GUIDANCE DOCUMENT
Redbook 2000: VII Glossary, Acronyms and Definitions April 2004
Toxicological Principles for the Safety Assessment of Food Ingredients
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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 |
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
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Food and Drug Administration
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All comments should be identified with the title of the guidance.