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Volume 15 Issue 2

Industry and Regulatory Collaboration Pays Off for Animals

 

The Environmental Protection Agency has updated a policy which will result in fewer products being tested in the eyes of rabbits. The policy is the outcome of a multi-year project between industry, the EPA and the non-profit testing laboratory, the Institute for In Vitro Sciences (IIVS). Coordinated by The Accord Group, the project successfully identified three non-animal tests which can be used in place of the rabbit test to determine the eye irritation potential of commonly used household cleaning products.

 

The majority of cleaning products in the US do not undergo pre-market registration by the EPA. However, those which carry anti-microbial claims (e.g."Kills cold and flu viruses") are considered pesticides and animal testing is required by the EPA before they can be sold.

 

"This policy illustrates the constructive way that industry and the regulatory community can work together to replace the use of animals in testing," comments Dr. Rodger Curren, current CEO of IIVS and lead scientist on the project. "It took a lot of commitment and resources from industry and the EPA to turn this concept into a reality." It is expected that these tests will provide useful information on the eye irritation of other types of products and result in even less animal testing in years to come. To view the EPA Alternatives Testing Framework, please click here.

SCIENCE

IIVS' Respiratory Toxicology Program

  

Photomicrograph of an H&E stained human lung slice.

The Respiratory Toxicology Program at IIVS was developed to meet a growing demand to test and assess the potential toxicity of pulmonary toxicants. The scope of potential toxicants is large and includes household products (e.g. cleaning agents), personal care products (e.g powders or talcs), fragrances (e.g. perfumes and air fresheners), pharmaceuticals, and more recently, modified risk tobacco products (e.g.  E-cigarette vapors and aerosols). IIVS' longstanding expertise in assay development, standardization, and validation will again play a prominent role in the Respiratory Toxicology Program's expansion.

 

IIVS' commitment to the development and use of in vitro, non-animal, models has resulted in the acquired expertise for assessing pulmonary toxicology, and several human derived models have been identified to achieve the most relevant and meaningful results. In addition to standard 2-dimensional cell models, current models of focus include the human primary cell-derived, 3-dimensional, reconstructed airway epithelium as well as human precision-cut lung slices. These latter 3D models contain a heterogeneity of cell types that are required to assay for more complicated events that may lead to disease states such as chronic obstructive pulmonary disease. The portfolios of assays that can be conducted on these tissues include those for cytotoxicity, viability, respiratory sensitization, acute and chronic inflammation, ciliary beat frequency analysis, etc. The methods and assays used will be tailored to meet clients' needs, whether it is inhalation exposures (e.g. to evaluate an inhaled substance), systemic exposures (e.g. to assess pharmaceutical off-target effects), or a combination of both (e.g. to evaluate the efficacy of a pharmaceutical product in mitigating an adverse effect). Scientists within the program will work closely with the specific needs of clients and sponsors to meet their objectives using in vitro assay testing for product development.

 

IIVS achieves its mission in a multi-pronged manner, using science, outreach, and education as a means to promote the use of in vitro models. The Respiratory Toxicology Program has already applied this paradigm by hosting two workshops, with a third planned for spring 2016. In December of 2014, IIVS held the first workshop, "In Vitro COPD Models for Tobacco Regulatory Science", which was attended by over 60 stakeholders including industry, animal protection, academia, and government regulatory scientists (e.g. FDA Center for Tobacco Products) and was funded, in part, by a FDA R13 small workshop grant*. The Workshop Report is now available on the IIVS website, and a proceedings manuscript is being generated. The conclusions of this first in a series workshop led to a recently held (June 16-18, 2015) technical workshop, "In Vitro Models for Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays" where experts met to review these assays and generate outlines for a common protocol that will be tested in the coming months by several laboratories in a proof of principle phase. Additionally, due to the success of the 2014 workshop and continued stakeholder interest in other relevant topics, IIVS is organizing the next workshop, "In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products" scheduled for April 4-6, 2016 in Bethesda, MD. The overarching goal of these workshops is to educate scientists of all backgrounds in the use of in vitro pulmonary models and to set a path for standardization to position these models and assays into the regulatory framework of product safety assessment.

 

For more information about the Inhalation Toxicology Program, please contact Dr. Holger Behrsing at [email protected].


*Funding for the December 2014 conference was made possible, in part, by the Food and Drug Administration through grant 1 R13 FD 005299 - 01. Views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Humans Services; nor does any mention of the trade names, commercial practices or organization imply endorsement by the United States Government."


