DENR-DOH Guidelines on Health Care Waste Mngmt

Legal basis and covered statutes

The DENR and DOH issue the guidelines pursuant to, among others, the Clean Air Act of 1999 (Republic Act 8749).
The guidelines are issued pursuant to the Toxic Substances, Hazardous Waste, and Nuclear Waste Control Act of 1990 (Republic Act 6969).
The guidelines are issued pursuant to the Ecological Solid Waste Management Act of 2000 (Republic Act 9003).
The guidelines are issued pursuant to the Refuse Disposal of the Sanitation Code of the Philippine (Chapter XVIII, Implementing Rules and Regulations, Presidential Decree 856).
The guidelines are issued pursuant to the Clean Water Act of 2004 (Republic Act 9275).
The guidelines are issued pursuant to the Environmental Impact Statement (EIS) System (Presidential Decree 1586).
The guidelines are issued pursuant to the Hospital Licensure Act (Republic Act 4226).
Related permits, clearances, and compliance are governed by referenced laws including RA 6969, RA 8749, RA 9275, RA 9003, and PD 1586.

Purpose, objectives, and policy rationale

The guidelines provide rules for the effective and proper handling, collection, transport, treatment, storage, and disposal of health care wastes.
The guidelines are directed to generators, transporters, and owners or operators of TSD (treatment, storage, disposal) facilities.
The guidelines clarify the jurisdiction, authority, and responsibilities of DENR and DOH regarding health care waste management.
The guidelines harmonize the efforts of DENR and DOH for proper health care waste management.

Scope and definitional rules

The guidelines apply to health care waste generators, health care waste transporters, owners or operators of treatment, storage, and disposal (TSD) facilities, and final disposal facilities.
Health Care Wastes include all wastes generated from: diagnosis, treatment, management, and immunization of humans or animals; research related to these activities; producing/testing biological products; and waste from minor or scattered sources (e.g., dental clinics and alternative medicine clinics).
The categories of health care wastes are enumerated in Annex “A.”
Health Care Waste Generators include health care facilities, institutions, business establishments, and similar health care services that generate health care waste; they include (among others) hospitals by level of care, infirmaries, birthing homes, clinics (medical, ambulatory, dialysis, surgical, alternative medicine, dental, veterinary), laboratories and research centers, drug manufacturers, institutions, mortuary and autopsy centers, and related entities listed in the order.
Health Care Waste Transporters are persons licensed by DENR Environmental Management Bureau (EMB) to convey health care waste through air, water, or land.
Treatment, Storage and Disposal (TSD) Facilities are facilities where hazardous wastes are stored, treated, recycled, reprocessed, and/or disposed of under DENR AO No. 2004-36, Chapter 6-2 (Categories of TSD Facilities).

Implementing agencies and responsibilities

The order is implemented by DENR through EMB and its Regional Offices, the National Solid Waste Management Commission (NSWMC), and by DOH through designated offices and centers including CHD, BHFS, BHDT, EOHO of NCDPC, NCHFD, and NRL–East Avenue Medical Center, Quezon City.
DENR-EMB acts as the primary implementing government agency for health care waste management rules, especially issuance of permits and clearances for transport, treatment, storage, and disposal governed by RA 6969, RA 8749, RA 9275, RA 9003, and PD 1586.
DENR-EMB formulates policies, standards, and guidelines on transport, treatment, storage, and disposal of health care wastes.
DENR-EMB oversees compliance by generators, transporters, TSD facility operators, and final disposal facility operators.
DENR-EMB conducts regular sampling and monitoring of wastewater in health care and TSD facilities to determine compliance with RA 9275.
DENR-EMB requires TSD facility operators and on-site treaters to present to DENR copies of microbiological test results of treated health care waste (treated using autoclave, microwave, hydroclave, and other disinfection facilities) prior to renewal of their permits under RA 6969.
DENR-EMB provides technical assistance and support to advocacy programs on health care waste management.
DENR-EMB notifies DOH on cases of non-compliance or violations involving DOH-licensed health care facilities, institutions, and establishments.
DOH regulates hospitals and other health facilities through licensure and accreditation under Republic Act No. 4226.
DOH formulates policies, standards, guidelines, systems, and procedures on health care waste management.
DOH develops training programs and modules on health care waste management.
DOH provides technical assistance for preparation of health care waste management plans required for licensing or renewal.
DOH requires use of DOH-BHDT registered equipment or devices for treatment of health care wastes by TSD facility operators and health care waste generators with on-site waste treatment facilities.
DOH-BHDT conducts regular performance evaluation of treatment equipment/devices and monitors treated waste microbiological tests to ensure compliance with DOH standards.
DOH evaluates compliance of DOH hospitals with proper health care waste management programs.
DOH issues Department Circulars to ensure environmental requirements are complied with.
DOH notifies DENR on actions taken on cases of non-compliance or violations involving health care facilities, institutions, and business establishments.
DOH-Centers for Health Development (CHD) advocate health care waste management practices to Local Chief Executives, key leaders, and stakeholders; monitor practices in hospitals and health care facilities; and provide technical assistance via training, advisory on HCWM plans, dissemination of policies and information, monitoring and validation, development/reproduction/dissemination of IEC materials, and participation in public hearings related to HCWM.
DOH-CHD ensures compliance by health care waste generators with pertinent HCWM laws, rules, and regulations.

