Articles

On March 7, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, which provides a report of the discussion and recommendations from the January 2013 expert meeting on ecotoxicology and environmental fate....

The European Union Biocidal Products Regulation dramatically changes the way biocidal active substances and biocidal products are regulated under European law. This new regulatory system is subtly different from those in other jurisdictions and EU neighboring countries, and fundamentally redefines biocidal products and treated articles. Companies exporting to the EU as a component of their global business must ensure that their supply chains and product designs are compliant with the regulation....

On January 29, 2014, the U.S. Environmental Protection Agency (EPA) released two final Alternatives Assessment Reports for the flame retardant decabromodiphenyl ether (DecaBDE) and bisphenol A (BPA) in thermal paper. The EPA’s Design for the Environment (DfE) program developed the assessments, which profile the environmental and human health hazards for DecaBDE, BPA, and their alternatives. This article explains why these assessments are important....

On February 12, 2014, the U.S. Environmental Protection Agency (EPA) issued, through a direct final rule, significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 35 chemical substances that were the subject of premanufacture notices (PMN). The 35 substances include four identified as multi-walled carbon nanotubes (generic) that were the subject of a December 3, 2012, TSCA Section 5(e) consent order....

The German Federal Environment Agency (UBA) has posted an English translation of a 2012 document entitled Concept for a European Register of Products Containing Nanomaterials. See http://www.umweltbundesamt.de/en/publikationen/concept-for-a-european-register-of-products The document states that, due to the particular uncertainties concerning evaluation of the possible risks of nanomaterials for human health and the environment, UBA supports the establishment of a European register of...

The Occupational Safety and Health Administration (OSHA) recently proposed revisions to the injury and illness reporting and recordkeeping requirements for employers. The proposal would increase workplace safety and health through improved tracking of workplace injuries and illnesses....

This “Compliance Advisor” column outlines thoughts on what might be headed our way in 2014 from the Office of Chemical Safety and Pollution Prevention (OCSPP) of the U.S. Environmental Protection Agency (EPA). Beyond the election-driven rhetoric, demands of the discrete issues that routinely come before program management will drive the EPA. An added and complicating concern may be the impact on these and all issues of continued budget cuts that challenge the EPA’s ability to...

The International Organization for Standardization (ISO) published on January 6, 2014, a report entitled Nanotechnologies — Considerations for the development of chemical nomenclature for selected nano-objects (ISO/TR 14786:2014), which is intended to provide information and analyses in support of the development of chemical nomenclature for the naming of “nano-objects.”...

The EPA issued important guidance under the Resource Conservation and Recovery Act (RCRA) on the regulatory status of commercial chemical products (CCP). This “Legal Lookout” column explains why the guidance is important, and explains it in more detail....

Biofuels have gotten all the press. But biobased chemicals have equal environmental and health potential, and also the most exposure under the Toxic Substances Control Act. Implications range from irritating to crippling, depending upon a manufacturer’s response....

In a game-changing bipartisan show of support for reform of the Toxic Substances Control Act (TSCA) that few saw coming, United States (US) Senators David Vitter (R-LA) and the late Frank Lautenberg (D-NJ)—among bipartisan others—introduced on May 22, 2013, the Chemical Safety Improvement Act (CSIA), later designated Senate Bill 1009 (S.1009). CSIA provides a new and streamlined approach to reforming TSCA that stakeholders may view favorably when compared to legislative templates that have...

Most GHS adoptions will complete implementation by 2015, mandating that all mixtures must be classified according to the particular legislation of that jurisdiction. Although some variation will remain between labelling information and hazard category adoption, this greatly simplifies the process of classification and labelling for retail and consumer products. This level of harmonisation, together with the standardisation of transport labels, offers the promise of greatly simplifying and...

On December 20, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013-2016. See http://www.cdc.gov/niosh/docs/2014-106/ NIOSH describes the document as “the roadmap being used to advance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during...

On December 4, 2013, the U.S. Environmental Protection Agency (EPA) issued a final rule entailing the use of electronic reporting for certain reporting requirements under the Toxic Substances Control Act (TSCA), effective March 4, 2014. This article summarizes the final rule....

The International Organization for Standardization (ISO) has published Technical Specification (TS) 13830:2013, “Nanotechnologies — Guidance on voluntary labelling for consumer products containing manufactured nano-objects.” See https://www.iso.org/obp/ui/#iso:std:iso:ts:13830:ed-1:v1:en The purpose of the guidance “is to provide a framework to facilitate a harmonized approach for the voluntary provision of labelling for [consumer products containing...

