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Bishop P.L.,People for the Ethical Treatment of Animals | Bishop P.L.,PETA International Science Consortium Ltd. | Willett C.E.,The Humane Society of the United States
Birth Defects Research Part B - Developmental and Reproductive Toxicology | Year: 2014

The U.S. Environmental Protection Agency (EPA) Endocrine Disruptor Screening Program (EDSP) currently relies on an initial screening battery (Tier 1) consisting of five in vitro and six in vivo assays to evaluate a chemical's potential to interact with the endocrine system. Chemical companies may request test waivers based on Other Scientifically Relevant Information (OSRI) that is functionally equivalent to data gathered in the screening battery or that provides information on a potential endocrine effect. Respondents for 47 of the first 67 chemicals evaluated in the EDSP submitted OSRI in lieu of some or all Tier 1 tests, seeking 412 waivers, of which EPA granted only 93. For 20 of the 47 chemicals, EPA denied all OSRI and required the entire Tier 1 battery. Often, the OSRI accepted was either identical to data generated by the Tier 1 assay or indicated a positive result. Although identified as potential sources of OSRI in EPA guidance, Part 158 guideline studies for pesticide registration were seldom accepted by EPA. The 93 waivers reduced animal use by at least 3325 animals. We estimate 27,731 animals were used in the actual Tier 1 tests, with additional animals being used in preparation for testing. Even with EPA's shift toward applying 21st-century toxicology tools to screening of endocrine disruptors in the future, acceptance of OSRI will remain a primary means for avoiding duplicative testing and reducing use of animals in the EDSP. Therefore, it is essential that EPA develop a consistent and transparent basis for accepting OSRI. © 2013 Wiley Periodicals, Inc.


Sharma M.,PETA International Science Consortium Ltd | Shatkin J.A.,Vireo Advisors LLC | Cairns C.,Independent Consultant | Canady R.,Neutral Science L3C | Clippinger A.J.,PETA International Science Consortium Ltd
Risk Analysis | Year: 2016

This article presents a multistage framework for evaluating the strength of evidence of nanomaterial (NM) exposure characterization data to optimize the utility of in vitro testing strategies for human health risk assessment. This framework is intended to aid risk assessors in evaluating the relevance of data from in vitro tests and to optimize the development of new in vitro testing strategies. The initial stage frames the exposure scenarios of interest in advance of testing to incorporate aspects such as release points, route of exposure, biological and environmental transformations, dose metrics, and biological targets in subsequent stages. The second stage considers characterization in the context of a realistic exposure and the third stage involves designing a testing strategy based on expected exposure conditions. For the fourth and final stage, we propose a matrix approach to evaluate the strength of evidence obtained in the first three stages as a basis for determining the best combination of test conditions and analytical methods available to characterize and measure exposure based on the NM type. This approach can also be used to evaluate existing data for their relevance to the expected exposure scenario and to further develop and optimize in vitro testing strategies. Implementation of the proposed strategy will generate meaningful information on NM properties and their interaction with biological systems, based on realistic exposure scenarios, which will be cost effective and can be applied for assessing risk and making intelligent regulatory decisions regarding the use and disposal of NMs. © 2016 Society for Risk Analysis


Stoddart G.,PETA International Science Consortium Ltd | Brown J.,PETA International Science Consortium Ltd
ATLA Alternatives to Laboratory Animals | Year: 2014

The successful development and validation of non-animal techniques, or the analysis of existing data to satisfy regulatory requirements, provide no guarantee that this information will be used in place of animal experiments. In order to advocate for the replacement of animal-based testing requirements, the PETA International Science Consortium Ltd (PISC) liaises with industry, regulatory and research agencies to establish and promote clear paths to validation and regulatory use of non-animal techniques. PISC and its members use an approach that identifies, promotes and verifies the implementation of good scientific practices in place of testing on animals. Examples of how PISC and its members have applied this approach to minimise the use of animals for the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation in the EU and testing of cosmetics on animals in India, are described. © 2014 ATLA Alternatives to Laboratory Animals.


Polk W.W.,Integrated Laboratory Systems, Inc. | Sharma M.,PETA International Science Consortium Ltd | Sayes C.M.,Baylor University | Hotchkiss J.A.,Dow Chemical Company | Clippinger A.J.,PETA International Science Consortium Ltd
Particle and Fibre Toxicology | Year: 2016

Aerosol generation and characterization are critical components in the assessment of the inhalation hazards of engineered nanomaterials (NMs). An extensive review was conducted on aerosol generation and exposure apparatus as part of an international expert workshop convened to discuss the design of an in vitro testing strategy to assess pulmonary toxicity following exposure to aerosolized particles. More specifically, this workshop focused on the design of an in vitro method to predict the development of pulmonary fibrosis in humans following exposure to multi-walled carbon nanotubes (MWCNTs). Aerosol generators, for dry or liquid particle suspension aerosolization, and exposure chambers, including both commercially available systems and those developed by independent researchers, were evaluated. Additionally, characterization methods that can be used and the time points at which characterization can be conducted in order to interpret in vitro exposure results were assessed. Summarized below is the information presented and discussed regarding the relevance of various aerosol generation and characterization techniques specific to aerosolized MWCNTs exposed to cells cultured at the air-liquid interface (ALI). The generation of MWCNT aerosols relevant to human exposures and their characterization throughout exposure in an ALI system is critical for extrapolation of in vitro results to toxicological outcomes in humans. © 2016 Polk et al.


