1. (1) Storage.

   1. (a) Storage of biomedical waste at the generating facility shall not exceed 30 days. The 30 day period shall commence when the first non-sharps item of biomedical waste is placed into a red bag or sharps container, or when a sharps container containing only sharps is sealed.
   2. (b) Storage of biomedical waste in a place other than at the generating facility shall not exceed 30 days. The 30 day storage period shall begin on the day the waste is collected from the generator.
   3. (c) Indoor storage areas shall have restricted access and be designated in the written operating plan. They shall be located away from pedestrian traffic, be vermin and insect free, and shall be maintained in a sanitary condition. They shall be constructed of smooth, easily cleanable materials that are impervious to liquids.
   4. (d) Outdoor storage areas, including containers and trailers, shall, in addition to the above criteria, be conspicuously marked with the international biological hazard symbol as described in paragraph 64E-16.004(2)(b), F.A.C., and shall be secured against vandalism and unauthorized entry. The international biological hazard symbol on an outdoor storage area shall be a minimum of six inches in diameter.

2. (2) Containment.

   1. (a) Packages of biomedical waste shall remain sealed until treatment, except when compacted in accordance with the requirements of this chapter as stated in Section 64E-16.006(2), F.A.C. Ruptured or leaking packages of biomedical waste shall be placed into larger packaging without disturbing the original seal.

   2. (b) All packages containing biomedical waste shall be visibly identifiable with the international biological hazard symbol and one of the following phrases: “BIOMEDICAL WASTE”, “BIOHAZARDOUS WASTE”, “BIOHAZARD”, “INFECTIOUS WASTE”, or “INFECTIOUS SUBSTANCE”. The symbol shall be red, orange, or black and the background color shall contrast with that of the symbol or comply with the requirements cited in subpart Z of 29 C.F.R. subparagraph 1910.1030(g)(1)(C), Occupational Exposure to Bloodborne Pathogen Standard.

      
      

   3. (c) Bags.

      1. Biomedical waste, except sharps, shall be packaged and sealed at the point of origin in impermeable, red plastic bags or, at the discretion of the generator, into sharps containers. The international biological hazard symbol shall be at least six inches in diameter on bags 19'' × 14'' or larger, and at least one inch in diameter on bags smaller than 19'' × 14''. Each plastic bag shall meet the following physical properties:

      a. Impact resistance of 165 grams and tearing resistance of 480 grams in both the parallel and perpendicular planes with respect to the length of the bag. Impact resistance shall be determined using ASTM D-1709-91, and tearing resistance shall be determined using ASTM D-1922-89.

      b. Incidental sum concentrations of lead, mercury, hexavalent chromium and cadmium shall be no greater than 100 ppm for dyes used in the coloration of bags.

   4. (d) Sharps containers.

      1. Sharps shall be discarded at the point of origin into single use or reusable sharps containers. Needles and scalpel blades shall not be placed directly into double-walled corrugated containers. Sharps containers must be sealed when full. A sharps container is considered full when materials placed into it reach the designated fill line, or, if a fill line is not indicated, when additional materials cannot be placed into the container without cramming or when no additional materials are to be placed in the container.

      2. Permanently mounted sharps container holders shall bear the phrase and the international biological hazard symbol described in paragraph 64E-16.004(2)(a), F.A.C., if this information on the sharps container is concealed by the sharps container holder.

      3. Reusable sharps containers shall only be emptied into a treatment cart or directly into a treatment unit. They shall be constructed of smooth, easily cleanable materials, and shall be decontaminated after each use.

      4. The international biological hazard symbol shall be at least one inch in diameter on sharps containers.

   5. (e) All outer containers shall be rigid, leak-resistant and puncture-resistant. Reusable outer containers shall be constructed of smooth, easily cleanable materials and shall be decontaminated after each use.
   6. (f) The international biological hazard symbol shall be at least six inches in diameter on outer containers 19'' × 14'' or larger, and at least one inch in diameter on outer containers less than 19'' × 14''.

Rulemaking Authority 381.006, 381.0098 FS. Law Implemented 381.006, 381.0098, 395.002(13), 395.1011 FS. History–New 6-19-89, Amended 4-2-90, 12-14-92, 1-23-94, 8-20-95, 6-4-97, Formerly 10D-104.004.