Ariz. Admin. Code § R18-13-1401 - Definitions

In addition to the definitions in A.R.S. § 49-701, the following definitions apply in this Article:

1. "Administrative consent order" means a bilateral agreement between the consenting party and the Department. A bilateral agreement is not subject to administrative appeal.

2.

1. "Alternative treatment technology" means a treatment method other than autoclaving or incineration that achieves the treatment standards described in R18-13-1415.

3. 2. "Approved medical waste facility plan" means the document that has been approved by the Department under A.R.S. § 49762.04, and that authorizes the operator to accept biohazardous medical waste at its solid waste facility.

4. 3. "Autoclaving," means using a combination of heat, steam, pressure, and time to achieve sterile conditions.

5. 4. "Biohazardous medical waste" is composed of one or more of the following:

a. Cultures and stocks: Discarded cultures and stocks generated in the diagnosis, treatment or immunization of a human being or animal or in any research relating to that diagnosis, treatment or immunization, or in the production or testing of biolog-icals.

b. Human blood and blood products: Discarded products and materials that are saturated and/or dripping with human blood or caked with dried human blood, including items that would release blood in a liquid or semi-liquid form if compressed or broken, and items that contain serum, plasma, and other blood components. An item would be considered caked if it could release flakes or particles when handled.

c. Human pathological wastes: Discarded organs, tissues, and body parts, including cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid and amniotic fluid, removed during surgery or other medical procedures, including autopsy, obstetrics, or emergency care. Human pathological wastes do not include the head, spinal column, hair, nails, or teeth.

d. Medical sharps: Discarded sharps that pose a stick hazard that have come into contact with blood, blood products, or pathological waste. Examples include hypodermic needles; scalpel blades; and needles attached to tubing or syringes.

e. Research animal wastes: Animal carcasses, body parts, and bedding of animals that have been infected with agents that produce, or may produce, human infection.

f. Tattoo and body modification waste: any waste generated during the course of physically altering a human being, including tattooing, ear piercing, or any other process where a foreign object is used to cut or pierce the skin.

g. Trauma scene waste: any crime scene, accident, or trauma clean-up wastes generated by individuals or commercial entities hired to clean crime scenes or accidents, such as sharps and materials that contain human blood and blood products.

6. 5. "Biologicals" means preparations made from living organisms or their products, including vaccines, cultures, or other biological products intended for use in diagnosing, immunizing, or treating humans or animals or in research pertaining to these activities.

7. 6. "Biological indicator" means a representative microorganism used to evaluate treatment efficacy.

8. "Blood and blood products" means discarded human blood and any product derived from human blood, including but not limited to blood plasma, platelets, red or white blood corpuscles, and other derived products.

9. 7. "CFR" means the Code of Federal Regulations.

10. 8. "Chemotherapy waste" means any discarded material that has come in contact with an agent that kills or prevents the reproduction of malignant cells.

a. Trace contaminated chemotherapy waste includes: masks, empty drug vials, gloves, gowns, IV tubing, empty IV bags/bottles, and spill clean-up materials.

b. Bulk chemotherapy waste, such as full expired vials of chemotherapy drugs, is not biohazardous medical waste. Bulk chemotherapy waste may be considered hazardous wastes and must be handled according to the hazardous waste regulations if deemed a hazardous waste by the generator.

11. 9. "Dedicated vehicle" means a motor vehicle or trailer that is pulled by a motor vehicle used by a transporter for the purpose of transporting biohazardous medical waste in conjunction with other compatible waste according to the USDOT requirements, listed at 49 CFR 177.848, revised as of October 1, 2020, and no future editions or later amendments, is incorporated by reference in this rule and on file with ADEQ.

10. "Department-approved facility" means a storage, transfer, treatment, or disposal facility that has undergone plan approval as described in R18-13-1410.

12. 11. "Discarded drug" means any prescription medicine or over-the-counter medicine used in the diagnosis, treatment, or immunization of a human being or animal, that the generator intends to abandon. The term does not include hazardous waste or controlled substances regulated by the United States Drug Enforcement Agency.

13. 12. "Disposal facility" means a municipal solid waste landfill that has been approved by the Department under A.R.S. § 49-762.04 to accept untreated biohazardous medical waste for disposal.

13. "Emergency situations" include those situations where following location restrictions may result in an imminent threat to human health and the environment.

14. "Facility plan" has the meaning given to it in A.R.S. § 49-701.

15. "Free flowing" means liquid that separates readily from any portion of a biohazardous medical waste under ambient temperature and pressure.

16. 15. "Generator" means a person whose act or process produces biohazardous medical waste, or a discarded drug, or whose act first causes medical waste or a discarded drug to become subject to regulation.

17. 16. "Hazardous waste" has the meaning prescribed in A.R.S. § 49-921.

18. 17. "Health care worker" means, with respect to R18-13-1403(B)(5), a person who provides health care services at an off-site location that is none of the following: a residence, a facility where health care is normally provided, or a facility licensed by the Arizona Department of Health Services.

