Gradient is presenting at the SETAC North America 45th Annual Meeting, taking place October 20-24, 2024, in Fort Worth, Texas.
Gradient Senior Environmental Scientist and Geologist Dr. Qian Zhang will be presenting at the 2024 RemTEC & Emerging Contaminants Summit, October 15-17, 2024 in Westminster, CO.
US FDA recently held a public meeting to introduce a two-pronged, fit-for-purpose process for post-market assessment of chemicals in food to be implemented by the agency’s newly established Human Foods Program (HFP).
On September 25, 2024, the US Food and Drug Administration (US FDA) held a public meeting on its proposal to develop an enhanced systematic process for post-market assessment of chemicals in food under the newly established Human Foods Program (HFP). In this meeting, US FDA provided additional details regarding the process outlined in its recent discussion paper and an opportunity for external stakeholder comments.
To date, US FDA has conducted its post-market assessment of chemicals in food on an ad hoc basis, centering its activity around regulatory petitions or resubmissions, issues of great public interest or inquiry, and potential topics identified by US FDA experts. In addition, most of the agency’s work in this capacity has not been publicized unless there was a regulatory action. In the public meeting, US FDA acknowledged that the increasing number of state-level restrictions and questions surrounding the adequacy of current pre-market systems have prompted the agency, in part, to develop this enhanced approach for post-market assessment.
In its proposal, US FDA outlines an approach that aims to leverage artificial intelligence (AI) to monitor and identify “signals,” which are then triaged and addressed in a fit-for-purpose manner. This two-pronged process includes assessments that are both focused (relatively limited in scope) and comprehensive (complex and resource intensive), and the agency intends to publish scientific assessments and/or conclusions from both assessment types. In addition, US FDA notes that the process should allow for flexibility to address chemicals with varying levels of pre-market activity, including generally recognized as safe (GRAS) substances, food and color additives, food contact substances, and environmental contaminants.
Gradient scientists are at the forefront of the toxicological assessment of food ingredients and contaminants, including conducting weight-of-evidence reviews, providing regulatory comments, and overseeing ingredient vulnerability assessments. To discuss this issue further, please contact:
Charlotte Marsh, M.S., CPPS
Senior Toxicologist
Charlotte.Marsh@gradientcorp.com
Ari Lewis, M.S.
Principal
Ari.Lewis@gradientcorp.com
Julie Goodman, Ph.D., DABT, FACE, ATS
Principal
Julie.Goodman@gradientcorp.com
California’s Toxic-Free Medical Devices Act prohibits the use of intentionally added DEHP in IV solution containers and tubing products beginning January 1, 2030.
California recently passed the Toxic-Free Medical Devices Act (AB 2300), prohibiting the use of di-(2-ethylhexyl) phthalate (DEHP) in almost all intravenous (IV) solution containers and tubing. The bill also prohibits replacing DEHP with eleven other specified ortho-phthalates, including benzyl-butyl phthalate (BBP), di-isononyl phthalate (DINP), and di-n-octyl phthalate (DNOP). The ban on intentionally added ortho-phthalates for IV containers starts on January 1, 2030, six months ahead of similar European Union (EU) restrictions; the ban on IV tubing starts on January 1, 2035. Unintentionally added DEHP, i.e., DEHP in an IV solution container or IV tubing product that is not used for functional or technical effect on the product, may be present at a quantity at or above 0.1 percent weight per weight (w/w).
List of Banned Ortho-phthalates (Including DEHP):
Exemptions to the Ortho-phthalates Ban Include:
Timeline of the Ortho-phthalates Ban:
Choosing the Right Alternatives
Do you need help selecting potential alternatives to satisfy California and EU requirements? Gradient’s experts specialize in alternative assessments comparing the hazards, performance, and regulatory trend of alternatives to prevent regrettable substitutions. When choosing the right alternative, it is also important to consider degradation products under clinical and harsh extraction solvent conditions to minimize safety concerns.
Our colleagues at Cambridge Polymer Group offer holistic thinking on material selection. For example, downstream sterilization techniques dictate upstream material selection, but this is often overlooked until the very end. Choice of starting material must be driven by the anticipated end-use, and often this is influenced by forces out of the designer’s control, such as the regulatory bans being discussed here.
“Selecting the right alternatives goes beyond engineering and performance. It requires holistic evaluations of biological safety and material regulatory trends, all tailored to your device and manufacturing processes.”
Medical Device Approval
A DEHP-free reformulation will require pre-approval from US FDA and/or updates to the product’s design history file. Gradient’s team of medical device experts can help with the biological evaluation and toxicological risk assessment from the material change. In addition, Cambridge Polymer Group can offer material selection consulting support, as well as testing, including chemical characterization.
Gradient Contacts:
Jiaru Zhang, M.P.H., DABT
Principal Scientist
Jiaru.Zhang@gradientcorp.com
Joel M. Cohen, Sc.D., DABT
Principal
Joel.Cohen@gradientcorp.com
Lindsey Borton, M.P.H.
