Partners E. Lynn Grayson and Steven M. Siros have published a new article titled “Nanotechnology: U.S. Regulatory Framework and Legal Risk Management” in the Westlaw Journal of Toxic Torts addressing some of the legal and technical challenges associated with nanotechnology. While nanotechnology offers the opportunity for tremendous scientific advances in industrial, commercial, and consumer products, and has been referred to by some as the second coming of the Industrial Revolution, there has been growing concern and associated regulatory scrutiny with respect to how nanotechnology interacts with human health and the environment. The article provides an overview of how nanotechnology is defined, key regulatory initiatives, public and private partnerships assessing potential concerns, and risk management considerations.
Last week, the EPA-specific listing on the website of the Office of Information and Regulatory Affairs was updated with timelines on the EPA’s regulatory efforts. Of potential interest, in chronological order of expected release, are the following rules:
- May 2015 (Final Rule). Clean Water Rule: Definition of “Waters of the United States”. The U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers proposed a rule for determining whether a water is protected by the Clean Water Act.
- June 2015 (ANPRM and NRPM). Proposed Greenhouse Gas Endangerment and Cause or Contribute Findings Under CAA Section 231 for Aircraft, and ANPRM on the International Process for Reducing Aircraft GHGs and Future Standards. In this action, EPA will determine whether greenhouse gas emissions from aircraft cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare. Concurrent with these proposed findings, EPA will release an Advanced Notice of Proposed Rulemaking (ANPRM) to provide an overview of the International Civil Aviation Organization's (ICAO) efforts to reduce greenhouse gas emissions.
- June 2015 (NPRM). Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles--Phase 2. These second sets of standards would further reduce greenhouse gas emissions and fuel consumption from a wide range of on-road vehicles from semi-trucks to the largest pickup trucks and vans, and all types and sizes of work trucks and buses.
- July 2015 (NPRM). Non-Hazardous Secondary Materials--Additions to List of Categorical Non-Waste Fuels; Other Treated Woods. The Treated Wood Council has submitted a petition for various types of treated wood to be added as categorical non-waste fuels. Materials classed as NHSM can be burned for fuel in lightly regulated boilers rather than more strictly regulated incinerators.
Tiny microbeads are introduced everyday into waterways from many personal care products and over the counter drugs. The plastic microbeads (often made of polyethylene or polypropylene) are recent additions in facial scrubs, soaps, toothpastes and other personal care products as abrasives or exfoliants. A single product may contain as many as 350,000 of these nanoparticles. Last week, EPA’s Janet Goodwin, Chief of the EPA Office of Wastewater’s Technology and Statistics, confirmed again that EPA lacks regulatory authority under the Clean Water Act to regulate consumer use of plastic microbeads entering wastewaters, despite growing concern over impacts to the environment.
According to Ms. Goodwin, most of the plastic microbeads that are found in wastewater effluent come from consumer use. The EPA only has authority to regulate plastic microbeads that enter wastewater from industry, either through effluent guidelines or pretreatment standards.
On April 28, 2015, EPA announced the availability of a problem formulation and initial assessment document for the Work Plan Chemical 1,4-Dioxane and opened a 60-day public comment period until June 29. The notice also seeks input on EPA's Office of Pollution Prevention and Toxics' (OPPT) initial concerns about the industrial solvent 1,4-Dioxane.
Following receipt of comments on the problem formulation and initial assessment document and consideration of any additional data or information received, EPA will initiate a risk assessment which is the process to estimate the nature and probability of adverse health and environmental effects in humans and ecological receptors from chemical contaminants that may be present in the environment.
At long last, with a 15-5 bipartisan vote, a Senate bill that would amend the Toxic Substances Control Act (TSCA) moved out of the Senate's Environment and Public Works Committee. Notwithstanding continuing objections from Senator Boxer, the bill that came out of the committee contained a host of changes from the original bill that were intended to address concerns that had been raised by democrats, environmental and public health advocates and U.S. EPA.
Several of these key changes include:
On Friday, April 17th, Jenner & Block partnered with ComEd and Exelon to clean up the 12th Street beach at Northerly Island, in cooperation with the Alliance for the Great Lakes. Our group picked up over 85 pounds of broken glass, plastic beverage containers, food wrappers, cigarettes, and other miscellaneous trash and debris.
The Adopt-a-Beach program is the premier volunteer initiative for the Alliance for the Great Lakes. Teams remove litter and enter results into the Adopt-a-Beach online system to share with local beach authorities, educate the public, and improve the beaches and the health of the Great Lakes.
