December 7, 2019

NTP Publishes Technical Report on Toxicity Studies of 1020 Long Multiwalled Carbon Nanotubes

On December 5, 2019, the National Toxicology Program (NTP) announced that the NTP Technical Report on the Toxicity Studies of 1020 Long Multiwalled Carbon Nanotubes Administered by Inhalation to Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats and B6C3F1/N Mice is now available.  In 2003, the Rice University Center for Biological and Environmental Nanotechnology nominated nanoscale materials as a class of substances for toxicological evaluation.  The recommended...
December 6, 2019

DOE To Host Workshop On Plastics For A Circular Economy

By Lynn L. Bergeson From December 11 through 12, 2019, DOE’s Office of Bioenergy Technologies Office will host a workshop titled “Plastics for a Circular Economy” in Denver, Colorado. The workshop will include discussions on technology solutions to address plastic waste and focus on the development of new recycling and degradation strategies. The objective of the workshop will be to identify early-stage applied research problems in the aforementioned area that need to be...
December 6, 2019

Iowa Governor Demonstrates Further Support For The Biofuels Industry

By Lynn L. Bergeson On December 3, 2019, Governor of Iowa, Kim Reynolds, signed an Executive Order that requires all new contracts for the purchase of state vehicles with diesel engines to have written support from the manufacturer to use B20 biodiesel (a mix of 20 percent biodiesel and 80 percent petroleum-based diesel) or more. The Iowa Department of Transportation (DOT) started using biodiesel blends in 1994. B20 is used for most of the year...
December 6, 2019

Scientists Uncover Production Of Aromatic Alcohols From Lignocellulosic Biomass

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. First published last week, on November 25, 2019, the article titled “Consolidated Production of Coniferol and Other High-Value Aromatic Alcohols Directly from Lignocellulosic Biomass” has gained media attention across the globe. Given the finite geological oil reserves, the competition to identify alternative biobased and biorefinery processes continues to grow. According to the article, the aim in identifying such products is not...
December 5, 2019

Researchers Find Nanotoxicity Studies May Be Affected by Nanoparticles Staying Behind in Syringes

On November 25, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the publication of a study published in Frontiers in Pharmacology entitled “Unpredictable Nanoparticle Retention in Commonly Used Plastic Syringes Introduces Dosage Uncertainties That May Compromise the Accuracy of Nanomedicine and Nanotoxicology Studies.”  The researchers in the study radiolabeled a variety of different nanoparticles, loaded suspensions of particles into different plastic...
December 3, 2019

ECHA Releases New, Updated Guidance Documents for Registering Nanoform Substances

The European Chemicals Agency (ECHA) announced on December 3, 2019, that it has developed a new Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification.  According to ECHA, it aligns ECHA’s guidance with the amended annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation that will apply to nanomaterials and enter into force on January 1, 2020.  The new guidance document explains the term nanoform,...
December 3, 2019

EPA Grants First Two Manufacturer Requests for Risk Evaluation

The U.S. Environmental Protection Agency (EPA) announced on December 2, 2019, that it granted the first two manufacturer requests for risk evaluations for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production.  EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under the Toxic Substances Control Act (TSCA).  Manufacturer-requested risk evaluations are conducted in the same...
December 2, 2019

White Paper Identifies Challenges Associated with Regulating Nanotechnology-Enabled Health Products in the EU

The European Commission’s Joint Research Center (JRC) recently published a white paper entitled Anticipation of regulatory needs for nanotechnology-enabled health products.  The white paper notes that at this time, “no specific regulatory framework exists for nanotechnology-enabled health products but the current regulatory practice requires additional guidance in order to fully cover the particularities of such products.”  The white paper identifies the following major...
November 27, 2019

ChemSec Adds Carbon Nanotubes to SIN List

The International Chemical Secretariat (ChemSec) announced on November 14, 2019, that it added more chemicals, including carbon nanotubes, to its Substitute It Now! (SIN) List.  ChemSec describes carbon nanotubes as “one of the more well-studied nanomaterials” and notes that “they are used to make durable, lightweight materials, for electrical conductivity, as a super black pigment and for water purification, among other uses.”  Dr. Anna Lennquist, Project Manager for...
November 27, 2019

