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On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). The new law amended significantly the Toxic Substances Control Act (TSCA) and in so doing, is redefining supply chain relationships, rewriting the rules of engagement for due diligence in mergers and acquisitions, reopening debate on new avenues in product liability and tort law, and raising important questions regarding right-to-know vs. confidential business information (CBI). TSCA, as amended, is no longer an arcane chemical statute that only chemists, consultants, and counsel for chemical manufacturers need to understand. We discuss below the significant changes in commercial transactions, supply chain relationships, and related legal areas of which Section members need to be aware, anticipate, and address. We also briefly consider TSCA and its alignment and differences with the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, and speculate on the impact Brexit might have on chemical management.
Implementation of the newly amended Toxic Substances Control Act (TSCA), signed into law last June, is in full swing. The U.S. Environmental Protection Agency (EPA) has been working hard to meet statutorily imposed deadlines for promulgating three “framework” rules by June 2017. To date, the EPA is on target. This column discusses the three framework rules.
The U.S. Environmental Protection Agency (EPA) finally concluded January 12, 2017, a ten-year effort to issue a Toxic Substances Control Act (TSCA) Section 8(a) rule establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances manufactured or processed at nanoscale. This column summarizes the rule. Reports are due to the EPA no later than May 12, 2018. The final rule is effective May 12, 2017.
The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on February 10, 2017, inviting comment on a proposed information collection plan, "Survey of Engineered Nanomaterial Occupational Safety and Health (OSH) Practices." The goal of the project is to assess the relevance and impact of NIOSH's contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace. The intended use of the data is to inform NIOSH's research agenda to enhance its relevance and impact on worker safety and health in the context of engineered nanomaterials.
Each year, millions of consumers, including large numbers of children, are exposed to unknown quantities of anti-mold pesticides when they open a shoebox. Although the active ingredient in these mostly unregistered anti-mold pesticides is undisclosed and the products are marketed as all natural, many stickers contain allyl isothiocyanate (AITC). These stickers have not been registered for this use, nor has this use, or the resulting exposure to consumers, been reviewed for safety by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or by any other regulatory agency.
It’s unlikely that shoe retailers and distributors are aware of the staggering tort liability that could be hibernating in shoeboxes. Someday, millions of unsuspecting and unprotected consumers, including children, could allege they were harmed by products few ever noticed. Even more alarming is that any consumer claims of injury from exposure to an unregistered pesticidal agent cannot be subject to preemption under FIFRA Section 24(b), 7 U.S.C. § 136v(b) because the products are unregistered and have not been reviewed by EPA. This puts U.S. distributors or retailers at risk, especially if they knew that an unregistered pesticide was present in the product and failed to warn consumers.
The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials: Current State of Knowledge and Research Needs to Advance Their Use.
On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and in so doing significantly revised the Toxic Substances Control Act (TSCA) for the first time since its enactment in 1976. This article reviews and analyzes TSCA as amended and focuses narrowly on how new TSCA specifically impacts nanoscale materials. Although the new TSCA dramatically changes how the Environmental Protection Agency (EPA) evaluates and manages industrial chemicals, including nanoscale chemicals, the absence of words or phrases such as nano or nanoscale materials means that there are no specific or additional requirements that apply explicitly to such materials. This was a significant shift from many of the earlier TSCA reform bills, which explicitly addressed nanoscale materials by proposing new definitions such as “substance characteristics” and “special substance characteristics” that included concepts such as size or size distribution; shape; surface structure; and reactivity. The new TSCA is noticeably silent on this subject and does not distinguish nanoscale materials or treat such materials differently from other chemical substances regulated under TSCA.
Last year was full of surprises, two of which will drive much of the agenda in 2017 for the Office of Chemical Safety and Pollution Prevention (OCSPP) of the U.S. Environmental Protection Agency (EPA). First, Congress significantly amended the Toxic Substances Control Act (TSCA). Although many thought the chances of successful TSCA legislation were slim, the second surprise event was even more unexpected — the election of Donald Trump as President.
Nanotechnology, biotechnology, and synthetic biology are the ploughs and tractors of the twenty-first century. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges. Genetically modified E. coli is being used to produce synthetically derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Nanopesticides and nanofertilizers are being effectively used in drought-stricken regions, eliminating or minimizing the need for conventional agricultural chemicals. These and similar technologies are essential to enable today’s agricultural professionals to compete with an increasingly unforgiving Mother Nature and an ever-increasing demand for food.
