Exponent News & Events

California Proposition 65 - New Updates

Wed, 08 May 2013 15:53:44 GMT

In 1986, the state of California enacted the Safe Drinking Water and Toxic Enforcement Act, better known as "Proposition 65". Proposition 65 requires the state of California to publish a list of chemicals known to cause cancer, birth defects, or other reproductive harm. It also prohibits the purposeful release of these listed chemicals into sources of drinking water and prohibits the purposeful exposure to a listed chemical without a clear warning. Today, this list contains over 750 chemicals including additives, pesticides, household products, drugs, dyes, foods, metals, or solvents.

On May 7th, Governor Jerry Brown of California proposed reforms to strengthen and restore the intent of Proposition 65. Although much of the proposed reforms involve legal issues, the reforms also address improving how the public is warned about dangerous chemicals and strengthening the scientific basis for warning levels. From a scientific point of view, the California Environmental Protection Agency and the Legislature will be looking to:

Compliance is complicated in that the limits for identified chemicals can vary for compound and product. Product limits are often established based on settlements resulting from prior litigation from individual or groups challenging the warning requirements.

At Exponent we work with clients to address a variety of Proposition 65 issues including:

EPA Sustainable Futures Training Workshop

Fri, 24 May 2013 20:05:37 GMT

Exponent and the EPA Office of Chemical Safety and Pollution Prevention are co-hosting a Sustainable Futures Training Workshop July 16–18, 2013 in Washington, DC.

Sustainable Futures™ is a voluntary EPA initiative that aims to promote the incorporation of Pollution Prevention principles into chemical stewardship. The goal of the Sustainable Futures™ Initiative is to make new chemicals safer, available faster, and at lower cost. It works by giving public stakeholders the same risk-screening models that EPA uses to evaluate new chemicals before they enter the market.

During this hands-on 3-day workshop, registrations will learn about a variety of tools, methods, and models that can be used to assess the hazard and potential exposure of chemicals. Methods addressed will include hazard and risk screening for human health, ecotoxicity, and environmental fate.

For more information, including workshop highlights, cost, and registration, please visit the workshop webpage or contact Exponent Senior Scientist Dr. Wendy Hillwalker.

Exponent Consultants Present at SAE World Congress

Tue, 07 May 2013 07:00:00 GMT

Several members of Exponent's consulting staff presented at the SAE World Congress in April.

In addition, Don Parker was a session organizer for a Technical Session on occupant protection related to rollover incidents. More information on the event, held April 16-18th in Detroit, can be found on the SAE website

Exponent Contributes Again to the FDLI Book “Bringing Your Medical Device to Market – Third Edition”

Wed, 22 May 2013 18:01:07 GMT

Medical device companies face extraordinary obstacles to successfully develop and market a medical device. Exponent scientists and engineers across multiple practices contributed again to the update to this book, now in its third edition. This practical, yet comprehensive book is a must-have tool for guiding medical device manufacturers through the complex process of bringing a new device to market.

Exponent Engineers Publish Hazard & Use Assessment Report on Li-Ion Batteries

Tue, 21 May 2013 22:15:47 GMT

Exponent engineers recently had their article "Lithium Ion Batteries Hazard and Use Assessment Phase IIB - Flammability Characterization of Li-Ion Batteries for Storage Protection” published by the Fire Protection Research Foundation and the Natiional Fire Protection Association (NFPA). Exponent's report compared cartoned lithium ion batteries and FM Global standard commodities. All data was supplied by FM Global and the project was conducted in conjunction with the Property Insurance Research Group (PIRG) and was directed through the Fire Protection Research Foundation. This report presents the results of Phase II of the project which is a comparative flammability characterization of common lithium ion batteries to standard commodities in storage.

The entire report can be found on the NFPA website.

Exponent Staff Participating in Symposium on Loss Prevention and Safety Promotion in the Process Industries

Mon, 29 Apr 2013 21:13:04 GMT

Exponent staff members are participating at the technical program of the 14th European Federation of Chemical Engineers Symposium on Loss Prevention and Safety Promotion in the Process Industries, on 12-15 May 2013, in Florence, Italy. This symposium, which occurs every three years, serves as a key gathering opportunity for practicing chemical engineers and process safety professionals. The objectives of this conference are to share new developments, lessons learned, and best practices in process safety, risk analysis and loss prevention. All accepted papers are peer reviewed by three independent reviewers and are also published in Chemical Engineering Transactions.

Exponent will present the following case-study derived papers at the symposium:

Additional information regarding the symposium and details regarding the papers being presented are available here.

Exponent to Host Medical Device Seminar in Shanghai, China

Thu, 02 May 2013 07:00:00 GMT

Exponent is pleased to invite China’s medical device industry to a seminar designed to educate industry participants on medical device development and the associated regulatory pathway. The seminar will be held May 15 and 16th at the Sheraton Four Points Pudong.

Participants will learn about the latest developments in implant materials and interfaces; be introduced to current trends in hip, knee, and spine technology; and review the regulatory pathway to China SFDA approval.

Exponent Speakers include Dr. Steve Kurtz, Director of our Biomedical Engineering Practice, Ryan Siskey, Senior Manager of Exponent's Philadelphia Medical Device Laboratory and Dr. Goy Teck Lim, Managing Engineer in the Polymer Science & Materials Chemistry practice based in our Shanghai office.

