ICCVAM Agency Activities: 2015

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NIEHS: NICEATM Director Wins SOT Award (December 2015)

NICEATM Director Warren Casey has won the Society of Toxicology (SOT) 2016 Enhancement of Animal Welfare Award. In announcing the award, SOT specifically noted Casey’s efforts to improve the quality of data from traditional animal studies that are used to evaluate new approaches, and his leadership on projects supporting replacement of animal tests with high throughput screening approaches and computational models.

Read article about Casey’s award in the January 2016 issue of the NIEHS “Environmental Factor” newsletter

USDA: Guidance for Reducing Animal Use for Vaccine Testing (October 2015)

The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) recently issued CVB Notice 15-13, Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae. The notice describes an exemption from the titration requirement in vaccination-challenge potency assays for Leptospira Serogroups Canicola and Icterohaemorrhagiae. Removal of the back-titration hamsters could reduce animal use by 50% for potency testing on these two fractions. The policy is effective Oct. 8. CVB Notice 15-13 is available on the USDA website.

NIEHS: Database of Rodent Uterotrophic Bioactivity Now Available (October 2015)

An article published October 2 as an advance publication in Environmental Health Perspectives describes curation and evaluation of a database of rodent uterotrophic bioactivity. The uterotrophic assay is a widely accepted in vivo test for identifying chemicals with potential estrogen receptor agonist activity.

The new database, which includes data from studies that adhere to six criteria specified in accepted regulatory test guidelines, is being proposed as a resource both for understanding in vivo outcome variability and for evaluating performance of in vitro alternative assays that measure estrogenic activity. For example, the database was used to validate an approach that could use high-throughput assays and computational methods to replace the uterotrophic assay in the U.S. Environmental Protection Agency’s (EPA’s) Endocrine Disruptor Screening Program (see article in the August Environmental Factor).

Reference: Kleinstreuer NC, Ceger PC, Allen DG, Strickland J, Chang X, Hamm JT, Casey WM. A curated database of rodent uterotrophic bioactivity [published online ahead of print 2 Oct 2015]. Environmental Health Perspectives.

NIEHS: Version 2 of S1500+ Human Gene Set Now Available (October 2015)

NIEHS and National Toxicology Program scientists along with Tox21 partners have developed a list of environmentally responsive genes to be used in toxicogenomics approaches to screening large numbers of chemicals. Genes on the list were identified through both bioinformatics approaches and experimental data establishing certain genes’ importance to responses to toxicity. The recently updated “S1500+” gene list contains approximately 2750 genes that will be used to evaluate transcriptional changes in human cells or tissues in response to chemical exposure. These genes may also be useful for biomarker development and basic research efforts. 

NIEHS/NIH: Nature Biotechnology Paper Reports Results of Crowdsourcing Challenge (August 2015)

An international study published in Nature Biotechnology presents the combined results of a crowdsourcing initiative to test how well the effects of a toxic compound can be predicted in different people. The study shows that computational methods can be used to predict some toxic effects on populations, although they are not yet sensitive enough to predict such effects in individuals. It also presents algorithms useful for environmental risk assessment.

The community-based challenge, known as the DREAM Toxicogenetics Collaboration, was led and organized by scientists from NIEHS, EMBL-EBI, Sage Bionetworks, IBM, the University of North Carolina, and the NIH’s National Center for Advancing Translational Sciences. Hundreds of computational biologists from all over the world tried their hand at predicting the toxicities of environmental compounds that had potential adverse health effects. One key benefit of the study is that it offers new methodologies for improvements in some areas of hazard evaluation and assessment.

DOD: Report Outlines Predictive Toxicology Approach for Defense Applications (August 2015)

The National Academies Press has issued a report on “Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense.” Prepared in response to a request by the U.S. Department of Defense, the report provides a conceptual approach that could be used to evaluate chemicals that could pose threats to deployed personnel. In addition to providing an overview of current computational and high-throughput testing approaches and methods for integrating data and predictions, the report summarizes lessons learned from current high-throughput screening programs and suggests initial steps for investment. The report can be read online or downloaded as a PDF for free.

NIH: NIH Invites Comments and Suggestions on a Framework for the NIH-wide Strategic Plan (July 2015)

In order to advance its mission, NIH is developing an NIH-wide Strategic Plan. The goal of this 5-year plan is to outline a vision for biomedical research that ultimately extends healthy life and reduces illness and disability. NIH senior leadership and staff have developed a proposed framework for the Strategic Plan that identifies areas of opportunity across all biomedicine and unifying principles to guide NIH’s support of the biomedical research enterprise. The aim is to pursue crosscutting areas of research that span NIH’s 27 Institutes, Centers, and Offices. The Strategic Plan is due to the Congress in late December 2015.

