Transcript 1-dan-CESQG-Pharm-Waste-Disposal-training

OVERVIEW of TODAY’S
PRESENTATION
1. RCRA for healthcare
2. Discuss specific requirements for proper
management and disposal of RCRA hazardous
waste
3. What to expect during a hazardous waste
inspection
4. Frequently Asked Questions!
Definitions
1. RCRA – Resource Conservation Recovery Act
• Regulations that govern hazardous waste
• Created by Congress in 1976
• EPA rolled out RCRA in early 1980’s
• EPA is governing agency, states can be
authorized. Colorado is an authorized state
which administers RCRA with EPA oversight.
• Designed for industry
2. Solid Waste, Medical Waste, Hazardous Waste,
Household Waste
• Specific definitions
• Different regulatory disposal requirements
3. Hazardous – RCRA? OSHA? Bio-hazardous?
Dangerous?
Typical Healthcare Waste
Streams
•
•
•
•
•
•
•
•
•
•
•
•
•
Solid waste – waste or product?
Medical waste/sharps/bio-hazardous
Medications
Healthcare Laboratories (solvents)
pH adjusters
Acids/bases
Reagents
Stain/staining lines
Test kits
Aerosols
Hand sanitizers/lotions/select shampoos
Cleaning supplies
Light bulbs/batteries/electronics
CATAGORIES OF MEDICAL
WASTE
•
•
•
•
•
•
Sharps
Blood and body fluids
Pathological waste
Trauma scene waste
Non-RCRA waste pharmaceuticals
and vaccines
Other as determined by the
Department
Urine or feces
• Lightly to moderately
contaminated bandages
• Garments or disposable
bedding
• RCRA pharmaceuticals
•
Regulation/Agency
Primary Concern
CDPHE, Hazardous Waste
Regulations
Disposal at hazardous waste facility
CDPHE, Solid Waste Regulations
•Non acceptance of hazardous
waste;
•landfill suitability for medication waste
CDPHE, Health Facilities Division
•Proper dispensing of medication to
patients;
•safety
DEA
Prevention of diversion, drug abuse,
accidental poisonings
State Board of Pharmacy
Proper dispensing of medication;
safety
Local POTW, local landfill, OSHA Various!
Household wastes are exempt from
regulation as medical waste
•
•
•
•
•
•
Multiple sets of regulations yields multiple
definitions for waste
Healthcare manages multiple types of
waste streams
Medical waste is typically the largest
category of waste medical facilities
manage
Is it a waste or is it still product?
All waste starts off as a solid waste!
Households are exempt from some
regulations, including RCRA.
Typical Pharmaceutical Waste that
could be RCRA Hazardous Waste
in Healthcare
-
Partial vials
Un-dispensed medications
Un-administered medications
Discontinued medications
Patient prescriptions
Physician Rx samples
Pre-instilled IVs
Hospital re-packs
Pre-filled syringes
Partial syringes
Certain empty packages/containers (Plisted)
WHERE HAS RCRA
HAZARDSOUS HEALTHCARE
WASTE HISTORICALLY BEEN
DISPOSED?





DRAIN
RED BAGS
SHARPS CONTAINERS
DIRECT TO THE LANDFILL
LOCAL INCINTERATORS
A hazardous waste is a solid, a liquid or a
contained gaseous material that is no
longer used and that no longer serves the
purpose for which it was produced, and
could pose dangers to human health and
the environment after it is discarded.
Any business that produces a RCRA
hazardous waste is called a “generator”
in RCRA regulations.
 Must determine what wastes are RCRA
hazardous wastes.
 Must ensure that RCRA hazardous waste
is disposed of at a permitted hazardous
waste disposal facility.
 Other requirements apply depending on
the generator category.


Requirements apply as soon as waste is
generated, not in a few months after a
pile has accumulated!

