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South Carolina

Regulated Medical Waste

Background Information
Definition of Infectious Waste
Managing Infectious Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information



Background Information

Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Infectious Waste

An infectious waste is any used material which is: generated in the health care community in the diagnosis, treatment, immunization, or care of human beings; generated in autopsy or necropsy; generated in research pertaining to the production of biologicals which have been exposed to human pathogens; generated in research using human pathogens. Examples include: sharps; specimens, cultures, and stocks of human pathogenic agents; blood and blood products; pathological waste; contaminated animal waste; and isolation waste.  Also, any material designated by written generator policy as infectious, or any other material designated by a generator as infectious by placing the material into a container labeled infectious is an infectious waste. In addition, any solid waste which is mixed with infectious waste becomes designated as infectious and must be managed unless expressly excluded. 

Certain wastes are excluded from the definition of infectious waste such as infectious waste residues resulting from discharges, hazardous waste which is to be managed pursuant to the hazardous waste management regulations, radioactive material which is managed pursuant to the department regulation, infectious wastes generated in a private residence except when determined by the commissioner to be an imminent or substantial hazard to public health or the environment.

Managing Infectious Waste

The Department will determine how individual waste fits into the definitions and/or categories.

Generator Requirements.

  • All in-state generators of infectious waste must register with the Department of Health and Environmental Control.  Information to be given should include the name of the business, name of the owner and responsible party if different, physical location of the site of waste generated, mailing address of the site of generation, telephone number of the site, a contact name of the infectious waste coordinator, and the categories and amount of infectious waste generated annually (estimated within + or -20%).

  • When any changes occur in the information required the Department must be notified in writing of such changes within thirty (30) days.

  • Renewal of registration will be every three (3) years for all generators. Registered generators will be notified of renewal requirements by the Department.

  • Fees for registration are due at the time of registration and renewal.

  • Each generator must have a designated infection control committee with the authority and responsibility for infectious waste management. This committee must develop or adopt a written protocol to manage the infectious waste stream from generation to disposal. The written protocol must include contingency plans and a Quality Assurance program to monitor their own onsite treatment procedures. Small quantity generators are not required to have an infection control committee or a written protocol.

  • Each generator must:

    • segregate infectious waste from other waste at the point of generation;
    • assure proper packaging and labeling of waste to be transported offsite;
    • initiate the manifest if waste is to be transported offsite;
    • prevent infectious waste containing radioactive material;
    • maintain records;
    • store waste properly;
    • manage infectious waste in a manner which prevents exposure to the public or release to the environment;
    • treat infectious waste onsite or offer infectious waste for offsite transport only to a transporter who maintains a current registration with the Department;
    • weigh waste prior to sending off-site for disposal; and
    • maintain monthly generation rates in the facility operating record.

Small Quantity Generators

  • All in-state generators that produce less than fifty (50) pounds of infectious waste per calendar month are small quantity generators and are exempt from some of the provisions of this regulation. (see complete regulations below).

  • Generators who qualify as small quantity generators, as defined above, may transport their own waste provided they never transport more that fifty pounds at a time, the waste is packaged and labeled as required and the waste is not transported in the passenger compartment of the vehicle and is in an enclosed compartment to protect the container from inclement weather.

  • If a small quantity generator offers infectious waste for transport offsite for treatment at a destination facility, the waste must be appropriately managed (e.g., segregated, packaged, labeled, etc.).

Segregation Requirements

Generators must segregate infectious waste from solid waste as close to the point of generation as practical to avoid commingling of the waste. If infectious waste is put in the same container as other waste, or if solid waste is put into a container labeled as infectious waste, the entire contents of the container must be managed as infectious waste unless hazardous and/or radioactive material regulations apply, then the most stringent regulations apply.

Packaging Requirements

  • Generators must assure that infectious waste is properly packaged before transporting or offering for transport offsite; must place and maintain all sharps in rigid, leak resistant, and puncture resistant containers which are secured tightly to preclude loss of the contents and which are designed for the safe containment of sharps; all other types of infectious waste must be placed, stored, and maintained before and during transport in a rigid or semi-rigid, leak proof container which is impervious to moisture. 

  • Containers must have sufficient strength to prevent bursting and tearing during handling, storage, or transportation.  They must be sealed to prevent any discharge of the contents at any time until the container enters the treatment system.

  • Plastic bags used inside of containers must be a red or orange color and have sufficient strength to prevent tearing.

  • Dumpsters, trailer bodies or other vehicle containment areas do not constitute a rigid containment system but are only a transport mechanism.

  • Infectious waste must be contained in disposable or reusable containers that are appropriate for the type and quantity of waste, must withstand handling, transfer, and transportation without impairing the integrity of the container, must be closed tightly and securely, and must be compatible with selected storage, transportation, and treatment processes.

  • Reusable containers are acceptable. These containers must be properly disinfected after each use.

