FDOH Proposed Changes to Chapter 64E-16 (Biomedical Waste Regulations)

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Proposed Changes to the Florida Administrative Code for Biomedical Waste Chapter 64E-16

Substantial rewording of Rule 64E-16 Biomedical Waste. See below for proposed changes.

Click here to view the current Florida administrative code biomedical waste policy chapter 64E-16.

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All changes are highlighted in yellow.

64E-16.001 Scope of Chapter Rules

(1) These rules prescribe minimum standards relating to the management of biomedical waste.

(a) Minimum standards are established for permitting biomedical waste generator facilities, storage facilities, and treatment facilities, and for registration of biomedical waste transport facilities. Such requirements are established to ensure that the waste is properly handled by all facilities that generate, transport, store, or treat biomedical waste.

64E-16.002 Definitions

4. Discarded prescription drugs which are managed in accordance with section 64F-12.023, Florida Administrative Code.

(3) Biomedical waste facility - Any person who generates, stores, transports, or treats biomedical waste at a given physical address.

(6) Decontamination - The process of removing biomedical waste from an inanimate surface with the use of a United States Environmental Protection Agency registered tuberculocidal disinfectant in accordance with the manufacturer's instructions.

(16) Person - Any individual, partnership, corporation, association, or public body engaged in the generation, storage, transport, or treatment of biomedical waste.

(18) Point of origin - The room or area where biomedical waste is generated.

(21) Receipt – Written documentation which specifies the type of biomedical waste; amount of biomedical waste; name of transporter, storage facility, or treatment facility; name and physical address of generator; and date of pick up, delivery, or treatment.

(26) Storage -The holding of packaged biomedical waste.

(27) Storage facility - A facility that stores biomedical waste.

(e) Develop a written operating plan, which must be implemented by the facility to manage biomedical waste, in accordance with section 381.0098, F.S., and these rules. This plan shall be available for review by the department and facility personnel. The plan shall include the following: a description of training for personnel, procedures for segregating, labeling, packaging, transporting, storing, and treating biomedical waste; and procedures for decontamination. Plans shall be site specific for each location at which a facility provides services. Facilities which treat biomedical waste shall include a treatment contingency plan should the facility experience treatment unit down time which would prevent the treatment of biomedical waste in accordance with subsection 64E-16.010(9). Written operating plans for treatment facilities shall also include items referenced in subsection 64E-16.010(7). Plans shall be updated when regulations, facility policies, or procedures change.

(f) Provide and document training in proper biomedical waste procedures, in accordance with the facility's operating plan, for new personnel, including temporary personnel and interns, who handle biomedical waste as part of their work responsibilities. Training shall be provided prior to commencement of duties related to biomedical waste handling. Refresher training shall be completed annually by all personnel who handle biomedical waste. Training for treatment facility personnel shall also include that which is referenced in subsection 64E-16.010(8).

(g) Maintain paper or electronic biomedical waste management records for biomedical waste facilities for three years. Records shall be available for review by the department at the time of inspection for the previous 12-month period for permitted or registered facilities and the previous three-year period for exempted facilities. Examples of biomedical waste management records include, transporter pick-up receipts, storage facility receipts, treatment facility receipts, receipts from any facility to which biomedical waste is self-transported, weight logs, purchase and return receipts for mail-in sharps treatment systems, purchase receipts for approved single-use treatment processes, treatment records, training records, and as other.

 

Plans shall be updated when regulations, facility policies, or procedures change.

 

(f) Provide and document training in proper biomedical waste procedures, in accordance with the facility's operating plan, for new personnel, including temporary personnel and interns, who handle biomedical waste as part of their work responsibilities. Training shall be provided prior to commencement of duties related to biomedical waste handling. Refresher training shall be completed annually by all personnel who handle biomedical waste. Training for treatment facility personnel shall also include that which is referenced in subsection 64E-16.010(8)

(3) 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", "REGULATED MEDICAL WASTE", or "INFECTIOUS SUBSTANCE." The symbol shall be red, orange, or black and the background color shall contrast with that of the symbol; or the symbol and background color must comply with the requirements cited in subpart Z of 29 CFR sub-subparagraph 1910.1030(g)(1)(i)(C), Occupational Exposure to Bloodborne Pathogen Standard.

(a) Bags.
1. Biomedical waste, except sharps, shall be discarded at point of origin into impermeable, red plastic bags. Bags shall be sealed at the point of origin.

(b) Sharps containers.
1. Sharps shall be discarded at the point of origin into single use or reusable sharps 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 the contents reach three quarters of the sharps container height.

64E-16.006 Generator Facility Requirements.

(1) All biomedical waste generators must obtain a permit or exemption from the department.

(a) Mobile units, such as bloodmobiles, that are part of a stationary biomedical waste generator facility may operate under the permit of the stationary facility providing they return to the stationary facility daily.

(b) A biomedical waste generator who produces less than 25 pounds of biomedical waste in each 30-day period during the previous 12 months shall be exempted from permit and fee requirements of this chapter but shall comply with all other requirements. A biomedical waste generator choosing to apply for exemption or an exempted biomedical waste generator shall maintain documentation to prove exemption eligibility, as set forth in subparagraph 64E-16.013(1)(a)2.

(c) A permitted or exempted generator may work at a branch office for no more than six hours in any seven day period without applying for an additional permit or exemption. These generators must notify the county health department(s) having jurisdiction over both the main and branch office(s) of the address and operating hours of the branch office within 30 days of commencement of operation at the branch office.

