Blogs

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...

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,...

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  EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under the Toxic Substances Control Act (TSCA).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...

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...

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...

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...

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 obtain heroic...

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...

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...

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...