19. 18. "Improper disposal of biohazardous medical waste" means the disposal by a person of untreated or inadequately treated biohazardous medical waste at any place that is not approved to accept untreated biohazardous medical waste.

20. 19. "Independent testing laboratory" means a testing laboratory independent of oversight activities by a provider of alternative treatment technology.

21. 20. "Medical sharps container" means a vessel that is rigid, puncture resistant, leak proof, and equipped with a cap capable of being securely closed.

22. 21. "Medical waste," as defined in A.R.S. § 49-701, means "any solid waste which is generated in the diagnosis, treatment or immunization of a human being or animal or in any research relating to that diagnosis, treatment or immunization, or in the production or testing of biologicals, and includes discarded drugs but does not include hazardous waste as defined in A.R.S. § 49921 other than conditionally exempt small quantity generator waste."

23. 22. "Medical waste treatment facility" or "treatment facility" means a solid waste facility approved by the Department under A.R.S. § 49-762.04 to accept and treat biohazardous medical waste from off-site generators.

24. 23. "Multi-purpose vehicle" means any motor vehicle operated by a health care worker in the course of providing health care services, where the general purpose is the non-commercial transporting of people and the hauling of goods and supplies, but not solid waste. A multi-purpose vehicle is limited to hauling biohazardous medical waste generated at a location other than a hospital or clinic.

25. 24. "Off site" means a location that does not fall within the definition of "on site" contained in A.R.S. § 49-701.

26. 25. "Packaging" or "properly packaged" means the use of a container or a practice under R18-13-1407.

27. 26. "Putrescible waste" means waste materials capable of being decomposed rapidly by microorganisms.

28. 27. "Radioactive material" has the meaning under A.R.S. § 30-651.

29. 28. "Secure" means to lock out or otherwise restrict access to unauthorized personnel.

30. 29. "Spill" means either of the following:

a. Any release of biohazardous medical waste from its package while in the generator's storage area.

b. Any release of biohazardous medical waste from its package or the release of packaged biohazardous medical waste by the transporter at a place or site that is not a medical waste treatment or disposal facility.

31. 30. "Store" or "storage" means, in addition to the meaning under A.R.S. § 49-701, either of the following:

a. The temporary holding of properly packaged biohazardous medical waste by a generator in a designated accumulation area awaiting collection by a transporter.

b. The temporary holding of properly packaged biohazardous medical waste by a transporter or a treater at an approved medical waste storage facility or treatment facility.

32. 31. "Technology provider" means a person that manufactures or a vendor who supplies alternative medical waste treatment technology.

33. 32. "Tracking document" means the written instrument that signifies acceptance of biohazardous medical waste by a transporter, or a transfer, storage, treatment, or disposal facility operator.

34. 33. "Transportation management plan" means the transporter's written plan consisting of both of the following:

a. The procedures used by the transporter to minimize the exposure to employees and the general public to biohazardous medical waste throughout the process of collecting, transporting, and handling.

b. The emergency procedures used by the transporter for handling spills or accidents.

35. 34. "Transporter" means a person engaged in the business of hauling of biohazardous medical waste from the point of generation to a Department-approved storage facility or to a Department-approved treatment or disposal facility.

36. 35. "Treat" or "treatment" means, with respect to the methods used to render biohazardous medical waste less infectious: incinerating, autoclaving, or using the alternative treatment technologies prescribed in this Article.

37. 36. "Treated medical waste" means biohazardous medical waste that has been treated and that meets the treatment standards of R18-13-1415 . Treated medical waste that requires no further processing is considered solid waste.

38. 37. "Treater" means a person, also known as an operator, who receives solid waste facility plan approval for the purpose of operating a medical waste treatment facility to treat biohazardous medical waste that is generated off site.

39. 38. "Treatment certification statement" means the written document provided by either a generator who treats biohazardous medical waste on site or by a treater to inform a solid waste disposal or recycling facility that biohazardous medical waste has been treated as prescribed in this Article, and therefore is no longer subject to regulation under this Article.

40. 39. "Treatment standards" mean the levels of microbial inactivation, prescribed in R18-13-1415, to be achieved for a specific type of biohazardous medical waste.

40. "USDOT" means the United States Department of Transportation.

41. "Universal biohazard symbol" or "biohazard symbol" means a representation that conforms to the design shown in 29 CFR 1910.145(f)(8)(ii) (Office of the Federal Register, National Archives and Records Administration, July 1, 1998) and which is incorporated by reference in this rule. This incorporation does not include any later amendments or editions. Copies of the incorporated material are available for inspection at the Department of Environmental Quality and the Office of the Secretary of State.

42. "Vehicle not dedicated to the transportation of biohazardous medical waste but which is engaged in commerce" means a motor vehicle or a trailer pulled by a motor vehicle whose primary purpose is the transporting of goods that are not solid waste or biohazardous medical waste and that is used by a transporter for the temporary transportation of biohazardous medical waste.

Notes

Ariz. Admin. Code § R18-13-1401

New Section adopted by final rulemaking at 5 A.A.R. 3776, effective September 17, 1999 (Supp. 99-3). Amended by final rulemaking at 27 A.A.R. 2801, effective 1/4/2022.