All Knowledge & Insights By Date

On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food.  EFSA is seeking comments from interested parties on the assessments.  The first assessment considers the chronic effects of multiple pesticides on the thyroid system.  The second looks at acute effects on the nervous system. EFSA produced the assessments in collaboration with the...

By Lynn L. Bergeson On September 3, 2019, the Chinese Ministry of Ecology and Environment (MEE) and National Health Commission (NHC) jointly issued a final Technical Framework Guideline for Environmental Risk Assessment of Chemical Substances (Trial). This Trial Guideline provides a basic framework, including evaluation steps, technical requirements, and report preparation, for the environmental risk assessment of a single chemical substance under standard production and uses. The Trial...

The European Union (EU) Observatory for Nanomaterials (EUON) has created a Nanopinion section, where it invites views from different contributors ranging from policy-makers and authorities to industry and civil society on their work and priorities related to nanomaterials on the EU market.  The first item, posted on September 16, 2019, is “EUON:  past, present and future,” written by Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA).  As reported in our...

This week, we have B&C’s and The Acta Group’s Senior Regulatory Consultant, Karin Baron, back in the studio to discuss K-REACH, its recent amendment, and potential harmonization of chemical regulations in the region.  K-REACH is the South Korean government’s industrial chemical substance registration program signed into law in 2013, and effective in 2015. Karin is uniquely well-suited to provide practice tips and information on why our listeners should be aware of...

EC Study To Analyze Integration Of REACH In Customs Procedures: The European Commission (EC) will launch a “call for tender” in relation to Action 13 of the Second Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Review, which addresses enhancement of enforcement. In a document entitled “REACH and customs contract” issued following the 30th Meeting of the Competent Authorities for REACH and Classification, Labeling, and Packaging (CLP) (CARACAL), the...

On September 9, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) published a notice in the Federal Register announcing the availability of, and an opportunity for comment on, a document describing an “interim process” that OPP’s Environmental Fate and Ecological Effects Division is currently using to evaluate potential synergistic effects of mixtures of pesticide active ingredients on non-target organisms. As part of...

The Chinese Ministry of Ecology and Environment (MEE) notified the World Trade Organization (WTO) of its “Environmental Risk Assessment and Control Regulation for Chemical Substances (Notification Draft)” (the draft Regulation) and “Measures on the Environmental Management of New Chemical Substances (Notification Draft)” (the draft Measures) on September 2, 2019. The draft Regulation is a revised version of the Consultative Draft of the Regulation published on January 8, 2019,...

On September 4, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ Environmental Fate and Effects Division (EFED) announced that the next Environmental Modeling Public Meeting (EMPM) will be held on October 16, 2019.  The EMPM is a semi-annual public forum for EPA, pesticide registrants, and other stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for risk assessments in a regulatory...

On July 1, 2020, the Australian Industrial Chemicals Introduction Scheme (AICIS) will replace the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The Industrial Chemicals Act 2019, which was passed by Parliament in February 2019 and received Royal Assent in March 2019, created AICIS, a new regulatory scheme for the importation and manufacture of industrial chemicals in Australia. Currently, NICNAS assesses the risks of industrial chemicals and provides...

On August 13, 2019, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a four-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will be held November 19-22, 2019.  The meeting location will be announced in the future on the FIFRA SAP website.  The title of the SAP meeting is “Approaches for Quantitative Use of Surface Water Monitoring Data in Pesticide...

On August 14, 2019, the California Department of Pesticide Regulation (DPR) issued cancellation notices to thirteen California registrants of pesticide products containing chlorpyrifos, including Dow Agrosciences LLC (now Corteva).  Each of these notices is referred to as an "Accusation," and each affected registrant has 15 days to request a hearing concerning the proposed cancellation.  DPR's issuance of these notices followed a final decision by the U.S....

The U.S. Environmental Protection Agency (EPA) released on August 9, 2019, the draft risk evaluation for 1-bromopropane (1-BP), the fourth of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA). The draft risk evaluation states that there could be unreasonable risks to workers, occupational non-users, consumers, and bystanders under certain conditions of use. EPA did not find unreasonable risk to the environment under any of the...

On August 2, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it has decided to reduce the Food Quality Protection Act (FQPA) safety factor for infants and children for pyrethroids from its current value of 3X to a new value of 1X.  This decision is based on a July 1, 2019, OPP report entitled “USEPA Office of Pesticide Programs’ Re-evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data...

On July 12, 2019, the U.S. Environmental Protection Agency (EPA) announced in a Decision Memorandum that it has registered new uses and restored previously registered uses for sulfoxaflor.  EPA has approved the use of sulfoxaflor on alfalfa, corn, cacao, grains (millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, and restored the uses on citrus cotton, cucurbits (squash, cucumbers, watermelons, some gourds), soybeans, and strawberries.  EPA states that...

