Expert Details
Food Safety and Integrity
ID: 738020
Maryland, USA
Expert spent over two decades developing science and policy in the FDA Center for Food Safety and Applied Nutrition. He was the first FDA Food Allergen Coordinator and contributed to the creation of the Preventive Controls for Human Foods Rule, the Gluten-Free Labeling Rule, and multiple agency guidance documents. He also provided support to FDA inspection and enforcement programs.
He is an internationally recognized expert on food allergen management and on safety assessments for new food proteins.
Expert has worked with food producers, regulators, and organizations in the US and internationally to protect businesses and consumers, including practical support for meeting regulatory requirements and quality standards.
He has been an instructor in programs organized by the FDA, the Institute of Food Technologists, the International Association for Food Protection, state agencies, and the National Center for Food Safety and Technology (now IFSH).
Expert holds a B.S. in Chemical Engineering and a Ph.D. in Cell and Developmental Biology. He has advanced training in risk assessment, food law, HACCP, and Preventive Controls.
He works from the Washington DC area.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1977 | Degree: Ph.D. | Subject: Cell Biology | Institution: University of California, Irvine |
| Year: 1972 | Degree: BS | Subject: Chemical Engineering | Institution: Case Western Reserve University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2022 to Present | Employer: Undisclosed | Title: Principal | Department: Principal |
Responsibilities:Provide independent consulting and advising to food companies and organizations of all sizes to develop, benchmark, and improve food safety systems, as well as to meet regulatory needs. Guide clients in adapting their organizations and operations to meet changing priorities and expectations.• Benchmark and improve food safety plans • Develop and implement risk mitigation plans. • Identify and evaluate development opportunities. • Support fraud prevention and integrity protection. • Assist product development and regulatory submissions for novel ingredients. • Conduct effective training on current and emerging safety and regulatory requirements. |
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| Years | Employer | Title | Department |
| Years: 2017 to 2021 | Employer: US Pharmacopeia | Title: Senior Director | Department: Food Science |
Responsibilities:Directed group of scientists, whose members created international compendium of quality and safety standards for food ingredients, including responsibility for personnel supervision and mentoring, budget control, program strategic direction, coordination with other corporate programs, and communication with other organizations and experts. Oversaw USP Foods Program to produce Food Chemicals Codex and related standards that protected food quality, safety, and integrity. Program focus included documentary standards, analytical methods, and reference materials for foods and food ingredients, as well as food fraud mitigation tools and strategies.• Created and managed program goals and budget, supervised scientific experts, and communicated with senior leadership. • Developed and implemented new future-oriented strategic plan that focused on stakeholder needs, with emphasis on international public health impact, first time that program had defined strategic plan. |
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| Years | Employer | Title | Department |
| Years: 2015 to 2017 | Employer: IEH Laboratories and Consulting Group | Title: Vice President | Department: Food Allergens |
Responsibilities:Provided expertise to corporate clients to ensure regulatory compliance with FDA food safety regulations. Supported corporate marketing and collaborated on product development. Organized and led training classes required under FDA regulations for a wide range of food manufacturers. Provided consulting, assistance, and support to food manufacturers and organizations of all sizes. Carried out facility assessments, supporting recall activities and corrective actions. Spoke to industry, academic, and public audiences about food safety.• Applied scientific and regulatory expertise to develop and implement food safety systems, allergen control plans, supply chain assessments, and testing programs that met regulatory and certification requirements. • Completed projects for 30 companies to ensure that each produced safe food under conditions that met all regulatory and audit requirements. • Coordinated activities among several company laboratories that led to development of new products for industry allergen testing. |
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| Years | Employer | Title | Department |
| Years: 2010 to 2014 | Employer: US Food and Drug Administration | Title: Food Allergen Coordinator (Policy Expert) | Department: Center for Food Safety and Applied Nutrition |
