All Knowledge & Insights By Date

On November 1, 2016, the National Institute for Occupational Safety and Health (NIOSH) published a blog item entitled “Never fear!  NEAT 2.0 is here! — How to perform nanomaterial exposure assessment in the workplace.”  NIOSH notes that in 2009, it developed and was the first to recommend using the nanoparticle emission assessment technique (NEAT).  According to NIOSH, NEAT made use of a condensation particle counter to identify tasks that result or can result in the...

Role of “Conditions of Use” Under Sections 5 and 6 of Amended Toxics Law The concept of “conditions of use” plays an important role in the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.   Conditions of use is a centralizing concept under which the U.S. Environmental Protection Agency (EPA) determines how a chemical is made, processed, used, and disposed.  The term is defined in Section 3...

On October 12, 2016, the U.S. Environmental Protection Agency (EPA) announced a public meeting on the draft Algae Guidance for the Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions (Algae Guidance) in the Federal Register.  This meeting will receive public input and comments on the draft Algae Guidance that describes EPA’s data needs for supporting risk assessments of genetically engineered algae and cyanobacteria that are manufactured, imported, or...

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility.  The report states that in a long-term research strategy, the higher federal authorities responsible for...

The European Commission (EC) requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano forms.  Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has concerns about the safety of the nanomaterial, it will refer it to the SCCS for a full risk assessment....

The synopsis is available for the June 6-7, 2016, U.S.-European Union (EU) Nano Environmental and Health Safety (NanoEHS) Research Efforts joint workshop.  According to the synopsis, the first day of the workshop was devoted to an interactive nanoEHS scrimmage in which the groups collectively responded to a spill of a hypothetical nanotechnology-enabled product.  U.S.-EU Communities of Research (COR) representatives planned the scrimmage, and the highlights and findings from...

The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on colloidal silver (nano). Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has concerns about the safety of the nanomaterial, it will refer it to the SCCS for a full risk assessment.  According to the EC, it has received 63 notifications of...

On August 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice of the establishment of a Science Advisory Committee on Chemicals (SACC) under Section 9(a) of the Federal Advisory Committee Act and pursuant to Section 26(o) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The notice also solicits comments and requests nominations for new members of the SACC.  The SACC expects to...

The National Institute of Environmental Health Sciences (NIEHS) is funding a new interdisciplinary Nanosafety Research Center at the T.H. Chan Harvard School of Public Health (HSPH).  The main focus of the new HSPH-NIEHS Center is to bring together scientists from across disciplines — material science, chemistry, exposure assessment, risk assessment, nanotoxicology, and nanobiology — to assess the potential environmental health and safety implications of engineered nanomaterials. ...

China Implements Requirements For Shipments From Zika-Infected Countries, Including The U.S.: In March 2016, the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) began requiring all countries on its Zika-infected list to comply with disinsection requirements. The United States Department of Agriculture (USDA) Foreign Agricultural Service's (FAS) August 19, 2016, "Update on China's Requirements for Shipments from Zika-Infected Countries" reports that...

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 EU-U.S. NanoEHS workshop, “Enabling a Sustainable Harmonized Knowledge Infrastructure Supporting NanoEHS Assessment,” will be held October 24, 2016.  The objective of the workshop is to facilitate networking, knowledge sharing, and idea development on the requirements and implementation...

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).  Canada will use the proposed approach to:  (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the information available will be used to inform prioritization of nanomaterials for risk assessment; and (3) outline the...

On July 20, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.”  This SAP was convened to advise...

The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration's (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA's March 2012 final rule modifying the HCS to conform to the United Nations' (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals...

On June 8, 2016, the House of Commons held its first reading of an Act to amend the Canadian Environmental Protection Act, 1999 (CEPA) (nanotechnology) (C-287).  The bill would add Part 6.1 to CEPA primarily to implement procedures for the investigation and assessment of nanomaterials.  Member Peter Julian, New Democratic Party of Canada (NDP) House Leader, issued a June 8, 2016, press release stating that he first introduced the bill in 2010 and is “pleased to see...

On July 1, 2016, in an administrative appeal of the June 1, 2016, Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide...

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) submitted a status report in the Ninth Circuit Court of Appeals case concerning a petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke the tolerances and cancel the registrations for chlorpyrifos.  The Court of Appeals issued an order on December 10, 2015, requiring EPA to take final action concerning the PANNA and NRDC petition no later than December 30,...

On October 30, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on a proposal to revoke all tolerances for the insecticide chlorpyrifos.  EPA issued this proposal in response to an August 10, 2015, writ of mandamus by the U.S. Court of Appeals for the Ninth Circuit.  The court granted this unusual relief in response to a 2007 administrative petition to cancel chlorpyrifos registrations or to revoke chlorpyrifos tolerances by the...

In our June 29, 2016, Clients and Friends memorandum, Brazil Moves Closer to National Chemical Inventory, we discussed Brazil's pending Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação) predicting its imminent publication in the Brazilian Official Gazette, the Diário Oficial. On June 30, 2016, the Regulação was released for an approximately 45-day comment period. While generally adhering to both industry expectations for...

