Harnessing chemical and toxicological data for the evaluation of food ingredients and packaging
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1 Harnessing chemical and toxicological data for the evaluation of food ingredients and packaging Diane M. Schmit, Tammy Page, Kirk B. Arvidson, Patra Volarath, Leighna Holt US Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) College Park, Maryland ACS CINF 129, March 16,
2 Office Of Food Additive Safety (OFAS) OFAS is a program office within CFSAN Ensure the safety of food ingredients and packaging (and more) in U.S. Evaluate safety information in industry submissions Direct food additives (e.g., high intensity sweeteners) Generally Recognized as Safe (GRAS phosphoric acid) Food contact substances (e.g., plastic bottles, sanitizers) Foods from GE plants (e.g., herbicide-ready soybeans) Color additives (for foods, drugs, cosmetics, devices)
3 Background & History 1958 Food additive amendments to the Federal Food, Drug and Cosmetic Act (FFDCA) Petitions for direct additives, indirect additives, GRAS list 1960 Color additive amendments Petitions for color additive petitions 3
4 Background & History 1969 President Nixon direction Critical review of GRAS substances 1972 GRAS affirmations begin Petitions for GRAS 1987 FDA Modernization Act (FDAMA) Food contact notifications 1997 GRAS proposed rule GRAS notifications
5 5
6 CFSAN Chemical Information Management 1970s: CFSAN Thesaurus - controlled vocabulary to be used across all Foods programs; data entered on punch cards and information viewed on paper printouts 1979: The Scientific Information Retrieval and Exchange Network (SIREN) - bibliographic index using codes, interfacing with CFSAN Thesaurus to translate codes; documents were heavily indexed. Late 1990s: SIREN was replaced by FARM, a document repository system. Full text searching was implemented with a reduction in indexing. 6
7 CFSAN Thesaurus paper note cards punch cards with paper printouts database with limited direct access, but frequent printouts on microfiche Oracle database with GUI interface, but not user friendly STARI (2014)
8 STARI Scientific Terminology And Regulatory Information A user-friendly search and display for the CFSAN Thesaurus (an ontology of chemical, biological, technical, and foods regulatory data) 8
9 What s in STARI? There are currently over 290,000 terms accessed through STARI, including over 65,000 preferred terms over 49,000 chemical substances (with CAS or CFSAN IDs) over 110,000 synonyms, InChIs over 1400 regulations (primarily 21 CFR and 40 CFR ) with over 9500 connections to specific substances Over 37,000 CERES IDs crosslinked to CERES over 12,000 UNII codes crosslinked to FDA SRS relationships: broad/narrow, components Notes and comments are searchable. Includes reference sources, additional regulations, definitions, etc. 9
10 STARI Chemical Substance Categories Everything is connected to one or more categories Color additive (286) Direct food additive (821) FEMA GRAS substance (2751) Flavoring substance (3360) Food additive, not elsewhere classified (718) Food contact substance (303) GRAS list substance (1012) Indirect food additive (3468) Prohibited substance (31) Agrochemical substance (1199) Biological product (195) Cosmetic substance (5823) Drug for animal use (111) Drug for human use (6553) Nutritional substance (80) Pesticide chemical (1286) Toxin (465) Chemical, not elsewhere classified (29,807) 10
11 Search any term, CAS, code, regulation, partial or whole
12 More ways to search
13 Vanillin
14 Vanillin, categories, regulations
15 Vanillin, synonyms, system
16 Vanillin, component of
17 Search by regulations
18 Broader Terms
19 Narrow Terms, Component
20 Polymers
21 CERES Knowledgebase Chemical-Centric Food-Additives Knowledgebase Desktop access to: Regulatory data Chemical data Human intake values of food additives and their impurities Toxicity data Structure analog searching and data retrieval MoA QSAR Models Data entry tools Electronic memoranda forms
22 Available Data >96,651 Chemicals with CAS RN >44,869 Chemical structures 22 Toxicity study types In vitro assays clinical studies 11,300 toxicity tests >1796 Human intake values >9484 Regulatory references
23 CERES Central Terminal: TRAM
24 CERES Query Page
25 Query Results Page
26 Toxicity Test Results
27 Treatment Level Data
28 Structure Analog Search
29 Predictive Toxicity Endpoints
30 Toxicity Predictions
31 CERES in silico Paradigm
32 ememoranda Web based forms for scientific review staff Prepopulate chem and tox data from CERES Tox and chem memo dynamically linked Automatic transfer exposure values to Tox memo Eliminates recreating exposure tables Updates of CERES data from ememos No manual data collection or processing Track key chem and tox determinations
33 OFAS Public Web Inventories
34
35 Inventory of Food Contact Substance (FCS) Notifications
36 Indirect Additives (with 21 CFR)
37
38 FCN - details
39 GRAS Notices - Detail
40 Coming Regulatory Status of Color Additives
41
42
43 Future Directions Enhance data updates Increase efficiency and accuracy of data Two-way links between OFAS databases ememos Collect data within scientific review workflow Increase data sharing/transparency Center (CFSAN), Agencies, International and Public Design databases so it is easy to share
44 THANK YOU! 44
45 Contacts STARI/Inventories Diane Schmit Tammy Page CERES Kirk Arvidson US Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) College Park, Maryland ACS CINF 129, March 16,
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