Articles

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published on March 10, 2015, an Opinion concerning exposure to silver nanoparticles that “stresses the research that has been carried out to examine the potential health and environmental effects of silver nanoparticles but notes that this is still insufficient to allow the health risks to be assessed.”...

On Feb. 9, 2015, the U.S. Occupational Safety and Health Administration (OSHA) published the Enforcement Guidance for the Hazard Communication Standard (HCS) effective June 1, 2015. The Guidance offers important insights into OSHA’s HCS enforcement strategy with regard to mixtures, and is therefore a must-read for stakeholders if they wish to be in the best possible position to avoid enforcement consequences for non-compliance with the HCS....

Between the late 1990s and early 2000s, the EPA identified potential issues presented by PFOS, a perfluorinated acid. Data showed PFOS to be present in low levels in humans and wildlife worldwide, and that PFOS appeared to be highly persistent. At the time, PFOS was used in industrial and consumer applications, including soil and stain repellant sprays, fire-fighting foams and semiconductor manufacture. Between 2000 and 2002, 3M Company, the principal domestic manufacturer of PFOS, voluntarily...

On February 2, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs). The substances include polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) (PMN Number P-13-573), which is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order.  ...

On January 28, 2015, Environment Canada announced that, with Health Canada, it has initiated a review of significant new activity (SNAc) orders and notices currently in place under the Canadian Environmental Protection Act (CEPA). See http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2 According to Environment Canada, since publication of the first SNAc in 2001, policies and practices have evolved, particularly with respect to the nature and scope of...

The Federal Office of Public Health (FOPH) announced on December 17, 2014, that the Federal Council decided to continue the action plan for synthetic nanomaterials until 2019. See http://www.bag.admin.ch/nanotechnologie/12167/?lang=en The objectives of the action plan include:...

On December 29, 2014, the U.S. Environmental Protection Agency (EPA) published a final rule signaling renewed interest in asserting Toxic Substances Control Act (TSCA) jurisdiction over finished goods. The final rule adds nine benzidine-based chemical substances to the existing significant new use rule (SNUR) on these substances, and, with respect to both the newly added and previously-listed substances, makes inapplicable the exemption relating to persons that import or process the substances...

Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes. See http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=4BCC7425-1 Environment Canada and Health Canada conduct risk assessments on new substances. These assessments include consideration of information on physical and chemical properties, hazards, uses, and exposure to...

The United States Environmental Protection Agency (EPA) released on June 25, 2014, and on August 28, 2014, final risk assessments for targeted uses of four Toxic Substances Control Act (TSCA) Work Plan chemicals. The June Assessment consists of certain uses of trichloroethylene (TCE), and the assessments released in August are for uses of methylene chloride or dichloromethane (DCM), antimony trioxide (ATO), and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB). The...

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). For 13 NPs and NPEs, EPA would designate any use as a “significant new use,” and for two additional NPs, EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a “significant new...

“On November 24, 2014, the European Parliament (EP) Committee on Environment, Public Health and Food Safety (ENVI) considered draft legislation concerning novel foods. See http://www.europarl.europa.eu/news/en/news-room/content/20141125IPR80424/html/Novel-foods-MEPs-call-for-moratorium-on-nano-foods-and-labelling-of-cloned-meat. The Committee amended the draft legislation, proposing a moratorium on the use of nanomaterials in food based on the precautionary principle. The Committee...

“On September 16, 2014, EPA released its Final 2012 Effluent Guidelines Program Plan (Final 2012 Plan) and the Preliminary 2014 Effluent Guidelines Program Plan (Preliminary 2014 Plan) under the Clean Water Act (CWA). These are important plans as they telegraph EPA’s plans for developing effluent guidelines for targeted industries. This article discusses EPA’s current plans.”...

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). See http://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_STU(2014)536293. The study analyzes the main differences between European Union (EU) and U.S. legislation in eight areas: human medicines and medical devices; cosmetics; food and nutrition; sanitary...

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). These substances are recognized as persistent and toxic in the environment. This article discusses this important move....

Chemicals play a central role in our personal and professional lives. As consumers, we focus keenly on the chemicals in the products we use and with which we come into contact. Globalization and the emergence worldwide of sophisticated chemical management programs invite complex legal, commercial, and scientific challenges. These challenges extend far beyond compliance questions that, by comparison, seem now nostalgically straightforward. Understanding these programs and their evolution can only...

The United States Environmental Protection Agency (EPA) published in the May 19, 2014, Federal Register an advance notice of proposed rulemaking (ANPR) to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information. According to EPA, this mechanism could be regulatory (under Sections 8(a) and/or 8(d) of the Toxic Substances Control Act (TSCA)), voluntary, or a combination...

