U.S – The U.S. Food and Drug Administration (FDA) has announced revisions to its guidance on preventive controls for human food, alongside the withdrawal of a separate industry guidance document.
These moves come in the wake of a landmark court decision regarding the pesticide chlorpyrifos, triggering a cascade of changes in food safety regulations.
The FDA’s revisions to the “Hazard Analysis and Risk-Based Preventive Controls for Human Food” (PCHF) draft guidance signal a proactive effort to enhance food safety protocols.
Addressing feedback received since the original draft’s release in 2016, the updated version boasts expanded sections on training, references, and resources.
Notably, Appendix 1, focusing on potential hazards, has undergone substantial modifications to better align with stakeholder concerns and inspection practices.
Meanwhile, the controversy surrounding chlorpyrifos, a widely used pesticide, has taken a legal twist.
The U.S. Court of Appeals for the Eighth Circuit’s decision to void the U.S. Environmental Protection Agency’s (EPA) rule revoking all tolerances for chlorpyrifos has reinstated its legal status. This ruling has sparked intense scrutiny, particularly given the pesticide’s known health risks and ongoing debates over its agricultural use.
The legal wrangling over chlorpyrifos stems from concerns raised by environmental and public health advocates regarding its impact on human health, particularly in vulnerable populations such as children and farmworkers.
Concurrently, the EPA has initiated regulatory amendments to reflect the reinstated tolerances for chlorpyrifos residues.
This follows a complex legal saga initiated by a 2021 order from the U.S. Court of Appeals for the Ninth Circuit, directing the EPA to either revoke all chlorpyrifos tolerances or modify them to meet safety standards outlined in the Federal Food, Drug, and Cosmetic Act (FFDCA).
However, due to data limitations and time constraints, the EPA revoked all tolerances in August 2021, a decision that was later challenged and ultimately overturned by the Eighth Circuit in December 2023.
While the Ninth Circuit had previously ordered the EPA to take action on chlorpyrifos, the recent Eighth Circuit decision has thrown the regulatory landscape into disarray, forcing a reevaluation of existing policies and enforcement approaches.
The reinstatement of chlorpyrifos tolerances raises pressing questions about the adequacy of current regulatory frameworks in safeguarding public health.
With conflicting rulings from different circuits, stakeholders are left grappling with uncertainty surrounding the pesticide’s safety and permissible usage.
Revisions to PCHF draft guidance
Simultaneously, the FDA has unveiled revisions to its “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance).
These revisions, informed by stakeholder feedback and evolving food safety concerns, aim to enhance the clarity and utility of the guidance.
Notable changes include an expanded glossary of terms, new sections on training and resources, and significant modifications to Appendix 1, which addresses known or foreseeable food hazards.
The revised guidance is open for public comment for 120 days following its publication in the Federal Register.