3745-27-34 Standards for the packaging of infectious waste.

(A) Packaging of infectious wastes, other than those subject to paragraph (b) (15) (g) of rule 3745-27-01 of the Administrative Code, shall meet the following requirements:

(1) Bags shall be red in color or conspicuously labeled with the international biohazard symbol. Each bag shall be constructed of material of sufficient single thickness to preclude ripping, tearing, or bursting under normal conditions of handling as determined by the one-hundred-sixty-five gram minimum “Dropped Dart Impact Resistance Test (D1709)” as prescribed by the “American Society for Testing and Materials” and certified by the bag manufacturer. In addition, the bags shall be of sufficient film strength, strength of seals, and leakage resistance as demonstrated by filling a bag with twenty-five pounds of water and carrying the bag suspended from the top of the bag for a time period of sixty seconds without leakage. The international biohazard symbol on the bags shall be a minimum of five inches in diameter;

(2) Bags shall be impervious to moisture;

(3) Filled bags shall be securely tied or sealed to prevent leakage or expulsion of wastes from them during storage, handling, or transport;

(4) Bags containing infectious wastes that are being transported off the premises shall be placed inside a second sealed plastic bag which meets the requirements of this paragraph or one single bag within a fully enclosed, rigid, sturdy container. If containers, other than bags and “sharps” containers as specified in paragraph (b) of this rule, are utilized:

(a) Containers for infectious waste shall be at a minimum labeled with the international biohazard symbol on two opposite sides; and

(b) Containers shall be kept in good repair, shall be kept clean on the outside, shall be leak resistant, shall have tight-fitting covers, and shall have sufficient strength to withstand handling during transport without compromising their integrity. These containers may be reusable or disposable-; and

(c) Reusable containers shall be thoroughly cleaned with a detergent and disinfected after each use. The disinfectant shall be either an U.S. EPA registered hospital disinfectant that is also tuberculocidal, for a contact time as specified by the manufacturer, a unexpired dated stablized bleach product that is an U.S. EPA registered hospital disinfectant that is also tuberculocidal, for a contact time and as specified by the manufacturer, or materials necessary to prepare a minimum ten per cent sodium hypochlorite solution prepared immediately prior to use with a minimum thirty minutes of contact time with the container.

[Comment: Household bleach depending upon brand is three to five per cent sodium hypochlorite by volume. A 1:10 dilution of household bleach (one part household bleach to nine parts of water) contains a minimum ten per cent volume/volume sodium hypochlorite solution and will produce a solution with 3000-5000 parts per million of free available chlorine.

To make a ten per cent household bleach solution for disinfection, add approximately 6.4 ounces of household bleach to 57.6 ounces of tap water. This yields 1/2 gallon of solution.]

(5) This paragraph does not apply to generators who meet all of the following:

(a) Generate less than fifty pounds of infectious waste each month;

(b) Do not hold a registration certificate as a generator of fifty pounds or more of infectious waste in any one month; and

(c) Have treated specimen cultures and treated cultures of viable infectious agents in accordance with paragraph (a) of rule 3745-27-32 of the Administrative Code.

[Comment: We recommend an internal tracking mechanism e.g., bar coding of the secondary sealed plastic bag, secondary container or reusable container.]

(B) Packaging of infectious wastes specified in paragraph (b) (15) (g) of rule 3745-27-01 of the Administrative Code and all unused discarded hypodermic needles, syringes, and scalpel blades, and all discarded hypodermic needles, syringes, and scalpel blades used by the generator that are not infectious waste as defined in rule 3745-27-01 of the Administrative Code shall meet the following requirements:

(1) Infectious wastes “sharps” containers shall be rigid, puncture-resistant, leak resistant, and closed tightly to prevent loss of contents. “Sharps” containers shall be only those containers specifically designed and manufactured for the management and/or disposal of “sharps.” “Sharps” containers shall be labeled “sharps” and, if not treated in accordance with rule 3745-27-32 of the Administrative Code, shall be conspicuously labeled with the international biohazard symbol;

(2) All unused discarded hypodermic needles, syringes, and scalpel blades; and all discarded hypodermic needles, syringes, and scalpel blades used by the generator that are not infectious waste as defined in rule 3745-27-01 of the Administrative Code shall be packaged in accordance with the minimum operational requirements of rigid, puncture-resistant, leak resistant, and closed tightly to prevent loss of contents.

[Comment: For items that pose minimum puncture potential, such as hard plastic pipets and syringes, a cardboard box lined with a plastic bag meets the minimum operational requirements of being rigid, puncture-resistant, leak resistant, and closed tightly to prevent loss of contents for the packaging.

For items that pose puncture potential, such as hypodermic needles, scalpel blades, lancets and broken glassware, a cardboard box lined with a plastic bag may meet the minimum operational requirements of being rigid, puncture-resistant, leak resistant, and closed tightly to prevent loss of contents.]

(c) Containers holding infectious wastes shall not be dropped, managed, or transferred in such a manner as to cause damage to the bag or container. Infectious wastes shall not be transferred through the use of chutes.

Eff 5-1-90; 12-1-97

Rule promulgated under: RC Chapter 119.

Rule authorized by: RC 3734.021

Rule amplifies: RC 3734.021

ORC 119.032 review date: December 1, 2002