This analysis reviews the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as passed by the Senate on December 17, 2015, and compares it to the previous version of S. 697 (identified as Lautenberg2 in this analysis), passed by the Senate Environment and Public Works (EPW) Committee in June 2015. This review also briefly compares S. 697 to H.R. 2576, the [Toxic Substances Control Act (TSCA)] Modernization Act of 2015, which passed the House of Representatives on...
Category: Risk Assessment Issues
December 18, 2015
Danish EPA Posts Several Publications Regarding Nanomaterials
This month the Danish Environmental Protection Agency (Danish EPA) published the following publications, in English, concerning nanomaterials: Better control of nanomaterials — summary of the 4-year Danish initiative on nanomaterials: The “Better control of nanomaterials” initiative intended to create an overview of the possible risks of using nanomaterials, focusing on consumers and the environment. The report states: “Generally, there is still a need for more information on where...
December 16, 2015
IRSST Publishes Best Practices Guidance for Nanomaterial Risk Management in the Workplace
On December 11, 2015, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), a leading occupational health and safety research center in Canada, published the second edition of its Best Practices Guidance for Nanomaterial Risk Management in the Workplace. IRSST intends the Guidance to support the safe development of nanotechnologies in Québec by bringing together current scientific knowledge on hazard identification, strategies for determining nanomaterial...
In a press release issued on November 22, 2015, the Canadian province of Québec (Quebec) announced its release of Québec Pesticide Strategy 2015-2018. Although the Strategy itself is available only in French, Québec has provided a summary of the Strategy in English, which is available here. Québec’s press release states that the Strategy “sets out the major directions and goals that will guide government action to protect public health, pollinators, and the environment in...
November 11, 2015
Denmark Posts Several Publications Concerning Nanomaterials
On November 10, 2015, the Danish Environmental Protection Agency posted the following publications concerning nanomaterials: Environmental assessment of nanomaterial use in Denmark: This is the concluding report of the project “Nanomaterials — occurrence and effects in the Danish environment” (NanoDEN). The projects in NanoDEN aimed to investigate and generate new environmentally relevant knowledge concerning nanomaterials on the Danish market and to assess the possible associated risks to...
November 9, 2015
Australia Implementing Reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
As most recently reported in The Acta Group's (ACTA®) October 28, 2015, Global Regulatory Update, the Australian government is implementing reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). According to an item in the October 6, 2015, issue of The NICNAS Bulletin, the September 2015 implementation plan outlines opportunities for community and industry consultation; timing of legislative and information technology (IT) system...
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...
October 26, 2015
NanoValid Publishes “Nano to go!”
In September 2015, “Nano to go!” was published. “Nano to go!” is “a practically oriented guidance on safe handling of nanomaterials and other innovative materials at the workplace.” The German Federal Institute for Occupational Health (BAuA) developed it within the NanoValid project. “Nano to go!” includes the following materials: A brochure, Safe handling of nanomaterials and other advanced materials at workplaces, that supports risk assessment and risk...
Like so many other regulatory programs in China, pesticide regulations are changing. At the 8th China High-Level Forum on Pesticides, Ying Ji, Chief Agronomist of the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), stated that the future of pesticide regulation in China will see more emphasis placed on industrial development, registration security, the application of more risk assessment techniques, and will focus more on reducing the burden of procuring...
October 2, 2015
OECD Posts Preliminary Guidance Notes on Nanomaterials Concerning Interspecies Variability Factors in Human Health Risk Assessment
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. The report includes the following recommendations for further work: The Expert Opinion prepared in support of the project noted a general lack of availability of data from repeated-dose toxicity studies in different species. In...
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 September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs...
September 30, 2015
EPA Releases Final Comprehensive Environmental Assessment Applied to MWCNTs in Flame-Retardant Coatings in Upholstery Textiles
The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments. The final report presents a case study of multiwalled carbon nanotubes (MWCNT) used in flame-retardant coatings applied to upholstery textiles. EPA states that the case study is organized...
September 18, 2015
Multiple Algae-related Agency And Industry Events In Coming Weeks
Stakeholders working with algae to produce chemicals and fuels should take note of these upcoming opportunities: EPA's "Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae," September 30, 2015. Registration closes on September 25, 2015; The U.S. Department of Energy's (DOE) Request for Information (RFI) from algae stakeholders regarding their views on the requirements necessary to develop reliable and sustainable supplies of...
September 14, 2015
Ninth Circuit Vacates EPA’s Unconditional Registration for the Neonicotinoid Pesticide Sulfoxaflor Based on Hazard to Bees
In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies. Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other...
September 11, 2015
EC Invites Scientists to Apply for Membership in SCCS and SCHEER
The European Commission (EC) invites scientists to apply for membership in its non-food scientific committees, the Scientific Committee on Consumer Safety (SCCS) and Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). SCCS and SCHEER provide the EC with “high quality and independent risk assessment and scientific advice in the areas of public health, consumer safety and environmental risks.” SCCS provides opinions on questions concerning health and safety risks...