On November 28, 2013, the International Agency for Research on Cancer (IARC) announced that the Working Group for IARC Monographs Volume 111, “Some Nanomaterials and Some Fibres,” will meet September 30 to October 7, 2014. IARC states that “[d]etails will follow shortly.”...

When the Natural Resources Defense Council sued the U.S. Environmental Protection Agency immediately after the EPA conditionally registered HeiQ AGS-20 and AGS-20 U nanosilver pesticide products, the nano community collectively held its breath. On Nov. 7, 2013, that same community let out a collective sigh of relief as the U.S. Court of Appeals for the Ninth Circuit largely upheld the EPA’s approach under the Federal Insecticide, Fungicide and Rodenticide Act in registering the first...

The U.S. Environmental Protection Agency (EPA) issued in October 2013 a final rule amending a significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances. The rule is receiving praise because it narrowly and precisely targets the scope of the “articles” (finished products) subject to the SNUR requirements....

Japan’s National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces....

On November 7, 2013, the U.S. Court of Appeals for the Ninth Circuit granted in part and denied in part the Natural Resources Defense Council’s (NRDC) petition for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20) nanosilver products....

On August 28, 2013, California’s Office of Administrative Law (OAL) approved the California Department of Toxic Substances Control (DTSC or department) Safer Consumer Products Regulations (regulations). The regulations took effect on October 1, 2013. The regulations are the much-anticipated regulatory implementation of California’s Green Chemistry Initiative. The regulations and final statement of reasons are available at http://www.dtsc.ca.gov/SCPRegulations.cfm. The scope of the...

In August 2013, the Occupational Safety and Health Administration (OSHA) proposed a controversial rule lowering the 40-year-old permissible exposure limits (PEL) for crystalline silica particles. This is big news from an agency from that we hear little....

On October 8, 2013, Sweden issued a report proposing a national action plan for the safe use and management of nanomaterials. An English summary of the report’s recommendations is available at http://nanotech.lawbc.com/uploads/file/00125741.PDF...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs....

The California Department of Toxic Substances Control (DTSC) Safer Consumer Products Regulations are now in effect (See “California Cracks Down on Chemicals”). While the most onerous requirements for “responsible entities” (manufacturers, importers, assemblers and retailers) will not hit for a while, companies should consider taking some initial steps now to understand how these regulations may affect operations in the future....

The application of the Toxic Substances Control Act (TSCA) to biobased chemicals is sometimes overlooked, given the enthusiasm supporting the commercialization of biobased products. This “Washington Watch” article explains TSCA’s application to these products and outlines strategies to ensure the successful marketing of biobased chemical products....

The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments....

The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments....

On Aug. 1, 2013, President Barack Obama issued Executive Order (EO) 13650, ordering federal agencies to review safety rules at chemical facilities in response to the April explosion at the West Fertilizer Co., in West, Texas. The order, Improving Chemical Facility Safety and Security, seeks to close gaps in the regulation of facilities that the government believes contributed to the fatal accident. Here is a summary of that order....

Throughout 2013, the issue of the contribution of pesticide use to the decline in honeybee colony health, known as colony collapse disorder (CCD), has been increasingly controversial. Of particular concern is the role that a particular class of pesticides, known as neonicotinoids, may play in CCD. While EPA generally maintains its view that pesticides, including the neonicotinoids, are one of many factors in contributing to CCD, in July 2013, it took steps to control more...

On September 20, 2013, the National Toxicology Program (NTP) published a Federal Register notice requesting information on 20 substances, mixtures, and exposure circumstances, including nickel nanoparticles, nominated for possible review for future editions of the Report on Carcinogens (RoC)....

On August 23, 2013, the California Department of Toxic Substances Control (DTSC) released changes to the near final Safer Consumer Products Regulations (SCPR). These game-changing regulations took effect October 1, 2013. This column broadly outlines the rule and summarizes the changes....

Despite 40 years of policy tinkering and lawsuits, there is still major disagreement over the scope of the Clean Water Act (CWA) jurisdiction today. A series of conflicting lower court decisions led the Supreme Court to twice address the definition of “waters of the U.S.” (WOTUS) with respect to wetlands policy. In 2011 the EPA and the U.S. Army Corps of Engineers decided to incorporate all of the Justices’ opinions in sweeping, new draft guidance...

On June 14, 2013, the EPA proposed revisions to the Renewable Fuel Standard. The amendments seek to clear up some fuel classifications to ease the burden on the industry. The proposal would allow use of biogas from landfills to meet the obligations imposed on refiners and importers to utilize renewable feedstocks in transportation fuels; also, it clarifies the renewable biofuels that can be categorized as cellulosic biofuels. This article discusses the revisions....

On August 27, 2013, the U.S. Environmental Protection Agency (EPA) announced its proposed decision to register “Nanosilva,” a nanosilver-containing antimicrobial pesticide product....