These emerging technologies do not come without potential risks, however. How to regulate them is a subject upon which stakeholders disagree.
Against this backdrop, this article considers emerging agricultural technologies, and discusses domestic agricultural oversight systems and their ability to keep pace with innovation. As discussed below, the domestic governance system is capable of addressing comprehensively the potential risks posed by these evolving technologies. The system, however, could be improved by better integration of measures to educate policy makers and regulators on these technologies, and greater involvement by the private sector in facilitating a predictable flow of information on these technologies to all stakeholders.
On December 12, 2016, the U.S. Environmental Protection Agency (EPA) issued a long-awaited final rule to reduce exposure to formaldehyde vapors from certain wood products produced domestically or imported into the United States. Formaldehyde is found in the adhesives used in a range of composite wood products. This column summarizes the new rule.
The Occupational Safety and Health Administration (OSHA) released on December 20, 2016, a white paper entitled Sustainability in the Workplace: A New Approach for Advancing Worker Safety and Health. See https://www.osha.gov/sustainability/docs/OSHA_sustainability_paper.pdf The paper highlights the importance of including worker safety and health in the growing movement toward sustainability and corporate responsibility. According to the paper, research on sustainability does not include occupational safety and health.
On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document. See http://www.environment.gov.au/protection/chemicals-management/national-standard/draft-national-standard-environmental-risk-management-industrial-chemicals According to the Department, the primary purpose of the papers is to outline the design and operation of the National Standard.
October 15, 2016, was a historic day for international climate action: nearly 200 countries reached an agreement to phase out use of hydrofluorocarbons (HFC) at the 28th meeting of the parties to the Montreal Protocol in Kigali, Rwanda. This column summarizes this historic event and its implications.
The Montreal Protocol is the international treaty designed to protect the earth’s ozone layer by requiring the phasing out of production and use of chlorofluorocarbons (CFC), substances believed to contribute to ozone depletion, many of which also contribute to greenhouse gas (GHG) production. By many accounts, the Montreal Protocol is one of the most successful international agreements ever implemented.
“Next Generation Compliance” is the U.S. Environmental Protection Agency’s (EPA) signature initiative intended to increase compliance with environmental regulations by using advances in pollution monitoring and information technology and by more effectively using and designing regulations and permits to reduce pollution and enhance compliance. This column describes EPA’s initiative, discusses several examples of its applications in rulemakings and civil enforcement settlements, discusses another new compliance-related tool, eDisclosure, and outlines the implications for industry of these novel approaches to incentivizing compliance.
Commission Implementing Regulation (EU) 2016/9 (Implementing Regulation) entered into force with retroactive effect on 26 January 2016, providing several new and important considerations and obligations for companies sharing data under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The Implementing Regulation aspires to: (1) provide useful clarity on data sharing and data compensation under REACH by providing detail on the “fair, transparent and non-discriminatory” standard; and (2) reinforce the “One Substance, One Registration” (OSOR) principle.
The U.S. Environmental Protection Agency (EPA) is continuing its brisk pace to be on target with implementing the new requirements of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (see “Grasp the Gravity of the New TSCA,” and “EPA Releases Q&As on New TSCA”). Congress has in its sights persistent, bioaccumulative, and toxic (PBT) chemicals — with the goal to reduce exposures to them. The EPA’s recent action to fast track review of five such chemicals does just that. Here’s what the EPA announced, and its impact on industry.
President Barack Obama signed into law amendments to the Toxic Substances Control Act on June 22. The amendments bring sweeping changes to the nation’s primary chemicals law. In this Bloomberg BNA Insights, Charles M. Auer and Lynn L. Bergeson look specifically at the role of ‘‘conditions of use’’ in Sections 5 and 6 under the amended law and other chemical exposure considerations.
Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions. Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions. This article analyzes that question.
On September 13, 2016, the Minnesota Department of Health (MDH) announced the availability of an updated list of chemicals of high concern. See http://www.health.state.mn.us/divs/eh/hazardous/topics/toxfreekids/highconcern.html#list
On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&As). This column explains the significance of this guidance.