Day One Presentations Include:

Day 2 Presentations Include:

For registration information, click here

Potential TSCA Reform Introduced in U.S. Senate:The Lautenberg-Vitter “Chemical Safety Improvement Act of 2013"

Thu, 23 May 2013 17:25:29 GMT

A groundbreaking bi-partisan agreement to modernize the Toxic Substances Control Act (TSCA) was announced on May 22, 2013 with the introduction of The Lautenberg-Vitter Chemical Safety Improvement Act of 2013. The Act, if passed in Congress and signed into law, would significantly update and improve TSCA, which is a very dated law.

Passed in 1976, TSCA is the main law aimed at regulating chemicals in commerce. It requires EPA to compile, keep current, and publish a list of each chemical substance that is manufactured or processed in the United States. Today more than 84,000 chemical substances are on the TSCA inventory. However, TSCA has come under increased scrutiny by environmentalists, public health officials, and industry because not all chemicals brought into the stream of commerce have been tested for safety.

The new legislation would ensure that all chemicals are screened for safety to protect public health and the environment, give industry confidence that the current regulatory process would be more transparent, and support innovation. The revised law will provide the EPA the tools that it needs to make critical determinations. A new TSCA could mean significant changes and opportunities in toxicology testing and the management of safety for chemicals not covered under pesticide, drug, or other specific laws.

The Lautenberg-Vitter "Chemical Safety Improvement Act of 2013" was introduced by U.S. Senators Frank R. Lautenberg (D-NJ) and David Vitter (R-LA) and is co-sponsored by U.S. Senators Kirsten Gillibrand (D-NY), Mike Crapo (R-ID), Richard Durbin (D-IL), Lamar Alexander (R-TN), Charles Schumer (D-NY), James Inhofe (R-OK), Tom Udall (D-NM), Susan Collins (R-ME), Mary Landrieu (D-LA), Marco Rubio (R-FL), Joe Manchin (D-WV), John Boozman (R-AR), Robert Menendez (D-NJ), and John Hoeven (R-ND).

How Exponent Can Help?

Exponent’s toxicologists, ecotoxicologists, chemists, and environmental fate and exposure assessment professionals have a wide-range of experience in managing complex projects. Exponent has the technical and regulatory expertise to assist clients with TSCA’s new and existing chemical requirements. Our staff includes consultants who have previously held managerial positions in the EPA Office of Chemical Safety and Pollution Prevention (OCSPP), and we additionally have significant and successful technical and administrative task force management experience. Our consultants assist chemical manufacturers in the design of programs to support TSCA requirements.

For more information, please contact:

James C. Lamb, IV, Ph.D., DABT, Fellow ATS
Principal Scientist & Center Director
(571) 227-7203
jlamb@exponent.com

Proposed FDA Order Reclassifying Tanning Beds

Mon, 20 May 2013 19:33:37 GMT

On May 9, 2013, the U.S. Food and Drug Administration (FDA) published a proposed rule to reclassify sunlamp products, which include tanning beds, as Class II medical devices. As Class II medical devices, tanning beds would be subject to the Quality System Regulations (QSR), which define good manufacturing practices for medical devices (21 CFR § 820), and special controls, as described in 21 CFR § 360c. (a) (1) (B). Also, as Class II devices, manufacturers of tanning beds would henceforth be required to submit a 510(k) premarket notification to FDA and obtain FDA clearance in order to continue marketing these devices in the US. The requirements for a 510(k) submission are described in 21 CFR § 807.

Rapid Solutions Improve Soldiers’ Capabilities

Fri, 17 May 2013 21:45:34 GMT

Exponent's Technology Development practice has recently been featured in several news publications about our rapid prototyping and support capabilities at the US Army's Rapid Equipping Force Expeditionary Lab in Afghanistan. Exponent designed and built this lab which is dedicated to providing quick solutions to issues hampering soldiers’ performance and safety in the field. Soldiers bring their problem to the lab and our engineers immediately began producing prototype solutions. This saves the Army time and money in the product development cycle and solves problems quickly and efficiently. Dr. Stephen Jackson and Dr. San Gunawardana are currently working in the Expenditionary lab for Exponent.

Exponent has extensive experience with providing support to the military by working with the warfighter directly in theater. We have been providing a variety of engineering and technical services in support of the U.S. Army’s Rapid Equipping Force (REF) with embedded Engineers and Scientists in Iraq and Afghanistan since 2002. Exponent has worked directly with REF staff and operational commanders to quickly provide tailored off-the-shelf and novel development solutions to stated operational requirements. Exponent has outfitted, maintained and staffed field laboratories in Camp Victory, Iraq; Kandahar Airfield, Afghanistan, and Salerno Forward Operating Base, Afghanistan. Using Exponent’s skills, technical knowledge, rapid prototyping and development capability, and lab operational services in theater, we can uniquely help the military with developing and delivering critical solutions for deployed forces facing ever-changing battlefield conditions.

Recent Changes in the Endangered Species Act

Mon, 13 May 2013 17:45:48 GMT

The Endangered Species Act (ESA), along with the Bald and Golden Eagle Act and the Marine Mammal Protection Act, are among the most critical regulatory drivers to be considered in many project settings. Agriculture, renewable and conventional energy, pharmacology, mining, and other extractive industries are examples of businesses whose bottom lines are currently being affected by failure to properly consider the far-reaching impacts of the ESA.

Exponent closely tracks ESA litigation, as well as the increasingly sophisticated scientific tools needed to support endangered-species studies. To that end, we regularly provide high-level scientific consulting to help our clients manage the risks associated with the ESA.

Read more about the recent changes in the ESA landscape including how the ESA and the increase in litigation pressure means that what was heretofore a complex issue is now even more so: Exponent Alert: Recent Changes in the Endangered Species Act.