On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and...
By Lynn L. Bergeson On April 25, 2019, the Environmental Law Institute (ELI) held an event to provide an overview of their latest publication, a book titled Legal Pathways to Deep Decarbonization in the United States. Providing an overview of the book, a few of the authors were part of a panel discussion opened by William K. Reilly, former EPA Administrator under President George H. W. Bush. In his opening remarks, Mr. Reilly emphasized the potential existing with politics to change culture to...
By Lynn L. Bergeson In April 2019, Navius Research Inc. (Navius Research) published a report titled “Biofuels in Canada 2019: Tracking biofuel consumption, feedstocks and avoided greenhouse gas emissions.” Using public data, the report analyzes the volume of transportation biofuels consumed in each Canadian province and estimates the impact of this consumption on greenhouse gas (GHG) emissions and transportation energy costs. An increase in both ethanol and renewable fuel consumption...
By Lynn L. Bergeson On April 29, 2019, the National Chicken Council submitted a letter to EPA’s Office of Transportation and Air Quality outlining the potentially negative impact of the changes to the biofuels policy on the poultry industry. In his letter to EPA, Mike Brown, President of the National Chicken Council, reported concern with EPA’s proposal on year-round ethanol-15 (E15) use under the Renewable Fuels Standard (RFS) Program. The National Chicken Council believes that EPA...
By Lynn L. Bergeson On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on the petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim. Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the...
The International Organization for Standardization (ISO) has published standard ISO/TS 21361:2019, “Nanotechnologies — Method to quantify air concentrations of carbon black and amorphous silica in the nanoparticle size range in a mixed dust manufacturing environment.” The standard provides guidelines to quantify and identify particles of carbon black and/or amorphous silica in air samples collected in a mixed dust industrial manufacturing environment. The guidelines describe air sample...
On May 1, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) sent a memorandum to Alexandria Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, announcing that it “plans to begin preliminary research on the Office of Pollution Prevention and Toxics processes to implement the work to meet statutory deadlines of the Lautenberg Act.” OIG’s objectives are to determine whether EPA has met the deadlines...
On April 30, 2019, the U.S. Environmental Protection Agency (EPA) announced it would be hosting two webinars for companies, organizations, and individuals required to report under the Mercury Inventory Reporting Rule of the Toxic Substances Control Act (TSCA). The final rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA,...
On March 5-6, 2019, a workshop on “Fostering EU‐U.S. Cooperation in Nanosafety” was held. According to the workshop report, the workshop intended to answer two main questions: What should be the future research priorities in nanosafety and other advanced materials; and What are the opportunities for European Union (EU)‐U.S. cooperation priorities in nanosafety. The discussion was based on the state of implementation of the 2013 report, Nanosafety in Europe...
April 29, 2019
Ninth Circuit Issues Order Requiring EPA to Rule on Objections to Denial of Tolerance Revocation for Chlorpyrifos within 90 Days
On April 19, 2019, the U.S. Circuit Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order following an en banc rehearing in League of United Latin Am. Citizens (LULAC) v. Wheeler, No. 17-71636. The February 6, 2019, Ninth Circuit decision to grant a U.S. Environmental Protection Agency (EPA) request for rehearing effectively vacated an August 9, 2018, decision in LULAC that had ordered EPA to revoke all tolerances and cancel all registrations for...
April 26, 2019
Recommendations on Priorities for IARC Monographs Include Multi-Walled Carbon Nanotubes, Nanomaterials
An Advisory Group of 29 scientists from 18 countries met on March 25-27, 2019, to recommend priorities for the International Agency for Research on Cancer (IARC) Monographs program during 2020-2024. The Advisory Group assessed the response to a public call for nominations and considered more than 170 unique candidate agents, including the recommended priorities remaining from a similar Advisory Group meeting convened in 2014. The Advisory Group deliberated on all nominated agents both by...
On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim. Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule: ...
By Lynn L. Bergeson On April 17, 2019, Mark Carney, Governor of the Bank of England, Francois Villeroy de Galhau, Governor of the Banque de France, and Frank Edelson, Chair of the Network for Greening the Financial Services (NGFS), published an open letter on the financial implications of global warming. Co-signed by the NGFS coalition, consisting of 34 central banks, the letter warns of global warming’s potential damage to infrastructure and private property, negative human health...
April 26, 2019
IRFA Speaks Against SREs For The 2018 RFS Blend Levels
By Lynn L. Bergeson On April 17, 2019, the Iowa Renewable Fuels Association (IRFA), a Biobased and Renewable Products Advocacy Group (BRAG®) member, spoke at a press conference alongside Iowa Secretary of Agriculture, Mike Naig, on how the approval of small-refinery exemptions (SRE) for the 2018 Renewable Fuel Standard (RFS) blend levels would undermine RFS in an irreversible way. IRFA’s Executive Director, Monte Shaw, pointed out that under current conditions all a refinery...
