2021 FDA Science Forum
The Increased Need for FDA Laboratory to Keep Their Neighbors Informed: How the FDA Northeast Laboratory Answered New York State Requirement for a Permit for Handling Regulated Medical Waste
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Contributing OfficeOffice of Regulatory Affairs
Abstract
The FDA Northeast Laboratory operates in two primary areas; Food & Feed and Medical Products (NFFL and NMPL). Each area has its sub-specialties either in Microbiology or Chemistry. The prime function of these laboratories is to detect contaminants in our regulated commodities. In the Microbiology laboratories of both areas, samples that are tested and found to be positive, along with untested portions and laboratory controls must be methodically processed to rid them of the infectious contaminants before they are carted away as medical waste.
The Microbiology Branch also has a Biosafety Level 3 (BSL-3) suite where samples being tested for the most serious pathogens are handled under strict containment. This laboratory has operated within the boundaries of the Select Agent law (42 CFR Part 73, Public Health) since its inception in 2004. Compliance to this law is monitored by the Federal Select Agent Program (FSAP) biannually.
In 2017, New York State revised Title 6 of their Environmental Regulations to include Parts 360 and 365 (Quality Services), specifically, Management of Regulated Medical Waste (RMW). As a result of these revisions, the BSL-3 and any all microbiology laboratories not associated with a medical facility, must be permitted by the state to handle their RMW.
The first requirement from the state was that the project be handled by a New York state-licensed Professional Engineer. Additionally, a core team was developed including environmental consultants, budgetary analyst, the FDA Associate Director of Business, an industrial hygienist, a microbiologist, a management analyst and the Director of NFFL/NMPL.
The main thrust of the project was to show a complete understanding of any waste accumulated on the property for the past several years. Also, a full presentation of the engineering structures leading from the laboratories to storage and cleaning of laboratory equipment and waste as well as detailed waste accumulation, treatment procedures and cartage was desired.
Following the successful presentation of the application to the state, the neighboring public was invited to participate in a meeting for full disclosure of the operation of the project which lasted for over a year.
The FDA Northeast Laboratory was permitted to continue to handle its waste.
