All Knowledge & Insights By Date

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.

By Lynn L. Bergeson On February 26, 2019, Bio-based World News will host a webinar titled: “The new wave in bio-based materials: maximum value from lignin with industry-specific fractions.” The webinar, as implied in its title, will focus on renewable biochemical and biobased materials derived from lignocellulosic feedstock. New fractionation technologies of lignin, including controlled fragmentation, polymerization, depolymerization, and activation, allow for its entire biomass to...

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, 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 misbranded.  FDA notes that it has not established...

On February 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was releasing an update to the Toxic Substances Control Act (TSCA) Inventory listing the chemicals that are actively being manufactured, processed and imported in the United States, which is required under amended TSCA.  Some of the highlights from EPA’s announcement are: A key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47...

On February 18, 2019, the European Union (EU) NanoSafety Cluster (NSC) announced that it is supporting the Malta Initiative by linking various projects with activities developed within the Malta Initiative.  According to NSC’s website, the Malta Initiative began in 2017, when Germany approached the EU Directorate-General (DG) for Research and Innovation to request political and financial support to develop and amend Organization for Economic Cooperation and Development...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce an exciting and important new component to our suite of Toxic Substances Control Act (TSCA) offerings. Our TSCA Tutor™ training platform provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training. Companies can mix and match training modules and training approaches to provide the most...

On January 9, 2019, the New York Department of Environmental Conservation (NYDEC) announced it was delaying its enforcement of the New York Household Cleansing Product Information Disclosure Program (NYDP) to October 2, 2019. NYDEC’s announcement was published in the Environmental Notice Bulletin. This article explains the significance of this development.

The February 2019 issue of Computational Toxicology includes an article entitled “Grouping of multi-walled carbon nanotubes to read-across genotoxicity:  A case study to evaluate the applicability of regulatory guidance.”  The article describes a case study, performed by scientists at the European Commission’s (EC) Joint Research Center (JRC), to explore and illustrate read-across of genotoxicity data by following the “Recommendations for nanomaterials applicable to the Guidance on...

On February 15, 2019, Inside EPA featured comments by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding a suit brought against the Trump EPA's policy barring any recipient of an EPA grant from serving on one of its many scientific advisory committees McFadden's ruling is not a total victory for EPA, since the agency had argued for dismissal on standing, ripeness and merits grounds. While McFadden dismissed the suit on the merits, he did find...

By Lynn L. Bergeson Minnesota’s Department of Agriculture has announced the AGRI Biofuel Blending Infrastructure Grant to provide funding for biofuel blending infrastructure equipment. In hopes of promoting economic growth and environmentally friendly practices in Minnesota’s biofuels industries, the Grant aims to develop new or enhanced markets that improve blending outcomes, including but not limited to increasing sales and greater access to fuels. The Grant is open to...

By Lynn L. Bergeson On February 7, 2019, the U.S. Department of Energy (DOE) Energy Efficiency and Renewable Energy’s (EERE) Bioenergy Technologies Office (BETO) announced the development of spatial models, from a BETO-funded project, to determine how forest management can produce biofuels, restore at-risk salmonids, and reduce the risk of wildfires. Conducted by scientists at Pacific Northwest National Laboratory (PNNL), Oak Ridge National Laboratory (ORNL), and the U.S. Forest Service...

By Lynn L. Bergeson On February 7, 2019, Representative Ocasio-Cortez (D-NY), in partnership with Senator Ed Markey (D- MA), released the outline for the Green New Deal, a policy package designed to reduce greenhouse gas (GHG) emissions through the transformation of the U.S. economy. The outline includes highlights on the systemic impact from climate change, particularly on women, indigenous populations, deindustrialized and migrant communities, the poor, communities of color, depopulated rural...

The European Commission’s (EC) Joint Research Center (JRC) published on February 13, 2019, a report entitled An overview of concepts and terms used in the European Commission’s definition of nanomaterial.  The report supports the implementation of the EC’s Recommendation on a definition of nanomaterial (2011/696/EU).  It addresses the definition’s key concepts and terms and discusses them in a regulatory context.  Corresponding to the broad scope of the definition, the report states...

The European Chemicals Agency (ECHA) announced on January 30, 2019, that it has submitted a restriction proposal for microplastic particles that are intentionally added to mixtures used by consumers or professionals.  According to ECHA, if adopted, the restriction could reduce the amount of microplastics released to the environment in the European Union (EU) “by about 400 thousand tonnes over 20 years.”  ECHA states that its assessment found that intentionally added...

The U.S. Consumer Product Safety Commission (CPSC) published a Federal Register notice on February 11, 2019, announcing that it will hold a public hearing to receive information from interested parties about possible changes to www.SaferProducts.gov, CPSC’s Publicly Available Consumer Product Safety Information Database, to improve the website’s usefulness and ease of use. 84 Fed. Reg. 3134. CPSC also requests written comments on possible improvements. The public hearing will...

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,...

By Lynn L. Bergeson On January 29, 2019, the Renewable Fuels Association (RFA) President and Chief Executive Officer (CEO), Geoff Cooper, submitted a letter to EPA Acting Administrator, Andrew Wheeler, regarding the Renewable Fuel Standard (RFS) Reset Rule. Addressing EPA’s final RFS rule that would be released in Spring 2019 resetting statutory RFS blending obligations for 2020, 2021, and 2022, as well as biomass-based diesel blending obligations for 2021 and 2022, the letter reflects...

Recently, the European Commission kicked-off a process to evaluate and likely revise the current EU Food Contact Materials (FCM) legislation. Now, this is a big deal for any stakeholders in this space—domestic or European -- considering that the current legislation has been in in-place for many years and the proliferation of national standards has greatly complicated an already complex area. That is why I was excited when Renato Addis, of the Brussels-based regulatory consulting firm EPPA and...

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...

On February 5, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced the launch of its Twitter account, @EPAChemSafety.  EPA states that this account will post the latest news on chemicals and pesticides including updates on its chemical review initiatives under the Toxic Substances Control Act (TSCA) and information on upcoming webinars and public meetings