NIH published a Request for Information (RFI) seeking input from stakeholders throughout the extramural community and the general public regarding the Framework for the 5-year NIHS-wide Strategic Plan on July 22, 2015. Feedback to the RFI may be submitted through the NIH Grants website. Comments are due by August 16.

NIEHS: NIEHS Offers Financial Support for Test Method Development (July 2015)

The National Institute of Environmental Health Sciences (NIEHS) will provide additional support to current federal grantees for validation and commercialization of replacement or reduction alternatives to tests required by U.S. government agencies. These Small Business Innovation Research (SBIR) Phase IIB awards will support further development of non-clinical toxicology tests for use as stand-alone replacements or elements of a weight-of-evidence testing approach. Phase IIB awards will assist small businesses in pursuing the next appropriate milestone(s) necessary to advance promising methods towards U.S. federal agency acceptance and for subsequent commercialization of these test methods for products intended for global markets. Highest priority will be given to supporting development of methods that can serve as stand-alone replacements for animal-based tests currently used or required by U.S. federal agencies.

SBIR Phase IIB awards are available only to U.S. small business concerns that currently receive SBIR/STTR Phase II funding for their projects from NIEHS, other NIH institutes, or other federal agencies. However, note that Phase IIB funding will be offered in three rounds during 2015, 2016, and 2017. If your project does not currently qualify for Phase IIB funding, the funding announcement provides guidelines for future eligibility. Letters of intent for the first round of funding are due October 17, 2015, with applications due November 17, 2015.

View more information on the Phase IIB awards on the NIH Grants website

View information about this and other funding opportunities for alternative methods development

EPA: EPA Requests Comments on Use of High-Throughput Assays for EDSP (June 2015)

The Environmental Protection Agency (EPA) requests comments on a plan to incorporate validated ToxCast/Tox21 high-throughput assays and an associated computational model as an alternative to three Tier 1 tests used in its Endocrine Disruptor Screening Program (EDSP) to assess estrogenic activity. Described as “groundbreaking” in an EPA press release, the use of high-throughput assays and computational methods will accelerate the pace of screening, decrease costs, and reduce animal testing. The EPA plan was developed and validated by EPA and NICEATM scientists and is described in detail in a paper by Browne et al. in the journal Environmental Science and Technology. Comments on the plan are requested by August 18.

View June 19 Federal Register notice requesting comments on the plan

USDA: USDA Requests Comments on Petition to Revise Animal Use Reporting Requirements (June 2015)

The Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) has received a petition from the National Anti-Vivisection Society (NAVS) to increase the level of detail in information collected from research facilities in their reports on animal use. NAVS is asking that the annual report required under the Animal Welfare Act include more information on how animals are being used for research and experimentation.

APHIS is soliciting comments to help determine what action, if any, to take in response to this request. In particular, APHIS invites responses to the following questions. Comments are requested by August 24.

  1. Should APHIS amend the regulations to require research facilities that use animals for teaching, testing, and experimentation to provide specific information about how regulated animals are used (for example, for safety testing, teaching purposes, or disease research)? Would reporting this information improve animal welfare? If so, how?
  2. If research facilities were required to report the purposes of their animal research activities, what types of information should be provided, and why?
  3. What might be the effects, if any, on research facilities if they are required to collect and report this additional information?
  4. Does the annual reporting form currently required to be used by research facilities capture sufficient information? If not, what information is missing?

View June 24 Federal Register notice requesting comments relevant to the petition

View petition and comments received

NIH: NIH Updates Solicitation for SBIR/STTR Grant Applications (June 2015)

The NIH has updated the solicitation announcement for SBIR and Small Business Technology Transfer (STTR) grant applications. The NIEHS section has been updated to include a section on “Toxicity Screening, Testing, and Modeling,” which states an interest in “technologies to improve predictivity in toxicology testing to support the goals and initiatives of Tox21.” Specific technologies of interest include (1) physiologically relevant cell-based systems or phylogenetically lower order animal models for toxicity screening, (2) computational approaches for predictive toxicology, and (3) other technologies for enhanced toxicity testing including high-throughput measurement of gene expression, improved methods for fixing and preserving tissues, and real-time in vivo detection of oxygen radicals. The next deadline for applying for SBIR and STTR grants is September 5.