April 26, 2019
EPA Announces Proposed Procedures For Review Of CBI Claims For The Identity Of Chemicals On The TSCA
By Lynn L. Bergeson On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory. 84 Fed. Reg. 16826. The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in...
On April 23, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making available its Interpretive Statement addressing whether the Clean Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES) permit program applies to releases of a pollutant from a point source to groundwater (Interpretive Statement) for comment. 84 Fed. Reg. 16810. EPA is issuing the Interpretative statement to “provide clarity on [EPA’s] interpretation...
April 25, 2019
EPA Proposes TSCA CDR Revisions and Update to Small Manufacturer Definition for TSCA Section 8(a)
On April 25, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. 84 Fed. Reg. 17692. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing,...
On April 23, 2019, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice inviting comment on a proposed information collection project entitled “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.” The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of engineered nanomaterials in the workplace. ...
On May 16, 2019, the American Chemical Society (ACS) will hold a webinar on working safely with nanomaterials in the laboratory. Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH), will moderate a panel including: Ken Kretchman, Director of Environmental Safety, NC State University; Craig Merlic, Professor of Chemistry, University of California, Los Angeles (UCLA); and Debbie Decker, Chemical and...
April 23, 2019
EPA Announces Proposed Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory
On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory. 84 Fed. Reg. 16826. The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the...
On April 18, 2019, the Food and Drug Administration (FDA) published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not...
On April 19, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 8, 2019, from 9 a.m. to 5 p.m. and May 9, 2019, from 9 a.m. to 12:00 p.m. (EDT) in the first-floor conference center at One Potomac Yard South, 2777 South Crystal Drive in Arlington, Virginia. 84 Fed. Reg. 16486. The Federal Register notice states that the agenda is not yet...
April 19, 2019
Warren Writes Article Declaring Her Plan For Public Lands
By Lynn L. Bergeson On April 15, 2019, U.S. Senator Elizabeth Warren (D-MA) wrote an article for Medium Politics, titled “My plan for public lands.” In the article, Warren highlights the importance and value of U.S. public lands and the need to make them part of the climate solution rather than the issue. Emphasizing her position on corporate profits and how they should not be prioritized over local communities’ health and safety, Warren states that on her first day in office...
April 19, 2019
DOE Announces Solar Decathlon Design Challenge Winners
By Lynn L. Bergeson On April 16, 2019, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the winners of DOE’s Solar Decathlon® Design Challenge, which was held at the National Renewable Energy Laboratory in Golden, CO, from April 12-14, 2019. The Challenge consisted of ten contests in which student teams designed highly efficient and innovative buildings powered by renewable energy. The winners are teams that best...
April 19, 2019
USDA APHIS Reopens Public Comment Period On The dEIS And PRA
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...
April 18, 2019
France Bans Titanium Dioxide Food Additive Beginning in 2020
On April 17, 2019, the Ministry of Ecological and Solidarity Transition issued a press release announcing that France will prohibit foods containing food additive E171 (titanium dioxide) from being placed on the market beginning January 1, 2020. The press release cites the April 15, 2019, opinion from the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES). The expert group established by ANSES conducted a literature review on the...
The NanoBusiness Commercialization Association (NanoBCA) will hold its 18th Annual NanoBusiness Conference on June 4, 2019, in Washington, D.C. Speakers will include: Arpana Verma, Ph.D., Chief Science Officer, NanoMech Industries, Inc.; Doyle Edwards, Director, Government Programs, Brewer Science; Lynn L. Bergeson, Managing Director, Bergeson & Campbell, P.C.; Hugues Jacquemin, Chief Executive Officer (CEO), OCSiAI LLC; Paul Stimers, Partner, K&L Gates; Deb...
April 17, 2019
EPA Releases Updated Systematic Review Supplemental Files for CI PV29 Risk Evaluation; Reopens Comment Period
On April 17, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of updated systematic review supplemental files with data evaluation scoring sheets as supporting documents for the draft risk evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 16011. EPA states it is “seeking public comment on the draft risk evaluation for PV29 in light of the additional materials already made...
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...
April 15, 2019
EPA Proposes TSCA CDR Revisions and Update to Small Manufacturer Definition for TSCA Section 8(a)
On April 12, 2019, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every...
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...
April 12, 2019
EPA to Host Webinar on New Approaches for Respiratory Sensitization related to Meeting Goal of Reducing Animal Testing under TSCA
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...
Last week, from April 3-5, 2019, Biofuels Digest hosted its annual Advanced Bioeconomy Leadership Conference (ABLC) in Washington, D.C. Among those present were various industry stakeholders, government representatives, and federal agency staffers. Innovative technologies were presented and much networking was done. The Biobased and Renewable Products Advocacy Group’s (BRAG®) presence was welcomed and provided an opportunity for industry stakeholders to gain insight into...