(2) All biomedical waste generated in Florida must be transported by a department registered biomedical waste transporter, United States Postal Service approved mail back service, or the generator of the biomedical waste in accordance with these rules.

(3) Biomedical waste generators transporting less than 25 pounds of their own generated biomedical waste, in their own transport vehicle, on any single occasion, are exempted from transporter registration, fee, and vehicle marking requirements of these rules.

(4) Storage of biomedical waste shall not exceed 30 days at the generating facility. The 30-day period shall commence when the first non-sharps item of biomedical waste is placed into a red bag; when a sharps container is sealed.

(a) Indoor storage areas shall be:

1.   Restricted from public access;

2.   Designated in the written operating plan;

3.   Vermin and insect free;

4.   Maintained in a sanitary condition; and

5.   Constructed of smooth, easily cleanable materials that are impervious to liquids.

1.   Visibly identified with a minimum six inches in diameter international biological hazard symbol as described in subsection 64E-16.004(3), and

2.   Restricted by lock.

(5) Biomedical waste generators that treat less than 25 pounds of their own generated biomedical waste in a 30-day period shall be exempted from treatment facility permit and fee.

(6) Health care providers shall inform their home-user patients verbally and in writing of the recommended method for handling biomedical waste generated by the patient in the home setting. Health care providers, who administer in-home services, shall remove or have removed by a registered biomedical waste transporter or use of a United States Postal Service approved mail-back service, all biomedical waste generated while the client is a patient of the healthcare provider.

(7) Home users should segregate and package their biomedical waste in a manner that reduces the chance of exposure to the public. Rulemaking Authority 381.006, 381.0098 FS. Law Implemented 381.0098, FS. History-New 6-19-89, Amended 4-2-90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly 10D-104.006, Amended

64E-16.013 Permits and Exemptions

(1) All biomedical waste generator, storage, and treatment facility permits shall be obtained from the department annually.

(a) Each person who plans to construct, purchase, change control, reopen, or operate a biomedical waste generator, storage, or treatment facility shall apply for and receive a permit from the department prior to the commencement of operation.

1. Biomedical waste generator permit - Application for an initial permit shall be submitted to the department on form DH 4089, 1/10, Application for Biomedical Waste Generator Facility Permit, herein incorporated by reference.

2. Biomedical waste generator exemption – Application for an exemption shall be submitted to the department on form DH (# to be assigned) 1/10, Application for Biomedical Waste Generator Facility Exemption, herein incorporated by reference. A biomedical waste generator applying for exemption from permitting shall submit to the department documentation from the previous 12 months showing the biomedical waste generated in each 30-day period during those 12 months was less than 25 pounds. Documentation must include the weight of the biomedical waste generated in each 30-day period for the previous 12 months and may be in the form of a monthly log or receipts. If within any 30-day period during the previous 12 months an exempted generator produced a total of 25 pounds or more of biomedical waste at the main office and any branch offices, a permit must be obtained.

(d) Biomedical waste generator, storage, and treatment permits shall expire on September 30 each year, except that permits for temporary biomedical waste facilities shall be valid for a period of time not to exceed 14 consecutive days. The permit, or a copy thereof, shall be maintained within the facility and shall be made available for review by department personnel.

Generator Facility Permit:
Initial permit $85.00

64E-16.015 Enforcement and Penalties.

(1) According to section 381.0025, F.S., any person who generates, transfers, treats, stores, transports or disposes of biomedical waste in violation of this chapter; or who interferes with, hinders, or opposes any employee of the department in the discharge of his or her duties, or who impersonates an employee of the department, is chargeable with a misdemeanor of the second degree, punishable as provided in sections 775.082 and 775.083, F.S.

(2) Any registered, permitted, or exempted biomedical waste facility is subject to having their biomedical waste facility registration or permit denied, suspended, or revoked, pursuant to section 381.0098, F.S., and in accordance with the procedural requirements of section 120.60, F.S., upon a finding by the department that the facility:

(a) Has submitted false or inaccurate information in the application or annual report;

(b) Has violated the provisions of any statute or rule which the department is authorized to enforce;

(c) Has refused to allow inspection of records or equipment by department personnel.

(3) For violation of any provision of Chapter 64E-16, F.A.C., the department shall deny, suspend or revoke any biomedical waste permit or impose an administrative fine of up to $2500 per day for each violation of this chapter or pursue other enforcement action authorized by law. In determining the type and degree of enforcement action necessary, the department shall take into consideration the following:

(a) The gravity of the violation, including the probability that death or serious physical harm to any person may result or has resulted, the severity of the actual or potential harm, and the extent to which the provisions of the applicable statutes or rules were violated.

(b) Actions taken by the owner or operator to correct violations.

(c) Any previous violations.

Rulemaking Authority 381.006, 381.0098 FS. Law Implemented 381.0098 FS. History-New _________

Disclaimer: This transcript was taken from the FDOH Proposed Changes on Ch64E-16 notice sent out by the Florida Department of Health. While this information is accurate to the best of our knowledge, please contact the FDOH and/or your biomedical waste company to ensure that you are following all rules and regulations and that your facility is in compliance with federal, state, and local laws. This information is provided for educational purposes only, and Sharps MD and it's partners and affiliates assume no responsibility for either the accuracy of the information or it's use thereof.