On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act, ushering in a significantly enhanced, and effective immediately, chemical management law. (See “Grasp the Gravity of the New TSCA.")
The EPA has wasted no time in beginning the challenging process of implementing the law. This first step consists of preparing rulemakings and issuing guidance documents in the form of useful Q&As on a variety of topics.
The U.S. Environmental Protection Agency (EPA) has made much of its “Next Generation Compliance” initiative, created “to increase compliance with environmental regulations by using advances in pollutant monitoring and information technology combined with a focus on designing more effective regulations and permits to reduce pollution.” This involves more effective regulations and permits that include built-in compliance mechanisms, such as continuous monitoring for stationary sources; advanced monitoring, including fence-line monitoring and infrared camera systems; greater transparency, including public availability of electronic data and third-party audits; and “innovative” enforcement, including incorporating these elements in administrative and judicial settlements and injunctive relief demands. This column briefly outlines these new initiatives so Chemical Processing readers can take advantage of these programs.
It is the author’s view that the central failing of old TSCA was its inability to produce the testing needed by EPA to assess and understand the hazards, exposures, and risks of existing chemicals. New TSCA makes important changes to the authority available to EPA to compel industry to generate the information needed by EPA to meet the purposes articulated under the new law. This paper briefly reviews the issues and problems that EPA encountered in using old TSCA for this purpose, discusses the improvements in new TSCA, and discusses why the author believes they offer the potential of future success in the testing area.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182, significantly amends the Toxic Substances Control Act (TSCA). The Act was signed into law by President Obama on June 22, 2016. The date of signature is both the date of enactment and of entry into force of amended TSCA. New TSCA fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years. The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.
Two workshops, a European Union (EU)-U.S. Nano Environmental and Health Safety (NanoEHS) workshop and a nano modeling workshop, will be held in advance of the October 2016 OpenTox Euro Conference.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amends the Toxic Substances Control Act (TSCA), particularly with regard to Section 8 record keeping and reporting obligations. This article highlights a number of important changes and deadlines of which companies subject to TSCA should be aware.
On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL).
The European Commission (EC) published on July 14, 2016, a regulation in the Official Journal of the European Union that amends Annex VI, the list of ultraviolet (UV) filters allowed in cosmetic products, of the cosmetics regulation.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act makes seismic changes in domestic industrial chemical management. If you think the extensive revisions to the Toxic Substances Control Act (TSCA) enacted on June 22, 2016, don’t impact your business, think again. TSCA reform affects virtually every domestic business sector involving chemicals and manufactured goods containing chemicals, and will continue to do so for years to come.
On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles. The petition summary states: "Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer. Because the precautionary principle applies in the EU, the petitioner urges a ban on these small particles as soon as possible."
The Congressional Research Service (CRS) prepared a June 28, 2016, report, Nanotechnology: A Policy Primer. The report provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness in the field, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. According to the report, while more than 60 nations established similar programs after the launch of the National Nanotechnology Initiative (NNI), "it appears that several have moved away from centralized, coordinated nanotechnology-focused programs (e.g., the United Kingdom, Japan, Russia), some in favor of market- or application-oriented topic areas (e.g., health care technologies)."
The global chemicals industry has been presented with significant, often unfamiliar, challenges by the concept and functioning of SIEFs under REACH. Through years of experience in SIEF participation on our clients’ behalf, Acta has identified the following questions to consider when participating in a SIEF.
In-house counsel unfamiliar with the tsunami-like changes in domestic chemical management headed our way soon may wish to read this article. If you think for a second that the extensive revisions to the Toxic Substances Control Act (TSCA) expected to be enacted imminently do not impact your legal practice or your client’s business operations, think again. TSCA reform impacts virtually every business sector in the United States, and will continue to do so for years to come. Here are the reasons why you should care.
On May 3, 3016, Mexico's Ministry of Economy published a notice beginning a public consultation on two draft nanotechnology standards. ISO/TS 80004-5:2011 lists terms and definitions related to the interface between nanomaterials and biology. It is intended to facilitate communications between scientists, engineers, technologists, designers, manufacturers, regulators, non-governmental organizations (NGO), consumer organizations, members of the public, and others.
