Palmer A. Orlandi, Jr., Ph.D., senior science officer and research director in FDA’s Office of Foods and Veterinary Medicine, has been promoted to the rank of Rear Admiral and the U.S. Assistant Surgeon General. Orlandi received the flag-grade promotion during a ceremony held Thursday afternoon in the FDA Wiley Building.
“As the senior ranking officers in the Commissioned Corps, flag officers exemplify the core values for which Commissioned Officers of the U.S. Public Health Service are held in high esteem. Flag officers provide executive-level leadership within the Department and within the Agencies in which they serve. Our flag officers also carry the title of Assistant Surgeon General and, as such, we rely on them to support special initiatives and exhibit the highest caliber of public health leadership.” – Commissioned Corps of the U.S. Public Health Service
Orlandi joined FDA 20 years ago, beginning his work at a research lab for CFSAN. It was there that he developed rapid and molecular detection methods for Cyclospora and Cryptosporidia and the Microsporidia (emerging food-and waterborne protozoan parasites). In 2008 he became the science coordinator in the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA) where he oversaw collaborative analytical methods programs for ORA and the Food Emergency Response Network. In 2012 Orlandi took on the role of senior science advisor to the chief scientist officer at the Office of Food and Veterinary Medicine. He played an active role in integrating science and research efforts across the agency’s foods program, and working to align research and lab programs to regulatory field lab needs.
Orlandi received a Commission as an officer in the U.S. Army in 1981. He has been an officer in the Commission Corps of the Public Health Service since 1991.
FDA has standard templates and worksheets, along with an electronic submission form that can be used to pull data related to lab testing. However, within industry not all of these electronic systems speak to each other. During an FDA Town Hall at the Food Labs Conference last week, Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA’s Office of Food and Veterinary Medicine, answers an audience question about the issue and discusses the challenges associated with standardized templates that are used by various federal and state labs and the compatibility issues.
Laboratories play a key role in FSMA, including providing data and analytical support, and assistance in surveillance and outbreak activities.
According to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA, success in the laboratory to support all the activity involving FSMA hinges on the following:
Mutual reliance on partners (federal, state and FDA)
Data-sharing capabilities (how data is generated and transmitted)
Acceptance of lab data
Establishing uniform standards of performance surrounding data quality and sharing, and ensuring that data has been verified and can be trusted lay the groundwork for data acceptance. Orlandi discussed the process of establishing data acceptance criteria at the 2015 Food Safety Consortium conference.
As FSMA promises to increase the responsibility of food laboratories, companies must pave a path forward by working more closely with industry as a whole, government and non-government organizations, as well as with each other. This was the clear message relayed by Pamela Wilger , assistant director of global food safety at Cargill, at IAFP 2015.
“We consider a lab any person generating data,” said Wilger, who emphasized the “lab” is not just the room itself. Lab testing should not focus on a single narrow view (i.e., one test); companies should be efficiently applying their resources, considering both science and risk. “Non-science based testing can lead to conflicts between suppliers and customers and manufacturers and regulators, and destruction of wholesome product.”
Here’s where improvement is needed in food labs:
Disseminating best practices. “We don’t even share that [as an industry],” said Wilger. “We don’t have time to replicate the same work.”
Aligning international rules
Cooperating with national regulators, including local/regional entities.
Testing and improving compliance policies
Building consumer trust and confidence
Training/competency development. Finding the right people, and encouraging employee knowledge sharing
Being prepared for the next intentional economic adulteration
Palmer Orlandi, Ph.D., CAPT, U.S. Public Health Service Sr. Science Advisor in the Office of Foods and Veterinary Medicine at FDA, shared insights on how FSMA will affect lab responsibilities moving forward, with a focus on prevention versus reaction. The objective for lab capacity programs is to facilitate submission and acceptance of meaningful and actionable data to all regulatory agencies, he said.
Reset, expand and integrate: A need to focus on resources
Method performance and “fit for purpose”, harmonized standards
Large-scale focused surveillance activities; statistical significance, real-time evaluation of data generated
Real-time communications, bioinformatics, IT infrastructure, data-sharing platforms
Technology and innovation partnerships, including on an international basis
In less than two weeks, FDA is holding a Demo Day at the Center for Food Safety and Applied Nutrition in Maryland. The agency will be awarding $500,000 to the team that can develop a technique or technology that creates “significant improvements” in the speed at which FDA can detect Salmonella in fresh, minimally processed produce.
A few months ago, Capt. Palmer Orlandi, Ph.D., senior science advisor at FDA’s Office of Veterinary Medicine, describes exactly why FDA is offering such a hefty prize. It can take between three and five days to detect Salmonella in product, and with full serotyping, it can take as long as two to three weeks to obtain results.