This picture shows our team after clean up efforts at 12th Street beach:
What will you do to celebrate Earth Day 2015? How about participating in the Adopt-a-Beach program?
To learn more about beach clean up opportunities or to schedule an event, visit http://www.greatlakes.org/.
A special thanks to our own Gay Sigel for organizing the Jenner & Block team. Thanks, Gay!
EPA has proposed one-time reporting and record keeping requirements on nanoscale chemical substances in the marketplace. The proposed rule contains a 90-day public comment period. After the comment period, EPA will review and consider those comments before issuing any final rule. EPA also anticipates a public meeting during the comment period to obtain additional public input.
Specifically, EPA proposed requiring companies that manufacture or process (or intend to manufacture or process) chemical substances in the nanoscale range to electronically report information, including the specific chemical identity, production volume, methods of manufacture, processing, use, exposure and release information, and available health and safety data. The proposed rule would apply to chemical substances that have unique properties related to their size. The proposed rule contains exclusions for chemical substances in the nanoscale range that would not be subject to the rule. In addition to this proposed one-time reporting on chemical substances manufactured or processed as nanoscale materials already in commerce, EPA currently reviews new chemical substances manufactured or processed as nanomaterials prior to introduction into the marketplace to ensure that they are safe.
Chemical substances that have structures with dimensions at the nanoscale -- approximately 1-100 nanometers (nm) -- are commonly referred to as nanoscale materials or nanoscale substances. A human hair is approximately 80,000-100,000 nanometers wide. These chemical substances may have properties different than the same chemical substances with structures at a larger scale, such as greater strength, lighter weight, and greater chemical reactivity. These enhanced or different properties give nanoscale materials a range of potentially beneficial public and commercial applications; however, the same special properties may cause some of these chemical substances to behave differently than conventional chemicals under specific conditions.
EPA is proposing this new requirement under TSCA Section 8(a) to determine if further action, including additional information collection, is needed.
More information about the proposed rule, including the Federal Register notice, EPA fact sheet and press release, are available at http://www.epa.gov/oppt/nano/.
EPA Administrator Gina McCarthy recently testified before the Senate Environment and Public Works Committee regarding EPA's proposed 2016 fiscal year budget. EPA's 2016 fiscal year from October 1, 2015 through September 30, 2016. EPA is seeking an increase of $453M over the FY2015 budget to $8.6B proposed in FY2016.
FY2016 budget highlights include funding to address:
1. Making a visible difference in communities across the country—efforts focused on coordination with other federal agencies, states, tribes and stakeholders to provide community support for needed assistance and support for capacity building, planning, and implementation of environmental protection programs;
2. Addressing climate change and improving air quality—actions to reduce climate change and support the President's Climate Action Plan including new proposed funding for greenhouse gases through commonsense standards, guidelines and voluntary programs;
3. Protecting the Nation's Waters—focus on to ensure waterways are clean and drinking water is safe because there are far reaching effects when rivers, lakes and oceans become polluted;
4. Taking steps to improve chemical facility safety—support to improve the safety and security of chemical facilities and reduce the risks of hazardous chemicals to facility workers and operators, communities and responders;
5. Protecting our lands—continued work to cleanup hazardous and nonhazardous wastes that can migrate to air, groundwater and surface water and soils;
6. Ensuring the safety of chemicals and preventing pollution—expand chemical safety programs and enhance quality, accessibility and usefulness of information about commercial chemicals and pesticides;
7. Continuing EPA's commitment to innovative research & development—R&D efforts to address the interplay between air quality, climate change, water quality, healthy communities and chemical safety;
8. Supporting state and tribal partners—new funds for categorical grants and setting the bar for continuing partnership efforts with states and tribes;
9. Maintaining a forward looking and adaptive EPA—emphasis on physical footprint including space optimization and essential renovations of laboratories throughout the U.S.; and,
10. Reducing and eliminating programs—elimination of programs that have served their purpose and accomplished their mission for a cost savings of $44M.
For more information on the proposed budget, visit http://www2.epa.gov/planandbudget/fy2016.
On March 13, 2015, the Environmental Appeals Board ("EAB") struck down a landmark $2,751,800 penalty that had been imposed on Elementis Chromium for its alleged failure to comply with the Toxic Substances Control Act's ("TSCA") reporting obligations under Section 8(e). Under TSCA Section 8(e), companies are obligated to report information showing that chemicals and/or mixtures that they manufacture pose substantial health or environmental risks unless it can be demonstrated that U.S. EPA has been "adequately informed" of the health and/or environmental risks.
