Alternatives to Animal Testing: Emerging Uses and Policy Implications.” Casey and other panelists discussed how to use non-animal and alternative toxicology and safety testing methods to better protect consumers and public health while using fewer animals. Topics considered included how to spark research that advances the development and application of alternatives, as well as what policy discussions are required to ensure regulatory frameworks can adapt while realizing the fastest possible innovation. The briefing was organized by the American Chemical Society and the Johns Hopkins Bloomberg School for Public Health, and sponsored by the offices of Representatives Earl Blumenauer (D-OR) and Ken Calvert (R-CA).

NIH: Computational Biology Symposium September 16 (September 2016)

PLoS Computational Biology is presenting a Computational Biology Symposium on the National Institutes of Health campus on Friday, September 16, from 9:30 a.m.-4:00 p.m. Keynote speakers will include Dr. David J. Lipman of the National Center for Biotechnology Information, Dr. Jennifer Lippincott-Schwartz of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Dr. Bert Vogelstein of Johns Hopkins Medical Institutes. The agenda also includes two discussion panels comprised of PLoS Computational Biology editors from a range of fields. The morning panel will consider the “Biggest Challenges and Greatest Opportunities in Computational Biology over the Next 10 Years,” while the topic of the afternoon panel is “How Computational Biology Will Affect Human Health.”

The symposium is open to all National Institutes of Health staff and the wider community. Attendance is free and no preregistration is required. More information is available on the PLoS website. The symposium will also be webcast; more information about the webcast is available on the NIH Videocast website.

FDA: Comments Requested on Draft Guidance for Toxicokinetics Studies (September 2016)

A U.S. Food and Drug Administration (FDA) notice in the September 8 Federal Register requested comments on draft guidance titled “ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies—Questions and Answers.” The draft guidance facilitates interpretation of the ‘‘S3A Guidance: The Assessment of Systemic Exposure in Toxicity Studies,’’ especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies, and acknowledges the benefits (and some limitations) of the use of microsampling. Comments on the draft guidance are requested by December 7.

NIH: Chips in Space (August 2016)

The National Center for Advancing Translational Sciences (NCATS) and the Center for the Advancement of Science in Space are promoting a new program for research on the International Space Station United States National Laboratory (ISS-NL): we’re sending tissue chips to space! This program will leverage recent advances in tissue engineering and microfabrication to create microphysiological systems and organ-on-chip technology platforms to better understand the molecular and cellular basis of human disease in microgravity. Translation of this research to the ISS-NL promises to accelerate the discovery of molecular mechanisms that underlie a range of common human disorders and advance understanding of therapeutic targets and treatments in a reduced fluid shear, microgravity environment that recapitulates cellular and tissue matrices of Earth.

NCATS has published a notice of intent to publish a funding opportunity for this initiative. Grant applications are not currently being solicited, but interested investigators are encouraged to begin developing meaningful collaborations and responsive projects.

FDA: Comments Requested on Proposed Amendments to GLP (August 2016)

A Proposed Rule published by the U.S. Food and Drug Administration (FDA) in the August 24 Federal Register describes amendments to the regulations for good laboratory practice (GLP) for nonclinical laboratory studies. The new amendments will require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. FDA is proposing additional management responsibilities and standard operating procedures consistent with the proposed requirement for a GLP Quality System. In addition, the testing facility definition will be revised to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity. Comments on the Proposed Rule are due by November 22.

NIEHS: Workshop Report on Carcinogenicity of Mixtures Now Available (August 2016)

An August 2015 workshop sponsored by the National Institute of Environmental Health Sciences evaluated the scientific support for the Low-Dose Mixture Hypothesis of Carcinogenesis and developed a research agenda. A report from this workshop is now available on the Environmental Health Perspectives website. NICEATM Deputy Director Nicole Kleinstreuer, Ph.D., was a breakout group moderator and co-authored the report.

The Low-Dose Mixture Hypothesis of Carcinogenesis suggests that ongoing low-dose exposures to mixtures of commonly encountered environmental chemicals can produce effects in concert that promote carcinogenesis. The workshop report describes the science that supports this novel theory, identifies knowledge gaps, recommends future methodologies, and explores preventative risk assessment and policy decision making that incorporates cancer biology, environmental health science, translational toxicology, and clinical epidemiology. The workshop participants concluded that the theoretical merits of the Low-Dose Carcinogenesis Hypothesis are well founded with clear biological relevance and the premise warrants further investigation.

EPA: TSCA Reform Bill Becomes Law, Will Promote Use of Alternatives (June 2016)

A bill signed into law June 22 by President Obama updates the Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) provides the Environmental Protection Agency (EPA) with the authority and a consistent source of funding to evaluate chemicals on the basis of health risks. The new law also includes language that requires EPA to develop a plan to promote the use of alternative methods that reduce, refine, or replace vertebrate animal testing and include in that plan a list of acceptable alternative methods.

The highlights of the Lautenberg Chemical Safety Act were outlined in a blog post by EPA Administrator Gina McCarthy. A news release from the Physicians Committee for Responsible Medicine summarizes aspects of the bill relevant to alternative methods development.

