Articles

Competing proposals are working their way through the House and Senate to amend the Toxic Substances Control Act, the nation’s primary law for managing chemicals in commerce. In this article, former senior Environmental Protection Agency officials Charles Auer and James Aidala and attorney Lynn Bergeson discuss making the bill clearer and how congressional direction can be provided on what EPA is to do with certain new provisions to implement them in the first years of any amended TSCA.

With little fanfare, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out...

Imagine receiving a certified letter from the US Environmental Protection Agency (EPA) announcing that it plans to conduct an audit of your company’s facility in two weeks. The audit will focus on your company’s compliance obligations as a chemical manufacturer under the Toxic Substances Control Act (TSCA). Would you be prepared or are you unsure of what TSCA is and whether it applies to you? This article explains how TSCA applies to biobased chemicals and how nomenclature and chemical...

On May 29, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published the “Interim Enforcement Guidance for Hazard Communication 2012 (HCS 2012) June 1, 2015 Effective Date” (Interim Guidance). This supplements the February 9, 2015, “Enforcement Guidance for the Hazard Communication Standard’s (HCS) June 1, 2015 Effective Date” (Enforcement Guidance). The Interim Guidance clarifies specific points to manufacturers, importers, and distributors...

The Organization for Economic Cooperation and Development (OECD) issued a June 9, 2015, press release entitled "OECD chemical studies show way forward for nanomaterial safety."

On June 5, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 22 chemical substances that were the subject of premanufacture notices (PMN), including graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns (PMN Number P-14-763).

On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named "NSPW-L30SS," or "Nanosilva."

In the second installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products across a manufacturing process, from feedstock to product. In this last installment, I present options for updating TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered in as part of the original TSCA Inventory. The key is to find a way to level the field...

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Since then, S. 697 has gained additional backing from both Republicans and Democrats. These events are important because they demonstrate significant bipartisan support for reform of the Toxic Substances Control Act (TSCA), and suggest TSCA reform actually may be in our future.

Membership in the Sustainable Nanotechnology Organization (SNO) offers a number of benefits to members of the nano community. SNO's purpose is to provide a professional society forum to advance knowledge in all aspects of sustainable nanotechnology, including both applications and implications.

On April 27, 2015, the National Institute for Occupational Safety and Health (NIOSH) announced publication of "Carbon Nanotube and Nanofiber Exposure Assessments: An Analysis of 14 Site Visits" in Annals of Occupational Hygiene.  The paper is the second report from NIOSH's Industrywide Study. According to NIOSH, the findings illustrate which tasks have the highest exposures, trends in exposure, nature and character of materials involved, effectiveness of controls when used, and continued...

In the first installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products. In this article, we will look across a manufacturing process. TSCA applies to chemical substances that are used for purposes other than food, food additives, animal feed, cosmetics, drugs, tobacco and tobacco products, pesticides, munitions, and nuclear source materials. Biobased chemicals, that is, chemicals made from lignocellulose or other biomass, are finding...

Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable...

The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Nano Task Force published an article in Regulatory Toxicology and Pharmacology entitled "A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping)."

As all chemical companies doing business in the European Union (EU) should know, the "A" in REACH stands for Authorisation, the last of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) processes to be implemented since the regulation entered into force in 2008. This article reviews the path to Authorisation and reports on key developments shared during the "Lessons Learnt on Applications for Authorisation" ECHA conference held 11 February, 2015. 

On April 6, 2015, the U.S. Environmental Protection Agency (EPA) proposed a Toxic Substances Control Act (TSCA) Section 8(a) rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. 

On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the attention of the European Commission. 

On October 1, 2014, the US Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for certain related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE) (Federal Register [Fed. Reg.], 2014). For 13 NPs and NPEs, the EPA would designate any use as a “significant new use,” and for two additional NPs, the EPA would designate that any use other than use as an intermediate or use as an...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidance documents and one draft guidance document that FDA believes will provide greater regulatory clarity for industry and other stakeholders on the use of nanotechnology in FDA-regulated products. In this article, Lynn Bergeson and Carla N. Hutton review the recent guidance and highlight important considerations.

The U.S. Environmental Protection Agency's (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register. 

The resurgence of chemical production derived from renewable feedstocks reflects the new business imperatives of which chemical product manufacturers are all keenly aware: produce greener chemicals and reduce carbon footprints. Careful review of the Toxic Substances Control Act (TSCA), a law enacted almost forty years ago during the heyday of petroleum-derived chemical production, suggests that more can be done now to promote the commercialization of renewable chemicals to achieve these...

The U.S. Department of Agriculture (USDA) National Organic Program (NOP) issued on March 24, 2015, a policy memorandum clarifying the status of nanotechnology in organic production and handling under the USDA organic regulations.

Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition.

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: Development of regulatory framework conditions for the responsible handling of synthetic nanomaterials; Creation of scientific and methodical conditions aimed at identifying and preventing potential harmful...

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 use.” Persons subject to the SNURs...

“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 Space Administration...

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 veterinary...

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.