Documentary permits and licensure requirements

Health Care Waste Generators are required to register and secure required permits and licenses.
For generators, DENR-EMB issues or provides the following:
- Environmental Compliance Certificate (ECC) for establishment of hospitals and health care facilities covered by PD 1586, issued by EMB Central Office or its Regional Offices.
- Permit to Operate (P/O) for Air Pollution Source and Control Installation from EMB Regional Office.
- Discharge Permit issued by the EMB Regional Office and the Laguna Lake Development Authority (LLDA) based on RA 9275.
- Hazardous Waste Generator’s Registration under RA 6969 implementing rules and regulations (DAO 29 series of 1992 and DAO 36 series of 2004) from EMB Regional Office.
For generators, DOH-Bureau of Health Facilities and Services (BHFS) issues or provides:
- Licenses for hospitals, laboratories, dialysis clinics, birthing homes, infirmaries, psychiatric hospitals, dental prosthetic laboratories, blood banks, ambulatory clinics, and drug treatment and rehabilitation centers.
- Certificate of Accreditation for overseas Filipino workers (OFW) medical clinics, surgical clinics, drug testing laboratories, HIV testing laboratories, water testing laboratories, medical technologist intern training centers, and training centers for embalmers.
Health Care Waste Transporters must: register with EMB Central Office as health care waste transporter; secure Transport Permit from DENR-EMB Regional Office; comply with the DENR Manifest System; and comply with other requirements under the implementing rules and regulations of RA 6969.
TSD facilities must secure from DENR-EMB and DOH the required ECC/permits/clearances, including ECC for SLF and TSD Facility; Notice to Proceed for controlled dump facility as repository of health care waste; registration as TSD facility under RA 6969 implementing rules and regulations; Technology Approval for non-burn technologies prior to Permit to Operate; Permit to Operate for air pollution source and control installation; and Discharge Permit from DENR-EMB Regional Office or LLDA.
For treatment equipment/devices, TSD facilities must secure Certificate of Product Registration for equipment/devices used for treating health care wastes from DOH-BHDT, and Certificate of Technical Evaluation from NRL–EAMC for such equipment/devices.
Permits and licenses are secured following the established procedures of DENR and DOH.

