FEATURE SPOTLIGHT: FOOD SAFETY
APHL Committee Instrumental in Enhancements to FDA Food Chemistry Data Review Protocols
By Robyn Randolph, MS, program manager, Food Safety and Maria Ishida, PhD, laboratory director, New York State Department of Agriculture and Markets
HFP response:
• More Targeted Requests: HFP began requesting data packages only when a product action was likely, reducing data package requests by 17 % from 2023 – 2025.
• Improved Review Rates: During the same period, the percentage of data packages that received technical reviews increased by 14 %.
APHL advisory committees are a powerful conduit for change. This was recently illustrated through the Human and Animal Food Committee’ s( HAFC) successful effort to streamline processes for state food chemistry data.
Protecting the nation’ s food supply from harmful contaminants is a hallmark of human and animal food testing programs. State laboratories produce valuable analytical results that should be utilized for regulatory purposes at the federal level. The process for assessing food contaminants varies depending on the type( biological or chemical) and the associated health risks. For biological foodborne pathogens or toxins posing an immediate health risk, the US Food and Drug Administration( FDA) conducts a quick and straightforward review. However, removing food with chemical contaminants from commerce can be hampered by bottlenecks in the FDA review process for state food chemistry data. The primary health risk is exposing people to chemicals that aren’ t immediately harmful but can cause longterm health effects.
At a December 2023 HAFC meeting, members noted FDA’ s internal review of food chemistry data packages can take from three to 12 months. Others noted FDA’ s request for dense data packages( often 100 + pages) within three days as a major resource burden. Inconsistent or unclear data requirements caused confusion, and requests for additional data, sometimes weeks or months later, disrupted workflows and required unanticipated resources.
HAFC members expressed frustration that their data was slow to be acted upon and heavily scrutinized. Most state regulatory food testing laboratories are accredited to ISO / IEC 17025, which attests to strong quality systems and defensible data. FDA’ s ability to act on state data was a key driver for its investment in state laboratories becoming ISO / IEC 17025 accredited. Members were perplexed by resistance when using test methods different from FDA’ s, despite their accredited status and demonstrated capability to deliver comparable results with proficiency samples.
Recognizing this as a broader concern, HAFC appealed to federal partners. In August 2024, APHL sent FDA a letter and issue brief outlining key issues and recommended actions to improve efficiency and effectiveness of FDA’ s chemical data package review. FDA’ s Human Foods Program( HFP) listened and took major strides towards improvements. One year later, HFP leaders presented, to the HAFC, process changes and metrics showing marked improvements in food chemistry data package review.
Streamlining Data Package Requests
APHL Concern: A three-day turnaround for submitting data packages to FDA was too demanding.
• Extended Submission Window: Deadline for data packages was extended to within five business days, except for critical risk cases.
Reducing Delays in Data Package Reviews
APHL Concern: Long delays— ranging from three to 12 months— in FDA’ s review of food chemistry data packages.
HFP response:
• Review Timeliness: Samples receiving a review determination within two months improved by 80 % from 2023 – 2025.
• Product Action Recommendations: The percentage of samples receiving a product action recommendation rose from 5 % in 2023 to 100 % in 2025— a 95 % improvement.
HAFC members value their strong relationships with FDA and the ability to have honest conversations about difficult topics. FDA has committed to working with APHL to identify additional opportunities for improvement. This collaboration will continue through a HAFC work group addressing an unresolved concern about inconsistent data review feedback. The work group will develop method-specific checklists based on state laboratory experiences to accompany food chemistry data packages. Through continuous dialogue with HFP partners, HAFC efforts to improve food chemistry data review processes will continue. g
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