EDUCATION

Workshop Presents the Current Science of Non-Animal Test Methods

 
In May, IIVS organized a workshop for scientists from the People for the Ethical Treatment of Animals' (PETA) Regulatory Testing Department in Washington, D.C. to give updates on various non-animal testing methods currently being used by industry. The overall aim of the workshop was to provide PETA scientists with a deeper practical understanding of the methods, and to discuss how the current science can be used to provide the best information on a substance's safety without the need for additional animal testing. IIVS has presented similar workshops for other animal protection organizations as well as industry groups and regulatory agencies as part of our mission to educate stakeholders on the current science behind the use of non-animal testing methods.  The meeting began with a general presentation of IIVS's mission and the history of collaboration with PETA.  IIVS Study Directors presented on methodologies that have OECD Test Guidelines focusing on eye irritation, skin irritation and corrosion, skin sensitization, phototoxicity, and skin penetration. Special attention was given to discussing unique case studies and troubleshooting measures. PETA scientists visited the IIVS laboratory the day after the presentations for a tour and live demonstrations of some of the methods discussed. The meeting concluded with a summary and wrap-up question and answer session with all of the IIVS presenting scientists. Participants from both organizations felt this was a successful meeting and look forward to continued collaborations in the future.


 


Mid-Atlantic Society of Toxicology (MASOT) Webinar Presentation


 

Dr. Rodger Curren, CEO of IIVS, spoke on the status of regulatory acceptance of in vitro methods during a May webinar organized by the Mid-Atlantic Society of Toxicology (MASOT). The well-attended webinar, hosted by Dr. George DeGeorge of MB Research Labs,  began with a general overview of alternative methods. Information on the regulatory acceptance of these methods was shared with participants, particularly focusing on recently-validated tests. Other speakers included Thomas Hartung, CAAT/JHU and Warren Casey, NICEATM. The webinar concluded with thoughts on up-and-coming methods and current and future regulatory challenges. Abstracts from the presentations from the webinar are available on the MASOT website.


OUTREACH

Cosmetic Design Skin Care Ingredient Online Event


IIVS participated in this year's Skin Care Ingredient Online Event as a bronze sponsor. This event, the fifth event of its kind sponsored by Cosmetics Design, was created to provide the attendees the latest consumer and market insights, scientific developments and technical innovation concerning skin care ingredients. IIVS Study Director Dr. Kimberly Norman presented a webinar on the use of in vitro test methods for safety and efficacy testing on ingredients and also participated in the round table discussion at the close of the conference where general information on the global acceptance and use of in vitro methods was discussed. Additional webinar recordings and informational handouts on in vitro toxicology testing were available to participants in the event. The online event portal will remain open until September 2015. Please visit the event website to gain access to recordings of the day's presentations and additional information available in the resources area.



IIVS Continues Outreach Activities in China

 

IIVS Senior Scientist Quanshun Zhang presents on the drivers for use of in vitro methods at the Guangdong Society of Toxicology.

Through the support of its Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA) and contributors to our International Outreach Program, Dr. Rodger Curren, CEO, Ms. Erin Hill, President, and Dr. Quanshun Zhang, Senior Scientist,  attended several meetings in China to present the scientific merits of non-animal test methods to key scientists in the country. Dr. Curren gave a well-received presentation at the National Institute for Drug Control (NIFDC) in Beijing on the major concepts to consider when designing or evaluating assay validation. This was followed by participation in the "4th Annual Workshop on Alternatives" in Guangzhou. The meeting was organized by Guangdong CIQ and Sun Yat-sen University. Approximately 50 participants attended the IIVS lecture on in vitro methods for skin sensitization, a timely topic given the recent issuance of OECD test guidelines.  IIVS also participated in the "Workshop on Cosmetic Risk Assessment and Alternatives to Animal Testing" organized by the Guangdong CDC and Unilever. This meeting drew over 200 attendees from industry, academia and representatives from several provincial and national government institutions such as the China FDA (CFDA).  Dr. Curren again spoke on validation concepts while Dr. Zhang focused his presentation on the technical aspects of currently used in vitro test methods. IIVS has received several comments from regulatory officials in China that our efforts are resulting in greater interest in in vitro methods within the regulatory community. IIVS will continue supporting China's efforts to move toward the use of non-animal test methods by helping China's scientists gain momentum to advance regulatory science through training and sharing of our experiences.


 


 

Recent Publications
Upcoming Events
September 2, 2015
Research Triangle Park, NC, US

The 2015 Tissue Engineering Congress
September 8, 2015
London, UK

September 13-16, 2015
Porto, Portugal

September 15-19, 2015
Cold Spring Harbor, NY, US

September 30 - October 2, 2015
Dublin, Ireland

October 1-2, 2015
Durham, NC, US

October 21-22, 2015
Newark, NJ, US

Meeting the Information Requirements of the Animal Welfare Act: A Workshop
October 28-29, 2015
Beltsville, MD, US


News
IIVS Office Expansion and Dedication

IIVS officers and Michael Ellis, son of William Ellis, cut the ribbon on the new Ellis Suite.
In January, IIVS expanded into new office space within our current location at 30 West Watkins Mill Road in Gaithersburg, MD. An additional 3,000 square feet of administrative and office space was added to our existing facility to meet the demand of our expanding program offerings. In March, IIVS hosted a "Friends and Family" reception to open the new space and dedicate it to a long-standing member of our Board of Directors, Mr. William Ellis. Please contact us to arrange for a time to visit and tour our laboratory and new Ellis Suite.

