- What is TiPED? TiPED is a design tool for chemists. TiPED guides the synthesis of inherently safer materials by helping chemists identify and avoid chemicals likely to disrupt the endocrine system. TiPED was designed by a team of 23 biologists and chemists – two fields that don’t generally work together in chemical design. This collaboration between fields expands the scope of both biologists and chemists to lead design safer and effective chemicals.
- So how does TiPED work? TiPED starts with a chemist theoretically at “the drawing board”. It consists of five testing tiers ranging from computer modeling up through cell-, tissue-, and whole animal-based tests. Chemists who want to know whether something they are making has the potential to disrupt the hormone system would work with partners in biology and toxicology to conduct tests from one or all of the tiers, depending on the degree of detailed knowledge they want, and the degree of confidence they need that a new molecule is not an EDC.
- What are ‘EDCs’? Where are they found? EDCs are endocrine disrupting chemicals - chemicals which can interfere with the human hormone system. The human endocrine system uses chemical signals—hormones—to direct development and reproduction, regulate body function and metabolism, control cell processes that can lead to cancers such as breast and prostate cancer, and influence behavior and immunity. Endocrine disruption takes place when a chemical interferes with normal hormone signaling. Science indicates that endocrine disruption is linked to problems such as infertility, genital malformation, obesity, diabetes, among other health issues. EDCs are everywhere – from food containers to household dust. They are everywhere because the process to design new chemicals never had as its responsibility the need to avoid endocrine disruption. It wasn’t that chemists set out to include them in consumer products. People didn’t know how to ask the right questions. As a result, many common consumer products contain chemicals that scientists now know to be EDCs. The U.S. Centers for Disease Control and Prevention has measured widespread human exposure to EDCs at levels that current scientific research suggests may not be safe.
- Why do we need TiPED? Consumers want products that do not contain suspected EDCs: moms want baby bottles that do not leach estrogenic chemicals into milk, people are worried about the health effects of flame retardants in their furniture, we read about hermaphroditic fish in our rivers. Companies want to make safe products but until now they have not had the right tools. TiPED can help companies and research chemists design chemicals and products that are, to the best of our scientific knowledge, unlikely to be EDCs.
- Does TiPED measure other kinds of toxicity? TiPED is intended to specifically measure the likelihood that a chemical is an EDC because there are currently no tools that can do this job. We expect to build upon the TiPED platform and address other toxicity questions.
- Are TiPED tests validated by the EPA? Assays identified for use in TiPED are not “validated” in the U.S. regulatory sense, which requires acceptance of a particular outcome as reflecting an “adverse” effect. Thus, TiPED tests do not need to be validated in this regulatory sense because they are based on widely accepted scientific principles and are performed with a battery of known controls (both positive and negative) to provide reliable information to the chemist. The goal of TiPED is to prevent EDCs from ever reaching the market, rather than proving that an already marketed chemical is toxic or an EDC.
- What does ‘inherently less toxic’ mean? Does this mean that most products on the shelf are toxic? By ‘inherently less toxic’, we mean that, by using a battery of TiPED tests, designed and performed by experts with demonstrated experience in measuring EDC effects, one can be highly confident that a chemical is not an EDC. No product on the shelf today is tested for EDC activity before it goes to market and only a very few afterward. This does not mean that they are all toxic, but it does mean that no one knows which products are “safe” from EDC activity.
- Aren’t chemicals rigorously studied and safety determined by the EPA? The EPA does not actually test chemicals. The EPA has the authority to issue data development regulations that require manufacturers and processors of existing chemicals to test their chemicals for health and environmental effects. Companies are not currently required to test for EDC activity. EPA is also exploring “high throughput” mechanized tools to measure potential chemical toxicity, called ‘ToxCast’ and Tox21. Since these tools provide only a part of the necessary picture on EDC activity, TiPED would augment these tools.
- Does using TiPED guarantee a product is safe? TiPED is not a guarantee, it gives a user confidence that, to the extent of current science, their chemical is not an EDC. TiPED will not detect all possible mechanisms of endocrine disruption, because scientific understanding of these phenomena is advancing rapidly. Going forward, TiPED or any EDC testing tool must continue to incorporate new science as it emerges.
- Why would a company want to use TiPED? Is TiPED expensive? There is a growing demand for products that are safe from EDC activity. Consumers are anxious; media coverage of the latest problem chemical seems to be ever increasing. State legislatures now consider chemical bans. All of this makes for a very uncertain market for companies. The cost of testing to make sure a chemical is safe is much less than the costs of defending that chemical in future lawsuits, than lobbying to prevent bans, or in retrofitting products. There are costs associated with doing TiPED tests, ranging from $5,000 to $500,000, depending on the depth of knowledge one wants and the degree of certainty one requires. But “an ounce of prevention is worth a pound of cure,” as Ben Franklin said, or as everyone’s mom knows, better safe than sorry.
- How can an interested company or scientist use TiPED? If interested in developing a TiPED test strategy, please call: (434-220-3701) or email info@tipedinfo.com.