3.1 Safe Handling, Administration and Disposal of Chemotherapy Agents

Introduction
There have been increasing numbers of reports in the literature describing the possible effects of chemotherapy drugs on health care professionals (Fuchs et al., 1997; Grummt et al., 1993; Selevan et al., 1985; Valanis et al., 1997). It has therefore become imperative that staff is knowledgeable regarding the safe handling of chemotherapy drugs. The risk to health care professionals from handling a hazardous drug stems from its inherent toxicity and the extent to which workers are exposed to the drug. The primary routes of exposure are through direct skin contact and through inhalation of aerosolized drug products. Other potential exposure occurs during the disposal of the drugs, disposal of the items used in drug preparation and administration, and when caring for patients who have received these drugs.

Although the absolute risk cannot be eliminated, much can be done to reduce the relative risks associated with the handling of chemotherapy agents (Mayer, 1992). Health care professionals who handle chemotherapy are advised to be well informed of the potential health hazards, be familiar with safe handling and disposal of these agents, utilize appropriate protective equipment and adhere to available written policies, procedures and guidelines.

The information related to health risks to fetuses due to the handling of chemotherapy agents during pregnancy is limited. The risks involved can be reduced significantly if one adheres to standard safety precautions while handling chemotherapy agents. This risk of exposure can be minimized by personal protective equipment (PPE), a needle-less system, and ventilation cabinets. Please refer to your institution’s policy on Pregnancy and exposure to chemotherapy agents.

This evidence based document is intended to facilitate the standardization of institutional practice guidelines for the safe handling of chemotherapy agents across the Province of Ontario. Following these guidelines will assist in minimizing unnecessary exposure and maximizing safety. These recommendations do not differentiate between high- and low-risk situations, as there is no known minimum safe exposure and always the potential for contamination.

Receiving of Chemotherapy Agents
Handling procedures need to begin with safely receiving these products into the hospital.

• Institutional policies for accidental exposures must be in place.
• Please refer to the Occupational Safety and Health Administration (OSHA) and the American Society of Hospital Pharmacists (ASHP) guidelines.
• As there is a risk of broken vials, individuals receiving packaged cytotoxic agents should be protected to the same degree recommended for those preparing and administering chemotherapy.
• Chemotherapy spill kits should be available in the Institutional Receiving Department and departments where chemotherapy is being prepared, dispensed and administered.
• In the event of a spill or untoward exposure, notify appropriate authorities, e.g. Occupational Health & Safety, Environmental Services, as per institutional policies.

Education
All pediatric oncology nursing orientation programs should include a review of hospital policy, procedures and guidelines for administrating oral chemotherapy, for monitoring chemotherapy infusions, caring for patients receiving chemotherapy and the risk of occupational exposure.

• Parenteral chemotherapy should only be administered by health care professionals who have been specially trained in parenteral chemotherapy administration.
• Standardized courses and curricula for chemotherapy administration should be developed at each tertiary institution. If satellite centres do not have a pediatric oncology orientation program, satellite nurses are to be trained and tested in chemotherapy administration at a tertiary centre.

Preparation of Chemotherapy Agents
It is recommended that all pharmacies follow the OSHA guidelines when preparing and dispensing of chemotherapy. All Cytotoxic drugs and containers should have an appropriate label to alert handler of special precautions needed for handling.

As a reference, click here to link to CCO guidelines for Safe Handling.

Unpacking and Storage
Packaging can have high levels of contamination; therefore it is strongly recommended that:

• there be an unpacking area in the pharmacy limiting exposure risks

• the unpacking area be a separate dedicated space, separate from eating areas
• there be a receptacle for cytotoxic waste in the unpacking area
• workers at risk of exposure wear a protective gown and two (2) pairs of gloves when unpacking and cleaning cytotoxic drugs, from the opening of the external packaging to the placing of the secondary and/or primary packaging in their storage space.
• workers check the integrity of all packaging at every step of the unpacking process
• damaged contents be treated as a spill
• the primary and or secondary packaging be cleaned prior to being placed in storage
• a regular cleaning protocol be in place
• all drug containers be cleaned to reduce external contamination; ensure that this does not interfere with the integrity of the container or with reading of the label.
• procedures be in place to minimize the risk of contamination of surfaces during the cleaning of vials (e.g. use of a disposable, plastic-backed, absorbent pad)
• all surfaces be cleaned when the task is complete
• when removing or transporting drugs out of the storage area, one pair of gloves and a gown be worn.