  
 
Congratulations to Michael Balls for winning the Bjorn Eckwall Award

Congratulations to Professor Michael Balls for receiving this year's Bj�rn Ekwall Memorial Award. Prof. Balls has significantly contributed to the field of in vitro toxicology during his time as the first head of the European Center for the Validation of Alternative Methods (ECVAM), as director of the UK based animal welfare organization FRAME (Fund for the Replacement of Animal Methods) and through his continued work as an editor of the alternatives publication ATLA. The award will be presented at this year's scientific workshop of the Scandinavian Society for Cell Toxicology where Prof. Balls will deliver the "Bjorn Ekwall Memorial Lecture."

Personal Care Products Council Science Symposium

October 21-22

Newark, NJ

 

 Join IIVS and your colleagues in the personal care products industry for two days of workshops on topics ranging from safety assessment to quality assurance. IIVS Study Director Dr. Kimberly Norman will be presenting a talk titled "Current Approaches for Assessing Eye and Skin Safety of Cosmetics Using Non-Animal Methods", and will be available to answer questions at the IIVS booth. To register for the meeting, please follow this link to the PCPC website. 

 



Click here for a full list of IIVS Contributors


 


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TSCA Reform Bill Introduced

 
The Frank R. Lautenberg Chemical Safety for the 21st Century Act was introduced by Senators Tom Udall and David Vitter and contains language to pave the way for using non-animal test methodologies and tiered testing strategies in the safety evaluation of new chemicals.  The act places restrictions on the use of animal testing and calls for the evaluation of existing (i) toxicity information; (ii) computational toxicology and bioinformatics; (iii) high-throughput screening methods and the prediction models of those methods; and (iv) scientifically reliable and relevant alternatives to testing on animals that would provide equivalent information prior to requiring animal testing. The act also calls for the use of both in silico and in vitro tests (along with in vivo tests) as screening level tests within a tiered testing strategy. The complete language of the proposed bill can be viewed here.


 

    


 
 ICCVAM Public Forum

 

ICCVAM held a public forum on May 27, 2015, at the National Institutes of Health Natcher Conference Center in Bethesda, Maryland to hear ideas and suggestions from interested stakeholders and the public. The meeting began with presentations by NICEATM and ICCVAM members on current activities related to the development and validation of alternative test methods and approaches for assessing acute systemic toxicity, endocrine activity, vaccine safety, and skin sensitization potential, as well as updates on the ICCVAM processes. Updates were presented on relevant activities within several different government agencies. Participants also made public oral statements to inform ICCVAM on topics relevant to its mission and current activities. A recording of the webcast is available here on the NTP website.
    


 
 
Humane Cosmetics Act Proposed in the US Congress

 

In June, a bill was introduced in the House of Representatives to phase out animal testing on cosmetics, and prohibit the sale of cosmetics tested on animals in the US. The act, referred to as the Humane Cosmetics Act, covers both final products and ingredients.  Please read information on the bill here. 
    

  

EURL-ECVAM Recommends 

h-CLAT Method as Part of a Skin Sensitization Testing Strategy

 

 The previous issue of the IIVS newsletter mentioned the release of OECD Test Guidelines for the use of the KeratinoSens and DPRA assays for determination of a substance's skin sensitization ability. Since then, the European Commission's Joint Research Center (JRC) EU Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM) has released a statement that the human call line activation test (h-CLAT) has been validated. ECVAM is recommending the use of this method as part of an integrated testing strategy, which could also include data from other non-animal methods and in silico predictions. It is hoped that this position will strengthen discussions at the OECD aimed toward producing a test guideline on the h-CLAT method. Please read the information on the JRC website.

    


  
American Society for Cellular and Computational Toxicology


 

Join us for the 4th Annual Meeting: 


 

Integrated Approaches to Testing and Assessment: Promises

and Challenges of a More Flexible Approach to Toxicology Testing


 

October 1-2, 2015

Environmental Protection Agency

Durham, NC


 

Plenary speakers include: Warren Casey, NICEATM and Craig Rowlands, Dow Chemical Company. Please visit the ASCCT website for additional information on the program, abstract submission, and registration.


 

The American Society for Cellular and Computational Toxicology (ASCCT) is a scientific society dedicated to the promotion of toxicology testing and research that reduces and replaces the use of animals.