All Knowledge & Insights By Date

Gov4Nano is a Horizon 2020 project that aims to design an effective risk governance process for nanotechnologies, including improving the availability of nano-relevant data.  To meet its aims, Gov4Nano is conducting a “Data Sharing and FAIR Data Use Survey” to obtain views and opinions from data users and producers on data availability and sharing and how these can be improved.  Gov4Nano seeks to determine how barriers to data availability can be lowered and incentives for data...

As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are...

Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses. Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know...

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on...

Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers).  The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name...

If anyone on planet Earth thinks the Toxic Substances Control Act (TSCA), as amended, is not commercially consequential, think again. The implementation of the 2016 amendments by the U.S. Environmental Protection Agency (EPA) is triggering tremendous commercial disruption. The EPA’s March 8, 2021, announcement seeking comment on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, and, importantly, granting a rare “No Action Assurance”...

As reported in our April 30, 2021, blog item, on April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.” EPA announced on May 14, 2021, that it is extending the notification deadline to June...

On February 8, 2021, the U.S. Environmental Protection Agency (EPA) received a petition seeking a rule reversing EPA’s 1991 Bevill regulatory determination excluding phosphogypsum and process wastewater from phosphoric acid production (process wastewater) from hazardous waste regulation under Subtitle C of the Resource Conservation and Recovery Act (RCRA). The petition also urges EPA to promulgate regulations under RCRA Subtitle C governing the safe treatment, storage, and disposal...

On March 10, 2021, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on “The Path Forward: Restoring the Vital Mission of EPA.” According to the March 7, 2021, memorandum from Representative Frank Pallone, Jr. (D-NJ), Chair of the Committee, to the Subcommittee, the U.S. Environmental Protection Agency’s (EPA) current responsibilities include reviewing national air pollution standards and overseeing or carrying out cleanups at most of the...

On March 3, 2021, Representatives Frank Lucas (R-OK), Ranking Member of the House Science, Space, and Technology Committee; Stephanie Bice (R-OK), Ranking Member of the Environment Subcommittee; and Jay Obernolte (R-CA), Ranking Member of the Investigations and Oversight Subcommittee, sent a letter to the U.S. Environmental Protection Agency (EPA) urging EPA to expedite any reevaluation of the Toxic Substances Control Act’s (TSCA) systematic review methods.  As reported in our...