On Aug. 25, 2014, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a proposed rule seeking to harmonize the hazardous materials regulations (HMR) with international regulations and standards. The rule would revise proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations and vessel stowage requirements....

Synthetic biology is delivering on its promise as an emerging scientific field in providing society with effective new sustainable products in diverse areas including renewable energy, contamination remediation, and medical applications, among others. As is the case with any rapidly evolving technology, the pace of technological innovation challenges regulators’ ability to identify and address adequately the substantial uncertainties they confront when discharging their legal obligations under...

On July 31, 2014, EPA published a Request for Information (RFI) seeking information and data on potential revisions to its Clean Air Act (CAA) Risk Management Program (RMP) regulations and related programs. In the RFI, EPA asks for information on specific regulatory elements and on Occupational Safety and Health Administration (OSHA) Process Safety Management (PSM) approaches, the public and environmental health and safety risks they address, and the costs and burdens they may impose. This...

On August 9, 2014, Canada published a proposal for adopting the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). GHS compliance is a big issue for just about all manufacturers, and understanding the approach of our neighbor to the north is important. This column summarizes the highlights....

The EPA’s Office of Air Quality Planning and Standards (OAQPS) has concluded that there is adequate evidence for lowering the existing National Ambient Air Quality Standard (NAAQS) for ozone (O3) from 75 parts per billion to between 70 ppb and 60 ppb. The recommendation is found in a 600 page long Policy Assessment for the Review of the Ozone National Ambient Air Quality Standards, issued on Aug. 29, 2014....

The National Nanotechnology Coordination Office (NNCO) announced in the September 8, 2014, Federal Register that it will hold a technical interchange meeting entitled “Realizing the Promise of Carbon Nanotubes — Challenges, Opportunities and the Pathway to Commercialization” on September 15, 2014. See http://nano.gov/2014CNTTechInterchange The meeting is sponsored by the National Nanotechnology Initiative (NNI) and co-sponsored by the National Aeronautics and...

The Federal Trade Commission (FTC) has stepped up its enforcement initiatives and recently settled two cases with companies that market plastic lumber and related products. FTC alleged that these companies misled consumers in violation of Section 5 of the FTC Act in their marketing materials regarding the environmental attributes of their products....

The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. See http://apvma.gov.au/node/11191 APVMA states that it “has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products.” APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and...

Nano product registries in Europe are the newest twist to satiating the public’s relentless “right to know.” Nominally intended to prevent hazards, facilitate monitoring, and promote consumer choice, nano product registries also risk stigmatizing nano products, diverting limited government and private resources, and potentially creating commercial barriers to a promising technology. This article in the American Bar Association’s Natural Resources & Environment magazine focuses on...

On August 1, 2014, the Pipeline and Hazardous Materials Safety Administration (PHMSA), which falls under the U.S. Department of Transportation (DOT), published an important proposed rule intended to improve the safety of transportation of large quantities of flammable materials by rail — particularly crude oil and ethanol. The proposal responds to several catastrophic railcar derailments, all involving crude oil and resulting in fatalities. The DOT also issued on the same day a companion...

On June 19, 2014, the U.S. Environmental Protection Agency (EPA) issued a direct final rule exempting manufacturers of three chemical substances from certain reporting-process-and-use information requirements under the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) rule for those compounds. This column discusses the rule and the potential value of public petitioning....

The growing number of rail mishaps involving oil is attracting much press attention and now regulatory attention as well. On May 7, 2014, the U.S. Department of Transportation (DOT) issued an emergency order requiring all railroads operating trains containing bulk quantities of UN 1267, petroleum crude oil, Class 3 that either originates or is sourced from the Bakken formation in the Williston Basin (Bakken crude oil) to notify State Emergency Response Commissions (SERC) about the...

On June 2, 2014, the U.S. Environmental Protection Agency (EPA) issued an ambitious and likely contentious rule to diminish significantly the United States’ contribution to greenhouse gases (GHG). The rule is proposed under the authority of the Clean Air Act (CAA) and takes direct aim at the coal industry by requiring a 30 percent reduction in carbon dioxide (CO2) emissions from existing fossil fuel-fired power plants by 2030, using 2005 as the baseline year. This...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402499.htm. One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance...

Reform of the Toxic Substances Control Act (TSCA) may be a little closer to reality since Rep. John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released on February 27, 2014, a much anticipated discussion draft that would update TSCA. The Chemicals in Commerce Act (CICA) keys off of Senate Bill (S.) 1009, the Chemical Safety Improvement Act (CSIA), which was introduced on May 22, 2013, by late...