On June 20, 2016, the European Food Safety Authority (EFSA) published a scientific opinion entitled “Priority topics for the development of risk assessment guidance by EFSA’s Scientific Committee in 2016-2018.”  EFSA asked its Scientific Committee to review its cross-cutting guidance for scientific assessments to identify gaps requiring either new or revised guidance.  The Scientific Committee identified topics to be included in its 2016-2018 work program without...

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA's plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182, and copies are expected to be available from the U.S. Government Publishing...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Later that day, the U.S. Environmental Protection Agency (EPA) announced the creation of a web page on the new law, landmark legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). EPA's web page includes links for users to access: The text of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act); ...

Bergeson & Campbell, P.C. (B&C®) announced today the launch of the Toxic Substances Control Act (TSCA) Blog (TSCAblog™) to track and report regulatory, scientific, legal, and policy developments under the "new TSCA." On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which makes important changes to TSCA and is the first revision of U.S. domestic chemical management law in 40 years. Stakeholders will need...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which makes important changes to the Toxic Substances Control Act (TSCA). Lautenberg results in fundamental shifts in the requirements and approach under TSCA, while introducing important new concepts and approaches. It is our view that the body of changes, including the careful balancing of competing needs and interests and the deft and assiduous drafting, yield a...

On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed regulations, as well...

On June 10, 2016, Bloomberg BNA Daily Environment Report included comments from Lynn L. Bergeson, Managing Partner of Bergeson & Campbell P.C. (B&C®), speaking about the impacts of passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act. […] “The bill's many deadlines will drive EPA activities at a frantic pace,” said Lynn Bergeson, managing partner of Bergeson & Campbell. […] Among the deadlines the EPA faces in the first year of the law's...

On May 10, 2016, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued guidelines on highly hazardous pesticides (HHP) (Guidelines) as part of the International Code of Conduct on Pesticide Management (Code of Conduct).  HHPs are defined in the Guidelines as “pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted...

On June 1, 2016, the German Environment Agency (UBA) published a report entitled Nanomaterials in the environment:  Current state of knowledge and regulations on chemical safety.  The aim of the report is to outline the necessary further development of chemicals regulations for nanomaterials with regard to the environment from UBA’s perspective.  The report is addressed “particularly to players and decision-makers involved in discussions related to the adaptation of the various...

The Swiss National Science Foundation issued a May 12, 2016, press release announcing that researchers from the National Research Program “Opportunities and Risks of Nanomaterials” have developed a new model to track the flow of the “most important nanomaterials in the environment.”  To assess how man-made nanoparticles make their way into the air, earth, or water, researchers developed a computer model to determine the environmental accumulation of nanosilver, nanozinc, nano-titanium...

On May 9, 2016, Jack Housenger, Director of the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP), announced the selection of Anna Lowit for the Senior Science Advisor Position in OPP’s Immediate Office.  Lowit has been a toxicologist in OPP’s Health Effects Division since 1998. Housenger’s announcement of Lowit’s selection notes that she has “provided expert technical advice and guidance to senior management on issues related to toxicity testing, human...

On April 19, 2016, the European Union (EU) NanoSafety Cluster announced the availability of the “Closer to the Market” Roadmap (CTTM).  The NanoSafety Cluster states that the CTTM is a “multi-dimensional, stepwise plan targeting a framework to deliver safe nano-enabled products to the market.”  The steps include:  (1) building an inclusive collaboration network; (2) bringing together scientific and entrepreneurial experts; (3) strengthening dialog of all stakeholders to raise...

On April 22, 2016, California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) issued a final notice listing styrene as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). OEHHA also issued a proposal to adopt a Prop 65 No Significant Risk Level (NSRL) of 27 micrograms per day for styrene. The listing of styrene has been contentious. OEHHA previously attempted to propose...

On April 15, 2016, Bloomberg BNA Daily Environment Report published “European Commission Sets Out Terminology for Nanomaterial Assessment,” an article focusing on the EC Joint Research Center’s release of definitions for 43 nanotechnology risk assessment terms. […]JRC technical reports are respected resources that have demonstrable value, and can be widely used, but it has no binding legal effect, Lynn Bergeson, managing partner of the U.S.-headquartered law firm Bergeson &...

On March 16, 2016, the European Commission (EC) issued its final report on the sustainable use of biocides.  Article 18 of the European Union’s (EU) biocidal products regulation (BPR) directs the EC to issue a report on how the BPR contributes to the sustainable use of biocidal products, and on whether there is a need to introduce additional measures, in particular for professional users, to reduce the risks posed to human health, animal health, and the environment by...

On March 17, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), announced in an open letter to stakeholders, that it has developed new tools to “enhance the quality of its risk assessments and risk management decisions and better ensure protection of human health and the environment from pesticide use.”  These tools have been developed as part of EPA’s efforts to implement OPP’s Strategic Vision for Adopting 21st Century Science...