On May 31, 2016, the European Chemicals Agency (ECHA) began a public consultation on a harmonized classification and labeling (CLH) proposal submitted by France for titanium dioxide. The CLH report states: "Based on available evidence and information in the registration dossier (e.g. mechanism of carcinogenicity, characterization of the particles), the proposed scope for the Annex VI entry is: ‘Titanium dioxide in all phases and phase combinations; particles in all sizes/morphologies.'"
On March 14, 2016, the U.S. Environmental Protection Agency (EPA) proposed much-anticipated amendments to the Risk Management Program (RMP) regulations. This column summarizes the proposed amendments and industry’s response to them.
The genesis of the proposal is President Obama’s Executive Order (EO) 13650, which was issued in the aftermath of the catastrophic explosion that occurred in April 2013 that claimed 15 lives in West, Texas. The EO requires various federal agencies to develop options for better chemical facility safety and security that identify “improvements to existing risk management practices through agency programs, private sector initiatives, government guidance, outreach, standards, and regulations.” The EPA’s RMP regulations fall squarely in the zone of interest for purposes of the EO. Required under Section 112(r) of the Clean Air Act, these regulations, codified at 40 C.F.R. Part 68, apply to stationary sources that hold specified regulated substances in excess of certain thresholds. These “facilities” are required to assess their potential release impacts, undertake steps to prevent releases, plan for emergency response to releases, and summarize this information in a risk management plan submitted to the EPA.
On April 29, 2016, Australia's National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published the third consultation paper on its reform initiative. See https://www.nicnas.gov.au/about-nicnas/nicnas-reforms/consultation-paper-3 and https://www.nicnas.gov.au/about-nicnas/nicnas-reforms Under the reforms, the requirements to establish that a new chemical can be classified as being not hazardous to human health or the environment, and therefore falls in Hazard Band A, include consideration of several factors, including whether the chemical is a nanomaterial. The consultation paper states that the risk matrix applies to chemicals (and their nanoforms) that are not listed on the Australian Inventory of Chemical Substances (AICS).
On May 11, 2016, the National Nanotechnology Coordination Office (NNCO) will hold a webinar for small- and medium-sized enterprises (SME) that will focus on the experiences, successes, and challenges for SMEs working in nanotechnology and on issues of interest to the business community. See http://www.nano.gov/node/160 The National Science Foundation's Center for High-rate Nanomanufacturing, at Northeastern University's College of Engineering in Boston, will host the webinar.
Registration is now open for the June 6-7, 2016, U.S.-European Union (EU) "Bridging NanoEHS Research Efforts" joint workshop. See https://docs.google.com/forms/d/1-wZatJVQ3b9LSx9rrJeeEZqFO-8DZVs-80txK-9DBmQ/viewform and http://us-eu.org/2016%20-us-eu-nanoehs-workshop/ The workshop will bring together the U.S.-EU Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nanotechnology environmental, health, and safety (nanoEHS) research.
On April 18, 2016, the Silver Nanotechnology Working Group (SNWG) submitted comments on the National Institute for Occupational Safety and Health's (NIOSH) draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. See https://www.regulations.gov/#!documentDetail;D=CDC-2016-0001-0017 and https://www.regulations.gov/#!documentDetail;D=CDC-2016-0001-0002 The draft Current Intelligence Bulletin (CIB) includes a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects.
On March 25, 2016, the U.S. Occupational Safety and Health Administration (OSHA) issued its long-awaited revised standards for occupational exposure to respirable crystalline silica (81 Fed. Reg. 16286). OSHA issued two separate standards — one for general industry and maritime, and the other for the construction industry — to tailor requirements to the unique circumstances found in these sectors. The rule impacts more than 2.3-million American workers across a wide spectrum of industries, according to OSHA, and is expected to save the lives of more than 600 workers per year. Its implementation will likely have broad logistical and cost implications for many employers in numerous industry sectors. This article provides highlights of the final rule.
Toxic Substances Control Act (TSCA) reform has been a “work in progress” for years. House and Senate passage in 2015 of substantive TSCA reform measures considerably improved the odds that Congress would enact TSCA-reform legislation in 2016. Recent events suggest otherwise, however, and as of this writing in mid-March the fate of TSCA reform remains decidedly uncertain. Momentum has dissipated as a dithering House has been slow to engage with Senate counterparts to reconcile the different approaches contemplated under each bill. The surprisingly harsh Republican response to Associate Supreme Court Justice Scalia’s untimely demise has hardened the partisan divide that threatens to tank Congressional action on any important initiative, let alone legislation as significant and potentially divisive as TSCA reform. It is hoped that cooler heads will prevail and leverage the hard work and momentum that has brought us to this momentous place in history. This Commentary provides an update on the current state of TSCA reform efforts.