September 4, 2015
EPA To Hold Public Meeting on Biotechnology Algae
On August 25, 2015, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a Public Meeting and Opportunity for Public Comment on Considerations for Risk Assessment of Genetically Engineered Algae. The public meeting, entitled "Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae," is intended to receive public input and comments on the data needs of EPA to support risk assessments of biotechnology...
August 28, 2015
EPA Issues Draft Guidance on Pesticide Cumulative Risk Assessment: Framework for Screening Analysis
The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015. EPA’s draft framework provides guidance on how the EPA will screen groups of pesticides for cumulative evaluation. EPA proposes using a two-step approach, beginning with the evaluation of available toxicological information and, if necessary,...
The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the workshop will inform an update to an EPA...
On August 4, 2015, the U.S. Environmental Protection Agency (EPA) announced the availability of its Final 2014 Effluent Guidelines Program Plan. The Final Program Plan includes the following findings from EPA’s review of engineered nanomaterials in industrial wastewater: Some manufacturing and processing methods likely generate wastewater, but the quantity generated and waste management practices are not documented; Toxicity hazards from engineered nanomaterials have been...
The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology. EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches. EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states...
The Organization for Economic Cooperation and Development (OECD) has issued the following publications in its Series on the Safety of Manufactured Nanomaterials: No. 55 — Harmonized Tiered Approach to Measure and Assess the Potential Exposure to Airborne Emissions of Engineered Nano-Objects and their Agglomerates and Aggregates at Workplaces: The primary goal of this publication is to describe a reliable formal methodology for conducting consistent exposure related...
With little fanfare or advanced notice to the general public, 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...
July 6, 2015
Biotechnology: White House Announces Effort to Modernize the Regulatory System for Biotechnology Products
In a bit of a surprise announcement, 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 released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, 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...
July 1, 2015
China Publishes Revised New Chemical Notification and Registration Guidance for Public Comment
After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the "Guidance for New Chemical Substance Notification and Registration (Draft)" (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (guidance@mepscc.cn). In addition, MEP-SCC will hold a meeting to explain the...
The American Bar Association (ABA) Section of Environment, Energy, and Resources' Young Lawyers Division presented a fascinating webinar on June 23, 2015, on the key areas of alignment and non-alignment between the European Union's (EU) and the United States' approach to chemical management by exploring the EU's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and the Toxic Substances Control Act (TSCA). The webinar was moderated by Lynn L....
June 22, 2015
SUN Opens Survey on Risk Management of Nanotechnology
On May 26, 2015, Sustainable Nanotechnologies (SUN) began a survey on risk management of nanotechnology. A key objective of SUN is to build the SUN Decision Support System to facilitate safe and sustainable nanomanufacturing and risk management. It will integrate tools for ecological and human health risk assessment, lifecycle assessment, economic assessment, and social impact assessment within a sustainability assessment framework. SUN seeks responses from personnel of companies involved in...
June 17, 2015
Court of Appeals Grants Writ of Mandamus Requiring EPA to Take Final Action on Chlorpyrifos Petition
On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition requested that EPA cancel all registrations and revoke all tolerances for the insecticide chlorpyrifos. An order granting a writ of mandamus is unusual, and indicates that the Court is impatient about what it perceives to be the slow pace of review by the U.S. Environmental...
June 16, 2015
European Court of Justice Dismisses Case Regarding Confidential Treatment of Information Submitted to EFSA
On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential. The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information...
On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will cooperate and coordinate specified agency actions. The RPS and Work Plans are the most recent steps since the United States and Canada established the Regulatory Cooperation Council (RCC) in 2011 to align regulatory systems and boost North American trade and...
June 12, 2015
EFSA Issues Call for Data on the Health and Environmental Effects of Neonicotinoid Pesticides
On May 22, 2015, the European Food Safety Authority (EFSA) issued a call for new scientific information relevant to the evaluation of the risk to bees in the European Union (EU) from the use of the three neonicotinoid pesticide active substances: clothianidin, imidacloprid, and thiamethoxam (the substances). The call for data complies with the decision taken by the European Commission in May 2013, Commission Implementing Regulation (EU) No. 485/2013, to put in place measures to...
The House Energy and Commerce Committee convened a markup session on June 2 and 3, 2015, to consider a slightly revised version of the TSCA Modernization Act of 2015 as H.R. 2576. As reported in our June 3, 2015, memorandum, the House Committee passed the marked up bill. The House Energy and Commerce Subcommittee on Environment and the Economy had considered and passed an earlier discussion draft version of the TSCA Modernization Act (TMA2 DD) in May 2015, while an initial discussion draft...
June 1, 2015
Proposed Harmonized Classification and Labeling Would Apply to Nanosized Titanium Dioxide
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 proposed entry in Annex VI of the Classification, Labeling, and Packaging (CLP) Regulation is “Carc. 1B, H350i.” 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...
On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to...
April 16, 2015
EPA Issues Letter Stating It is “Unlikely” to Approve New Outdoor Neonicotinoid Pesticide Uses
On April 2, 2015, the U.S. Environmental Protection Agency (EPA) sent a letter to all registrants of nitroguanidine neonicotinoid pesticide products stating that “until the data on pollinator health have been received and appropriate risk assessments completed,” EPA is “unlikely to be in a position to determine that such uses would avoid ‘unreasonable adverse effects on the environment’ as required under FFIRA to support further regulatory expansion of these pesticides in...
