Waste-Regulated Regulations

The provision of health care is resource intensive, with significant input of materials, water, and energy that results in output of waste, effluents, and emissions pollution. Health care generates waste and emissions in almost every waste/emission category, resulting in oversight from numerous regulatory agencies that may have overlapping regulations depending on the type of input (e.g., where the material is generated) and type of output. These agencies also focus on who (or what) a particular regulation is designed to protect. The tougher rule, the one that is more stringent, always trumps. The table below provides a very brief outline of some of the agencies that regulate waste and emissions generated by health care facilities.

Agency/Organization
Focus/Audience
Major Focal Areas Related to Waste
U.S. Environmental Protection Agency (EPA) Protection of the planet, primarily from hazardous chemicals
  • RCRA – Resource Conservation and Recovery Act (hazardous chemicals)
  • CWA – Clean Water Act
  • CAA – Clean Air Act
  • CERCLA – Comprehensive Environmental Response, Compensation, and Liability Act (Superfund)
  • EPCRA – Emergency Planning and Community Right-to-Know Act
  • TSCA – Toxic Substance Control Act
  • FIFRA – Federal Insecticide, Fungicide, and Rodenticide Act
U.S. Occupational Safety and Health Administration (OSHA) Protection of workers (people) from work-related injuries
  • Bloodborne Pathogens Standard
  • Hazard Communication Standard
  • Respiratory Protection Standard
Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) Protection of patient health and safety
  • Environment of care
  • Safety and leadership
U.S. Department of Transportation (DOT) Protection of public safety by regulation of material transportation on public roads and highways
  • U.S. Postal Service has mailing requirements for shipment of health care-related items
U.S. Drug Enforcement Agency (DEA) Protection of the public from controlled substances (pharmaceutical wastes)
  • DEA-controlled substance management
Nuclear Regulatory Agency (NRC) Protection of the public from use of radioactive materials and wastes
  • RCRA also regulates mixed waste.
Centers for Disease Control and Prevention (CDC) Protection of workers and public health related to regulated medical wastes, infection control, etc.
  • Guidelines and recommendations for infection control, sterilization, hand hygiene, etc.
U.S. Department of Health and Human Services (HHS) Provision of regulations overseeing a variety of health care-related issues
  • Food and Drug Administration (FDA)
  • Centers for Medicare & Medicaid Services (CMS)
  • HIPAA
State governments
  • Public health department
  • State EPA
  • Local fire department
  • Local emergency planning
Regulatory authority in many waste-related areas. In particular, states mandate rules for the management of regulated medical waste.
  • Have the ability to be more stringent than federal regulations. More stringent regulations always trump those less so.
Local POTWs (publicly owned treatment works) Water treatment from local and regional communities and businesses
  • Can set local standard requirements for water discharge allowances and issue permits

 

Overlapping Regulations. From cradle-to-grave, the oversight of the same material can cross several different regulatory agencies. The regulations enforced by these agencies generally are not in conflict, but they can be confusing. Take, for example, the overlapping regulatory agencies monitoring the production, transportation, use, and disposal of a hazardous pharmaceutical drug:

  • Manufacture—FDA
  • Transportation—DOT for handling, packaging, labeling
  • Safe use—OSHA HazCom for labeling, storage, training; respiratory protection, if aerosolized; BBP, if sharp; and DEA, if a controlled substance
  • Waste management—RCRA if hazardous waste
  • Transportation—DOT for handling, packaging, labeling
  • Treatment/disposal—RCRA, CWA, CAA, TSCA

Life cycle regulation can get very complex. A health care facility's hazardous waste vendors should be a knowledgeable and trusted resource. However, health care facility administrators are responsible for the proper management of the hazardous waste generated in their facilities. It is appropriate to ask for guidance, but it is best to continuously check the regulations. Health care administrators are legally accountable for understanding the regulations and knowing where waste is going and tracking it to its final disposition location. Paperwork, manifests, and invoices are legal documents and should be kept meticulously.

Changes in Regulations. One of the easiest ways to keep up with changes in regulations is to follow a few different RSS feeds. First, go to your state EPA (called many different things by state) and sign up for their RSS feed, checking for relevance to health and welfare regulations. Some vendors have RSS feeds that are terrific sources of information; it's critical to their business that they get the information right. Make sure you are in the informational loop to be notified of changes.