As one of the U.S. Environmental Protection Agency (EPA) Administrator Gina McCarthy’s first official acts, on July 23, 2013, the Administrator signed a final rule easing the requirements under the Resource Conservation and Recovery Act (RCRA) for solvent-contaminated rags and wipes. The rule has been long in the making and much anticipated....

This article presents the results of a January 2013 workshop convened at the California NanoSystems Institute of the University of California, Los Angeles (UCLA) and hosted by the University of California Center for the Environmental Implications of Nanotechnology, as well as the UCLA Center for Nanobiology and Predictive Toxicology. Using carbon nanotubes as a case study, national and international leaders from government, industry, and academia discussed the utility of alternative test...

On August 7, 2013, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) through a direct final rule for 53 chemical substances that were the subject of premanufacture notices (PMN), including two PMN substances whose reported chemical names include the term “carbon nanotube” (CNT)....

While regulators are generally supportive of new chemistries that can replace older, petroleum-based ones, biobased chemicals are subject to the same Toxic Substances Control Act (TSCA) that governs every other chemical substance in the United States. Surprisingly, biobased chemicals that are considered to be “new chemicals” may actually receive more scrutiny under this law than established chemicals do. The following article provides practical information about the TSCA provisions that are...

Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. The renewable chemicals’ market is estimated to reach $83.4 billion by 2018 in applications ranging from transportation and agriculture to textiles and cosmetics. In addition to all the elements great companies need to succeed — a great product, a great brand, inspiring leadership, and vision — biobased product companies need to understand how the U.S....

Senators David Vitter (R-LA) and the late Frank Lautenberg (D-NJ) introduced S. 1009, the Chemical Safety Improvement Act (CSIA), in May 2013. The CSIA provides a new approach to Toxic Substances Control Act (TSCA) reform that, to date, has met with broad stakeholder approval. Highlights of the draft bill are below....

The U.S. International Trade Commission (ITC) published a notice in the July 30, 2013, Federal Register announcing that, following receipt of a letter from the United States Trade Representative (USTR), it instituted investigation No. 332-541, “Trade Barriers that U.S. Small and Medium-sized Enterprises Perceive as Affecting Exports to the European Union.”...

The U.S. Environmental Protection Agency (EPA) recently released a fact sheet (www.epa.gov/oppt/newchems/pubs/isotopes.pdf) on reporting chemical substances that contain different isotopes of the same elements listed on the Toxic Substances Control Act (TSCA) Inventory. The document has enforcement consequences, so stakeholders should review it carefully. This column explains its significance. ...

As with many countries, Korea is pursuing a chemicals management approach that ensures substances being placed on its market are assessed for risk potential based on its use patterns while placing the burden of safe use on chemical businesses....

On April 29, 2013, the U.S. Government Accountability Office (GAO) released a report entitled “Toxic Substances: EPA Has Increased Efforts to Assess and Control Chemicals but Could Strengthen Its Approach.” The report is available at www.gao.gov/products/GAO-13-249. This article summarizes the findings and its implications....

On June 21, 2013, the European Commission (EC) began a consultation on the modification of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation annexes on nanomaterials. According to the EC, the objective of the initiative is to provide further clarity on how nanomaterials are addressed....

The United States Environmental Protection Agency (US EPA) released its first draft risk assessments developed under the Toxic Substances Control Act (TSCA) “Work Plan Program” on January 4, 2013. The draft risk assessments cover particular uses of five chemicals found in household products. While the chemicals covered in these first draft assessments may or may not be of interest to Environmental Quality Management readers, the draft assessments can give us a sense of how the...

On June 13, 2013, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Nanotechnology (WPN) published the final report Nanotechnology for Green Innovation. The report summarizes information collected from various projects undertaken by the WPN regarding the use of nanotechnology for green innovation....

In a rare bipartisan expression of support for reform of the Toxic Substances Control Act (TSCA), Sen. David Vitter, R-La., and the late Frank Lautenberg, D-N.J., introduced on May 22, 2013, the Chemical Safety Improvement Act (CSIA), S. 1009. The bill offers a new and potentially politically viable framework for TSCA reform and renewed hope that badly needed modernization of this ancient law may occur. Lawyers and others in this space need to be keenly...

As part of the Toxic Substances Control Act (TSCA) Work Plan, EPA announced on March 27, 2013, that it would begin assessments on 23 chemicals, with a specific focus on flame retardant chemicals. The Agency will evaluate 20 flame retardant chemicals, conducting full risk assessments for four of the flame retardants, three of which are on the TSCA Work Plan, and one of which was the subject of an Action Plan....