Handling, treatment, and final disposal standards

Handling, collection, storage, and transport of health care wastes must comply with RA 8749, RA 6969, and RA 9003, and with the DOH Health Care Waste Management Manual (Chapter 5).
Treatment technologies include: thermal, chemical, irradiation, biological processes, encapsulation, and inertization, subject to compliance with RA 8749, RA 6969, and RA 9003 and consistent with the DOH manual.
Autoclave, microwave, and hydroclave facilities must use microbiological tests to determine treatment efficiency, and must record and report test results to DENR under RA 6969 and RA 9003.
Health care waste generators and TSD facilities must achieve a microbial inactivation level of 6log10 reduction or greater than the most resistant microorganism of concern for the given process.
Treated wastes and inert residues from TSD facilities must be disposed in controlled disposal or a sanitary landfill licensed by DENR to handle the same.
Inertization is a suitable treatment for pharmaceutical wastes.
Encapsulation and other immobilization techniques are methods considered for sharps, chemicals, and pharmaceutical wastes, which must be placed in final disposal facilities indicated under the subsequent provisions.
Final disposal systems and facilities may be used only for health care wastes that have undergone the necessary treatment under the standards in the DOH Health Care Waste Management Manual.
Controlled Dump Facility (CDF) is an interim disposal facility for municipal solid waste or those considered non-hazardous and non-toxic; in the absence of a sanitary landfill, it may accept health care waste after indicative treatment.
A CDF commissioned to accept treated health care waste must be operated under the operational guidelines of the implementing rules of RA 9003 and also under specific requirements:
- Identify a particular cell for disposal of treated health care waste; measure capacity of the allotted cell(s) to determine accommodation volume.
- Place adequate signage in the health care waste deposition area.
- Line the cell with low-permeability material such as clay or a geo-membrane, including high-density polyethylene (HDPE) plastic liner, to contain leachate and prevent groundwater contamination.
- Ensure adequate soil cover is applied right after each waste spreading.
- Keep basic records of incoming wastes: time of receipt, volume/weight, source identification (name of generator/source), certification of treatment (or similar form showing necessary treatment occurred), and general condition of waste.
Sanitary Landfill Facility (SLF) is a disposal site designed, constructed, operated, and maintained with engineering control over significant potential environmental impacts.
Dedicated cells for treated health care wastes must be built/developed prior to SLF operation to prevent mixing with municipal solid wastes and other wastes.
Construction and development of an SLF must conform to RA 9003 and its implementing rules, particularly Sections 1 and 2, Rule XIV.
Existing sanitary landfills with approved ECC for municipal solid waste must secure an ECC amendment before accepting health care waste for disposal thereat.
Safe burial on health care facility premises is allowed in remote locations and rural areas where no TSD facilities are available, provided the on-site burial pit load/capacity is not exceeded.
Chemical treatment or disinfection is required prior to safe burial on hospital premises.
Standards for safe burial must follow the DOH Health Care Waste Management Manual (Annex “C”) and the operation must follow minimum landfill requirements.
Sharps and syringes disposal through concrete vault is allowed only as an alternative disposal means for used sharps and syringes.
Concrete vaults must carry signage: “CAUTION: HAZARDOUS WASTE OR SHARPS DISPOSAL AREA-UNAUTHORIZED PERSONS KEEP OUT.”
Concrete vaults must be watertight and constructed at least 1.5 meters above groundwater level.
Procedures for concrete vault disposal follow the DOH Health Care Waste Management Manual (Annex “D”).

Wastewater treatment requirement

Healthcare facilities must have their own Wastewater Treatment Facilities (WTF) or may connect to a sewage treatment plant.
Facilities with laboratories must pre-treat wastewater before discharge into a sewage treatment plant.

Annex rules: classifications and operational procedures

Annex “A” classifies health care wastes into General Waste, Infectious Waste, Pathological Waste, Sharps, Pharmaceutical waste, Genotoxic Waste, Chemical Waste, Waste with high content of heavy metals, Pressurized Containers, and Radioactive Waste.
Infectious waste includes cultures and stocks of infectious agents; waste from surgery/autopsies on patients with infectious diseases; waste from infected patients in isolation wards; waste in contact with infected patients undergoing hemodialysis; infected animals from laboratories; and instruments/materials in contact with infected persons/animals.
Sharps include needles, syringes, scalpels, saws, blades, broken glass, infusion sets, knives, nails, and other items capable of causing cut or puncture wounds.
Genotoxic waste includes certain cytostatic drugs and related waste streams, and the rules treat genotoxic wastes as highly hazardous with mutagenic/teratogenic/carcinogenic properties.
Chemical waste is classified as hazardous if it has at least one property: toxic, corrosive (acids of pH <2 and bases of pH >12), flammable, reactive (explosive, water-reactive, shock-sensitive), or genotoxic (e.g., cytostatic drugs).
Annex “C” requires, for safe burial within hospital premises, restricted access to authorized personnel; low-permeability lining; burial of hazardous health care waste; prohibition on burying large quantities of chemical/pharmaceutical wastes (>1kg); layer-by-layer earth cover; prohibition on locating burial sites in flood-prone areas; secured hospital grounds; placement downhill/down-gradient from wells and about 50 meters away from water bodies; permanent recordkeeping of pit size/location; a pit bottom at least 1.50 meters higher than groundwater; and limits indicating practicability for 1 to 2 years and total quantities of up to 5 to 10 tons, with longer-term solutions when exceeded.
Annex “D” requires concrete vault sharps disposal procedures including digging a pit with minimum dimensions 1 m x 1 m x 1.8 m deep; ensuring isolation and at least 152 meters away from groundwater supply sources and dwelling units; constructing concrete walls and slabs with an opening/manhole extended a few centimeters above soil surface; depositing safety boxes filled with used sharps/needles; and installing a security fence around the site.

Repeal, penalties, and effect on inconsistent issuances

All other issuances of DENR or DOH that are inconsistent with this Joint Administrative Order are repealed or modified accordingly (Repealing Clause).
Non-compliance with the policies/guidelines is subject to the penalty provisions of the applicable laws referenced in the order (Penalty Clause).
The order is effective immediately upon adoption (Effectivity).