On July 18, 2019, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a Federal Register notice announcing a final order denying the Pesticide Action Network North America’s (PANNA) and the Natural Resources Defense Council’s (NRDC) 2007 Petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos (Order).  This Order constitutes final Agency action denying all of the Petitioners’ objections to EPA’s...

ECHA’s Management Board Supports Efforts To Improve REACH Authorization And Evaluation: On June 20, 2019, ECHA issued a press release entitled “Management Board supports efforts to improve REACH authorisation and evaluation.” In its press release, ECHA provides that its Management Board “has expressed its confidence in the plans to adjust the process for applications for [authorization].” The Management Board also welcomed the joint action plan of ECHA and the EC to improve the...

BoA Issues Landmark Decision In Data Sharing Dispute: On April 15, 2019, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) issued its decision in a data sharing dispute concerning access to data and cost sharing for the substance Acid Orange 7. The Appellants in the case before the BoA were REACH & Colours Kft and REACH & Colours Italia S.r.l. REACH & Colours Kft is the Lead Registrant for Acid Orange 7, and REACH & Colours Italia S.r.l. represents...

The European Commission (EC) published on June 11, 2019, a call for data on the following ingredients used in cosmetic products:  gold (nano); colloidal gold (nano); platinum (nano); colloidal platinum (nano); copper (nano); and colloidal copper (nano).  The EC states that it has concerns about the use of nano forms of gold, colloidal gold, platinum, colloidal platinum, copper, and colloidal copper “because of the potential of nanoparticles to enter cells through dermal...

On May 31, 2019, Health Canada’s Pest Management Regulatory Agency (PMRA) issued its Proposed Re-evaluation Decision PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment (Updated Environmental Risk Assessment).  PMRA states that this re-evaluation “considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies” and that “Health Canada applies internationally accepted...

As reported in our May 30, 2019, blog item, the Organization for Economic Cooperation and Development (OECD) recently published several reports in its Series on the Safety of Manufactured Nanomaterials, including Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February...

The Organization for Economic Cooperation and Development (OECD) has posted the following reports in its Series on the Safety of Manufactured Nanomaterials: Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table: The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February 2019.  It aims to summarize relevant information on activities...

On May 16, 2019, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of eREACHNano, “a new web tool focused on helping small and medium-sized companies that may lack sufficient in-house expertise on the regulation covering nanomaterials.”  The web tool explains the data requirements for nanoforms according to the guideline documents of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, including:...

On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos.  In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health...

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method).  84 Fed. Reg. 22120.  It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide...

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia.  84 Fed....

On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 19782.  In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential...

On April 29, 2019, the German Federal Institute for Risk Assessment (BfR) announced InnoMat.Life, a joint research project to establish criteria for an efficient assessment of the human health and environmental risks of novel (nano) materials.  The Federal Ministry of Education and Research is providing 2.22 million euro to fund the project, which will be coordinated by BfR and includes ten partners from public authorities, academia, and industry.  BfR states that until now, nanosafety...

The Organization for Economic Cooperation and Development’s (OECD) April 2019 issue of its Chemical Safety and Biosafety Progress Report includes an update on OECD’s work to determine the safety of manufactured nanomaterials.  The Report notes that the applicability of OECD Test Guidelines for nanomaterials continues to be a major concern of the work of the Working Party on Manufactured Nanomaterials (WPMN).  WPMN agreed to work on three new projects related to testing...

By Lynn L. Bergeson On April 12, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the reopening of the public review and comment period for the draft Environmental Impact Statement (dEIS) and the preliminary Pest Risk Assessment (PRA). These two documents have been prepared in response to a permit application from a company requesting the environmental release of genetically engineered (GE) Citrus tristeza virus (CTV). The...

On April 8, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket on the draft toxicological profile for glyphosate. 84 Fed. Reg. 13922. ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile.  Comments are due by July 8, 2019. The draft profile includes a chapter on glyphosate’s potential for human exposure, which...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce the publication of “Benchmarking the Current Codex Alimentarius International Estimated Short-Term Intake Equations and the Proposed New Equations,” co-authored by Jason E. Johnston, M.S., Senior Scientist with B&C and Acta. The article was published by the Journal of Agriculture and Food Chemistry and can be accessed...

On January 22-24, 2019, a Mexico-European Union (EU) workshop on nanosafety was held in Mexico.  The aim of the workshop was to establish a stronger connection between the Mexican and European research communities within the context of bringing scientific information to the risk assessment, risk management, and policy levels.  According to the workshop report, Mexico is eligible to participate in the EU’s Horizon 2020 and Ninth EU Framework Programs, and the January workshop was...

On April 11, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act...

The European Food Safety Authority (EFSA) held a stakeholder workshop on April 1-2, 2019, on the implementation of its guidance on the risk assessment of applications of nanosciences and nanotechnologies in the food and feed chain.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,” in July 2018, EFSA published new guidance on how to assess the safety of nanoscience and nanotechnology applications. ...