Principal
Lindsey.Borton@gradientcorp.com
Cambridge Polymer Group Contact:
Gavin Braithwaite
CEO
gavin@campoly.com
Cambridge Polymer’s Additive Analysis Services
Gradient Principal Ari Lewis will be presenting at the 2024 Society for Chemical Hazard Communication (SCHC) Annual Meeting, September 24-26, 2024 in Charlotte, NC.
Gradient Principal Dr. Tom Lewandowski will be presenting on a panel at the 2024 Prop. 65 Annual Conference in San Francisco, CA on September 23, 2024.
US EPA provides guidance and recommendations for using a simple time-weighted average approach to assess cumulative lead risks that consider intermittent or variable exposures at secondary non-residential locations.
In August 2024, the US Environmental Protection Agency (US EPA) released new guidance and recommendations for the assessment of cumulative lead risks when exposures occur at multiple sites, including primary residences (for children), non-residential sites (for adults), and secondary non-residential sites (for both children and adults). US EPA also provided guidance for deriving Preliminary Remediation Goals (PRGs) and simulating intermittent air lead exposure pathways using a time-weighted average (TWA) approach. According to the guidance, secondary lead exposure sites may include recreational areas (i.e., neighboring parks or playgrounds) or contaminated worksites and should be incorporated into modeling when media lead concentrations at secondary sites differ from primary sites. Figure 1 below, from the US EPA guidance document, summarizes when intermittent or variable lead exposures should be incorporated into lead exposure modeling under the new guidance:
US EPA stated that this new methodology is not intended to replace the typical residential approach of the Integrated Exposure Uptake Biokinetic (IEUBK) model (i.e., for children 12-72 months) and non-residential approach of the Adult Lead Methodology (ALM); rather, this new guidance is intended to supplement existing guidance. Previously, US EPA’s lead models focused on simulating lead exposures at a single location. US EPA recommends incorporating secondary exposure scenarios only if receptors are exposed at a secondary site for at least three months, with exposures occurring at least once every seven days. According to US EPA, the reliability of models in predicting blood lead concentrations has not been assessed when exposures occur less than once every seven days for at least three months.
According to the new guidance, there are several factors that could contribute to either an overestimation or underestimation of blood lead concentrations when time-weighted exposures to media concentrations are used as inputs to the IEUBK model and ALM, including:
In combination with recently lowered guidance levels for lead-contaminated soil in residential areas, US EPA’s new TWA approach may impact its cleanup recommendations. Further, PRGs derived using this new approach could prompt remediation efforts at both primary and secondary exposure sites. Earlier this year, US EPA released the final version of the All Ages Lead Model (AALM), which can simulate the impact of intermittent exposures on lead concentrations in children and adults. US EPA’s new TWA approach did not discuss the AALM or how the new guidance intersects with evaluating intermittent lead exposures using the AALM.
For more information, refer to US EPA’s website and/or contact Gradient.
Contact:
Steven R. Boomhower, Ph.D.
Senior Toxicologist
Steven.Boomhower@gradientcorp.com
Kyle J. Colonna, Ph.D., M.P.H.
Epidemiologist
Kyle.Colonna@gradientcorp.com
Rosemary L. Mattuck, M.S.
Senior Environmental Engineer
Rosemary.Mattuck@gradientcorp.com
September 15, 2024
In this issue of Trends, we provide several articles on energy and the environment.
Our first article discusses the complexity of PM2.5 toxicity and implications for further refinements to ambient air quality standards. The second article explores the growing demand for centralized data centers and potential implications for human health and the environment. The third article identifies the conflicting value and risk associated with carbon dioxide (CO2) capture technology. Our fourth article, adapted from a blog post authored by attorneys from Foley Hoag LLP, looks at efforts in Massachusetts and nationwide to streamline the permitting of large transmission line projects, including those related to clean energy.
Gradient contributors to this Trends issue include Nicholas Drury, Ph.D.; Naomi Slagowski, M.S.; Christopher DesAutels, M.S.; Ari Lewis, M.S.; and Tatiana Manidis, M.E.M.
Articles:
Gradient is presenting at PSX 2024, taking place October 15-17, 2024, in Denver, Colorado. See presentation details below.
Gradient’s PSX 2024 Presentations:
“8C: Analytical Methods for Microplastics and Nanoplastics and Potential Product Stewardship Applications”
Andrew Yeh, Kim Reynolds Reid, Matthew Tymchak (Moderator)
Education Session
Room: Aspen Ballroom
10/16/24 @ 11:00 am-12:00 pm
“10A: Supplier Ingredient Disclosure Challenges and Prop 65”
Kim Reynolds Reid
Express Session
Room: Mt. Sopris A
10/16/24 @ 3:00 pm-3:30 pm
Gradient Principal Lindsey Borton will be presenting at the North American Biocompatibility Summit (NABS) 2024, September 11, 2024 in Minneapolis, MN.