Food and drug administration risk assessment - Process and toxicologic pathology

Toxicologic Pathology

Volumn 25, Issue 1, 1997, Pages 61-67

  Moch, Ronald W ^a,b   Dua, Prem N ^a   Hines, Fred A ^a  

^a U S DEPARTMENT OF AGRICULTURE   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

brain hemorrhages; carcinogenic assessment; dog studies; pathology evaluation; rodent studies; Safety evaluation

Indexed keywords

ANESTHETIC AGENT; FOOD ADDITIVE; NEW DRUG; OPIATE;

CARCINOGEN TESTING; CONFERENCE PAPER; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; INCIDENCE; LUNG INJURY; LYMPHADENOPATHY; NONHUMAN; PATHOLOGY; PRIORITY JOURNAL; RISK ASSESSMENT; STOMACH LESION; TOXICOLOGY;

CANIS FAMILIARIS; RODENTIA;

EID: 0031046323     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1177/019262339702500112     Document Type: Conference Paper

References (12)

1. Dua PN and Jackson BJ (1988). Review of pathology data for regulatory purposes. Toxicol. Pathol. 16: 443-450.
2. Flamm WG and Lorentzen RJ (1988). Quantitative risk assessment (QRA): A special problem in the approval of new products. In: Risk Assessment and Risk Management of Industrial and Environmental Chemicals, Advances in Modern Environmental Toxicology, Vol. XV, CR Cothern, MA Mehlman, and WL Marcus (eds). Princeton Scientific Publishing, Princeton, New Jersey, pp. 91-108.
3. Food and Drug Administration (1982). Policy for regulating carcinogenic chemicals in food and color additives; advance notice of proposed rule making. Fed. Reg. April 2: 14464-14470.
4. Gaylor DW and Kodell RI (1980). Linear interpolation algorithm for low dose risk assessment of toxic substances. J. Environ. Pathol. Toxicol. 4: 305-312.
5. Kokoski CJ and Flamm WG (1984). Establishment of acceptable limits of intake. In: Proceedings of the Second National Conference for Food Protection. U.S. Department of Health and Human Services, FDA, Washington, D.C., May 9-11, pp. 61-72.
6. Kokoski CJ, Henry SH, Lin CS, and Ekelman KB (1990). Methods used in safety evaluation. In: Food Additives, AI Branen, PM Davidson, and S Salminen (eds). Marcel Dekker, New York, pp. 579-616.
7. Lorentzen RJ (1984). FDA procedures for carcinogenic risk assessment. Food Technol. 38: 108-111.
8. Moch RW, Dua PN, and Hines FA (1996). Problems in consideration of rodent hepatocarcinogenesis for regulatory purposes. Toxicol. Pathol. 24: 138-146.
9. National Academy of Sciences, National Research Council (1983). Risk Assessment in the Federal Government: Managing the Process. National Academy Press, Washington, D.C.
10. Office of Science and Technology Policy (1985). Chemical carcinogens: A review of the science and its associated principles, Pt. II. Fed. Reg. March 14: 10371-10442.
11. Scheuplein RJ and Flamm WG (1989). A historical perspective on FDA's use of risk assessment. In: International Food Regulation Handbook, RD Middlekauff and P Shubik (eds). Marcel Dekker, New York, pp. 27-51.
12. US Food and Drug Administration, Center for Food Safety and Applied Nutrition (1993). "Draft": Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food; "Red Book II," U.S. Food and Drug Administration, Washington, D.C., pp. 8-17.