Conditionally Exempt Small Quantity
Generators (CESQG) (6 CCR 1007-3, Section
261.5) (less than 220 pounds per month of RCRA haz waste
and less than 2.2 pounds per month or onsite at any one time
of P-listed RCRA haz waste)

Small Quantity Generators (SQG) (6 CCR

Large Quantity Generators (LQG) (6 CCR
1007-3, Section 262.34) (between 220 and 2200 pounds per
month of RCRA haz waste and less than 2.2 pounds per month
or any one time of P-listed RCRA haz waste)
1007-3, Section 262.34) (greater than 2200 pounds per month
and/or more than 2.2 pounds per month or any one time of Plisted RCRA haz waste)
Two sides to RCRA hazardous waste determination –
listed and characteristic
1. Listed waste – on a list due to it’s pedigree (historical
use, background, derivation)
•
P-List (acute), U-List (toxic), F-List (typically solvents)
2. Characteristic waste – based on chemistry (physcial
properties)
•
Ignitable, corrosive, reactive, toxic
P and U lists are for unused commercial chemical
products. If the product was used, it will not be a P
or U listed waste but it still may be a characteristic
hazardous waste (nicotine patches as an example).
 For P-listed hazardous waste, 2.2 lbs or more per
month or stored onsite at any one time of acute (P
listed) hazardous waste means you operate as an
LQG. Tracking weights on a monthly basis is
important here for this very reason!
 Empty containers that held “P” listed drugs are
hazardous wastes (with exceptions) but you do not
count the weight of those containers toward your
2.2 pound threshold. It’s the residual inside the
container that counts toward your generation rate!
(no need to calculate residual).

Arsenic trioxide P012 ƒ
• Nicotine P075
• Phentermine (CIV) P046 ƒ
• Physostigmine P204 ƒ
• Physostigmine Salicylate P188 ƒ
• Warfarin >0.3% P001
•
Note: Epinephrine P042 and Nitroglycerin P081 are not regulated as P-listed
hazardous waste in Colorado.
P and U lists are for unused commercial
chemical products. If the product was used, it
will not be a P or U listed waste but it still may
be a characteristic hazardous waste (nicotine
patches as an example).
 For u-listed hazardous waste or any other
hazardous waste category (other than P-listed
waste) there is no specific weight threshold
other than the generator category thresholds.
 Typical u-listed waste in health care
includes chemotherapy drugs.

Chloral Hydrate (CIV) U034 ƒ •
Chlorambucil (chemo) U035 ƒ •
Chloroform U044 ƒ
•
Cyclophosphamide (chemo) •
U058 ƒ
•
• Daunomycin (chemo) U059 ƒ •
• Dichlorodifluromethane U075 ƒ •
• Diethylstilbestrol(chemo) U089 ƒ•
• Formaldehyde U122 ƒ
• Hexachlorophene U132 ƒ
•
• Lindane U129 ƒ
•
• Melphalan (chemo) U150 ƒ
• Mercury U151
•
• Mitomycin C (chemo) U010 ƒ
•
•
•
•
Paraldehyde (CIV) U182 ƒ
Phenacetin U187 ƒ
Phenol U188 ƒ
Reserpine U200 ƒ
Resorcinol U201 ƒ
Saccharin U202 ƒ
Selenium sulfide U205 ƒ
Streptozotocin
(chemo)U206 ƒ
Trichloromonofluromethane
U121 ƒ
Uracil mustard
(chemo)U237 ƒ
Warfarin <0.3% U248
 Do an internet search for RCRA P-list,
U-list, or F-list.
 Visit EPA’s website and search for
the list on their website.
 Refer to the regulations 6 CCR 1007-
3 261.33 for a listing.
Display one or more of the four
generic hazardous properties
 Ignitable, D001
 Corrosive, D002
 Reactive, D003
 Toxic, D004D043
• Hazardous Waste Code – D001
• Characteristics of Ignitability include
anƒaqueous solution (defined as
greater than 50% water) containing
24% alcohol or more by volume and a
flash point of <140 degrees Fahrenheit.
• Examples include rubbing alcohol,
topical preparations, some cancer
drugs (eg. Paclitaxel)
• Hazardous Waste Code – D002
• Characteristics of corrosivity include
a pH < or = 2, or, = or > 12.5.
• Examples include primarily
compounding chemicals such as
glacial acetic acid and sodium
hydroxide.
• Hazardous Waste Code – D003
• Characteristic of Reactivity ƒ-
explosive and water reactive
wastes ƒ
• Nitroglycerin formulations are
exempted federally as of 2001
which was adopted by Colorado.
Must still be evaluated for ignitability.
Waste Code
Contaminant
Maximum
Concentration
 D004
Arsenic
5 mg/L
 D005
Barium
100 mg/L
 D007
Chromium
5 mg/L
 D013
Lindane
0.4 mg/L
 D009
Mercury
0.2 mg/L
 D010
Selenium
1 mg/L
 D011
Silver
5 mg/L
The entire list of characteristic hazardous waste can
be found in the Colorado Hazardous Waste
Regulations, 6 CCR 1007.3 Section 261.24.

