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  6. Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products (Proposed Rule) Preliminary Regulatory Impact Analysis
  1. Economic Impact Analyses of FDA Regulations

Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products (Proposed Rule) Preliminary Regulatory Impact Analysis

If finalized, the proposed rule would require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc.

The benefits of the proposed rule include potential public health benefits from fewer asbestos exposures.  To the extent the proposed rule would reduce exposures to asbestos, health benefits would include fewer illnesses, such as mesothelioma, lung cancer, larynx cancer, and ovarian cancer.  We lack data to quantify these public health benefits, so we instead discuss them qualitatively. Benefits would also include cost savings to manufacturers of talc-containing cosmetics from fewer recalls each year. At a 7 percent discount rate, the present value of monetized benefits over 10 years would range from $0.00 million to $10.42 million, with a primary estimate of $0.48 million. Annualized monetized benefits over 10 years would range from $0.00 million to $1.39 million at a 7 percent discount rate, with a primary estimate of $0.06 million.

The costs of the proposed rule include monetized costs to read and understand the rule, monetized asbestos testing costs, and monetized costs of subsequent testing conducted on new batches of talc when an initial sample of talc tests positive for asbestos.  We assume that all manufacturers of talc-containing cosmetics would rely on certificates of analysis from talc suppliers to comply with asbestos testing requirements in the proposed rule.  As a result, talc suppliers would incur costs to test lots or batches of talc for asbestos, and manufacturers of talc-containing cosmetics would incur costs to maintain qualified talc-suppliers. At a 7 percent discount rate, the present value of monetized costs over 10 years would range from $9.72 million to $50.97 million, with a primary estimate of $26.58 million.  Annualized monetized costs over 10 years would range from $1.29 million to $6.78 million at a 7 percent discount rate, with a primary estimate of $3.54 million. 
 

Regulatory Impact Analysis
 

Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products Preliminary Regulatory Impact Analysis (PDF- 870KB)

Federal Register: 89 FR 105490 
Publication Date: December 27, 2024
Docket: FDA-2023-N-4225
 

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