Tips for Environmental Inspection Readiness

Several checklists are available to help you be prepared for an unannounced inspection. Below are questions that an inspector might ask to assess evidence of comprehensive programs. In other words, if the answers to the questions in these lists were YES, it might be taken as evidence that your facility could have concerns. Thus, a goal might be to be able to answer NO.

List 1—Infrastructure: Does a facility's infrastructure fundamentally address environmental compliance and improvement programs? Inspectors may ask these types of questions to signify a general knowledge and commitment to compliance and beyond.

List 2—Regulatory Compliance: Does the responsible person in your facility understand the top compliance violation issues in health care? Inspectors and surveyors know these are problematic areas and will come looking.

List 3—Overall Environmental Program Management: Does the facility have a pulse on the latest trends in environmental program priorities? Regulators look for environmental performance award winners and will ask questions about the latest trends.

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List 1—Infrastructure

Institutional

  1. Does the facility have an environmental management policy or manual (EMS or other) that outlines comprehensive commitments, policies and/or procedures concerning all aspects of environmental compliance, continuous improvement, and pollution prevention?
  2. Does the facility have a process that outlines how environmental issues are incorporated into hospital decision-making (institutional commitments to new and ongoing initiatives, e.g., new construction, new chemical purchases (EPP), mercury, EtO, or BPT elimination, etc.)?
  3. Is the facility an Energy Star partner or Climate Change partner? Has it won any environmental awards or taken any public pledges?

Leadership

  1. Has the Safety Committee (or other authorized committee) identified all the environmental regulatory requirements the facility is subject to? Does the committee have a procedure in place for keeping this list up to date in light of new regulations, changes in hospital operations, and voluntary undertakings (e.g., best practice recommendations from Practice Greenhealth or state P2 agencies)?
  2. Does the hospital periodically evaluate the status of compliance with environmental requirements (e.g., walk-through, third-party compliance audits) and report back to the Safety Committee?
    2.1   Is this effort documented in reports and resolutions?
    2.2   Is there a comprehensive mechanism for staff to report concerns that includes documentation, reporting, and follow-up?

  3. Has the hospital established an environmental leadership committee or “green team” to advise leadership of ways to improve the organization’s environmental performance and reduce the environmental liabilities of the medical facility?
  4. Does the facility have a primary responsible party (person) to oversee the environmental management system? Does this person have the necessary authority to implement changes to hospital practices that impact the environment and have direct access to top leadership if policy changes are needed?
    4.1   Based on the facility size and level of activity, have adequate human resources been allocated to the function (e.g., a 250+-bed facility could support a full-time person).
    4.2   Is there a job description for this person that adequately and clearly states the individual's role and legal and operational responsibilities of the task, including comprehensive oversight of all regulatory issues (OSHA—HazCom and BBP, RCRA, DOT, EPCRA, SPCC, CAA)? The job description should include the following:
    Employee training
    Policy development and maintenance
    Record keeping
    Operational oversight


Staff

  1. Does the facility have an education and training program in place for ongoing environmental education and training of all employees, on-site service providers, and contractors? Such a program should begin with new employee orientation and include annual update sessions.
    1.1   Does the responsible staff person have 40-hour hazwopper training?
    1.2   Do waste handlers have 8-hour hazwopper training?
    1.3   Do waste handlers have state-specific waste handler certifications?
    1.4   Do all new employees receive training on their first day of work and annually thereafter?

    Note: How does the hospital control the environmental impacts of contractors and on-site service providers?
  2. Do all organizational job descriptions specify responsibility for environmental performance and regulatory compliance specific to the job, including management job descriptions?
  3. Are policies and procedures in place related to the potential consequences of not following environmental procedures? Does Human Resources reward good environmental performers?

Facilities

  1. Is there adequate storage to provide appropriate handling, storage, and management of a comprehensive waste program?
  2. Are there adequate and appropriate waste receptacles to promote participation in waste segregation policies (e.g., solid waste containers, red-bag containers, sharps containers, recycling bins, chemotherapy disposal buckets, bulk pharmaceutical disposal containers, bulk RMW containers)? Is there appropriate labeling for each and every container?