On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published a draft National Pollutant Discharge Elimination System (NPDES) pesticide general permit (PGP) for public comment. The publication marks the first reissuance of the PGP since its inception in 2011. The Sixth Circuit’s decision in National Cotton Council v. EPA, F.3d 927 (6th Cir. 2009), which vacated EPA’s 2007 rule exempting pesticides from NPDES permitting, required EPA to issue the PGP. In October 2011, EPA published a five-year PGP, which expires on October 31, 2016. Additionally, all states with delegated NPDES program authority developed and issued state versions of the PGP.
The European Chemicals Agency (ECHA) announced on March 23, 2016, a new publication co-authored with the Dutch National Institute for Public Health and the Environment (RIVM) and Joint Research Center (JRC) that illustrates how to use data for different nanoforms within the same substance registration.
The U.S. Environmental Protection Agency (EPA) released on February 25, 2016, amendments to the accidental release prevention requirements of the Risk Management Programs (RMP) under the Clean Air Act Section 112(r)(7). This column summarizes this important proposed rule.
The February 24, 2016, Official Journal of the European Union includes the opinion of the European Economic and Social Committee (EESC) on "Nanotechnology for a competitive chemical industry."
The Organization for Economic Cooperation and Development (OECD) recently published the following reports: Physical-chemical properties of nanomaterials- Evaluation of methods applied in the OECD-WPMN testing programme and categorisation of manufactured nanomaterials workshop report.
Prompted by a 2013 Commission for Environmental Cooperation (CEC) report on hazardous waste exports from the United States (CEC, 2013) and changes to the 2001 Organisation for Economic Cooperation and Development's (OECD) Council Decision for waste exports and imports, the United States Environmental Protection Agency (EPA) announced on October 19, 2015, proposed changes to its regulations under the Resource Conversation and Recovery Act (RCRA) regarding the export and import of hazardous wastes from and into the United States (EPA, 2015). EPA also proposed changes to address and respond to concerns outlined in the EPA’s Office of the Inspector General’s (OIG) July 6, 2015, report entitled “EPA Does Not Effectively Control or Monitor Imports of Hazardous Waste” (EPA OIG, 2015). This article from the Spring, 2016, issue of Environmental Quality Management, summarizes key proposed changes.
PUBLIC CONCERNS LEAD TO CHEMICAL LAW
In the 1960s and early to mid-1970s, new reports of chemicals causing cancer appeared in the press or on TV almost every month. Polychlorinated biphenyls (PCBs), used in electrical transformers for over 40 years, were being found in fish and environmental samples from around the country. Other chemicals, including those not thought to be harmful, caused serious health or environmental effects. Chlorofluorocarbons (CFCs) were depleting the earth’s protective ozone layer. Asbestos, a mineral fiber widely used in insulation, caused lung cancer, especially in workers. Polybrominated biphenyls used as flame retardants were mistakenly mixed into animal feed and poisoned people and cattle in Michigan. Eating fish contaminated with mercury caused a severe neurological syndrome in adults as well as birth defects in Minamata, Japan. And the list went on.
Although society reaps enormous benefits from chemicals, there was little or no knowledge of the effects on health or the environment of the thousands of chemicals used and released into the environment. There was not even a list of the chemicals made and used in America. The drumbeat of concerns contributed to a growing realization that environmental chemicals might cause major problems. People were suddenly aware that a man-made chemical environment of unknown dimensions literally surrounded them. Other studies pointed to the large gap in existing laws for dealing with these problems. During the 1970s, the groundswell of public concern resulted in legislative action.
On February 16, 2016, the U.S. Occupational Safety and Health Administration (OSHA) released for public comment its “Guidance on Data Evaluation for Weight of Evidence Determination.” The document aims to help employers consider all available information when classifying hazardous chemicals for labeling and safety data sheet (SDS) completion purposes. Because of the critical importance of satisfying these regulatory obligations correctly, understanding the Guidance is essential.
