Hello, I'm Domenic Veneziano owner of Veneziano Consulting. I spent 24 years inside the U.S Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS) where I ultimately served as a senior FDA leader with prominent roles in the oversight of FDA's national import operations program, including the development and implementation of FDA's Targeting System PREDICT and the Import Trade Communication System (ITACS), the integration of CBP's Automated Commercial Environment (ACE) with FDA's Systems, and the new Food Safety Modernization Act (FSMA) and Food and Drug Safety and Innovations Act. My background and experience within the federal governments and working with other government agencies domestically and internationally have provided me with a broad range of experience and knowledge
I began my federal career as a field investigator in the New England District office where I conducted domestic and foreign inspections and investigations. I became a Supervisory Investigator assessing inspection reports, evaluating the observations within them and the supporting evidence and making decisions on behalf of the agency to endorse or support the inspection findings and classifications.
In 2005 I was asked to establish, staff and Direct FDA's Prior Notice Center, now known as the Division of Food Targeting and Defense (DFDT). The DFDT is the agency's first and only 24/7/365 operational center with a sole mission of responding to the requirements identified in the Bioterrorism Act of 2002. In 2007 I was asked to become the Director of the Division of Import Operations and Policy overseeing all of FDA's import operations while continuing to oversee the operations of the DFDT.
As the Director of the Division of Import Operations and Policy, now known as the Division of Import Operations (DIO) I was responsible for enforcing the import laws, developing and implementing field operational policy and procedures across the country covering over 320 port of entries, advising other FDA senior officials and senior Executives within FDA and other government agencies on all issues related to import operations, writing new regulations, developing new operational programs, testifying before Congress, representing the FDA for media inquiries, served as the FDA representative on the ACE/International Trade Data System board of directors, served as the agency representative on the Border Interagency Executive Council and several other items of note.
During my time in FDA I was in Headquarters for the re-organization of 2012 and also during the planning of FDA's latest and largest reorganization, affecting all of the field locations as well as the headquarters components. I have an inner knowledge and understanding of the agency directions and goals.
Co-author of the Foreign Supplier Verification Program under FSMA.
Champion and Subject Matter Expert of the FSMA Imports Working Group
Board member of the ACE/ITDS
Agency representative on the Border Interagency Executive Council
FDA Import representative on Tri-lateral working group with government counterparts in Canada and Mexico
Creator of the DFDT and all FDA operations under the Bioterrorism Act of 2002 including prior notice requirements and Food Facility Registration (FFR) requirements
Testified before Congress
Testified in criminal and civil court cases
Budget establishment, creation, testimonial support, hearing preparation
Drafting of Compliance Programs
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