FDA: FDA Issues Final Guidance and Presents Webinar on Biological Evaluation of Medical Devices (June 2016)

The Food and Drug Administration (FDA) has issued a final guidance document on the use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process.” FDA developed the guidance document to assist industry in preparing applications and notifications on medical devices so that the devices are appropriately evaluated for the potential for adverse reactions.

FDA will present a webinar on the new guidance on July 21 at 1:00 p.m. Eastern Daylight Time. The webinar is open to the public and there is no charge to view.

EPA: EPA Releases Training Videos on Data Requirements for Antimicrobials (June 2016)

EPA is releasing five training videos providing guidance on EPA’s 40 CFR Part 158W data requirements for antimicrobial pesticides. These training videos will help the public and the pesticide industry better understand the pesticide registration process and make the process more efficient and transparent. The videos include the 2013 amendments to the data requirements that were made to ensure pesticide risk management decisions are founded on the best available sound science.

Additional videos will be released in the future as they become available. The videos are available on the EPA website.

EPA: New Guidance for Testing Pesticides Will Reduce Animal Testing (March 2016)

In a March 17 press release, EPA announced the publication of two guidance documents and initiation of a pilot program, all of which will support its goal to significantly reduce animal use for acute effects testing.

Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies for FIFRA Regulatory Use” describes a transparent, stepwise process for evaluating and implementing alternative methods for the “six-pack studies,” which test for acute oral, dermal, and inhalation toxicity; skin and eye irritation; and skin sensitization. The document includes discussion of three major phases of the evaluation and implementation process, as well as the implications for reporting information required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Establishment of this process and the clear articulation of the related reporting requirements address challenges associated with adopting alternative methods.

EPA is also requesting comment on draft guidance titled “Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations.” This guidance document provides a rationale for waiving all acute dermal toxicity studies for pesticide formulations, and includes a data analysis conducted by the EPA Office of Pesticide Products (OPP) and NICEATM in support of this rationale. EPA is accepting comments on the guidance document until May 16.

Availability of the two documents was announced in an open letter to stakeholders from OPP Director Jack Housenger, who also announced a pilot program to evaluate alternative approaches to classify the toxicity of mixtures. Under the GHS Mixtures Equation Pilot, OPP will accept submission of oral and inhalation toxicity data paired with calculations done in accordance with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) to support the evaluation of pesticide product formulations.

Links to the two documents and Housenger’s letter to stakeholders, as well as instructions on how to submit comments on the draft guidance, are available on the EPA website.

NIEHS: NICEATM Deputy Director to Receive Teratology Society Award (February 2016)

NICEATM Deputy Director Nicole Kleinstreuer, Ph.D., has been named to receive the 2016 F. Clarke Fraser New Investigator Award from the Teratology Society. This award recognizes an active Teratology Society member that has, within 10 years of completion of training, established a successful independent research career in a field relevant to developmental biology. Kleinstreuer will be presented with her award during the Society’s Annual Meeting in June, at which she will give a plenary presentation about her research.

NIEHS: NICEATM Director Elected to Lead SOT IVAM Specialty Section (February 2016)

NICEATM Director Warren Casey, Ph.D., has been elected Vice President-Elect of the In Vitro and Alternative Methods (IVAM) Specialty Section of the Society of Toxicology (SOT). Casey will serve as Vice President-Elect for 2016-2017 and will then serve subsequent one-year terms as Vice President, President, and Past President of the specialty section.

The SOT IVAM Specialty Section members have expertise or special interest in the application of in vitro techniques to address problems of cellular toxicity, with a special emphasis on product safety evaluation. IVAM interests include the study of cellular processes involved in adverse outcomes of specific organs as well as whole animals, and the development of systems to predict in vivo toxicity for risk assessment purposes. Other topics of interest include in vitro test validation and all aspects of test development and acceptance for individual or regulatory purposes.

EPA, NIH, NIEHS: EPA and NIH Centers Launch Transform Tox Testing Challenge (January 2016)

U.S. government agencies are offering awards totaling $1 million to improve the relevance and predictivity of data generated from automated technology used for toxicity testing.

In a Jan. 8 press release, the U.S. Environmental Protection Agency (EPA) announced that it is partnering with the National Center for Advancing Translational Sciences and the National Toxicology Program to sponsor the Transform Tox Testing Challenge: Innovating for Metabolism. The challenge calls on innovative thinkers to find new ways to incorporate physiological levels of chemical metabolism into high throughput screening assays. This will help researchers more accurately assess effects of chemicals and better protect human health.

Participating teams will compete in three stages for a total award of $1 million. The first stage, which closes April 8, seeks practical designs that may be fully implemented. Up to ten entries may receive a prize of $10,000 each and an invitation to continue to the second stage, prototype development. The final stage will involve testing by the sponsoring agencies of commercially viable methods or technologies.

The challenge is closed to federal employees acting within the scope of their employment but is open to all other segments of government, industry, academia, or non-governmental organizations.