Regulatory and Policy Issues to Watch for in 2013


With 2013 quickly approaching, we met with our experts to get their take on some key regulatory and policy issues that may be developing in the new year. Here are the top issues that they identified, in no particular order:

1. ASTM Subcommittee to Address Standards for Fracking

A newly formed ASTM International Subcommittee (D18.26 ) will be tackling the topic of hydraulic fracturing in 2013 by addressing the need for consensus standards in this area of the energy field. With shale gas production projected to increase almost threefold over the next two decades, the challenge will be balancing economic growth with the need to protect environmental resources and overall public health. Proposed standards will address critical areas such as: background site investigation and permitting; well installation and borehole integrity testing; engineering and drilling techniques; management and disposal of drilling fluids; groundwater monitoring and remediation; reinjection of produced well fluids; and permanent well abandonment and data reporting.

In April 2012, U.S. environment regulators postponed implementation of emission standards for natural gas and oil drillers until January 2015. Their draft rule sought to cut emissions of so-called volatile organic compounds (VOCs) that contribute to smog by nearly 25 percent across the oil and gas industry and by 95 percent from wells that use fracking.

2. EPA Assessing Whether to Regulate Coal Ash as Hazardous Material

In 2013, the Environmental Protection Agency (EPA) will propose to regulate coal ash for the first time to address the risks associated with the disposal of the wastes generated by electric utilities and independent power producers. Two options are being considered. The first would list coal ash residuals as special wastes subject to regulation under RCRA Subtitle C when destined for disposal in landfills or surface impoundments. The other would regulate coal ash under the Subtitle D for non-hazardous wastes. While the EPA and environmentalists believe this will lead to greater incentive for recycling, many believe companies would be unwilling to use coal ash in their recycled products if it is labeled hazardous. Once coal ash is labeled a hazardous waste, the EPA will have direct enforcement authority rather than the states. Senator John Hoeven (R-ND) intends to advance legislation during the 2013 congressional session that would establish a framework for coal ash regulation preventing the EPA from regulating the material as a hazardous waste.

3. California and Federal Regulators Watching Flame Retardants

Look for continuing pressure to eliminate flame retardants in products due to concerns over human and environmental safety and fire tests not representing end-product performance. Building insulation will be targeted with the goal of changing the codes so flame retardants are not necessary. Similar efforts over the past few years with upholstered furniture are expected to result in a revised California standard this summer and movement on a federal regulation in the coming year. The impact of new standards on fire loss will be closely monitored.

4. FDA Implementing New Regulations for Medical Devices

Two recent Food and Drug Administration (FDA) regulations will have impact on medical devices in 2013. The FDA Safety and Innovations Act (FDASIA) provisions which went into effect October 12, 2012 and the rule for Unique Device Identification (UDI) released November 19, 2012 will affect most medical devices manufactured in the United States. Under the phased-in UDI rule, most medical devices will carry a UDI code that includes a device identifier, a production identifier, and the serial number and/or expiration date of the device. Rule implementation will reduce medical errors through rapid and precise device identification and help address counterfeiting as well. Under FDASIA, the way clinical trials are approved will change, postmarket surveillance capabilities will expand, timelines for scheduling appeals meeting and issuing decisions will be shorter, and the process for reclassification of devices will change. The act also amends the type of scientific evidence necessary to demonstrate the effectiveness of an application for premarket approval.

5. EPA Releasing New Vapor Intrusion Guidelines

The long-awaited Subsurface Vapor Intrusion Guidance from EPA is due out any time and has the industry waiting with bated breath. EPA’s Office of Solid Waste and Emergency Response (OSWER) stated that they have “made substantial progress during the past year in preparing its final guidance,” having “extensively engaged stakeholders and considered extensive and substantive public comments received in 2011 and 2012.” The guidance will be for assessing and mitigating risks from chlorinated solvents migrating through the subsurface.

But here’s where it gets dicey – this new guidance will give advice for regulators on how to calculate response action levels (RALs) in order to prevent harmful exposures from indoor air, a controversial issue that is restricting regulators’ efforts in assessing and monitoring remediation activities at contaminated sites. The final version allows regulators to calculate RALs, which, if exceeded, would warrant an immediate response. Since this could affect sites that were never considered warranting such a response, many companies could find themselves in an immediate bind.

What seems to have prompted the more stringent rules is the agency’s recent Integrated Risk Information System (IRIS) assessment for the solvent trichloroethylene (TCE) — a very common contaminant at Superfund sites — which indicated a risk of cardiac birth defects from acute exposure, a position recently bolstered by a National Research Council report released only a few weeks ago. EPA’s new focus on acute exposures will drive stricter cleanups because many non-cancer health effects are based on a threshold level rather than a range of risk levels available for preventing cancer.

6. EPA Performing Registration Review on Nanosilver

Nanosilver is currently undergoing the Environmental Protection Agency’s (EPA) registration review process. Registration review is meant to ensure that products continue to perform properly without serious negative effects on human health or the environment. Although nanosilver has been used for many years as pesticides and in other products for its antibacterial properties, some research suggests that nanosilver particles may harm the environment. The EPA is considering comments and calling for additional research that weighs the risks and benefits of nanosilver. The results of this review may require new product labels and additional testing of consumer products to prevent any liability issues. RJ Lee Group is currently assisting government agencies, national laboratories, and industry by evaluating the physio-chemical properties of nanosilver and its impact on the environment.

7. U.S. Senate Reviewing House Bill to Establish Drywall Standards

The Drywall Safety Act of 2012 is meant to prevent contaminated drywall from entering the U.S. marketplace. The Consumer Product Safety Commission (CPSC) would be required to set standards for allowable levels of elemental sulfur in all drywall despite the fact that it is domestically manufactured and rarely imported because of the cost. While the CPSC uses elemental sulfur as a marker for contaminated drywall, it has not cited evidence that this marker is the source of the problem. U.S. manufacturers who have never had issues would need to prove that their drywall product does not contain elemental sulfur above a CPSC limit (yet to be established). The analysis required to quantify trace amounts of elemental sulfur is not trivial because drywall is primarily composed of gypsum which is calcium sulfate. The CPSC will likely require a sampling protocol that is statistically adequate, meaning that manufacturers would have to test enough samples and implement procedures to ensure compliance. The bill was passed by the House of Representatives and has yet to be passed by the Senate in the lame duck session this year; look for re-introduction during the 113th Congress if action is not taken.


Richard J. Lee, Ph.D.

About Richard J. Lee, Ph.D.

Dr. Lee has over 30 years’ experience specializing in forensic problem solving and technology development. He has managed laboratory operations, designed and developed novel electron microscopes, laboratory automation and information management systems, and commercialized laboratory products. Under Dr. Lee's direction, RJ Lee Group has grown from a small group to more than 200 staff across the country. Dr. Lee serves as a consultant to a wide range of industrial and governmental organizations. He has been an advisor to the Environmental Protection Agency (EPA) regarding laboratory methods for analysis of asbestos, as well as the evaluation of contamination in NYC following the events on 9/11.

Dr. Lee has also served on American Society for Testing and Materials (ASTM) methods to define analytical methods. He has been qualified as an expert witness in state and federal courts. He holds six patents and has published over 200 scientific articles and publications. Dr. Lee earned his Ph.D. in Theoretical Solid State Physics from Colorado State University and his B.S. in Physics from the University of North Dakota.

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