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Redbook 2000: VII Glossary. Acronyms and Definitions April 2007

Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition,Office of Food Additive Safety

April 2004

Toxicological Principles for the Safety Assessment of Food Ingredients

Return to Redbook 2000 table of contents

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Acronym Definition
Act "The Act", i.e., Federal Food, Drug, and Cosmetic Act
ABS chromosome aberration(s)
ADI acceptable daily intake
A/G albumin-to-globulin
ANOVA analysis of variance
B-cells B lymphocytes
B/T ratio of B to T lymphocytes
CAC Cancer Assessment Committee
CAS Chemical Abstract Service
CCFAC Codex Committee for Food Additives and Contaminants
CFR Code of Federal Regulations
CFSAN Center for Food Safety and Applied Nutrition
CHO Chinese hamster ovary [cell(s)]
CMI cell mediated immunity
CSO consumer safety officer
DNA deoxyribonucleic acid
DTH delayed type hypersensitivity
EAFUS Everything Added to Food in the United States (database)
ECVAM European Centre for the Validation of Alternative Methods
EDI estimated daily intake
ELISA enzyme-linked immunosorbent assay
EPA Environmental Protection Agency (United States)
FAP food additive petition
FASEB Federation of American Societies for Experimental Biology
FASP food additive safety profile
FCS food contact substance
FCN Food Contact (Substance) Notification
FDA Food and Drug Administration
GLP good laboratory practices
GMPs good manufacturing practices
GRAS generally recognized as safe
HGPRT hypoxanthineguanine phosphoribosyl transferase activity
HTD highest treatment dose
IARC International Agency for Research on Cancer
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Ig immunoglobulin
JECFA Joint (FAO/WHO) Expert Committee on Food Additives
LOEL lowest observed effect level
LPS lipopolysaccharide
LSD least significant difference (refers to statistical test)
MFO mixed function oxidase
ML L5178Y mouse lymphoma cell
MLA mouse lymphoma assay
MLR mixed lymphocyte response
MTD maximum tolerated dose
OECD Organization for Economic Cooperation and Development
OFAS Office of Food Additive Safety (CFSAN)
PAFA Priority-Based Assessment of Food Additives (database)
PALS periarteriolar lymphocyte sheath
PB-PK physiologically based pharmacokinetic model
PHA phytohemagglutinin
PWM pokeweed mitogen
QAU Quality Assurance Unit
QRAC Quantitative Risk Assessment Committee
QRAs quantitative risk assessments
RBC red blood cells
Redbook I Toxicological Principles for the Safety Assessment of Direct Food Food Additives and Color Additives Used in Food (1982)
Redbook II draft Toxicological Principles for the Safety Assessment of Direct Food Food Additives and Color Additives Used in Food (1993)
Redbook 2000 Toxicological Principles for the Safety Assessment of Food Ingredients (2000, additions and updates in 2001, 2003, 2004)
RIA radio immunoassay
RNA ribonucleic acid
SAR structure activity relationship
SCE sister chromatid exchange
SHE Syrian hamster embryo cell
SOP standard operating procedure
SRBC sheep red blood cells
T-cells T-lymphocytes, or thymus derived cells
TK thymidine kinase
UDS unscheduled DNA synthesis
WBC white blood cells
WBA whole body autoradiography


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