It is regulated that there be adequate ventilation in the area, negative pressure and preferably vented to the outside.  Establish a dedicated negative-pressure storage area for cytotoxic drugs that minimizes the risk of contamination.

Cytotoxic Drug Preparation
It is strongly recommended that:

• the oncology pharmacy be in compliance with relevant guidelines from the Canadian Society of Hospital Pharmacists (CSHP) and Accreditation Canada standards. While the specific details of oncology pharmacy planning is beyond the scope of this document, details and some important considerations may be found in the Canadian Standard Association document CSA Z8000-11 (19)
• special requirements for heating, ventilation and air-conditioning (HVAC) systems in health care facilities be taken into consideration
• all mixing, and preparation of administration sets with a cytotoxic drug be performed in one centralized area in a specially designated class II type B biological safety cabinet that (18):

(a) is exhausted through a HEPA filter to the outside atmosphere in a manner that prevents recirculation into any inside area

(b) has exhaust and ventilation systems that remain in operation for a sufficient period of time to ensure that no contaminants escape from the biological safety cabinet into the workplace

(c) is equipped with a continuous monitoring device to permit confirmation of adequate airflow and cabinet performance.

• airlocks be considered if there are particular concerns about the propagation of airborne cytotoxic drugs.
• the layout facilitate the unimpeded cleaning of all surfaces (walls, floors, ceilings, doors, diffusers, windows)
• the furniture and equipment in the sterile preparation room be kept to a bare minimum
• there be a visual link (e.g. a window as a way to communicate between the sterile preparation room and the pharmacy, in order to view the work in progress)
• access to the sterile room be limited to trained and authorized workers.
• the biological safety cabinets remain in operation 24 hours a day, 7 days a week, as recommended by the manufacturers.

It is legislated that the facilities include an emergency eyewash that may or may not be hooked up to the airlock sink. As a minimum, that emergency eyewash should be able to provide 15 minutes of flushing to both eyes. It is strongly recommended that a full shower be accessible nearby.

Closed-drug transfer systems (e.g., PhaSeal®) are not a substitute for class II type B biological safety cabinets.

In the non-sterile drug preparation process (e.g., oral preparations), it is strongly recommended that the same level of worker protection be adhered to.

Establish policies and procedures regarding preventive maintenance, monitoring, certification and the optimal use of facilities and equipment.

Drug Preparation
The following recommendations apply to the preparation of all cytotoxic medications including parenteral, oral and topical, both sterile and non-sterile preparations. It is strongly recommended that:

• policies and procedures include the use of appropriate PPE, the equipment for preparation including appropriate ventilation, and other automated equipment for packaging and a dedicated work area.
• workers (pharmacists or pharmacy technicians) wear PPE, a cap, surgical/procedure mask, shoe covers, a protective gown and two (2) pairs of gloves to make sterile preparations of cytotoxic drugs in preparation cabinets.
• Organize the work to limit microbial and environmental contamination.
• workers cover the work surface with a disposable, absorbent, sterile, plastic-backed pad to absorb any liquid contamination that may occur. The pad should not cover the front and rear grilles of the preparation cabinet and should be changed after 3.5 hours of continuous work; for a new batch of preparations or in the event of a spill or contamination.

It is legislated that the pad be disposed of in a cytotoxic waste receptacle. Limit the quantity of supplies and cytotoxic drugs in the cabinet, to avoid adversely affecting the laminar flow and to facilitate regular cleaning of the work surface; place the sterile products in the centre and the non-sterile products (e.g., waste receptacle) along the sides of the cabinet.

