Kurt Herman is a member of Sigma Xi – Scientific and Engineering Honorary, MIT Chapter.
US EPA Proposes New or Strengthened Causal Relationships Between Lead Exposure and Health Effects in Its Updated “Integrated Science Assessment for Lead”
In its recently released draft update to the “Integrative Science Assessment for Lead,” US EPA proposed that scientific evidence now suggests lead exposure causes kidney effects and mortality, among other health effects.
In early 2022, US EPA announced plans to release an update to its “Integrated Science Assessment (ISA) for Lead (Pb),” and recently released the first draft. This updated draft ISA for Pb is part of a broader review of the National Ambient Air Quality Standards (NAAQS) for Pb. In the draft ISA, US EPA concluded that recent scientific evidence supports new, strengthened, or weakened causal relationships between Pb exposure and certain health effects. US EPA evaluates the overall strength of evidence for potential causal relationships between Pb and health effects using a five-level hierarchy, spanning “causal” to “not likely to be a causal relationship.”
A summary of the proposed changes in causal relationships outlined in the draft ISA for Pb, along with those published in the last ISA, is presented in the table below.
In addition, US EPA has released the third volume of its Integrated Review Plan (IRP Volume 3) for the NAAQS for Pb. In the IRP Volume 3, US EPA reaffirmed its conclusion that cognitive effects in children (specifically, intelligence quotient [IQ] decrement) remain to be the most sensitive endpoint on which the primary NAAQS for Pb should be based, as well as any potential changes in the primary standard.
Following review and feedback from the US EPA’s Clean Air Scientific Advisory Committee on June 13-14, 2023, the draft ISA for Pb will be revised; it is anticipated to be released in its final form in spring 2024.
If you have any questions about the updated draft ISA for Pb, the IRP Volume 3, or their implications, please visit our website or contact:
Steven Boomhower, Ph.D.
Senior Toxicologist
sboomhower@gradientcorp.com
Denali Boon, Ph.D., M.P.H.
Senior Epidemiologist
dboon@gradientcorp.com
Topics: Lead, Air Quality, Integrated Science Assessment (ISA), National Ambient Air Quality Standards (NAAQS)
Gradient will present on a panel discussion hosted by Boston Analytical on Navigating Unknown Compounds in Medical and Combination Device E&L Studies, from a Chemistry, Toxicology and Regulatory Standpoint! The panel will include individuals from Boston Analytical, Gradient and Kymanox – See below:
Will Parker, Director of E&L and Nitrosamines Laboratories at Boston Analytical
@Stefanie Johns, PhD, Director, Regulatory Affairs at Kymanox
Isaac Mohar, Ph.D., DABT, Principal Scientist/Toxicologist at Gradient
Click below to register today!
https://lnkd.in/eHetvZFZ
#extractables #leachables #regulatoryguidance #chemistry #toxicology #medicaldevices #combinationdevices #unknowns #unknowncompounds #devicesafety #industryknowledge #stayintheknow
Kurt Herman, M.Eng., P.G. is a member of the Society for Environmental Toxicology and Chemistry (SETAC) Sediment Advisory Group (SEDAG).
Gradient presenting at A&WMA’s 116th Annual Conference & Exhibition in Orlando, FL, June 5-8, 2023.
President Biden’s recent “Executive Order on Revitalizing Our Nation’s Commitment to Environmental Justice for All” expands the federal government’s focus on environmental justice (EJ) to include a “whole-of-government” approach and redefines the definition of EJ. This Executive Order builds on the previous presidential action by President Clinton nearly 30 years ago, which defined EJ and outlined an agenda for addressing its effects in vulnerable communities. That same agenda has been used by federal agencies ever since. According to President Biden’s recent Executive Order, EJ is now defined as:
“The just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, Tribal affiliation, or disability, in agency decision-making and other Federal activities that affect human health and the environment.”
The new EJ definition, which includes Tribal affiliation and disabilities, represents a more modern, action-oriented approach by the federal government to address environmental issues, including chemical exposures and climate change. As the definition of EJ changes and evolves and federal agencies more fully incorporate EJ in their policies and practices, vulnerable communities considered to be overburdened with EJ concerns could also change and evolve. Existing EJ tools that are used to map and screen for environmental and demographic socioeconomic indicators, such as the United States Environmental Protection Agency (US EPA) EJScreen and the Council on Environmental Quality (CEQ) Climate and Economic Justice Screening Tool (CEJST), will likely have to consider how to incorporate new EJ indicators, such as disabilities.
Along with a broadened EJ definition, the Executive Order could have impacts on federal rulemaking, regulations, programs, and practices. As agencies work to integrate EJ considerations into their missions, changes may be seen in permitting, compliance, monitoring, reporting, and enforcement. In addition, the Executive Order emphasizes an increased reliance on best available science and data to understand cumulative impacts and burdens.
Gradient scientists are staying on top of changes to regulations, guidance, and tools used to assess technical aspects of EJ-related issues to help our clients navigate the developing intersection between science and EJ policies and practices. If you have questions about how the Executive Order and revised EJ definition may impact your operations, please contact Gradient.
Andrew Yeh has been appointed to the Board of Directors of the Adopt A Stream Foundation (AASF), a non-profit organization in the State of Washington that focuses on environmental education (e.g., wildlife biology and ecology) and stream restoration (e.g., removing physical barriers for fish migrating through streams).
Gradient presenting at Society of Environmental Toxicology and Chemistry (SETAC) Europe 33rd Annual Meeting in Dublin, Ireland, April 30-May 4, 2023. Poster presentations include:
Gradient is presenting at American Society for Testing and Materials (ASTM) Workhop on Setting Acceptance Limits for Medical Device Cleaning Validation on May 9, 2023 in Denver, CO.
Andrew Yeh, Ph.D., DABT will serve as Senior Councilor in the Pacific Northwest Association of Toxicologists (PANWAT) for the 2023-2024 term. PANWAT is a Regional Chapter of the Society of Toxicology.