- As Agency Reviews Quats, ACI Reminds DTSC of Federal Regulation of Topical Antiseptic Ingredients
- Says DTSC Approach “Needs to be Better Informed”
The California Department of Toxic Substances Control (DTSC) should adopt a risk-based approach to potential regulation of important disinfectant chemicals and pay heed to existing federal regulations governing them, according to comments submitted by the American Cleaning Institute (ACI), the trade association for the cleaning product supply chain.
ACI provided feedback to DTSC on its Background Document on Quaternary Ammonium Compounds (QACs) in Cleaning Products and Beauty, Personal Care, and Hygiene Products.
QACs are a broad class of diverse chemicals characterized as ammonium cations with various alkyl or aryl groups. They are used in a wide variety of industrial and consumer applications due to a diverse range of properties.
In the comments, ACI:
- Advises that DTSC remain mindful of the preemption by U.S. Food and Drug Administration (FDA) regulations on topical antiseptics
- Recommends chemical clustering, as QACs are too diverse to be regulated as a single group
- Points to sources where DTSC can seek additional data on the environmental fate and toxicology of these substances
- References safety decisions made by other regulatory authorities
While ACI shares the agency’s goals of protecting human health and the environment and its effort to ensure a scientifically rigorous process, ACI believes “that the manner in which DTSC is soliciting information is premature and needs to be better informed.”
“At the outset, we recommend that DTSC adopt a risk-based approach to reviewing and prioritizing the QAC-product combinations by considering the product specific exposures of the QACs,” writes Dr. James Kim, ACI Senior Vice President, Science & Regulatory Affairs.
“With this perspective, DTSC needs to review all of the available regulatory information and risk assessments on the QACs in order to determine how they could be classified or clustered, with the understanding that many QACs may not need to be evaluated in this effort. In this way, DTSC will have a clearer view of the landscape, the information needed, and the questions to ask stakeholders.”
Dr. Kim also zeroed in on the fact that the “Federal Food, Drug, and Cosmetic Act includes an express preemption provision that prohibits state governments from imposing any requirement that is ‘different from or in addition to, or that is otherwise not identical with’ ‘federal law.” “Thus, any additional requirements implemented by DTSC in California law regarding the use of benzalkonium chloride (BAC) and benzethonium chloride (BZT) in OTC drug products will be preempted by federal law.”
Those chemicals are among the key germ-killing ingredients used in consumer antibacterial soaps, which are regulated by the FDA.
Read the full comments.
The American Cleaning Institute® (ACI – www.cleaninginstitute.org) is the Home of the U.S. Cleaning Products Industry® and represents the $60 billion U.S. cleaning product supply chain. ACI members include the manufacturers and formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical distributors. ACI serves the growth and innovation of the U.S. cleaning products industry by advancing the health and quality of life of people and protecting our planet. ACI achieves this through a continuous commitment to sound science and being a credible voice for the cleaning products industry.