Remove the packaging, when applicable, and clean all of the drug containers before taking them into the preparation cabinet. For sterile preparations, adhere to aseptic technique for sterility. Use handling techniques that limit the risk of injury or accidental exposure. It is strongly recommended that:

• spiking of bags and priming of tubing occur before the addition of the cytotoxic drug unless the clinical protocol requires otherwise.
• cytotoxic drugs be reconstituted in the pharmacy.
• the drug containers not be overfilled to avoid compromising their integrity.
• air never be removed from the IV tubing with a solution containing the drug.
• IV tubing is primed and air removed in the pharmacy, prior to adding the cytotoxic drug(s) to the infusion solution.

It is legislated that cytotoxic drugs be labeled to inform those handling these preparations of the nature of the drugs and the precautions to be taken. Cytotoxic drugs must display the “Cytotoxic” hazard symbol or the word “Cytotoxic”.

Transport and Storage Following Preparation
Transport cytotoxic drugs using a method that will prevent contamination of the environment in the event of breakage. It is strongly recommended that:

• cytotoxic drugs be placed in a closed, leak-proof plastic bag (e.g., Ziploc® type).
• transport of the cytotoxic drug in a closed, leak-proof plastic bag from the pharmacy be done in a rigid, shock-resistant, leak-proof container made of a material that can be easily cleaned and decontaminated.
• the bottom be covered with an absorbent, plastic-backed cloth.
• mechanical transport systems, such as pneumatic tubes, not be used because of the stress they put on the contents, and the whole transport system would be compromised if a leak occurred.

It is legislated that the transport container be identified with the “Cytotoxic” hazard symbol and be cleaned regularly.

Preparation for the Administration of Chemotherapy

Protective Clothing Recommendations
For all protective clothing and equipment (gowns, gloves, goggles, face shields), the manufacturer must provide documented evidence of the impermeability to chemotherapy agents. Research has shown that gowns made of high-density polyethylene provide the most protective barrier against spillage or aerosolization of cytotoxic drugs (ONS, 1997, pg.6).

Gowns Must Be:

• Worn wherever chemotherapy agents are being manipulated and administered.
• Disposable, impermeable/low permeability fabric, lint-free, with back closure and long cuffed sleeves, which should be tucked into the gloves.
• Changed in the event of an obvious spill (time to permeability of a vesicant is one hour).
• Single use (ONS, 2003) or according to the manufacturer’s recommendations.

Gloves:

• Use gloves that have been tested to protect against permeations by chemotherapy agents and are strongly recommended to comply with ASTM standard D-6978-(05)-13 (CCO guidelines).
• Hand washing should occur before donning gloves and after removing gloves.
• The minimum acceptable standard is powder-free surgical latex gloves (0.007 inches). Some newer products may be thicker and provide more protection. Other suitable materials include polyurethane, neoprene or nitrile.
• In the event of latex sensitivity, equivalent surgical nitrile gloves should be used.
• Gloves should be changed after each administration, OR if contamination or puncture occurs, OR every 60 minutes.

Masks:

• Must be worn throughout the process of chemotherapy drug manipulation and administration.
• Surgical masks are not acceptable.
• Masks that are designated to protect against aerosolized particles by the manufacturer should be used. It is strongly recommended that fit tested respirators such as NIOSH certified N95 or N100 be used to protect against airborne powder or aerosolized particles.
• The literature is unclear as to how long each mask offers protection. Masks should be changed with obvious contamination as well as when it no longer seals to face.

Eye and Face Protection:

• Plastic Face Shields must be worn wherever chemotherapy agents are being manipulated and administered.
• It is recommended that contact lenses should not be worn because of risk of absorption.
• Safety glasses or regular eye glasses are not adequate.
• Eye protectors should be cleaned after each use according to manufacturer’s recommendations.
• In the event of contamination, appropriate spill procedures must be followed (OSHA guideline).