On March 19, 2014, the U.S. Environmental Protection Agency (EPA) issued an administrative order to Pathway Investment Corp. (Pathway) of Englewood, New Jersey, to stop the sale of plastic food storage containers that are not registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to a press release issued on March 31, 2014, by EPA concerning the stop sale order, the Company’s Kinetic Go Green Premium Food Storage Containers...

On May 23, 2014, the U.S. Environmental Protection Agency (EPA) posted its 2014 Regulatory Agenda, which still includes RIN 2070-AJ54, “Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule.” See http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201404&RIN=2070-AJ54....

In late March, EPA and Army Corps of Engineers (Corps) proposed a rule that would dramatically revise and expand the reach of the Clean Water Act’s (CWA) jurisdiction. Unquestionably, determining the scope of the CWA’s jurisdiction, particularly over streams and tributaries, has become confusing and complex following several Supreme Court decisions and various EPA interpretations issued in response to these decisions over the years. For nearly a decade, Congress, state and local officials,...

How to address and manage potential risks posed by pesticide “drift” — the unintentional movement of some level of pesticide outside of the intended area of application — has long been a challenging, complex regulatory policy issue. It is difficult to dispute that when applying a pesticide product some small amount may, in some circumstances, move off-site. In other words: “drift happens.” The issue quickly becomes whether, from a risk management perspective, the amount of...

In last week’s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to “avoid an afterthought approach to regulatory compliance.” As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive...

Chemical plant safety is once again in the limelight due to some high profile and very public catastrophes. On January 3, 2014, a federal working group created by the Obama administration’s Executive Order (EO) 13650 issued a set of preliminary options intended to improve chemical plant safety and security. This is a priority topic commanding considerable attention and readers should be aware of and engaged in these developments. This column explains why....

The tragic spill of a chemical into the Elk River in West Virginia that occurred on Jan. 9, 2014, has spurred the development of new legislation. On Jan. 27, 2014, Senators Joe Manchin (D-W.V.), Barbara Boxer (D-Calif.), Chair of the Environment and Public Works Committee, and Jay Rockefeller (D-W.V.) introduced the Chemical Safety and Drinking Water Protection Act of 2014. The regrettable spill and the mismanagement of the spill’s consequences by federal and state regulators...

The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion on April 10, 2014, concerning HeiQ AGS-20 (AGS-20). See http://echa.europa.eu/documents/10162/21680461/bpc_opinion_heiq_ags-20_en.pdf....

Whatever window of opportunity exists to reform the Toxic Substances Control Act is closing. This is not only because the mid-term elections are fast approaching, or that there are too few legislative days left this session, or even that Congress is polarized and achieving passage of complicated chemical legislation seems intuitively beyond reach. It is also because of the emergence of international and state chemical management frameworks. This article is from the Environmental Law...

On March 7, 2014, the California Office of Environmental Health Hazard Assessment (OEHHA) released a proposal for a draft regulation amending Proposition 65 regulations. The proposal seeks changes to the warning requirements to include more detailed information, including the names of the chemicals covered by individual warnings, the ways that individuals are exposed to these chemicals, and how individuals can avoid or reduce their exposure to these chemicals. This column explains this proposal...

On Feb. 7, 2014, EPA issued a final rule under the Resource Conservation and Recovery Act authorizing the use of electronic hazardous waste manifests. The final rule will have immediate implications for virtually all domestic manufacturers of hazardous waste. This column explains why....

On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterization of nanomaterials: Best practice for REACH registrants....

On Jan. 3, 2014, a federal working group created by Executive Order 13650 issued a set of preliminary options intended to improve chemical plant security. This is a hot topic likely to command considerable attention in the New Year....

According to the study, Impact of REACH on SMEs in the Netherlands, commissioned by the Dutch Ministry for Infrastructure and the Environment, 23% of SMEs belonging to the chemical industry are not aware that they do, in fact, have obligations under REACH. A company does not need to be an SME, however, to have the false impression that it has no obligations under REACH. This article outlines frequent misconceptions regarding REACH obligations and provides guidance...

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....

It is official. California’s Office of Administrative Law (OAL) approved the California Department of Toxic Substances Control (DTSC) Safer Consumer Products regulations, and the program went into effect on October 1, 2013. The regulations mark 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. This new program is a true game-changer, and it...

Reform of the Toxic Substances Control Act (TSCA) is a little closer to happening since Representative John Shimkus (R-IL), chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released on February 27, 2014, a discussion draft updating the TSCA. The Chemicals in Commerce Act (CICA) keys off S. 1009, the Chemical Safety Improvement Act (CSIA), which was introduced last May by the late Senator Frank R. Lautenberg (D-NJ) and Senator David...

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....