The European Food Safety Authority (EFSA) has begun a public consultation on its draft guidance on the preparation and presentation of an application for authorization of a novel food.
In October, the U.S. Environmental Protection Agency (EPA) announced proposed changes to its regulations under the Resource Conservation and Recovery Act (RCRA) regarding the export and import for recovery operations of hazardous wastes from and into the United States.
On October 1, 2015, the U.S. Occupational Safety and Health Administration (OSHA) released a revised Field Operations Manual (FOM), Directive Number CPL 02-00-159, available here. The FOM aims to “provide OSHA offices, State Plan programs and federal agencies with policy and procedures concerning the enforcement of occupational safety and health standards.” Because OSHA can impose higher penalties as a result of the Bipartisan Budget Act of 2015, the document is a must-read for companies subject to OSHA enforcement.
The National Institute for Occupational Safety and Health (NIOSH) posted a RAND Corporation (RAND) report entitled Nanomaterial Safety in the Workplace: Pilot Project for Assessing the Impact of the NIOSH Nanotechnology Research Center.
Biotechnology is an area of growing domestic and international importance to the manufacturing sector, and this summer the federal government announced several important biotechnology initiatives of which stakeholders should be aware. This article from the Winter, 2015, issue of Environmental Quality Management explains each initiative, and outlines why stakeholders are encouraged to engage in each one.
According to an item in the U.S. Environmental Protection Agency's (EPA) Fall 2015 Regulatory Agenda, EPA intends to promulgate a final Toxic Substances Control Act (TSCA) Section 8(a) rule in October 2016 concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.
On October 20, 2015, the U.S. Federal Trade Commission (FTC) released a “Final Order and Opinion” against ECM BioFilms, Inc., stating that ECM made false and unsubstantiated environmental claims that its additives for plastics (ECM Plastics) would make treated plastics biodegrade in a landfill. The opinion come two years after FTC issued an administrative complaint against ECM and ten months after an FTC Administrative Law Judge (ALJ) issued an Initial Decision finding ECM violated FTC Act Section 5 because evidence did not support its claims that ECM Plastics would biodegrade plastics within nine months to five years. Significantly, FTC reverses part of the ALJ’s decision, finding that FTC counsel hadn’t met its burden in proving ECM made false, misleading, and material-implied biodegradable claims that ECM Plastics will completely biodegrade in a landfill within one year, a temporal period identified in the FTC Green Guides.
The pathway to market for new products utilizing synthetic biology can be difficult to navigate, posing a challenge for companies in their efforts to commercialize new ideas, while the novelty posed by some of these products can make it difficult for regulatory agencies to evaluate risks. This report from the Synthetic Biology Project,The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?, looks at the current regulatory oversight of synthetic biology in the United States through the lens of different products. The case studies in the report look at synthetic organisms, synthetic chemicals, biopesticides, biomining products, and genetically modified plants, which are regulated by the Environmental Protection Agency, Food and Drug Administration and U.S. Department of Agriculture.
“Our report demonstrates the regulatory complexity innovators face in seeking to commercialize their products,” says Lynn Bergeson, lead author of the report and managing partner at Bergeson & Campbell PC. “The report offers some common-sense and easily implemented solutions to help federal agencies do their jobs more efficiently and offers suggestions for the regulated community to be more proactive in expanding the technological literacy of the agencies with jurisdictional oversight over their products.”
The summer of 2015 was surprisingly busy in the industrial biotechnology policy and regulatory arenas with three important announcements regenerating lots of buzz. On July 2, 2015, the White House Office of Science and Technology Policy, the Office of Management and Budget, the US Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and USDA to update and modernize the Coordinated Framework for the Regulation of Biotechnology. A few weeks later, EPA’s Office of Pollution Prevention and Toxics (OPPT) announced a project intended to support public dialog concerning the development and use of biotechnology by developing a new algae “how to” document for Toxic Substances Control Act Purposes, and to help jump start much needed public discourse around the topic of biotechnology in general. Finally, OPPT also announced that it is updating its Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms. Each of these developments is important. This article discusses these initiatives, offers insights on why stakeholders should applaud these opportunities, and urges stakeholders to seize the moment and to engage vigorously in them.