Responsibilities:Participated in development of agency regulations and guidance documents, lead development of agency policy related to food allergen control, represented agency in multiple technical forums, and coordinated with international regulatory bodies. Drafted formal guidance document on food allergen ingredients (including writing, obtaining OMB approval, publication of draft in Federal Register, and final publication), participated in agency teams that wrote highly impactful food safety regulations on preventive controls for human foods and on gluten-free labeling, led risk assessments that evaluated agency options to major food safety problems, and coordinated use of resources across all FDA CFSAN offices to protect health and safety to food allergic consumers.• Conducted and coordinated technical, regulatory, and policy analyses. • Developed and published agency guidance and regulatory documents. • Supported compliance and enforcement actions. • Communicated with industry, other government agencies in U.S. and internationally, and public. Represented FDA at scientific conferences. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2010 to 2014 | Agency: Food and Drug Administration | Role: Policy Expert | Description: Participated in development of agency regulations and guidance documents, lead development of agency policy related to food allergen control, represented agency in multiple technical forums, and coordinated with international regulatory bodies. Drafted formal guidance document on food allergen ingredients (including writing, obtaining OMB approval, publication of draft in Federal Register, and final publication), participated in agency teams that wrote highly impactful food safety regulations on preventive controls for human foods and on gluten-free labeling, led risk assessments that evaluated agency options to major food safety problems, and coordinated use of resources across all FDA CFSAN offices to protect health and safety to food allergic consumers. • Conducted and coordinated technical, regulatory, and policy analyses. • Developed and published agency guidance and regulatory documents. • Supported compliance and enforcement actions. • Communicated with industry, other government agencies in U.S. and internationally, and public. Represented FDA at scientific conferences. |
| Years: 1990 to 2010 | Agency: Food and Drug Administration | Role: Risk Assessor/Project Manager/Supervisory Scientist | Description: Served as manager and technical expert supporting government policy development and regulatory actions related to a all aspects of food safety, including pathogen control, biotechnology safety, allergen safety, risk assessment modeling, and international communication. |
Career Accomplishments
| Associations / Societies |
|---|
| - Institute of Food Technologists, Member and Past Division Chair - International Association for Food Protection, Member and Food Fraud Protection Professional Development Group, Vice Chair - AOAC International, Member - International Society for Infectious Diseases, Member - ASTM, Committee D37 (Cannabis Products) - Technical Contact |
| Licenses / Certifications |
|---|
| Preventive Controls Lead Instructor, 2015 Certified Food Scientist, 2014 HACCP Alliance Certified (Practitioner), 2013 |
| Professional Appointments |
|---|
| - Editorial Board, Journal of Food Protection - Editorial Board, Food Quality and Safety - Environmental Protection Agency, Scientific Advisory Panels, 7 years - Technical Advisory Board, European Union InformAll Allergen Information Project - Chair, Food Microbiology Division of the American Society for Microbiology - Chair, Institute of Food Technologists Biotechnology Division - USDA/ARS External Research Expert Reviewer |
| Awards / Recognition |
|---|
| Certified Food Scientist (Institute of Food Technologists) Advisory Council - Institute of Food Science and Technology (Texas A&M University) Excellence in Collaboration (USP) |
| Publications and Patents Summary |
|---|
| ExpertGendel has over 40 publications since 2000. These publication cover regulatory and technical subjects related to food safety, food allergen control, food analysis, food fraud prevention, food regulation, and government food policy. Both US and international issues have been addressed in these publication. |
Additional Experience
| Training / Seminars |
|---|
| - Preventive Controls Lead Trainer, Food Safety Preventive Control Alliance, 2015 - Climate Change, United Nations e-Learn, 2014 - International Food Law, Joint Institute for Food Safety and Applied Nutrition, University of Maryland, 2014 - HACCP and Preventive Controls, 2013 - Public Health Informatics, Uniformed Services University, 2009 - Risk Analysis, Joint Institute for Food Safety and Applied Nutrition, 2005 - Biosafety Level 3 Facility Design, American Biological Safety Association, 2004 - Food Microbiological Control, Public Health Service, 1998 - Food and Drug Law, Food and Drug Administration, 1994 - Senior Leadership, Council for Excellence in Government, 1993-1994 |
| Other Relevant Experience |
|---|
| - European Commission, Joint Research Center, Expert Panel on Allergenicity Databases, Milan, Italy, 2001 - Co-Organizer, National Institute of Medicine Food Forum Workshop on Providing Healthy and Safe Food as We Age, Washington, D.C. - Organizer, Interagency Risk Assessment Consortium Workshop on Susceptible Populations, College Park, Maryland |
Fields of Expertise
food safety, Food Safety Modernization Act (FSMA), food allergy, food additive regulation, food additive safety, adulteration of food, risk assessment, Consulting, economically motivated adulteration of food, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration CFR-21 part 175, Food and Drug Administration compliance, Food and Drug Administration food regulation, food additive, food biotechnology, food processing good manufacturing practice, food regulatory compliance