HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE
740 15TH STREET NW NO 600, WASHINGTON, DC 20005 www.hesiglobal.org

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Organizations Filed Purposes: THE HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE (HESI) IS A NONPROFIT INSTITUTION WHOSE MISSION IS TO ENGAGE SCIENTISTS FROM ACADEMIA, GOVERNMENT, INDUSTRY, NONPROFIT, AND OTHER RESEARCH INSTITUTIONS TO IDENTIFY AND RESOLVE GLOBAL HEALTH AND ENVIRONMENTAL ISSUES.

PROTEIN ALLERGENS, TOXINS AND BIOINFORMATICS (PATB) THE PATB COMMITTEE IS A PUBLIC-PRIVATE SCIENTIFIC PROGRAM FOCUSED ON ADVANCING THE SCIENTIFIC UNDERSTANDING OF THE RELEVANT PARAMETERS DEFINING ALLERGENIC PROTEINS AND PROTEIN TOXINS, AND TO SUPPORT THE DEVELOPMENT OF ROBUST METHODOLOGIES FOR CHARACTERIZING THE ALLERGENIC POTENTIAL AND "TOXICITY" POTENTIAL OF NOVEL PROTEINS AND BIOTECHNOLOGY PRODUCTS. TO ACHIEVE ITS MISSION, THE COMMITTEE ENGAGES IN THREE MAIN ACTIVITIES: EXPERIMENTAL RESEARCH, DEVELOPMENT OF ASSESSMENT TOOLS AND INTERNATIONAL OUTREACH. THE COMMITTEE'S EXPERIMENTAL RESEARCH INCLUDES COLLABORATIONS WITH ACADEMIC CENTERS IN THE US AND IN EUROPE. IN 2019, TWO MULTI-YEAR EXPERIMENTAL PROJECTS REACHED FINAL STAGES: ONE FOCUSED ON EVALUATING THE IMPACT OF FOOD MATRICES IN DIGESTION AND THE POTENTIAL ALLERGENIC RISK OF PROTEINS THAT ARE CONSUMED IN FOODS; THE OTHER INVESTIGATED HOW THE CHEMICAL STRUCTURE AND AMINO ACID SEQUENCE OF A PROTEIN IMPACTS ITS POTENTIAL TO ELICIT ALLERGENIC RESPONSES IN HUMANS. THE RESULTS FROM THIS RESEARCH ACTIVITIES ARE BEING ANALYZED AND WILL BE DISSEMINATED VIA PEER-REVIEW PUBLICATIONS. AS PART OF THE ASSESSMENT TOOLS DEVELOPMENTS ACTIVITIES, PATB COMMITTEE EXPERTS SUPPORT THE ANNUAL UPDATE OF THE COMPARE ALLERGEN DATABASE, A PUBLIC RESOURCE PROVIDING A COMPREHENSIVE REPOSITORY OF PROTEIN SEQUENCES OF KNOWN ALLERGENS. IN 2019, SEVERAL NEW FEATURES WERE ADDED TO THE COMPARE DATABASE, INCLUDING A NEW BIOINFORMATICS BUILT-IN TOOL FOR SEQUENCE COMPARISONS AND A MORE "USER-FRIENDLY" INTERFACE. IN TERMS OF INTERNATIONAL OUTREACH, THE COMMITTEE HELD TWO ADVISORY MEETINGS; A PUBLIC INFORMATIONAL WEBINAR ON "EMERGING OPPORTUNITIES AND INNOVATIONS IN BIOTECHNOLOGY AND FOOD SAFETY ASSESSMENT: PRACTICAL SCIENTIFIC RESOURCES TO ENABLE THE DEVELOPMENT OF SAFE FOODS; AND PRESENTED TWO POSTERS AT INTERNATIONAL CONFERENCES.