PubMed | PETA International Science Consortium Ltd, Baylor University, Integrated Laboratory Systems, Inc. and Dow Chemical Company
Type: | Journal: Particle and fibre toxicology | Year: 2016

Aerosol generation and characterization are critical components in the assessment of the inhalation hazards of engineered nanomaterials (NMs). An extensive review was conducted on aerosol generation and exposure apparatus as part of an international expert workshop convened to discuss the design of an in vitro testing strategy to assess pulmonary toxicity following exposure to aerosolized particles. More specifically, this workshop focused on the design of an in vitro method to predict the development of pulmonary fibrosis in humans following exposure to multi-walled carbon nanotubes (MWCNTs). Aerosol generators, for dry or liquid particle suspension aerosolization, and exposure chambers, including both commercially available systems and those developed by independent researchers, were evaluated. Additionally, characterization methods that can be used and the time points at which characterization can be conducted in order to interpret in vitro exposure results were assessed. Summarized below is the information presented and discussed regarding the relevance of various aerosol generation and characterization techniques specific to aerosolized MWCNTs exposed to cells cultured at the air-liquid interface (ALI). The generation of MWCNT aerosols relevant to human exposures and their characterization throughout exposure in an ALI system is critical for extrapolation of in vitro results to toxicological outcomes in humans.


PubMed | Brown University, Purdue University, E.I. du Pont de Nemours and Company, ETH Zurich and 20 more.
Type: Journal Article | Journal: Environmental science & technology | Year: 2016

Engineered nanomaterials (ENMs) are increasingly entering the environment with uncertain consequences including potential ecological effects. Various research communities view differently whether ecotoxicological testing of ENMs should be conducted using environmentally relevant concentrations-where observing outcomes is difficult-versus higher ENM doses, where responses are observable. What exposure conditions are typically used in assessing ENM hazards to populations? What conditions are used to test ecosystem-scale hazards? What is known regarding actual ENMs in the environment, via measurements or modeling simulations? How should exposure conditions, ENM transformation, dose, and body burden be used in interpreting biological and computational findings for assessing risks? These questions were addressed in the context of this critical review. As a result, three main recommendations emerged. First, researchers should improve ecotoxicology of ENMs by choosing test end points, duration, and study conditions-including ENM test concentrations-that align with realistic exposure scenarios. Second, testing should proceed via tiers with iterative feedback that informs experiments at other levels of biological organization. Finally, environmental realism in ENM hazard assessments should involve greater coordination among ENM quantitative analysts, exposure modelers, and ecotoxicologists, across government, industry, and academia.


PubMed | Baylor University, Environmental and Radiation Health science Directorate, Interagency Center for the Evaluation of Alternative Toxicological Methods, nanoRisk Analytics LLC and 11 more.
Type: Journal Article | Journal: Archives of toxicology | Year: 2016

The increasing use of multi-walled carbon nanotubes (MWCNTs) in consumer products and their potential to induce adverse lung effects following inhalation has lead to much interest in better understanding the hazard associated with these nanomaterials (NMs). While the current regulatory requirement for substances of concern, such as MWCNTs, in many jurisdictions is a 90-day rodent inhalation test, the monetary, ethical, and scientific concerns associated with this test led an international expert group to convene in Washington, DC, USA, to discuss alternative approaches to evaluate the inhalation toxicity of MWCNTs. Pulmonary fibrosis was identified as a key adverse outcome linked to MWCNT exposure, and recommendations were made on the design of an in vitro assay that is predictive of the fibrotic potential of MWCNTs. While fibrosis takes weeks or months to develop in vivo, an in vitro test system may more rapidly predict fibrogenic potential by monitoring pro-fibrotic mediators (e.g., cytokines and growth factors). Therefore, the workshop discussions focused on the necessary specifications related to the development and evaluation of such an in vitro system. Recommendations were made for designing a system using lung-relevant cells co-cultured at the air-liquid interface to assess the pro-fibrogenic potential of aerosolized MWCNTs, while considering human-relevant dosimetry and NM life cycle transformations. The workshop discussions provided the fundamental design components of an air-liquid interface in vitro test system that will be subsequently expanded to the development of an alternative testing strategy to predict pulmonary toxicity and to generate data that will enable effective risk assessment of NMs.