D009-Mercury (0.2 mg/L)
› products w/thimerosal or phenyl-
mercuric acetate (eye drops,
nasal spray, some multi dose
vaccines)
• D024-M-cresol (200 mg/L)
- Insulin w/cresol
• Also may be U-listed
•
•
•
•
•
Definition of a RCRA hazardous waste
Regulations apply to businesses
Regulatory requirements kick in as
soon as the waste is generated – not
“later”
Generator categories based on
volume generated
Listed and characteristic RCRA waste
If your business generates less than 220 pounds of hazardous waste (total)
AND less than 2.2 pounds of P-listed hazardous waste on a monthly basis,
then your facility is a conditionally exempt small quantity generator
(CESQG) subject to the following requirements.
1.
2.
3.
4.
Hazardous waste determination – you must know
what RCRA hazardous wastes you generate.
Track your monthly hazardous waste volume (Plisted and characteristic) to prove generator
status.
Send waste to a disposal facility that is authorized
to accept RCRA hazardous wastes from CESQGs.
Ensuring proper disposal is the generators
responsibility.
Minimize potential for release to people and
environment.

Determine what
RCRA hazardous
wastes you
generate.

How do I do that?





When a material is no longer needed or usable for it’s
intended purpose, it becomes a waste and you need to
ask yourself “is this a haz waste when I go to dispose?”
Use this resource as a starting point:
https://www.colorado.gov/pacific/sites/default/files/HM_
mw-evaluating-health-care-waste-includingpharmaceuticals.pdf
Utilize the lists provided by CDPHE during training and
outreach and posted online here:
https://www.colorado.gov/pacific/sites/default/files/HM_
mw-examples-of-hw-pharmaceuticals.pdf
Ask your pharmacist(s) for assistance;
Ask your disposal company for assistance. A list of
potential disposal companies serving Colorado is on our
website located here:
https://www.colorado.gov/pacific/sites/default/files/HM_
mw-service-providers-list.pdf
Contact the manufacturer (for instance, Pfizer has a website
where you can type in the name of their medication and find
out whether it is a hazardous waste on disposal or not) located
here:
http://www1.pfizerpro.com/professional_resources/responsible_d
isposal
 Review the insert for that specific medication to find the active
ingredients in the medication and compare that to RCRA P and
U lists which are located here:
http://www.epa.gov/wastes/hazard/wastetypes/pdfs/listingref.pdf (scroll down the page to find the p and u listings).
 Review the safety data sheet (SDS) or equivalent to see if it
identifies whether it's a RCRA hazardous waste when disposed
(or not) or whether the SDS provides characteristic information
on the active ingredients;
 Regulations and regulatory guidance for health care facilities in
Colorado is included here:
https://www.colorado.gov/pacific/cdphe/medicalwaste

