P.R. Laws tit. 12, § 1336
The following words or phrases shall have the meaning stated below:
(a) Infectious agent.— Means microorganisms such as viruses and bacteria that may invade and reproduce in bodily tissues that are capable of causing diseases or adversely affecting human health.
(b) Regulated biomedical waste.— Means waste that has been submitted to a process that guarantees more than eighty percent (80%) of its destruction, and may not be recognizable nor reused after being ruined, mutilated, destructed, broken into pieces, melted, compacted, thermally destructed, encapsulated, compacted or turned into ashes after being incinerated in such a way that it cannot be reused in the event of inadequate management. These may be any of the following:
(1) Cultures, stocks and associated biological [products].—
(A) Cultures, stocks of infectious agents and biological products.
(B) Live or attenuated vaccines.
(C) Culture dishes and devices used to transfer, inoculate or mix cultures that have been used.
(2) Pathological waste.—
(A) Human pathological waste that has been removed through any procedure.
(B) Specimens of body fluids and their containers.
(C) Fluids associated with embalming.
(D) Animal carcasses.
(3) Human blood and blood byproducts.—
(A) Discarded human blood in its liquid state.
(B) Blood byproducts.
(C) Materials saturated with blood or blood byproducts or that were saturated with such substances and still have traces thereof when dry.
(4) Sharp waste.— Sharp or piercing objects and glass objects of the kind used in the treatment of humans or animals, medical research or industrial laboratories, whether used or not, due to the physical harm these may cause to human beings, such as puncture wounds or lacerations.
(5) Animal waste.— Carcasses or body parts of animals suspected to be contaminated with transmissible diseases or exposed to infectious agents. This also includes those places were these animals are kept to sleep.
(6) Isolation waste.— Biological waste and waste materials contaminated with human and animal blood, excretions, secretions, and exudations, which have been isolated to protect others from a possible transmission of contagious diseases.
(7) Exclusions and exceptions.— The following shall not be considered to be regulated medical waste:
(A) Domestic waste.
(B) Ashes from incinerators of regulated medical waste.
(C) Corpses, human parts and remains to be buried in cemeteries.
(D) Carcasses, animal parts and remains to be buried.
(E) Biomedical waste previously regulated that has undergone treatment or any other kind of destruction as provided in this chapter.
(F) Etiological agents which are transported within Puerto Rico following the applicable federal and state regulations.
(G) Samples of regulated biomedical waste transported by personnel from the Board.
(H) Biomedical waste that does not contain infectious agents. The person requesting an exemption shall demonstrate to the satisfaction of the Board that such biomedical waste does not contain infectious agents.
(8) Any non-hazardous solid waste which has been affected, affects, is mixed or enters into direct contact with regulated biomedical waste shall become regulated biomedical waste, even when they may be physically separated from one another. In the event that hazardous or radioactive solid waste is being affected, enters into direct contact, affects or is mixed with regulated biomedical waste, the result of such mixture shall be subject to the requirements of law or the most restrictive state and federal regulations.
(c) Destroyed regulated biomedical waste.— Means waste that has been submitted to a process that guarantees that this kind of waste may not be reused after being ruined, mutilated, broken into pieces, melted, compacted, destructed, encapsulated, compacted or turned into ashes after being incinerated in such a way that it cannot be reused in the event of inadequate management.
(d) Treated regulated biomedical waste.— Means the regulated biomedical waste that has been submitted to a decontamination or sterilization process, but that has not been destroyed; hence its physical characteristics have not been changed.
(e) Biomedical waste generator.— Means any natural or juridical person, including, among others, public or private hospitals, public or private forensic or research laboratories, embalming centers, animal treatment and research units, companies, or industrial laboratories engaged in the application of biotechnology for research or production purposes, medical, dental or veterinary offices, who in the practice of their profession, industrial activity or service rendering produce biomedical waste, among others.
(f) Incineration.— Means the controlled thermal oxidation process of any matter.
Final biomedical waste disposal facility.— Means the facility where incineration, treatment, and destruction of regulated biomedical waste is performed, including such facilities for the destruction or grinding, thermal destruction or encapsulation or compacting, used to destroy regulated biomedical waste that has been previously submitted to a treatment and destruction process, so that the regulated biomedical waste loses its usefulness as such, that is not infectious and that more than eighty percent (80%) of the destruction thereof is guaranteed, nor that it may be recognizable or neutralized so as to become non-special solid waste, for the tracking process to be completed. Furthermore, this definition shall apply to regulated biomedical waste exporters, and the pre-transport requirements shall not apply.
(g) Board.— Means the Environmental Quality Board, an agency of the Government of the Commonwealth of Puerto Rico created by virtue of § 8002a of this title, part of the act known as the “Environmental Public Policy Act”.
(h) Clinical laboratory.— Means any research, analysis or clinical facility that performs analyses relative to health care. This includes, but is not limited to, medical, pathological, and pharmacological research, as well as commercial and industrial laboratories.
(i) Intermediate regulated biomedical waste manager.— Means a facility or a person that temporarily stores or processes regulated biomedical waste. This term does not include the final disposal facilities, nor transportation services, however, pre-transport requirements shall apply.
(j) Manifest.— Means the document approved by the Board which identifies the amount, composition, volume, size, origin, route and destination, as it may apply, of some of the waste that is going to be transported within the jurisdiction of Puerto Rico to a facility for its management, storage, recycling, reuse, processing, exportation, disposal, incineration, treatment or destruction.
(k) Person.— Means the juridical entity, natural person or group of private or public entities that is responsible for any activity controlled by this chapter. This includes federal and state agencies, municipalities, public and private consortia and corporations, associations, cooperatives, trusts and partnerships.
(l) Biological products.— Means the preparations made from live organisms or its products, including vaccines, cultures, and others to be used in the diagnosis, immunization or treatment of humans or animals or in research.
(m) Biomedical waste treatment.— Means any method, technique or process designated to change the biological nature or the composition, without altering the physical features, of any regulated biomedical waste in such a way that its ability to cause diseases is reduced or eliminated, but its identity as such is preserved.
History —Aug. 6, 2008, No. 180, § 2.