  • Infectious waste must not be compacted by any means prior to entering the containment of the treatment process.

  • Exempt or excluded waste must not be packaged as infectious waste. Waste packaged as infectious waste must be managed as infectious waste.

  • When infectious waste is treated by a technology which does not change the appearance of the bag or outer container, it must be clearly labeled with the word “Treated” and the date of treatment on the outside of the container to indicate that the waste was properly treated. This labeling method may be hand written, an indicator tape or chemical reaction. The labeling process must be water-resistant and indelible.

Labeling of Containers.

  • Generators and transporters must assure that containers of infectious waste are properly labeled in English.

  • Containers of infectious waste offered for transport offsite must be labeled on outside surfaces with water-resistant and indelible ink so that it is readily visible with the universal biohazard symbol, the name or Department issued number of the in-state generator, and the name, address and phone number of the in-state generator if the waste is generated outside of this state.  The date the container was placed in storage or sent offsite and the words Infectious Waste, Biohazardous Waste, or Medical Waste must be noted. 

  • Each bag used to line the inside of an outer container must be labeled with indelible ink or imprinted as above.

  • Transporters must label each outer container at the time it is accepted as specified and must affix required labels so that no other required markings or labels are obscured.

  • Abbreviations may not be used in required labeling except for the common dictionary standard abbreviations.

Storage of Infectious Waste

  • Storage must be in a manner and location which affords protection from animals, vectors, weather conditions, theft, vandalism and which minimizes exposure to the public.

  • Outdoor storage areas must be locked (for example: dumpsters, sheds, trailers, van bodies, or any other storage area).

  • Storage areas must be labeled with the universal biohazard symbol sign and the words Infectious Waste, Medical Waste, or Biohazardous Waste.

  • Infectious waste must be maintained in a nonputrescent state using refrigeration when necessary.

  • All floor drains in storage areas must discharge into a Department approved sanitary sewer system or be transported to a Department approved sewerage treatment facility or permitted infectious waste treatment facility.

  • All ventilation in storage areas must be in compliance with applicable Department air quality requirements and minimize human exposure.

Disinfection Standards

  • Any material or surface which comes in contact with infectious waste must be disinfected prior to reuse.

  • Disinfection can be accomplished by appropriate use of an EPA registered disinfectant used according to the label instructions at the tuberculocidal strength.

  • Drainage from decontamination processes must discharge to a Department approved sanitary sewer system or be transported to a Department approved sewerage treatment facility or permitted infectious waste treatment facility.

Manifest Form Requirements for Generators

  • A generator who transports, or offers for transport, infectious waste for offsite treatment, storage, or disposal, must prepare a manifest on a form approved by the Department and filled out in a legible manner according to the instructions for that form. The manifest form must accompany the waste at all times after leaving the generator's facility.

  • The generator who offers regulated infectious waste for transport offsite must initiate the manifest required and must also sign where required.

  • The generator must retain one copy of the manifest after the transporter has signed accepting the shipment and must notify the Department in writing if he does not receive a completed manifest appropriately signed from the destination facility within fifty days after offering for transport.

Treatment

Treatment of infectious waste must be by one of the following treatment methods:

  • Incineration;
  • Steam sterilization;
  • Chemical disinfection; or
  • Any other Department approved treatment method.

Approval for other forms of treatment must be obtained from the Department and meet standards set at that time by the Department.

Disposal

After approved and adequate treatment, the waste residue may be disposed of in accordance with state and federal solid waste requirements.

The following infectious waste may be disposed of before treatment:

  • An approved liquid or semi-liquid waste other than microbiological cultures and stocks may be discharged directly into a Department approved  wastewater treatment disposal system; and
    Recognizable human anatomical remains may be disposed of by interment or donated for medical research.
  • Products of conception must be incinerated, cremated, interred, or donated for medical research.

Storage of infectious waste prior to treatment must be in accordance the regulations.

It is unlawful for any person to discharge infectious waste or treated infectious waste into the environment of this State except as permitted by the Department.

Small quantity generators may treat, by an approved method onsite, infectious waste which they generate onsite without being permitted as a treatment facility.

Treatment of infectious waste must be monitored by use of biological indicators or laboratory culture of the treatment residue to ensure that pathogens have been adequately treated. Frequency of this testing shall be determined by the Department on a case by case basis or as outlined in this regulation.

OSHA Regulations

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste.  South Carolina is one of 24 states operating an approved occupational safety and health program.  This program is operated by the Occupational Safety and Health Administration.  OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Statutes, Regulations and Guidelines

R.61-105, Infectious Waste Management Regulations, Bureau of Land and Waste Management S.C. Department of Health and Environmental Control

Contacts

The South Carolina Department of Health and Environmental Control, Division of Waste Management oversees the agency's hazardous, infectious, and radioactive waste programs.

More Information

None.