(b) Containment of regulated medical waste for handling, storage, and treatment shall be accomplished with a primary container for protection from the elements and limiting exposure to employees and the public. Each primary container holding regulated medical waste shall be:

1. (1) marked prominently with the universal warning sign or the word "biohazard";
2. (2) impervious to moisture, be secured and situated so as to prevent leakage or preclude loss of contents during handling, storage and/or transport; and
3. (3) be located away from pedestrian traffic, be vermin and insect free, and shall be maintained in a sanitary condition.

(c) Whenever regulated medical waste is transported off-site for treatment elsewhere, the primary container shall have affixed a label or imprint indicating the name and address of the generation facility and shall comply with the transport requirements of subdivision (h).

1. (1) In addition to the requirements of subdivisions (b) and (c) of this section, the primary container for regulated medical waste, with the exception of sharps, shall be a plastic bag; red in color; and of a strength sufficient to resist ripping, tearing, or bursting under normal conditions of use and handling.

2. (2) In addition to the requirements of subdivisions (b) and (c) of this section, the primary container for discarded sharps shall be rigid, leakproof, puncture-resistant and closable, and may serve as a secondary container for purposes of transport, provided it meets the definition of a secondary container.

   (e)

3. (1) Under no circumstances shall a sharps container be filled beyond the fill line indicated on the container.
4. (2) Sharps containers shall be removed from the patient care areas to a room or area designated for regulated medical waste storage, whenever the container has reached the fill line indicated on the container. Sharps containers shall be removed from patient care areas within 30 days or upon the generation of odors or other evidence of putrification, whichever occurs first, without regard to fill level.

(d)

(f) Regulated medical waste, with the exception of sharps as provided in subdivision (e) of this section, may be held in patient care areas for a period not to exceed 24 hours and at a clinical laboratory for a period not to exceed 72 hours, at which time the waste shall be moved to a storage area.

1. (1) Each storage area shall be adequate for the volume of regulated medical waste generated between scheduled waste pick-ups by a transporter, or, for facilities treating the waste on-site, the volume of waste that can be treated on-site within a 24-hour period.

2. (2) Each storage area shall:

   1. (i) display prominent signage indicating the space is used to store regulated medical waste;
   2. (ii) be designed or equipped to prevent unauthorized access;
   3. (iii) be designed or located to protect waste from the elements, and prevent access by vermin;
   4. (iv) hold the waste at a temperature that prevents rapid decomposition and resultant odor generation;
   5. (v) be appropriately ventilated; and
   6. (vi) be of sufficient size to allow clear separation of regulated medical waste from any other waste, whenever waste other than regulated medical waste is stored in the same area.
3. (3) Regulated medical waste shall not be stored for a period exceeding 30 days, except that a site generating under 50 pounds of regulated medical waste per month and not accepting regulated medical waste for treatment from other facilities, may store waste for a period not exceeding 60 days.

(g)

(h) Prior to transport off-site of the generating facility for treatment elsewhere:

1. (1) primary containers shall have affixed a label or imprint indicating the name and address of the generating facility; and

2. (2) primary containers, except as provided in paragraph (c)(2) of this section, shall be placed in a secondary container with an affixed label or imprint, indicating the name and address of the generating facility, and such container marked prominently with signage indicating that the contents are infectious or regulated medical waste; and, if applicable, with an affixed label indicating that the contents contain or are mixed with hazardous waste, and/or toxic drug waste.

   1. (i) All internal surfaces of a reusable secondary container used to hold regulated medical waste shall be completely protected by a disposable liner, which may also function as the primary container provided it meets the criteria for a primary container provided in subdivisions (b) and (c) of this section. The liner shall be removed as a secured unit with the waste and treated as regulated medical waste. A reusable secondary container shall undergo washing and decontamination upon emptying whenever the liner is compromised; visual inspection yields evidence that the container's surface has come in contact with the contained waste prior to treatment; the contained waste includes cultures and/or stocks; or the contained waste has a highly infectious bioload.