Lynn Bergeson, managing partner of Bergeson & Campbell P.C., told Bloomberg BNA in an e-mail that the council’s timetables for developing work plans on chemical risk assessments, SNAcs and SNURs are aggressive. Based on a December webinar the council held, interested parties will be involved in a Web conference, face-to-face meetings and consultations beginning this year and throughout 2016, she said.
February 6, 2015
EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed Publishes 2014 Annual Report
On February 16, 2015, the European Food Safety Authority (EFSA) published the 2014 annual report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed, which is intended to inform the public and the EFSA Advisory Forum about the Network’s specific activities and achievements. EFSA states that, during 2014, the Network followed-up on its priority areas and contributed to making inventories of applications of nanomaterials already present in the food/feed...
An ad hoc committee of the National Research Council (NRC) released a report, Review of California's Risk-Assessment Process for Pesticides, following its scientific and technical evaluation of the California Environmental Protection Agency’s (EPA) risk assessment process for pesticides. The NRC committee review, which commenced in October 2013, examined documents provided by the California EPA’s Department of Pesticide Regulation (DPR) regarding the processes it uses for hazard...
January 26, 2015
NRDC Files Petition for Review To Ban Flea Collars and Pet Products Containing Pesticides
On January 5, 2015, the Natural Resources Defense Council (NRDC) filed a petition for review in the U.S. Court of Appeals for the Ninth Circuit challenging the November 6, 2014, decision of the U.S. Environmental Protection Agency (EPA) to allow the continued use of tetrachlovinphos (TCVP) in flea control products used on pets. NRDC’s 2009 petition sought to cancel all pet uses of TCVP based on alleged potential health risks to children. Background In February 2014, NRDC filed a petition for a...
January 15, 2015
Canada’s New Substances Program Publishes Risk Assessment Summary for Multi-Wall Carbon Nanotubes
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. 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 determine whether a substance is or may become harmful to human health or...
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...
January 13, 2015
EPA Announces New Draft Guidance on Reducing Use of Lab Animals and Increasing Relevant Acute Toxicity Data on Pesticides
On January 9, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it released a new draft guidance document in its effort to help expand the acceptance of alternative methods for acute toxicity testing. EPA states that the rapid advances in science and continual development of new technologies, it recognizes there is an increasing potential for the use of alternative methods in regulatory risk assessments. EPA’s goals for alternative...
January 8, 2015
EPA’s Recently Released Revised Human Health Risk Assessment for Chlorpyrifos Reflects New Implementation of EPA Policy
The U.S. Environmental Protection Agency’s (EPA) January 5, 2015, release for public comment of the revised human health risk assessment of chlorpyrifos (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2008-0850-0195) reflects another step taken to implement its new spray drift and volatilization policies. These policies were long in the making and the subject of significant discussion and controversy over the years. EPA, with this assessment, has also taken a very public step to...
December 22, 2014
Lynn L. Bergeson, “EPA’s New, Final Work Plan Assessments And What They Mean To You,” Environmental Quality Management, December 22, 2014.
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 22, 2014, the U.S. Environmental Protection Agency (EPA) requested public comment on a proposal to remove 72 chemicals from its list of substances approved for use as inert ingredients in pesticide products. EPA reportedly is responding to petitions submitted by the Center for Environmental Health, Beyond Pesticides, Physicians for Social Responsibility, and others that have asked EPA to issue a rule requiring disclosure of 371 inert ingredients found in pesticide products. EPA...
The U.S. Environmental Protection Agency (EPA) released on August 28, 2014, final risk assessments for three Toxic Substances Control Act (TSCA) Work Plan chemicals -- 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 much anticipated release of these assessments marks a real milestone for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), and EPA is to be commended for...
April 16, 2014
ECHA Planning Workshop on Regulatory Challenges in the Risk Assessment of Nanomaterials
The European Chemicals Agency (ECHA) will hold a topical scientific workshop on October 23-24, 2014, on regulatory challenges in the risk assessment of nanomaterials. The workshop will bring together experts in the field of risk assessment of nanomaterials to discuss and update scientific principles and guidelines for assessing human health and environmental risks of chemicals substances in nanoform. According to ECHA, the workshop will also provide a platform for academia...
November 26, 2013
Lynn L. Bergeson, “Narrow Critique Does Not Alter EPA Nano Risk Assessment,” Law360, November 26, 2013.
When the Natural Resources Defense Council sued the U.S. Environmental Protection Agency immediately after the EPA conditionally registered HeiQ AGS-20 and AGS-20 U nanosilver pesticide products, the nano community collectively held its breath. On Nov. 7, 2013, that same community let out a collective sigh of relief as the U.S. Court of Appeals for the Ninth Circuit largely upheld the EPA’s approach under the Federal Insecticide, Fungicide and Rodenticide Act in registering the first...
The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments.
The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments.