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Updated: Aug 8, 2026
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High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)
Published on: May 10, 2016
Food and Drug Administration risk assessment--process and toxicologic pathology
1Pathology Branch, U.S. Food and Drug Administration, Washington, D.C. 20204, USA.
Toxicologic Pathology
|January 1, 1997
Summary
The Center for Food Safety and Applied Nutrition (CFSAN) outlines its risk assessment process using toxicologic data. Pathology reviews of rodent and dog studies inform evaluations for food additives and new drugs.
Area of Science:
- Toxicology
- Pathology
- Risk Assessment
Background:
- The Center for Food Safety and Applied Nutrition (CFSAN) employs rigorous toxicologic evaluations for regulatory decision-making.
- Pathology review is a critical component of assessing the safety of food additives and drugs.
Purpose of the Study:
- To describe the risk assessment framework at CFSAN.
- To illustrate the pathology review process with recent case examples.
Main Methods:
- Review of toxicologic data from animal studies.
- Pathological examination of tissues from rodent and canine subjects.
- Evaluation of data supporting indirect food additive petitions and investigational new drug applications.
Main Results:
- Detailed pathology reviews were conducted on data from rodent studies for indirect food additives.
- Canine study data supporting an investigational new drug (an opioid anesthetic) underwent thorough pathology review.
Conclusions:
- The described process highlights CFSAN's systematic approach to toxicologic risk assessment.
- Pathology evaluations are integral to ensuring the safety of products regulated by CFSAN.
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