If you have any questions in regards to the above, please do not hesitate to contact our offices so that we may explain the amendments to the provisions of the Code in more detail. Our address is:
Fiddler González & Rodríguez, P.S.C., P.O. Box 363507, San Juan, PR 00936-3507. Our fax (787) 759-3108.
We welcome your questions and comments.
Juan Carlos Gómez Escarce
María L. González Hernández
Pedro J. Reyes Bibiloni
November 16, 2016
2016 PUBLIC POLICY FOR REGULATED BIOMEDICAL WASTES IS ADOPTED
The Puerto Rico Environmental Quality Board (EQB) promulgated the Regulation for the Handling and Disposal of Regulated Biomedical Wastes to implement the public policy for handling and disposing of regulated biomedical wastes (RBW). The Regulation was promulgated on July 2016, became effective on August 2016, and repealed Chapter V of the Regulation for the Handling of Non Hazardous Solid Wastes of November 14, 1997 (Department of State Regulation No. 5717).
RBW are defined as solid wastes generated during the diagnosis, treatment (medical service practices), and immunization of human beings or animals, any investigation related to human beings or animals, the production of or testing with biological products, and the embalm of human bodies. The term also includes cultures, strains and biological products, pathological human wastes, human blood and its byproducts, sharp wastes, animal wastes, isolation wastes, any other waste designated as a regulated biomedical waste by the Department of Health. In addition, the Regulation provides a list of specific RBW. The Regulation applies to any person who generates, stores, handles, transports, treats, destroys, or proposes to dispose of RBW.
The Regulation distinguishes between destroyed biomedical wastes and treated biomedical wastes. A destroyed biomedical waste is a biomedical waste that has been subject to a process that ruins, mutilates, grinds, shreds, melts, compacts, destroys or incinerates the biomedical waste in a way that it could not be recognized and ensures that it cannot be reused. The following biomedical wastes are not destroyed biomedical wastes: domestic wastes, hazardous wastes, ashes from incinerators that burn biomedical wastes, sharp wastes, treated or destroyed biomedical wastes, discarded or seized biomedical wastes that were not used and are grinded or destroyed before their final disposal, and biomedical wastes that do not contain infectious agents if demonstrated by an analysis. A treated biomedical waste is a biomedical waste that has been subject to a decontamination process or sterilization, has not been destroyed and its physical characteristics have not been altered.
Generators must obtain an identification number from EQB prior to treating, offering for transportation, handling or storing a RBW. Generators must fill a manifest to track the biomedical waste from its origin to its final disposal. Generators who are not required to prepare a manifest must have a logbook. Generators must comply with several recordkeeping and reporting requirements. Transporters of RBW must have a permit from EQB and must also fill the manifest. Transfer stations must: obtain construction and operation permits from EQB, have a management plan, accept RBW that are packed, labeled and accompanied with a manifest, store a RBW for 15 days or less (from the date of receipt), maintain a daily record of the amount (in pounds) of RBW that are received and sent out of the station, and have an insurance, among others requirements.
Facilities that treat and destroy RBW must obtain construction and operation permits from EQB, have an operation plan and must comply with specific regulatory requirements, depending on the technique used to treat or destroy the RBW.
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