On March 8, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register stating that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will hold a three-day meeting scheduled for April 19-21, 2016, from 9:00 a.m. to 5:00 p.m. (EDT) to consider and review Chlorpyrifos:  Analysis of Biomonitoring Data.  The meeting will be held at EPA’s Conference Center, Lobby Level, One...

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 opinion addresses nanotechnology in an innovative Europe; nanotechnology in the chemical industry and medicine; nanotechnology as an economic component; nanotechnology as an environmental component; nanotechnology as an employment/social component; opportunities and risks associated...

On January 25, 2016, the Netherlands National Institute for Public Health and the Environment (RIVM) published a report that describes the content of a computer program that can be used for a risk assessment.  According to RIVM, the NanoCosmetics tool will need to cover all aspects of the risk assessment, including:  the physicochemical characterization of the nanomaterials; the estimation of the consumer exposure; the possible hazards (toxicity) induced by the nanomaterials; and the risk...

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. As reported in our December 22, 2015, blog item, the European Commission (EC) promulgated a final novel foods regulation in December 2015. Under the regulation, food consisting of engineered nanomaterials should be considered a novel food. EFSA intends the draft document to provide guidance on the data needed...

On February 2, 2016, the Executive Board of the North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) released details of its proposed strategic framework the next five years.  The environmental regulatory authorities in the U.S., Canada, and Mexico comprise the TWG and developed the strategy.  They are the U.S. Environmental Protection Agency (EPA), Health Canada’s Pest Management Regulatory Agency (PMRA), and Mexico’s Secretaría de...

Significant issues concerning the scope of the U.S. Environmental Protection Agency’s (EPA) authority to cancel conditional registrations are raised by recent events concerning flubendiamide products sold in the U.S. by BayerCrop Science LP (Bayer) under the trade name Belt.  Bayer announced on February 5, 2016, that it will not comply with EPA’s request that Bayer “voluntarily” cancel its registered flubendiamide products.  In a January 29, 2016, letter, EPA stated that...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Oscar Hernandez, Ph.D. has joined our teams as Senior Regulatory Chemist. Dr. Hernandez is the former Director of the Risk Assessment Division (RAD) in the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), where he managed a multi-disciplinary science group that provided expert scientific support in the areas of hazard and risk assessment of chemicals...

On January 7, 2016, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register the beginning of a 45-day comment period on the peer review draft of the Guidelines for Human Exposure Assessment (draft Guidelines). According to EPA, the draft Guidelines benefit from over two decades of experience with assessments conducted by EPA programs under their respective authorities and constraints, as well as from input from external panels, including the...

The Organization for Economic Cooperation and Development (OECD) has posted the following reports concerning nanomaterials: Considerations for Using Dissolution as a Function of Surface Chemistry to Evaluate Environmental Behaviour Of Nanomaterials in Risk Assessments:  A Preliminary Case Study Using Silver Nanoparticles — The December 18, 2015, report discusses preliminary findings on dissolution by media type, provides recommendations, compares silver nanoparticles to other...

The European Food Safety Authority (EFSA) published on January 11, 2016, the Scientific Network for Risk Assessment of Nanotechnologies in Food and Feed (Nano Network) annual report for 2015.  The report states that, during 2015, the Nano Network followed-up on its four priority topics:  (1) the need for an inventory of nanomaterials in products on the market; (2) the analysis and monitoring of products under development and on the market; (3) the need for suitable measuring...

In December 2015, the proceedings from the March 12-13, 2015, U.S.-European Union (EU) joint workshop on “Bridging NanoEHS Research Efforts” were posted online.  The workshop was sponsored by the European Commission (EC) and the National Nanotechnology Initiative (NNI).  It brought together European and American scientists engaged in nanotechnology environmental, health, and safety (nanoEHS) research to identify areas of shared nanoEHS interest and mechanisms for...

On January 6, 2016, the U.S. Environmental Protection Agency (EPA), in collaboration with California’s Department of Pesticide Regulation (DPR) announced the release of a preliminary pollinator risk assessment for the neonicotinoid insecticide, imidacloprid (Preliminary Risk Assessment or Assessment).  In its assessment, EPA states that imidacloprid potentially poses a risk to hives when the pesticide comes in contact with certain crops that attract pollinators.  EPA...

Click here for a PDF version of the memorandum. Even if Toxic Substances Control Act (TSCA) legislation is not enacted, 2016 will be a momentous year. As the curtain closes on eight years of the Obama Administration, there are a number of items expected to be among the "legacy" issues in the chemical and pesticide regulation space. Enhanced protections for farmworkers, more protective assessment policies, and a re-energized toxic chemical assessment program are among the short list of notable...

The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices.  RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years.  According to the report, knowledge is evolving on the safety evaluation of nanomaterials in general, and thus also when used...

The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28, 2015.  The revisions include codifying the inert ingredients list and adding specific chemical identifiers, where available, for all active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption.  Labeling...