View information on applying for NIEHS grants

View information about this and other funding opportunities for alternative methods development

EPA: EPA Updates Guidance on Non-Animal Eye Irritation Tests (June 2015)

EPA has updated its guidance document describing a non-animal testing scheme for assessing eye irritation potential of EPA-registered antimicrobial cleaning products. The testing scheme uses the bovine corneal opacity and permeability, EpiOcular, and cytosensor microphysiometer assays to identify antimicrobial cleaning product Toxicity Category I, II, and III eye irritants.

Download guidance from the EPA website

View general information about pesticide registration

USDA: USDA Updates Guidelines for Validation of In Vitro Potency Assays (May 2015)

The CVB recently updated Veterinary Services Memorandum No. 800.112, “Guidelines for Validation of In Vitro Potency Assays.” This memorandum provides guidance concerning the information a manufacturer of veterinary vaccines and other biological products should provide when submitting a new potency assay for consideration by the CVB. These guidelines apply to in vitro assays used to determine the potency of such products, and provide a framework for designing in vitro potency assays and the studies needed to validate those assays. Use of in vitro assays may replace, reduce, or refine animal use for this purpose.

Veterinary Services Memorandum No. 800.112 and other recently published CVB documents are available on the USDA website.

NIEHS: NTP Requests Comments on Human "S1500" Gene Set (April 2015)

NTP requests comments on a set of human genes that have been identified and prioritized as environmentally responsive genes. This set of approximately 1500 "sentinel" genes was developed with input from the scientific community, to be used in toxicogenomics studies to screen human cells or tissues against large numbers of chemicals and evaluate transcriptional changes in response to chemical exposures. The goal is to develop a gene set that (1) is representative of highly diverse gene expression changes reported to date, (2) is capable of predicting the gene expression changes observed across the transcriptome, and (3) covers all major biological pathways.

The current version of the human S1500 gene set can be found on the NTP website. This site will be updated as changes to the list are made. The consensus strategy for selection of an appropriate sentinel gene set can be accessed at the same site. Comments on the gene set should be submitted as Microsoft Word or Excel files to Genelist@niehs.nih.gov by May 15.

FDA: FDA Science Forum (April 2015)

The FDA will hold a Science Forum on May 27-28 at their White Oak Campus in Silver Spring, Maryland. The Forum will highlight the FDA’s cutting-edge research, demonstrate how this research informs FDA’s regulatory decision-making, and provide an opportunity for internal and external participants to develop collaborations. The focus of this year’s Forum will be FDA’s eight Regulatory Science priority areas, one of which is “Modernize Toxicology to Enhance Product Safety.”

The Forum is open to FDA staff, FDA collaborators, and the public; you may attend in person or view presentations remotely. There is no registration fee, but in-person and remote attendees must register by May 15, and early registration is recommended for in-person attendees as seating is limited. More information and links to registration forms are available on the FDA website.

FDA: Guidance Issued on Photosafety Testing (January 2015)

The FDA has issued guidance document "S10 Photosafety Evaluation of Pharmaceuticals." This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies, including in vitro test methods that might be useful. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. An announcement of availability of the guidance was published in the January 27 Federal Register.

NIH: Workshop on In Vitro Tools and Models for Drug Discovery (January 2015)

A free workshop on “Validation and Qualification of New In Vitro Tools and Models for the Pre-clinical Drug Discovery Process” will be presented at the National Institutes of Health (NIH) on February 12. The workshop is being organized by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) in partnership with the American Institute for Medical and Biological Engineering and the National Center for Advancing Translational Sciences (NCATS). It will be held in the Lister Hill Auditorium on the NIH campus in Bethesda, Maryland. Additional information, agenda, a link to registration, and information on previous workshops in this series can be found on the NIBIB website.

EPA: Draft Process Document Available for Comment (January 2015)

A draft EPA document describing a “Process for Establishing and Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies” is now available for comment. The document describes a transparent, stepwise process for evaluating and implementing alternative methods of testing for acute oral, dermal, and inhalation toxicity, along with skin and eye irritation and skin sensitization. In addition, there is a discussion of the three major phases of the process and the implications for reporting information under the Federal Insecticide, Fungicide, and Rodenticide Act. Please submit comments on the document by email to Christopher Schlosser. Comments will be accepted until March 10.