January 31, 2022
IWGACP white paper to inform future FDA efforts towards talc testing standardization
On January 13, 2022, the U.S. Food and Drug Administration (FDA) released a report titled "White Paper: IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc." This white paper was developed to inform FDA's considerations of standardized testing methods for talc-containing cosmetics and talc intended for use in cosmetics. If these scientific opinions are adopted, FDA may encourage, for example, the use of highly sensitive microscopy techniques and, if present, the quantification of not only regulated asbestiform minerals but also unregulated non-asbestiform minerals (e.g., cleavage fragments). FDA will prepare an external peer review of the white paper and engage the public to allow interested parties to provide comments.
FDA explicitly notes that the scientific opinions expressed in the report are those of the subject matter experts only and do not represent FDA's or other federal agency's recommendations, policies, or proposed changes to any regulations.
FDA formed the Interagency Working Group on Asbestos in Consumer Products (IWGACP) in 2018 to support the development of standardized testing methods for asbestos and other "biologically active" mineral particles in talc and talc-containing consumer products. FDA believes that standardization is needed to address laboratories differentially adapting published methods for analysis of asbestos in air or building materials, which will result in improved sensitivity, consistency, and inter-laboratory agreement.
In 2020, U.S. FDA held a public meeting to present IWGACP's "preliminary recommendations" related to terminology, analytical methods, and reporting and to receive public input on these preliminary recommendations. A goal described at this public meeting was to release IWGACP's final recommendations in the form of a "white paper." Meeting details, including preliminary recommendations, the agenda, presentation slides of government representatives and the public, a recording of the event, and public comments received after the meeting, are available on FDA's website.
IWGACP's scientific opinions on testing approach
FDA summarized IWGACP's scientific opinions as follows:
- "Utilizing both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) methods to identify and report the presence of asbestos and other similar particles;
- Reporting all asbestos and other "similar" particles greater than or equal to (≥) 0.5 µm in length with a length to width aspect ratio (AR) ≥ 3:1;
- Providing analytical reports with adequate documentation of findings;
- Establishing policies and procedures describing rigorous training, quality assurance, and quality control, to accompany testing methods, to ensure testing laboratories are qualified and their qualifications are reviewed on a regular basis; and
- Encouraging future research on reference materials and sample preparation methods to support standardized test methods for the detection of asbestos in talc and talc-containing cosmetics."
How Exponent Can Help
Exponent has considerable experience in various aspects of asbestos- and talc-related exposure science, toxicology, epidemiology, risk assessment, and risk communication relating to exposures in the occupational, para-occupational, bystander, and domestic environment. Exponent's consultants can help you navigate the challenges of developing sampling protocols to understand the potential for the presence of asbestos and non-asbestiform minerals (e.g., cleavage fragments) in your products and contextualize potential findings in relation to the state-of-the-science on exposure and health risk.