Nano-engineered materials (NMs) are a diverse class of extremely small-scale (loosely defined as <100 nm in at least one dimension) materials formed by engineering at the molecular level. NMs are currently being used or developed for various applications in technology, medicine, communication, foodstuffs and food packaging, dietary supplements, over-the-counter (OTC) drugs, and many other consumer products. The National Science Foundation previously estimated that worldwide revenues for products and applications built on nanotechnology will be $2.6 trillion by 2014, or about 15% of total manufactured goods.
The small size and design of NMs can confer unique chemical, electrical, magnetic, optical, and thermal properties, which can result in vast improvements for a wide variety of applications. These same properties may also result in unanticipated health and environmental effects. However, it is not always the case that smaller nano-scale substances are more toxic than their larger scale counterparts. Much can be learned from other small-scale materials that have been well studied, such as ultra-fine particles, welding fumes, and mineral fibers, although some properties will be unique to NMs. The feasibility and success of NMs will depend on the ability to safely and reproducibly manufacture uniform (homogeneous) materials with reliable characteristics while avoiding adverse effects on health or the environment during the life cycle of these products. The more that is understood about the factors that control material properties, exposure, and toxicity, the better engineering principles can be applied to reduce potential health and environmental risks.
With more than 40 years of experience in solving complex scientific and engineering problems, Exponent is uniquely qualified to assist in the area of NMs. In addition to our recent project experience in assessing various aspects of NMs in products, Exponent’s scientists have many years of industry experience in nano-scale product manufacturing settings, including manufacturing yield enhancement, process development, materials degradation, process tooling, clean-room science and micro-contamination, defect reduction, root cause, and corrective action analysis. Additionally, the expertise of our health scientists in exposure and risk assessment, food safety, toxicology, and industrial hygiene allows us to comprehensively examine the health, regulatory, and environmental exposures and consequences of product design, manufacturing and production, foreseeable use/misuse, wear, and disposal.
The combination of high-level engineering, technological expertise, and regulatory experience, with strong health sciences, food safety, and environmental practices, provides a complete team to evaluate diverse issues related to NMs.
Our services include:
- State-of-the-science reviews for specific NMs
- Health and environmental assessment of NMs in consumer products
- Materials science evaluations to determine the potential for exposure
- Evaluation of reactivity, fire, and explosion hazards of NMs during processing
- Human and ecological exposure assessment, evaluation of exposure potential, and bioavailability studies
- Life-cycle assessments, product stewardship, and product safety and liability
- Failure modes and effects analysis for product design
- Reliability testing on NM physics of failure
- Failure analysis and material property characterization
- Applied research on specific NMs
- Regulatory assistance in bringing products containing NMs to market under relevant statutes (e.g., TSCA, FIFRA, FD&C Act)
- Medical device assessments
- Evaluation of NM issues related to food safety, dietary supplements, and food packaging materials
- Evaluation of NM issues for OTC drugs and cosmetics
- Due diligence evaluations for NM applications
- Reverse engineering
- Intellectual property protection
- NM product and process design and manufacturing support, including process metrology and robustness
- Micro-contamination expertise and product yield enhancement
- Product recall investigations
- Evaluation of the regulatory future for food NMs
Exponent is continually involved in NM-related initiatives, including definition, use, and potential exposures to and toxicity of NMs. Our scientists have organized and regularly participate in technical symposia and legal education seminars on NMs. We have been active participants at regulatory agency hearings (e.g., EPA, FDA) and in standards-setting committees such as the Nanotechnology Standards Panel of the American National Standards Institute.