The P and U listings are based on the
active ingredient associated with the
Chemical Abstract Number (CAS)
 If you use the National Drug Code (NDC)
instead of the Chemical Abstract
Number, make sure to cross reference
the NDC with the CAS Number

All non RCRA- hazardous pharmaceuticals should be sent
to an authorized facility for incineration or other adequate
treatment (autoclaving is not an option for any
pharmaceutical waste). No drain!
 There are landfills (those owned by Waste Management)
in Colorado that have been recently permitted to accept
non-hazardous pharmaceutical waste – talk with your
disposal company and consider the issues on how to store
and get the material safely to the landfill. Beware of the
unlocked trash receptacle!!
 Consider whether the waste must be specially managed
according to other rules as:

› DEA-controlled substances;
› OSHA-chemotherapy drugs;
› US Nuclear Regulatory Commission.

Stay below the volume thresholds for CESQG
status.
› <220 lbs hazardous non-acutely hazardous
waste per month;
› <2.2 lbs p-listed waste

How has it been done?
› Weigh your waste monthly and document the
weights OR
› Add up the weights on your disposal log OR
› Devise another accurate way.
P-LISTED HAZARDOUS WASTE GENERATION RATE TRACKING LOG
NAME OF WASTE MEDICATION
Coumadin
nicotine
Coumadin
nicotine
Coumadin
nicotine
DATE PLACED INTO CONTAINER
MONTHLY WEIGHT
Cumulative Weight
1/1/2015
1/15/2015
total
1 pound
1 pound
total
2.5 pounds
3.5 pounds
total
1.5 pounds
5 pounds
2/5/2015
2/11/2015
3/2/2015
3/12/2015

Send waste to a disposal
facility that is authorized
to accept RCRA
hazardous wastes from
CESQGs.

Ensure proper disposal.
› Ask your disposal
company for
documentation that
they can accept RCRA
hazardous waste from
CESQGs;
› The verification should
include the name,
address, EPA ID # and
type of RCRA permit
held by the facility that
accepts the waste.
› Recommend using the
manifest!
Landfill
Disposal Scenarios
Incinerator
•Tissue
•Pharmaceuticals
•Chemo (trace and
bulk)
•Hazardous Waste (if
RCRA incinerator)
Autoclave
Healthcare Waste
•“Red bag” waste or sharps
•NO recognizable body
parts
•NO Pharmaceuticals
•NO radioactive waste
•NO chemo waste

Minimize releases.

How has it been
done?
› Make sure waste is
properly
containerized at all
times.
› If you are shredding
waste, use a unit
that effectively
contains dust or
discontinue
shredding.
Shredded waste should not be left open to
the environment.




New rule issued by DEA on September 9, 2014
in effect as of October 9, 2014.
Once a controlled substance is rendered nonretrievable the DEA and CDPHE Health
Facilities no longer consider that drug a
controlled substance and can be properly
disposed using the processes outlined herein.
Work with your pharmacist (DEA registrant) on
the proper management of controlled
substances.
http://www.deadiversion.usdoj.gov/fed_regs/r
ules/2014/2014-20926.pdf
How will you make your hazardous waste
determinations?
 Will you sort RCRA hazardous from nonRCRA hazardous?
 How will you keep track of the amount of
hazardous waste you generate?
 Who will you use to properly dispose of
your pharmaceutical waste?

Waste Cleaners or
Sanitizers
Sharps and Infectious Waste
Used
Batteries
Mercury–containing
Lighting Waste
Used Electronics
Label what it is – “waste bulbs”, “waste
batteries”, “waste lighting”, “waste
electronics”
 Date the container once the first piece
of waste is placed inside (you can hold
this waste for up to one year before you
have to dispose of it)
 Keep the container closed (watch out
for those bulbs and box sizes)