Monsanto Agrees to Plead Guilty to Illegal Use of Methyl Parathion and to Pay $10.2 Million in Penalties and Restitution, Thereby Avoiding Felony Convictions for Related Hazardous Waste Violations

On November 21, 2019, the U.S. Department of Justice announced a settlement with Monsanto Company (Monsanto) in which Monsanto agreed to plead guilty to a misdemeanor count of illegally using the pesticide Penncap-M, a methyl parathion product that was cancelled by the U.S. Environmental Protection Agency (EPA) on July 27, 2010.  This settlement of several criminal counts by Monsanto followed an investigation by the EPA Criminal Investigation Division.  Under the...
November 26, 2019

EPA Settles Two Cases Regarding Unregistered and Misbranded Pesticides

The U.S. Environmental Protection Agency (EPA) recently settled two cases involving allegations of non-compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Although the Consent Agreement and Final Orders (CAFO) and Stop Sale, Use or Removal Orders (SSURO) issued in these cases are not yet available online, the penalty amounts at issue — $200,000 and $1,489,000 — reflect increased enforcement in targeted areas and EPA’s willingness to seek and...
November 25, 2019

EPA Issues Final SNUR for Carbon Nanomaterial (Generic) (PMN P-10-366)

The U.S. Environmental Protection Agency (EPA) issued final significant new use rules (SNUR) on November 25, 2019, for 22 chemical substances, including carbon nanomaterial (generic) (PMN P-10-366), that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 64754.  Persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by the SNURs to notify EPA...
November 22, 2019

Ban on Retail Distribution of Methylene Chloride to Consumers for Paint and Coating Removal Begins November 23

The U.S. Environmental Protection Agency (EPA) issued a press release on November 22, 2019, reminding stakeholders that its regulations to prohibit the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use will go into effect after November 22, 2019.  Beginning November 23, 2019, it will be unlawful for any person or retailer to sell or distribute paint removal products containing methylene chloride for...
November 22, 2019

“Value Chain Communications Required under TSCA Consent Orders and SNURs: How to Formulate Them and Optimize Their Value” Recording Available Now

On November 13, 2019, Bergeson & Campbell, P.C. (B&C®), presented “Value Chain Communications Required under TSCA Consent Orders and SNURs:  How to Formulate Them and Optimize Their Value,” a complimentary webinar for our clients and friends.  Richard E. Engler, Ph.D., Director of Chemistry, B&C, outlined the categories of legally required risk communications to value chain participants required under TSCA Consent Orders and significant new use rules...
November 22, 2019

EC Requests Scientific Opinions on Nanoforms of Platinum and Gold

On November 22, 2019, the European Commission (EC) Directorate-General for Internal Market, Industry, Entrepreneurship, and Small- and Medium-Sized Enterprises (SME) requested two scientific opinions from the Scientific Committee on Consumer Safety (SCCS): The request for a scientific opinion on platinum (nano)-colloidal platinum (nano) and acetyl tetrapeptide-17 colloidal platinum (nano) states that the EC received 18 notifications for cosmetic products containing platinum (10 notifications)...
November 22, 2019

FDA Acting Director Of Therapeutic Biologics And Biosimilars Provides Statement On Continued Efforts

By Lynn L. Bergeson On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing...
November 22, 2019

EPA Announces OCSPP Meeting To Discuss TSCA New Chemicals Program

By Lynn L. Bergeson On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include: An overview of EPA’s updated “Working Approach” document that builds on...
November 22, 2019

Bicameral Bills Seek To Reform RFS

By Lynn L. Bergeson On November 14, 2019, Senator Tom Udall (D-NM) and Representative Peter Welch (D-VT) introduced legislation seeking to reform the Renewable Fuel Standard (RFS) under the Clean Air Act (CAA). The Growing Renewable Energy through Existing and New Environmentally Responsible (GREENER) Fuels Act is intended to mitigate the “harmful environmental impacts of the corn ethanol mandate,” according to a press release issued by the lawmakers. The bill would phase out the...
November 21, 2019

Ninth Circuit Issues Decision in Case Challenging EPA’s Prioritization and Risk Evaluation Rules

On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the Toxic Substances Control Act’s (TSCA) requirements. ...