On October 20, 2015, the White House announced a grand challenge to develop transformational computing capabilities by combining innovations in multiple scientific disciplines
The Organization for Economic Cooperation and Development (OECD) recently posted a new document in its Series on the Safety of Manufactured Nanomaterials, Developments on the Safety of Manufactured Nanomaterials: 2013.
The Organization for Economic Cooperation and Development (OECD) posted a new publication in its Series on the Safety of Manufactured Nanomaterials, Preliminary Guidance Notes on Nanomaterials: Interspecies Variability Factors in Human Health Risk Assessment.
On April 6, 2015, the United States Environmental Protection Agency (EPA) proposed an important rule under Section 8(a) of the Toxic Substances Control Act (TSCA) concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. This article from the Fall, 2015, issue of Environmental Quality Management assists stakeholders in the nanoscale chemical substance area who will be directly impacted by this rule when issued in final to review the proposal carefully, understand the reporting requirements, and prepare for the implications of EPA’s review of the forthcoming required information.
On August 31, 2015, the U.S. Environmental Protection Agency (EPA) proposed an important rule under the Resource Conservation and Recovery Act (RCRA) that would ease the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals. The proposal is of interest to all participants in the pharmaceutical value chain, from manufacturers to health care providers to end users. This column explains why.
The National Nanotechnology Initiative (NNI) announced on September 17, 2015, that the National Science Foundation (NSF) will provide a total of $81 million over five years to support 16 sites and a coordinating office as part of a new National Nanotechnology Coordinated Infrastructure (NNCI).
On September 14, 2015, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted a request from the EC for a scientific opinion on titanium dioxide (nano) as a UV-filter in sunscreens and personal care spray products.
This week, Belgium's Federal Public Service for Health, Food Chain Safety and Environment created an online portal for companies to register nanomaterials they put on the market.
On July 20, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued OSHA Directive Number CPL 02-02-079. The Directive is intended to establish “policies and procedures to ensure uniform enforcement of the Hazard Communication standard” (HCS 2012).
The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant benchmark in the program since the original List 1 test orders were issued in October 2009. This column explains why.
On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled "Guidance for Industry: Use of Nanomaterials in Food for Animals." The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.
On July 27, 2015, two petitions for review of the U.S. Environmental Protection Agency's (EPA) second conditional registration of a nanosilver pesticide product were filed in the U.S. Court of Appeals for the Ninth Circuit.
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 in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum could have significant implications for innovators in the biotechnology and synthetic biology commercial space.
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 identity can impact commercialization.
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 on OSHA’s HCS enforcement strategy.
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 without compromising the U. S. Environmental Protection Agency’s (EPA) mission and authority to protect human health and the environment.
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.
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 markets in food and cosmetic markets, but much of the recent innovation focuses on biobased fuels and commodity chemicals. For these final products, TSCA applies. Chemical products must be listed on the TSCA Inventory of Chemical Substances (the Inventory) or be eligible for an exemption. If the product is not listed on the Inventory, the manufacturer must file a premanufacture notification 90 days before manufacturing (or importing) that substance or qualify for an appropriate exemption.
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 refinement of the methods used to evaluate exposure of this high-priority class of nanomaterials.
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 Fuel Standard, fuel additive registration, or other CAA submissions. TSCA also applies to bioproducts used in industrial, commercial, and most consumer products, including fuels. TSCA reporting requirements are in addition to, and separate from, CAA reporting.
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 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 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.
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 imperatives. This article describes renewable chemicals, provides a brief overview of TSCA, discusses key TSCA challenges as applied to them, and suggests actions to ensure TSCA’s implementation now and potential future TSCA revisions to facilitate the commercialization of renewable chemicals.
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 phased the chemical out of production. Working with industry, the EPA followed this action with a series of SNURs that were effectively intended to limit uses for which alternatives were not available. Several years later, similar concerns were raised with regard to PFOA, other LCPFACs, and other chemicals known as fluorinated telomers that potentially could degrade to PFOA in the environment. The EPA worked with the manufacturers and users of these chemicals to understand the risks and encourage development of alternatives. These efforts yielded the 2010/2015 PFOA Stewardship Program through which industry made and delivered on a series of commitments that, over time, made the current proposed SNUR possible.
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 SNAcs, as well as the wording used to identify "significant new activities."