Home > Press > Nano-Toxicity Testing at Regulatory Sciences Summit: In Vitro Tests Can Most Efficiently Assess Nanomaterial Toxicity Abstract: The PETA International Science Consortium will present on nonanimal nano-toxicity testing at the Global Summit on Regulatory Science Nanotechnology Standards and Applications, September 7-9 in Bethesda, Maryland. In her talk, Dr. Monita Sharma, nanotechnology specialist for the Consortium, will describe how approaches based on nonanimal methods can predict what happens in humans exposed to nanomaterials. Nanomaterials are increasingly being used in consumer products such as cosmetics, food products, and building materials, which makes human exposure more likely. It is therefore important to assess the health effects of the growing number of nanomaterials using nonanimal methods, which more reliably predict what happens when humans are exposed than do tests on animals. Currently, the experiments conducted on animals involve applying test substances to their skin or eyes or forcing them to eat or breathe these materials. The nonanimal methods are likely to be cheaper, faster, and more accurate at predicting what happens in humans-a win for humans and animals. "Testing nanomaterials using scientifically-sound nonanimal methods is the only way to advance the field of nanotechnology while protecting human health," says Dr. Sharma. Organized by the U.S. Food and Drug Administration, the global summit is expected to draw more than 200 international participants from industry, regulatory agencies, academia, and standards-setting organizations. For more information, please visit PISCLtd.org.uk, www.piscltd.org.uk/nano, or follow us on twitter @PISCLtd. About PETA International Science Consortium Ltd. The PETA International Science Consortium was established in 2012 to coordinate the scientific and regulatory expertise of its members—PETA U.K., PETA U.S., PETA France, PETA Germany, PETA India, PETA Netherlands, PETA Asia, and PETA Australia. The Consortium works to accelerate the development, validation, and global implementation of alternatives to animal testing. For more information, please click If you have a comment, please us. Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.


Home > Press > Scientists propose non-animal tools for assessing the toxicity of nanomaterials: Particle and Fibre Toxicology publishes recommendations from expert group meeting Abstract: A workshop organized last year by the PETA International Science Consortium Ltd has resulted in an article published today in the journal Particle and Fibre Toxicology. It describes aerosol generation and exposure tools that can be used to predict toxicity in human lungs following inhalation of nanomaterials. Nanomaterials are increasingly being used in consumer products such as paints, construction materials, and food packaging, making human exposure to these materials more likely. One of the common ways humans may be exposed to these substances is by inhalation, therefore, regulatory agencies often require the toxicity of these materials on the lungs to be tested. These tests usually involve confining rats to small tubes the size of their bodies and forcing them to breathe potentially toxic substances before they are killed. However, time, cost, scientific and ethical issues have led scientists to develop methods that do not use animals. The tools described in the new article are used to deposit nanomaterials (or other inhalable substances) onto human lung cells grown in a petri dish. Co-authors of the Particle and Fibre Toxicology article are scientists from the PETA Science Consortium , The Dow Chemical Company, Baylor University, and the U.S. NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). "Promoting non-animal methods to assess nanotoxicity has been a focus of the PETA International Science Consortium", said Dr. Monita Sharma, co-author of the publication and Nanotechnology Specialist at the Consortium, "we organized an international workshop last year on inhalation testing of nanomaterials and this review describes some of the tools that can be used to provide a better understanding of what happens in humans after inhaling these substances." During the workshop, experts provided recommendations on the design of an in vitro test to assess the toxicity of nanomaterials (especially multi-walled carbon nanotubes) in the lung, including cell types, endpoints, exposure systems, and dosimetry considerations. Additional publications summarizing the outcomes of the workshop are forthcoming. About PETA International Science Consortium Ltd. The PETA International Science Consortium was established in 2012 to coordinate the scientific and regulatory expertise of its members - PETA UK, PETA US, PETA France, PETA Germany, PETA India, PETA Netherlands, PETA Asia, and PETA Australia. The Science Consortium works to accelerate and fund the development, validation, and global implementation of alternatives to testing on animals. About Particle and Fibre Toxicology Particle and Fibre Toxicology is a multi-disciplinary, open access, and peer-reviewed journal focused on understanding the physical properties and the chemistry of particles and fibres in relation to exposure in general and workplace environments and the resulting adverse human health effects. For more information, please click If you have a comment, please us. Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.


PubMed | National Center for Advancing Translational science, University Utrecht, Interagency Center for the Evaluation of Alternative Toxicological Methods, University of Stockholm and 11 more.
Type: | Journal: Toxicology in vitro : an international journal published in association with BIBRA | Year: 2017

Acute systemic toxicity testing provides the basis for hazard labeling and risk management of chemicals. A number of international efforts have been directed at identifying non-animal alternatives for in vivo acute systemic toxicity tests. A September 2015 workshop, Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing, reviewed the state-of-the-science of non-animal alternatives for this testing and explored ways to facilitate implementation of alternatives. Workshop attendees included representatives from international regulatory agencies, academia, nongovernmental organizations, and industry. Resources identified as necessary for meaningful progress in implementing alternatives included compiling and making available high-quality reference data, training on use and interpretation of in vitro and in silico approaches, and global harmonization of testing requirements. Attendees particularly noted the need to characterize variability in reference data to evaluate new approaches. They also noted the importance of understanding the mechanisms of acute toxicity, which could be facilitated by the development of adverse outcome pathways. Workshop breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, with each group crafting a roadmap and strategy to accomplish near-term progress. The workshop steering committee has organized efforts to implement the recommendations of the workshop participants.

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