Drug Preparation Area for Nursing Personnel
A dedicated area with restricted access and that is free of food and drink is required. Chewing of gum in this area should not be allowed.

• This designated area should not be heavily trafficked.
• Signs that restrict access to authorized personnel only should be displayed.
• Appropriate warning labels must be placed on all chemotherapy drug storage areas (OSHA guideline)
• A sink, an eyewash station and a spill kit should be available in this space. A less desirable alternative is the availability of large volumes of saline solution for eye washing purposes.
• A plastic-backed absorbent pad should be used under tubing, syringe or sites of potential leak.
• Leak-proof and puncture-proof biohazard containers should be present. All needles, syringes and other disposable items should be disposed of in these.

Preparation for the Administration of Oral Chemotherapy¹:
Examples: Mercaptopurine, Thioguanine.

It is recommended that all health care professionals administering oral chemotherapy adhere to the protective clothing guidelines as outlined above (Protective Clothing Recommendations).

Handling Precautions:

1. Transfer chemotherapy tablets/powder into empty syringe barrel without touching them (wear gloves).
2. Open capsules in a biohazard hood.
3. It is preferable to dissolve tablets in water instead of crushing them (see below).
4. Prepare each dose on an absorbent pad on an uncluttered surface.
5. Discard materials that have been in contact with the tablets/capsules (medicine cups, oral syringes, absorbent pad, etc) as hazardous waste.
6. Wash your hands after preparing medication.

Tablets
For children who cannot swallow tablets, methotrexate, mercaptopurine and thioguanine can be dissolved in water according to the following procedure:

Manipulate the required number of tablets into a liquid formulation immediately prior to dose time as follows:

1. Remove the plunger of a 10 mL oral syringe.
2. Place the required number of tablets into the barrel of the oral syringe.
3. Replace the plunger and draw up 5-7.5-10 mL of tap water (not hot water) into syringe.
4. Cap oral syringe with blue syringe tip
5. Wait 5-15 minutes to allow the tablets to disintegrate (gently rock back and forth; shake syringe occasionally)
6. Give the dose in usual manner.
7. Draw up another 5 mL of tap water into oral syringe. Cap syringe and shake well to dislodge any remaining particles. Give dose in usual manner.
8. Rinse the dissolve and dose device after each use.

Capsules
For children who cannot swallow capsules or where the dose is less than one capsule, the contents of the capsule can be emptied into a Dissolve and Dose (TM) container and made into a solution using the following procedure. This should be performed in a biohazard hood if possible. Examples include procarbazine, temozolomide, hydroxyurea:

1. Knock the powder down into one end of the capsule.
2. Take the top off the capsule and empty the contents into the Dissolve and Dose device.
3. Add 10 mL of tap water (not hot)
4. Cap the device, shake well and allow to sit for 2 minutes.
5. Measure the appropriate dose using an oral syringe.

For children who cannot swallow capsules where the dose is one or more capsules the contents of the capsule may be removed and mixed with food or liquid immediately prior to dose time as follows. This should be performed in a biohazard hood if possible.

Examples include lomustine, temozolomide, hydroxyurea, procarbazine:

1. Put the food or liquid you will mix the drug with in a small medication cup.
2. Knock the powder down into one end of the capsule.
3. Take the top off the capsule and empty the contents into the medication cup.
4. Mix the powder and the food/liquid that is in the cup.
5. Draw liquid mixed with drug into a syringe.

Administration and Disposal of Chemotherapy Agents
There should be no open food in patient room when the IV system is opened for the purpose of administering chemotherapy agents, as there is a potential for the food to be contaminated. In cases where food is used to help with taste aversions or as a comfort measure, exceptions can be made by the administering RN to give the chemotherapy agents with caution as per her/his discretion.