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List 2—Regulatory Compliance

  1. Does the hospital have records of its waste determinations? Does the staff know its hazardous waste generator category?
  2. Are hazardous waste storage areas clearly designated as either a main hazardous waste accumulation point, a satellite accumulation point, or a universal waste storage area?
  3. Are satellite accumulation points at or near the point of hazardous waste generation (i.e., can you throw a Frisbee from the point of generation and hit the satellite accumulation point)?
  4. Are all hazardous and universal waste containers sealed (except waste is being added or removed), in good condition, compatible with the material in the containers, and properly labeled?
  5. Does the hospital conduct weekly inspections of its hazardous waste accumulation points and keep records of these inspections?
  6. Has the hospital designated an emergency coordinator who is on-call or on-site at all times? Is emergency information available by the phone nearest to each hazardous waste accumulation point? Does the hospital have basic safety guidelines and emergency procedures in place? Does the hospital have properly maintained fire extinguishers and alarms, spill control equipment, and decontamination supplies? Has the hospital ever tested its emergency procedures? Has the hospital made advanced emergency arrangements with local fire, police, and emergency response teams; with equipment suppliers; and with emergency contractors?
  7. Is the hospital sending its waste to approved facilities and, if required, properly filling out hazardous waste manifests? Are copies of the manifests kept for three years?
  8. Are fluorescent lightbulbs and computers being thrown into dumpsters?
  9. How is the hospital handling its other P- and U-listed wastes, including unused or expired pharmaceuticals?
    9.1   Is the facility managing its P- and U-listed chemotherapeutics?
    9.2   Are they being managed as hazardous wastes?

  10. Does the hospital maintain all applicable emissions permits? Is the paperwork needed to show compliance kept with these permits?
    10.1   Water (e.g., direct wastewater discharges and/or approval from the publicly owned treatment works for any indirect discharges, including sink disposal of chemicals/waste; proper SPCC plan; floor drain site map; and proper use)
    10.2   Air (e.g., boilers, spray paint booths, degreasers, lab hoods)

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List 3—Overall Environmental Program Management

  1. Does the hospital have a hazardous waste minimization program?
  2. Has the facility implemented a comprehensive regulated medical waste (RMW) management and reduction program?
    2.1   Strategic placement of RMW containers
    2.2   Staff education programs that emphasize proper handling and disposal of RMW
    2.3   Implemented suction canister disposal program
    2.4   Implemented reusable sharps container program

  3. Does the facility have an environmentally preferable purchasing program whereby it replaces hazardous materials with less hazardous or non-hazardous materials, taking into account the total cost of the material (including disposal costs) and not just the initial purchasing cost? These are sample actions:
    3.1   Replace gluteraldehyde with Cidex OPA.
    3.2   Replace ETO with less hazardous alternatives.
    3.3   Implement solvent recycling programs in the lab (for xylene, alcohol, formalin).

  4. Has the facility undertaken any climate change reduction strategies?
  5. Has the facility implemented a mercury reduction program consistent with the 1998 national MOU goal of mercury elimination in health care?
    5.1   Does the facility have a policy statement and/or management plan for mercury reduction?
    5.2   Is the facility still using items containing mercury and, if so, does it have appropriate management, spill prevention, and spill clean-up processes in place?
    5.3   Is the facility sending mercury thermometers home with patients?

  6. Has the facility implemented a "green cleaning" program to minimize occupational exposure to hazardous cleaning chemicals while improving environmental performance?
  7. Does the facility have a complete departmental inventory of all hazardous chemicals found in any particular location? Is the inventory consistent with the material safety data sheets (MSDSs) available in that area?
  8. Are all hazardous chemicals labeled appropriately to identify handling and disposal requirements?
  9. Is there an integrated pest management (IPM) program in place? If not, how is the pest management program implemented and how are pesticides applied?
  10. Has a comprehensive chemotherapy management been implemented? Is there evidence of staff knowledge of procedures?
  11. Does the facility utilize the Green Guide for Health Care, LEED, Green Globes, or any environmental performance measurement system?

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