On September 29, 2023, EPA published a draft guidance and corresponding test method to allow the addition of planktonic Legionella pneumophila claims for cooling tower water. These documents have been released for public comment only and are not yet able to be used to support claims. EPA is accepting comments on the docket for 60 [...]
On September 28, 2023, EPA finalized the rule for Recordkeeping and Reporting Requirements of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA). This rule requires reporting of information on uses, production volume, disposal, exposure, and hazards of PFAS manufactured or imported since January 1, 2011. Reporting will be submitted electronically through [...]
UPDATE: On 11/09/2023, FDA released a notice that enforcement for product listing and facility registration requirements under MoCRA will be delayed by 6 months, making the new compliance deadline 07/01/2024. This update comes following delays to the release of the Cosmetic Direct platform. As new cosmetic product regulation compliance deadlines are quickly approaching, SRC Senior [...]
Effective June 28, 2023, all antimicrobial notifications submitted to the Antimicrobials Division (AD) prior to October 1, 2022 have been closed out by the Environmental Protection Agency (EPA). The Agency announcement, released on June 29, 2023, followed months of discussion between AD and the antimicrobial industry about how to best address the growing backlog of [...]
In response to recent simultaneous outbreaks of Marburg virus in Tanzania and Equatorial Guinea the United States EPA has engaged the Emerging viral Pathogens Policy (EVP). The Ministry of Health and Social Welfare for Equatorial Guinea first announced the outbreak on February 7, 2023. Since the announcement, 15 cases and 11 deaths have been confirmed [...]
What is MoCRA? The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 was signed into law by President Biden on December 29, 2022 as part of the 2023 Consolidated Appropriations Act , H.R. 2617. This Act significantly increases the U.S. Food & Drug Administration (FDA)’s oversight of cosmetic and personal care products from the 1938 [...]
In addition to compliance assistance with the new Food & Drug Administration (FDA) Modernization of Cosmetics Regulation Act (MoCRA) of 2022, SRC offers compliance support for cosmetic ingredient disclosure and reporting requirements for the California Safe Cosmetics Act of 2005 (CSCA) (and the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) (Senate [...]
SRC monitors industry trends through frequent communication with regulating agencies, and review of warning letters and enforcement actions. From our monitoring of FDA Warning Letters, we have noticed some recent trends in FDA enforcement and interpretation of the regulations of over-the-counter drugs. Bob MacDonald, SRC’s VP of Regulatory Services provides a breakdown of these trends. [...]
On Friday, February 24th, the U.S. EPA issued What You Need to Know About Producing, Distributing or Selling Pesticide Devices, a Compliance Advisory explaining how FIFRA regulations apply to pesticidal devices. EPA defines a pesticidal device as "an instrument or contrivance that is intended to destroy, repel, trap, or mitigate any pest, including but not [...]
Effective January 1, 2023, California’s Cleaning Product Right to Know Act (CPRTKA) requires intentionally added ingredients listed on Proposition 65 to be included in a designated product’s website and label disclosure. The Act allowed manufacturers to withhold from the label and website disclosure, such ingredients until January 1, 2023 (Note: website disclosure of nonfunctional constituents [...]