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First Non-Animal Test Method Accepted by China FDA
IIVS toxicologists, Nathan Wilt and Allison Hilberer demonstrate and lend hands-on support to scientists from the CFDA.
IIVS and stakeholders around the world welcomed the announcement last month by the CFDA that data from a non-animal test method can now be used to substantiate the safety of cosmetics made in China. The test, known as the In Vitro 3T3 NRU Phototoxicity Test ( OECD Test Guideline 432 ), measures a chemical's potential to cause harm after exposure to light.
 
The announcement came shortly after the 4th annual training of CFDA provincial regulators by IIVS scientists in Hangzhou, China. These annual trainings are a key component of a Memorandum of Understanding between the CFDA's National Institute for Food and Drug Control (NIFDC) and IIVS, and are designed to assist the CFDA with the adoption and implementation of non-animal methods. To date over 400 scientists have received hands-on training in non-animal methods, including the 3T3 Phototoxicity assay. These training efforts are supported by IIVS' Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA).
 
Following the announcement, the NIFDC posted the IIVS - produced training video on the 3T3 NRU Phototoxicity test to its website to help facilitate implementation of the method (see article below).
Director of CFDA, National Institute for Food and Drug Control (NIFDC) Visits IIVS

Pictured left to right, Nan Nan, NIFDC, Rodger Curren, IIVS CEO, Li Bo, NIFDC Director, Erin Hill, IIVS President, Zhang Qinsheng, NIFDC, and Zhang Quanshun, IIVS International Outreach.

 

Composed of 11 technical institutes, the NIFDC is responsible for the registration and post market surveillance of drugs, traditional Chinese medicines, medical devices, food and cosmetics. In addition to inspecting and testing these products for safety, the NIFDC publishes National Reference Standards for testing methods (such as the newly published standard for the In Vitro 3T3 NRU Phototoxicity test) and provides technical assistance and guidance for provincial control institutes.
 
Dr. Li Bo, Director of the NIFDC, visited IIVS to gain a broader understanding of the work we do and to thank the Institute for the role it has played in bringing non-animal test methods to China. IIVS has been recognized by both the CFDA and the NIFDC as a major contributor to their plan to adopt non-animal methods for the registration and surveillance of cosmetics.
 
 
Training Video Available for In Vitro 3T3 NRU Phototoxicity Assay
Funded by a grant from the European Partnership for Alternative Approaches to Animal Testing (EPAA), IIVS has released a technical training video for the In Vitro 3T3 NRU Photoxicity Assay (OECD TG 432). The 19-minute video is a detailed description of the key steps of the method and is created to help scientists from industry and regulatory agencies perform the test in their own laboratories. Many industries around the world, including the cosmetics and pharmaceuticals sectors, assess phototoxicity to ensure the safety of their products.
 
The Phototoxicity video is the second training video produced by IIVS with EPAA's support - the first described the Bovine Corneal Opacity and Permeability (BCOP) assay (OECD TG 437). Both videos are in English (with subtitled versions in Chinese and Portuguese) and are freely available on the IIVS YouTube Channel, the EPAA website, and the ECVAM website. Following the announcement of acceptance of the 3T3 NRU Photoxicity assay in China, the NIFDC posted that video to their website, making it more accessible for Chinese scientists.
 
Observational Training Spots Available for 2017 Training Workshop
Learn and train through observation at the upcoming 2017 Practical Methods for In Vitro Toxicology Workshop at IIVS in Gaithersburg, MD.

During this intensive 3-day program, participants will hear from experts in the in vitro toxicology field, and gain laboratory experience and instruction through observation. 

Emilia Costin Appointed to ROCAM Scientific Advisory Board
IIVS Senior Toxicologist, Emilia Costin, has been appointed as a member of the Scientific Advisory Board of the Romanian Center for Alternative Test Methods (ROCAM).

A Romanian native, Dr. Costin joined IIVS in 2007. She oversees a wide range of safety and efficacy studies and research projects using in vitro testing strategies. Dr. Costin is also heavily involved in IIVS educational workshops and trainings. 

Ray Tice Receives William and Eleanor Cave Award
Raymond Tice,  former NICEATM Deputy Director and National Toxicology Program (NTP) Biomolecular Screening Branch chief, is the 2016 recipient of the William and Eleanor Cave Award. 

The award, presented biannually by the Alternatives Research & Development Foundation (ARDF), recognizes the achievements in developing and implementing alternatives to the traditional use of animals in testing, research or education. ARDF Executive Director, Sue Leary, presented Dr. Tice with the award during the 5th Annual Meeting of the American Society for Cellular and Computational Toxicology (ASCCT) in RTP, NC in late September. Dr. Tice made a generous donation from the award to create the "Tox 21 Student Presentation Award".




OECD Publishes New Guidance Documents
The OECD has published two new guidance documents in order to help standardize and ensure consistency in the use of Integrated Approaches to Testing and Assessment (IATA) in regulatory decision-making.
  • Guidance Document No. 255 explains defined approaches to testing and assessment and provides templates for reporting defined testing approaches and individual information sources.
     
    • Annexes I and II present methods and case studies specific to skin sensitization.
       
  • Guidance Document No. 256 illustrates how the defined approaches and information sources should be documented to facilitate a harmonized methodology in their reporting.

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IIVS to Present at Fraunhofer Translational Lung Research Seminar
Dr. Holger Behrsing, IIVS Principal Scientist for respiratory toxicology, will present " Pragmatic Use of 3D Lung Models to Evalutate Exposure-Induced Adverse Effects that May Contribute to Pulmonary Disease, " at the 16th Fraunhofer translational lung research seminar, Models of Lung Disease . The seminar, to be held in January 2017, will examine  the current possibilities of experimental lung research and compare different models and experimental approaches. 

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Read the Latest Publications of Interest
Barroso, Joao, et al. "International Harmonization and Cooperation in the Validation of Alternative Methods."  Validating Alternative Methods for Toxicity Testing, Ed. Whelan and C. Eskes. Springer, 2016. 343-386.

Costin, Gertrude-Emilia. " Decoding and Modulating the Color of Human Skin ." The Cosmetic Chemist. November 2016. 


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