Alternative Approaches to the Safety Assessment of Natural Ingredients and Extracts in Cosmetics
Monday, Monday 12, 9:15 AM–12:00 Noon
There is growing consumer demand for naturally-derived ingredients and botanical extracts such as those used as food or as flavoring agents and those in personal care products. A major driver for this demand is the consumer’s perception that such products are more safe and therefore healthier and eco-friendly. While quality standards exist for certification of organic and natural cosmetics, there are no globally accepted safety assessment standards for these products. The overall goal of this session is to ensure everyone has a basic understanding of the current alternative approaches used in the safety assessment of botanical ingredients. The panelists will also discuss how to address additional knowledge and data gaps in order to gain a more global acceptance of their use in the safety assessment of topical cosmetic products.
Alternatives to Animal Testing 21st Century Validation Strategies—One Size No Longer Fits All
Monday, March 12, 2:00 PM–4:45 PM
Recent advances in systems biology, testing in cells and tissues and related scientific fields offer the potential to fundamentally change the way that chemicals and drugs are tested for their risk to humans. These advances in toxicology testing may also replace, reduce, or refine animal testing, but roadblocks exist to incorporating these new methods into regulatory assessments.
One major challenge is validating these new technologies for use in regulatory framework. Investments in new toxicology testing methods and better validation strategies can enable the regulatory agencies to better protect and promote the health of people in the United States and throughout the world. To meet this challenge will require an active dialogue and early collaboration among all stakeholders, including federal regulatory agencies, academia, industry scientists, and consumers.
Panelists open this dialogue and discuss what constitutes a more flexible approach to demonstrating that these new toxicology testing methods are scientifically valid and address the fundamental questions of human safety and efficacy.
Breast Cancer As a Multifactorial Disease: Interaction of Genetics, Life Stage, and Environment
Monday, March 12, 2:00 PM–4:45 PM
Despite decades of research into its causes and treatments, breast cancer remains the most common invasive cancer and the second leading cause of cancer mortality for women in the US About one in eight women will contract breast cancer in their lifetime. Worldwide, breast cancer comprises 22.9 percent of all cancers (excluding no melanoma skin cancers) in women. In 2008, breast cancer caused 458,503 deaths worldwide (13.7 percent of cancer deaths in women). Breast cancer is more than 100 times more common in women than breast cancer in men, although males tend to have poorer outcomes due to delays in diagnosis. To follow-up on the 2011 report of the Institute of Medicine’s Committee on Breast Cancer and the Environment study that was funded by Komen for the Cure, expert panelists will explore the complex interaction among the potential contributors to breast cancer risk.
Dietary Supplement Adulteration with Pharmaceutical Drugs
Monday, March 12, 9:15 AM–12:00 Noon
The market for dietary supplements has increased, and the products are more and more available in stores and online. The ingredients for these products are made in many different countries and may go through many hands before being used in the products. Adulteration (the purposeful addition of ingredients not listed on the product label) can occur at any stage in the manufacturing process, which means that consumers, companies, and governments have an increased need to monitor these products. Many companies produce high-quality dietary supplement products, but sometimes products are sold that have added prescription drugs, or other ingredients that are not mentioned on the product label. The use of these sorts of products unknowingly exposes people to prescription drugs and other possibly harmful ingredients. Panelists will examine the problem from a clinician’s perspective, a regulator’s perspective, and from the perspective of international regulators. Panelists will also examine possible tools to help resolve the problem, including the use of quality standards and specifications on purity and authenticity.
James Griffiths Interview on Dietary Supplement
Scientific, Regulatory, and Public Perspectives on the Credibility and Use of Alternative Toxicological Test Methods in a Legislative Framework
Wednesday, March 14, 12:00 Noon–1:20 PM
Primary research advances in toxicology and toxicity testing significantly out paces the rate at which they can be incorporated into the legislative and regulatory decision-making framework. One of the hurdles for incorporating new approaches, technologies, and tools in toxicology into the legislative and regulatory framework is a consensus that the replacements have the suitable precision, accuracy, and scientific rigor. Panelists will explore how various advances are being used in this framework and provide a scientific, regulatory, and public perspective on the credibility and applicability of new advances for use in legislation and regulation.
Toxicological Impact of Metals, Crude Oil, and Chemical Dispersants from the Gulf of Mexico Oil Crisis on Human and Wildlife Health
Wednesday, March 14, 9:00 AM–11:45 AM
The 2010 Gulf of Mexico oil crisis was the worst environmental pollution disaster in US history. By the time the well was capped, more than 200 million gallons of crude oil poured into the Gulf over an 87-day period and to address the problem, more than two million gallons of chemical dispersants were applied to the oil, which prevented oil accumulation at the ocean surface and instead moved it into the water column and onto the ocean floor. The panelists will present and discuss some of the first studies that evaluate the impact of this strategy in view of the toxicity of the crude oil, dispersants, dispersed oil, and oil-related metals on various species including fish, whales and invertebrates, and microbes.