TechConnect World Innovation Conference and Expo will be held June 17-19, 2019.  It will include the third installment of a panel started three years ago, “Tools and Techniques:  Applying the Best Health, Safety, and Environment Practices to Advanced Manufacturing.”  The Symposium Co-Chairs include: Sally Tinkle, Senior Strategy and Policy Advisor, IDA/Science and Technology Policy Institute; Chuck Geraci, Associate Director, National Institute for Occupational Safety and...

By Lynn L. Bergeson On April 3, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a request for comments on two documents related to the potential deregulation of a canola variety genetically engineered (GE) to convert oleic acid to docosahexaenoic acid (DHA) and eicosapentaeonic acid (EPA), as well as for resistance to an imidazolinone herbicide. The documents are a draft Environmental Assessment (dEA) and a draft Plant Pest...

On March 27, 2019, the U.S. Environmental Protection Agency (EPA) posted a signed final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). The final rule is significant because the 13 chemical substances are not also subject to consent orders. During the review, EPA identified certain reasonably foreseen conditions of use that it designated as...

On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program:  Reviewing its Progress and Roadblocks Ahead.”  The hearing focused on issues with the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical Assessments:...

Registration is available for the National Nanotechnology Initiative’s (NNI) April 9, 2019, webinar on “Characterization and Quantification of Engineered Nanomaterials:  Drivers of NanoEHS Research.”  The speaker will be Dr. Robert MacCuspie, Natural Immunogenics Corp., and Dr. Debra Kaiser, National Institute of Standards and Technology, will moderate.  The webinar will examine the significant progress in characterization and measurement of engineered...

The U.S. Consumer Product Safety Commission (CPSC) published a March 19, 2019, Federal Register notice announcing that it will hold a public hearing on May 1, 2019, to receive views from all interested parties about the CPSC’s agenda and priorities for fiscal years (FY) 2020, which begins on October 1, 2019, and 2021, which begins on October 1, 2020.  CPSC seeks comment on the following questions: What are the priorities CPSC should consider emphasizing...

On March 15, 2019, the U.S. Environmental Protection Agency (EPA) published a signed final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. EPA states that it “determined that the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality.” Under the final rule, paint removal products containing...

By Lynn L. Bergeson On, March 12, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) announced the publication of two draft documents related to the potential deregulation of a soybean variety GE for increased yield and resistance to the herbicide glufosinate.  The draft documents are Draft Plant Pest Risk Assessment (PPRA) and Draft Environmental Assessment (dEA) for Petition to Deregulate GE Soybean for Increased Yield and Herbicide Resistance. The PPRA will examine any...

On March 13, 2019, the House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on “Mismanaging Chemical Risks:  EPA’s Failure to Protect Workers.”  The hearing examined the U.S. Environmental Protection Agency’s (EPA) assessment and management of risks to workers from toxic chemicals under the Toxic Substances Control Act (TSCA) and other laws.  The Subcommittee focused on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for...

The 2019 U.S.-European Union (EU) NanoEHS Communities of Research (COR) Workshop will take place October 15-16, 2019, at the Europole de l’Arbois in Aix en Provence, France.  The workshop is organized by the U.S. National Nanotechnology Initiative (NNI) and the European Commission (EC).  The agenda for the October 2018 Bridging NanoEHS Research Efforts Joint Workshop and the following presentations are available: Carlos Eduardo Lima da Cunha, EC, “EU...

The U.S. Government Accountability Office (GAO) released on March 6, 2019, a report entitled High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas. GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges. GAO’s report describes the status of high-risk areas and outlines actions necessary to assure...

On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act.  The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has...

The U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) routinely reviews and amends the Hazardous Materials Regulations (HMR) to harmonize the HMR with international regulations and standards.  In February 2019, PHMSA’s Office of Hazardous Materials Safety (OHMS) contracted with the Cambridge Systematics (CS) Team to conduct a risk assessment for the transportation of aerosol containers to align U.S. and international regulations. ...

On February 20, 2019, during a cold, snow-filled winter day, the rugged staff of Bergeson & Campbell, P.C. (B&C®) as well as several hearty senior U.S. Environmental Protection Agency (EPA) officials got together over some steaming cups of coffee and discussed the upcoming fate of the Toxic Substances Control Act (TSCA) during a Bloomberg-hosted, B&C-developed webinar:  Chemical Policy Summit Series Part V: Chemical Regulation After the Mid-Terms: What We Can Expect to See...

On February 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its notice extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29,...

The European Food Safety Authority (EFSA) will hold a stakeholder workshop on nanoscience and nanotechnology on April 1-2, 2019, in Parma, Italy.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,” in July 2018, EFSA published new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into...