Biopharma & Medical Device Briefing: PFAS Reporting Requirements; ECHA Substances of Very High Concern List; and MicroRNA Discovery Wins Nobel Prize

At a Glance

• EPA’s original start date for required reporting under the Final Rule on Reporting and Recordkeeping Requirements for Per- and Polyfluoroalkyl Substances (PFAS) was November 12, 2024, but the Agency proposed a delay to 2025.
• The European Chemicals Agency (ECHA) recently proposed adding six new chemicals to the Candidate List for Substances of Very High Concern to human health or environment.
• The discovery of microRNA and the governance of gene activation and regulation earned two scientists the 2024 Nobel Prize in Physiology or Medicine.

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments that should be top-of-mind for companies in these sectors.

EPA Proposes Delaying the Start of PFAS Reporting Requirements to 2025

In 2023, the U.S. Environmental Protection Agency (EPA) published a Final Rule on Reporting and Recordkeeping Requirements for Per- and Polyfluoroalkyl Substances. For the purposes of the Rule, any compound containing at least one of the following structures is considered PFAS:

• R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons.
• R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons.
• CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons.

Under the Rule, for each year starting with 2011, PFAS manufacturers must provide to EPA detailed information about such chemicals, including their identity and molecular structure, categories of use, quantities manufactured or processed for each category of use, byproducts, environmental and health effects, workforce exposure and disposal methods. Originally, the starting date for the required reporting was set to November 12, 2024, but recently EPA proposed a delay to July 2025 (see TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances | US EPA).

ECHA List of Chemical Substances of Very High Concern May Grow Further

European Chemicals Agency (ECHA) is charged with implementation of the European Union’s policy and legislation regarding chemicals. To fulfil some of its obligations per the EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), ECHA oversees an Authorization process for Substances of Very High Concern to human health or environment. Even inclusion of a substance in the candidate list of substances of very high concern for authorisation creates a legal duty for suppliers to provide certain information to ECHA, and to notify consumers, if the chemical is present in an article in concentration above 0.1% w/w. Recently, ECHA proposed adding six more substances to the Candidate list, including Octamethyltrisiloxane (also known as dimethicone, used in skin care products), and O,O,O-triphenyl phosphorothioate (which can be used as antiseptic and disinfectant). As a next step, ECHA will review public comments on the proposed inclusions. If the new substances are added to the Candidate List, ECHA will assess which ones should be included in the Authorisation List as a priority.  

Discovery of MicroRNA Wins 2024 Nobel Prize in Physiology or Medicine

Victor Ambros and Gary Ruvkun have been jointly awarded the 2024 Nobel Prize in Physiology or Medicine for their discovery of microRNA and the governance of gene activation and regulation, which accounts for the variation and specialization of cells to carry out their specific roles and functions in all multicellular organisms. For nearly 25 years, it was thought that transcription factors — specialized proteins which selectively bind to DNA regions to modify gene expression — were the main players in gene regulation. This changed in the early 1990s when the new laureates discovered a short RNA molecule lacking a code for protein production when studying mutant strains of worms which exhibited defects in timing of gene activation. The short RNA sequence, later coined “microRNA,” matched critical segments of certain mRNA sequences, which allowed the microRNA to bind to complementary mRNA to prevent production of associated proteins. The discovery caught traction in 2000 when an additional microRNA sequence was discovered, and subsequent studies have identified hundreds more — as well as the role microRNAs and gene regulation plays in cancer, disordered conditions, various syndromes, and the function and evolution of complex organisms.