In November 2013, an Administrative Law Judge ("ALJ") ruled that Elementis had violated Section 8(e) by failing to report to U.S. EPA a 2002 study that allegedly showed an increased risk of lung cancers for workers exposed to hexavalent chromium and upheld a $2.5 million penalty that had been imposed by U.S. EPA. On appeal, Elementis argued that U.S. EPA's guidance on what needed to be reported under TSCA Section 8(e) was ambiguous and that Elementis could not have known that the 2002 study needed to reported, especially in light of the fact that OSHA had concluded that the study lacked any new risk information. Elementis also argued that the five-year statute of limitations provided for in 28 U.S.C. 2462 rendered U.S. EPA's claims time-barred (more than five years had lapsed between the time that Elementis had received the study in 2002 and U.S. EPA's 2010 enforcement proceeding).
The EAB agreed that Elementis was not required to provide the 2002 study to U.S. EPA. The link between hexavalent chromium and lung cancer has been known for decades and none of the information in the 2002 epidemiological study showed that hexavalent chromium exposure results in a more severe effect than lung cancer or a shorter time to the onset of lung cancer than was already documented in prior studies. The EAB noted that U.S. EPA's long-standing interpretive guidance provides that information is exempt from TSCA Section 8(e) reporting if it is corroborative of information U.S. EPA already is aware of. Per U.S. EPA, information is "corroborative" if it does not show that well-established adverse effect is of a more serious degree or different kind than previously known. Information may very well be new, different, and valuable without showing an adverse effect to be substantially more serious. However, unless such new information shows a more serious or different risk, per the EAB ruling, it does not need to be reported under TSCA Section 8(e).
Although the EAB reversed the ALJ's penalty determination, it did give U.S. EPA a victory on the statute of limitations issue. The EAB rejected Elementis' statute of limitations argument, finding that TSCA Section 8(e) imposed a continuing duty to report health and safety information. As such, a Section 8(e) violation constitutes a "continuing violation" for statute of limitations purposes. Thus, the period of limitations for a Section 8(e) violation commences anew each day that the information is not reported to U.S. EPA.
Please click here to read a copy of the EAB's March 13, 2015 decision.
On January 12, 2015, California's Office of Environmental Health Hazard Assessment ("OEHHA") proposed modifications to California's controversial Proposition 65 regulations. As any company that does business in California should know, Proposition 65 requires that a warning be provided for any product that contains one of hundreds of chemicals identified on the Proposition 65 list if there is any risk of a person being exposed to the listed chemical above a specified threshold. As a result, one is bombarded with Proposition 65 warnings from the point one disembarks onto the jet bridge until the time one arrives at his/her hotel and orders room service. OEHHA's proposed amendments to Proposition 65 appear to do little to ease the regulatory burden on companies that do business in California and/or minimize the burden of having to read all of the Proposition 65 warnings.
Overview of Proposed Changes
Warnings Must Now Identify Specific Chemicals: OEHHA has listed the following 12 chemicals which must be identified by name in any Proposition 65 warning: Acrylamide; Arsenic; Benzene; Cadmium; Carbon Monoxide; Chlorinated Tris; Formaldehyde; Hexavalent Chromium; Lead; Mercury; Methylene Chloride; and Phthalates.
Modified "Safe Harbor" Language: In order to avail oneself of the "safe harbor" warning, the warning must state that a product "can expose you" to a chemical or chemicals as opposed to the old "safe harbor" language that merely required that the warning state that the product "contains a chemical" that is known to the State to cause cancer or reproductive toxicity. In addition, for the following consumer products and services, specific warnings would be required: food and dietary supplements; alcoholic beverages; restaurant foods and non-alcoholic beverages; prescription drugs; dental care; furniture; diesel engine exhaust; parking facilities; amusement parks; designated smoking areas; petroleum products; service station and vehicle repair facilities.
New Lead Agency Website: The proposed regulations would also create a new section on the OEHHA website that would provide detailed information on products and exposures. OEHHA would also have the authority to request that businesses provide more detailed information, including estimated levels of exposure for listed chemicals.
Limited Responsibility for Retailers: Retailers would be relieved from Proposition 65 liability in most circumstances and the responsibility for providing the requisite Proposition 65 warning would fall squarely on the manufacturer, distributer, producer and/or packager.
OEHHA will be accepting written comments on the proposed changes until April 8, 2015. Not surprisingly, OEHHA's proposed regulations have not been warmly received by industry and it is expected that affected businesses and trade associations will be submitting comments in opposition to these proposed amendments. Please click here and here to see the text of the proposed amendments.