EMERGING SYSTEMS TOXICOLOGY FOR THE ASSESSMENT OF RISK (ESTAR) : THE MISSION OF THE ESTAR COMMITTEE IS TO DEVELOP AND DELIVER INNOVATIVE SYSTEMS TOXICOLOGY APPROACHES FOR RISK ASSESSMENT. THE COMMITTEE ACHIEVED THIS GOAL THIS YEAR THROUGH ITS FIVE WORKING GROUPS FOCUSED ON AREAS INCLUDING IMPROVING METHODS FOR EVALUATING GENOMIC INFORMATION FROM STORED TISSUE SAMPLES, BUILDING NEW METHODS TO ASSESS THE POTENTIAL GENETIC AND CANCER RISK OF CHEMICALS AND/OR PHARMACEUTICALS, AND IDENTIFYING NEW AND EASILY ACCESSIBLE BIOMARKERS TO EVALUATE ORGAN-SPECIFIC TOXICITIES RESULTING FROM EXPOSURES TO DRUGS OR CHEMICALS. THE COMMITTEE HAD SCIENTISTS FROM 14 GOVERNMENT/REGULATORY AGENCIES, 9 ACADEMIC AND RESEARCH INSTITUTES, AND 17 PRIVATE SECTOR COMPANIES PARTICIPATING IN THE PROGRAMS IN 2019 FROM NORTH AMERICA, EUROPE, AND ASIA. THEIR RESEARCH RESULTED IN SCIENTIFIC MANUSCRIPTS IN THE PEER-REVIEWED LITERATURE IN 2019 AS WELL AS 3 MORE THAT ARE CURRENTLY UNDER REVIEW BY SCIENTIFIC JOURNALS. ADDITIONALLY, THE COMMITTEE'S SCIENCE WAS INTEGRATED INTO A PUBLICLY ACCESSIBLE ONLINE TOOL FOR EVALUATING GENOMIC DATA VIA THE U.S. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES WEBSITE. THE COMMITTEE ALSO COMMUNICATED ITS WORK PUBLICLY IN 2019 VIA TWO SCIENTIFIC POSTERS AND TWO PRESENTATIONS AT EVENTS BOTH ONLINE AND AT SCIENTIFIC CONFERENCES.

DEVELOPMENT AND REPRODUCTIVE TOXICOLOGY (DART) TECHNICAL COMMITTEE: THE DART TECHNICAL COMMITTEE PROVIDES A FORUM WHERE SCIENTISTS FROM INDUSTRY, GOVERNMENT, ACADEMIA AND OTHER STAKEHOLDERS CAN EXCHANGE INFORMATION AND INITIATE ACTIVITIES TO ADVANCE SCIENCE RELATED TO DART, AND TO DEVELOP CONSENSUS ON THE APPROPRIATE USE OF EXPERIMENTAL DATA FOR HUMAN HEALTH RISK ASSESSMENT. IN 2019, THE COMMITTEE CONTINUED TO SPONSOR PROJECTS ADDRESSING DART SAFETY TESTING, PUBLISHED 2 SCIENTIFIC MANUSCRIPTS IN PEER-REVIEWED TECHNICAL JOURNALS BASED ON THE COMMITTEE'S RESEARCH, AND CO-HOSTED A PUBLIC SCIENTIFIC MEETING. SEVERAL ADDITIONAL MANUSCRIPTS ARE ALSO IN PROGRESS. KEY PROJECTS INCLUDE DEVELOPING REFERENCE VALUES FOR A NUMBER TESTS REQUESTED BY REGULATORY AGENCIES (JUVENILE CLINICAL PATHOLOGY, THYROID HORMONE, PREWEANING DEVELOPMENT), CONDUCTING A COMPREHENSIVE REVIEW OF PUBERTAL ENDPOINTS, DEVELOPING IN SILICO AND COMPUTATIONAL APPROACHES TOWARDS UNDERSTANDING DART-RELATED LIABILITIES, A MULTI-SITE EXPERIMENTAL PROGRAM COMPARING TWO METHODS OF PRECLINICAL SKELETAL EVALUATIONS.

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