• PPE, as outlined above, should be used.
• Plastic-backed absorbent pads should be placed under tubing and syringes.
• Only syringes and tubing with Luer-Lok connections should be used.
• Infusion bags should be changed at waist level (Brown et. al, 2001).

Disposal of Equipment /Personal Protective Equipment used to Administer Chemotherapy Agents:

• All syringes and needles should be discarded in containers that are puncture-resistant, leak-proof, that have a lid that seals securely, and that are appropriately labeled.
• Bags and solution administration sets should be discarded intact in appropriately labeled resealable containers that are both leak-proof and puncture-proof.
• PPE used during handling and administration should be disposed of in appropriately labeled container.

Nursing Care and Management of Patients Who Have Received Chemotherapy Agents
Potential duration of excretion of chemotherapy agents and their metabolites are not well defined. While there is some data derived from the adult population, the extent to which this is applicable to children is unclear. Therefore, there is a real potential risk to health care professionals and parents who are caring for children following the administration of chemotherapy agents. It is suggested that PPE should be worn up to 48 hours post administration of intravenous (IV) chemotherapy agents and for up to 7 days post oral chemotherapy agents administration.

Personal Protective Equipment (PPE)
PPE must be worn when handling any patient’s blood or body fluids.

• Plastic Face Shields should be worn when there is a risk of splash, e.g., flushing toilet, changing diapers, frequent or unpredictable vomiting.
• Parents must be gloved when handling excreta and diapers up to 7 days post treatment.
• Gloves should be discarded after each patient use, and when soiled or contaminated with body fluids, in appropriately labeled containers.
• Gloves and gowns should not be worn outside of the drug administration area.

Flushing of Toilets

• All toilets should be flushed twice, as recommended in the literature but not evidence based (Brown et. al, 2001, p.70).
• The toilet bowl (seat up) should be covered with a plastic-lined, absorbent pad (absorbent side facing down) prior to flushing. These pads should be disposed of in biohazard containers after each use.

Disposal of Diapers

• Diapers should be disposed of in a biohazard container for up to 7 days after chemotherapy administration.

Disposal of Contaminated Linen

• Contaminated, non-disposable, linen should be handled with gloves and gowns and should be dealt with in a manner consistent with institutional policies regarding handling and disposal of infectious linens.
• Parents should not clean up contaminated linens or clothing. This should be done by gowned and gloved health care personnel.

Patients who go to Other Areas of the Hospital

• Personnel in other areas of the Hospital (e.g., Diagnostic Imaging, Echocardiography) should observe these safe handling guidelines when handling patients who have received chemotherapy agents.
• These guidelines should be disseminated to all hospital personnel who may care for oncology patients in other areas.

Disposal of Biohazardous Contaminated Materials
As per OSHA guidelines – Section IX, all areas where chemotherapy drugs are handled should have specific disposable containers close at hand for easy and safe disposal.

• Needles and syringes should be disposed intact.
• Sharps and breakable items e.g. vials, ampoules should be disposed of in leak proof, puncture resistant containers with labels indicating chemotherapy (cytotoxic) waste.
• Non-sharp chemotherapy drug waste, e.g. plastic IV bags and tubing, personal protection equipment, should be sealed in leak proof, puncture resistant containers with appropriate labels.
• These containers should be of a different colour from regular disposal of hazardous waste containers.

Accidental Contamination and Chemotherapy Spills
Every institution should have policy and procedures in place for the management of accidental contamination and chemotherapy spills. All health care professionals who handle chemotherapy agents should be oriented and familiar with these policy and procedures.

It is strongly recommended that a spill management kit be readily available within the work area.

 SAMPLE WARNING LABEL

 References

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Primary authors Mr. Kaniska Young-Tai, The Hospital for Sick Children, Toronto and Ms. Sylvie Kozlowskyj, Health Sciences North, Sudbury. Reviewed by POGO Satellite Manual Review Nursing Group, 2016 and the POGO Satellite Manual Review Pharmacy Working Group, 2016.