April 12, 2019
Minnesota Department Of Agriculture Offers Grant Opportunity
By Lynn L. Bergeson The Minnesota Department of Agriculture is offering an opportunity for funding to advance a bioenergy or biochemical production technology toward commercial scale through the construction and operation of a pilot plant. To be eligible for the AGRI Bioenergy/Biochemical Pilot Project Grant, applicants must be a Minnesota-based company, learning institution, local government unit, Native American Tribal community, or individual (including for-profit businesses and...
By Lynn L. Bergeson On April 4, 2019, DOE EERE’s Bioenergy Technologies Office (BETO) announced the appearance of 23 journal articles from some of the nation’s leading biomass experts in the journal Frontiers in Energy Research. The collection of articles, titled Advancements in Biomass Feedstock Preprocessing: Conversion Ready Feedstocks, focuses on the many years of research and development into biomass preprocessing that has been largely supported by DOE EERE’s BETO....
April 12, 2019
DOE EERE Announces Prize Competition On FAST PSH
By Lynn L. Bergeson On April 8, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency & Renewable Energy (EERE) announced a new prize competition to support and accelerate the development of pumped storage hydropower (PSH). The prize, titled Furthering Advancements to Shorten Time (FAST) Commissioning for Pumped Storage Hydropower (PSH), seeks innovative solutions and technologies that can assist PSH developers facing non-regulatory challenges. It would also support...
April 10, 2019
Presentations Available from EFSA Stakeholder Workshop on Nanoscience and Nanotechnology
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...
April 8, 2019
EPA Releases Budget Justification that Increases Budget for Chemical Risk, Review, and Reduction Program
On March 11, 2019, the U.S. Environmental Protection Agency (EPA) released its Fiscal Year (FY) 2020 Justification of Appropriation Estimates for the Committee on Appropriations. EPA’s budget request reduces the overall budget by $2.76 billion (31 percent), to $6.068 billion, but requests $66.418 million to support its Chemical Risk Review and Reduction (CRRR) program, an increase of $5.313 million. EPA zeros out the other programs under Toxics Risk Review and Prevention,...
April 5, 2019
ECHA PEG Reviewing Draft Appendix for Nanoforms Applicable to the Guidance on Registration and Substance Identification
The European Chemicals Agency (ECHA) has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification. The draft guidance is being reviewed by a Partner Expert Group (PEG). The draft Appendix has been developed to provide advice to registrants preparing registration dossiers that cover nanoforms. It states that the advice provided covers nanospecific advice for issues related with registration and...
On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a 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). 84 Fed. Reg. 13531. 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...
By Lynn L. Bergeson On April 2, 2019, Nouryon, a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the launch of a new biobased polymer for “weightless” hair styling. The newly developed biobased polymer, called Amaze SP, assists formulators to meet the latest trends in hair styling, which include lighter textures. Amaze SP is plant-based and part of Nouryon’s efforts in expanding its offerings to customers in the personal care market, which also...
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...
By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...
April 5, 2019
EPA Releases Draft Guidance For Pesticide Registrants On Plant Regulator Label Claims, Including Pla
By Lynn L. Bergeson On March 25, 2019, the U.S. Environmental Protection Agency (EPA) finally weighed-in on the murky and often misunderstood topic of label claims for plant regulators and plant biostimulants in posting its Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. EPA states that the draft guidance, issued...
March 29, 2019
California Committee Includes Ultrafine Titanium Dioxide on Its Draft Priority 1 List for PEL Review
The California Division of Occupational Safety and Health’s (Cal/OSHA) Health Effects Advisory Committee (HEAC) for the Development of Permissible Exposure Limits (PEL) will meet on June 4, 2019. According to the meeting agenda, HEAC will discuss the selection of Priority 1 substances for HEAC review. HEAC has posted a draft 2019 Priority 1 List consisting of ten chemical substances. The draft List includes titanium dioxide, ultrafine (<100 nanometers...
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: Status of...
By Lynn L. Bergeson In March 2019, the National Wildlife Federation (NWF), a conservation organization working across the U.S., published a report called New Research Findings Link Biofuel Mandate to Environmental Harm. According to the report, the U.S. Renewable Fuel Standard (RFS) and its implementation are leading to environmental disaster which involves the destruction of the monarch butterfly habitat, climate change acceleration, and drainage of western aquifers, amongst other issues....
By Lynn L. Bergeson On March 27, 2019, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) Bioenergy Technologies Office (BETO) reminded funding opportunity applicants of the upcoming March 29, 2019, deadline for concept paper submissions on commercial truck, off-road vehicle, and gaseous fuels research. On March 1, 2019, EERE BETO announced a funding opportunity of up to $51.5 million for new and innovative research technologies for trucks,...
March 29, 2019
FDA’s Premarket Voluntary Plant Biotechnology Consultation Program Provides Opportunity For Develope
By Lynn L. Bergeson In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards. Plant biotechnology consists of methods...