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RCRA Hazardous and Universal Waste Education Seminar

RCRA Hazardous and Universal 
Waste Education Seminar
Presentation 1
RCRA and Universal Waste Basics
November 17, 2016
RCRA Hazardous and Universal Waste Education Seminar

What is “RCRA”?
▸The Resource Conservation and Recovery Act (RCRA)
▸Passed in 1976; amended and strengthened in 1984
▸Regulations under the United States Environmental 
Protection Agency established a regulatory framework 
for a “cradle‐to‐grave” hazardous waste management 
program
▸The New York State Department of Environmental 
Conservation (NYSDEC) is authorized to manage the 
RCRA  hazardous waste program in New York State

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RCRA Hazardous and Universal Waste Education Seminar

What is a RCRA hazardous waste?

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RCRA Hazardous and Universal Waste Education Seminar

What is a RCRA hazardous waste?

The material must first meet the definition of “solid 
waste”
▸ A solid, liquid or contained gaseous material that is:
▸Abandoned (thrown away) 
▸“Inherently waste‐like”
▸Discarded military munition 
▸Recycled 

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RCRA Hazardous and Universal Waste Education Seminar

What is a RCRA hazardous waste?

▸ Is the material specifically excluded from the RCRA definition 
of solid waste?:
▸ Domestic sewage
▸ Excluded scrap metal being recycled
▸ Shredded circuit boards being recycled
▸ Is the material specifically excluded from regulation under 
RCRA:
▸ Household hazardous waste 
▸ Certain arsenic‐treated wood
▸ Hot‐drained used oil filters

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RCRA Hazardous and Universal Waste Education Seminar

What is a RCRA hazardous waste?

Does the solid waste exhibit any of the four characteristics 
of a hazardous waste?:
▸Ignitability (D001)
▸ Liquids with flash points <140° F
▸ Non‐liquids capable of causing fire
▸ Ignitable compressed gas
▸ Oxidizers
▸Corrosivity (D002)
▸ Aqueous wastes with a pH ≤ 2 (acids)
▸ Aqueous wastes with a pH ≥12.5 (bases)
▸ Ability to corrode steel

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RCRA Hazardous and Universal Waste Education Seminar

What is a RCRA hazardous waste?

Does the solid waste exhibit any of the four characteristics 
of a hazardous waste?: (cont’d)
▸Reactivity (D003)
▸ Unstable under normal conditions
▸ Reacts violently with water
▸ Gives off toxic gases 
▸ Capable of detonation or explosion 
▸Toxicity (D004 – D043)
▸ Solid waste likely to leach dangerous concentrations 
of certain known toxic chemicals into groundwater

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RCRA Hazardous and Universal Waste Education Seminar

What is a RCRA hazardous waste?

Is the solid waste specifically identified on one of four 
lists?:
▸F‐list: Manufacturing and industrial waste from non‐
specific sources (includes some spent solvent waste)
▸K‐list: Manufacturing and industrial source‐specific 
waste
▸U‐list: Unused commercial chemical products 
▸P‐list: Acute hazardous unused commercial chemical 
products
▸B‐list: PCB‐containing solid waste (≥ 50 ppm)
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RCRA Hazardous and Universal Waste Education Program

How are Waste Generators 
Regulated under RCRA?

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RCRA Hazardous and Universal Waste Education Seminar

What is a hazardous waste generator?
Defined as any entity, by site: 
▸Whose acts or processes generate a solid waste that is 
▸ Listed in the hazardous waste regulations
▸ Determined to be characteristically hazardous, or 
▸ Otherwise identified as a hazardous waste

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RCRA Hazardous and Universal Waste Education Seminar

What is a hazardous waste generator?
Examples of typical hazardous waste generators include:
▸Manufacturing operations
▸Universities
▸Hospitals 
▸Small businesses (such as auto repair shops and dry 
cleaners)
▸Pharmacies 
▸Retail stores (including food stores)

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RCRA Hazardous and Universal Waste Education Seminar

How are hazardous waste generators 
regulated under RCRA?
▸Based the amount of hazardous waste generated in a 
calendar month and total quantity accumulated on‐site
▸Three categories with increasing regulatory 
requirements/responsibility:
▸Conditionally exempt small quantity generators 
(CESQGs)
▸Small quantity generators (SQGs)
▸Large quantity generators (LQGs)

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RCRA Hazardous and Universal Waste Education Seminar

Conditionally Exempt Small Quantity 
Generator (CESQG)
▸Generate:
▸ ≤100 kg (220 lbs)/month of hazardous waste
▸ ≤1 kg (2.2 lbs)/month of acute hazardous waste
▸Accumulate:
▸ ≤1,000 kg (2,200 lbs) of hazardous waste
▸ ≤1 kg (2.2 lbs) of acute hazardous waste
▸Regulatory Requirements:
▸ Hazardous waste determination
▸ Storage quantity limits
▸ Ensure delivery to a facility for proper treatment and 
disposal of waste

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RCRA Hazardous and Universal Waste Education Seminar

Small Quantity Generator (SQG)
▸Generate:
▸>100 to <1,000 kg (220 to 2,200 lbs)/month of hazardous 
waste
▸< 1 kg (2.2 lbs )/month of acute hazardous waste
▸Accumulate:
▸≤ 6,000 kg (13,200 lbs) of hazardous waste
▸< 1 kg (2.2 lbs ) of acute hazardous waste

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RCRA Hazardous and Universal Waste Education Seminar

Small Quantity Generator (SQG) (cont’d)
▸Regulatory Requirements:

▸ Hazardous waste determination
▸ Obtain EPA identification number
▸ On‐site management requirements
▸ Storage time and quantity limits
▸ Emergency preparedness and prevention
▸ Hazardous waste manifests/LDRs 
▸ Recordkeeping (3 years)
▸ Personnel training

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RCRA Hazardous and Universal Waste Education Seminar

Large Quantity Generator (LQG)
▸ Generate:
▸> 1,000 kg (2,200 lbs)/month of hazardous waste
▸> 1 kg (2.2 lbs)/month of acute hazardous waste
▸ Accumulate:
▸> 6,000 kg (13,200 lbs) of hazardous waste
▸> 1 kg (2.2 lbs) of acute hazardous waste
▸ Requirements (in addition to SQG Requirements):
▸90‐day storage requirements
▸Written contingency plan
▸Annual reports (required in NYS)

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RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Disposal
▸The final link in RCRA's “cradle‐to‐grave” concept is a 
permitted treatment, storage, and disposal facility (TSDF) 
▸Hazardous waste is transported to a TSDF by a permitted 
transporter 
▸Hazardous waste shipments are tracked from the 
generator’s facility to the TSDF on a hazardous waste 
manifest that is signed by the generator, transporter and 
TSDF
▸The generator receives a copy of the signed manifest 
from the TSDF to verify that the waste was delivered to 
the proper destination facility

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RCRA Hazardous and Universal Waste Education Program

What is a Universal Waste?

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RCRA Hazardous and Universal Waste Education Seminar

What is a Universal Waste?
▸Waste that meets the definition of hazardous waste but 
is widely generated including: 
▸ Spent lamps and bulbs (such as fluorescent, high 
intensity discharge, neon, mercury vapor, high 
pressure sodium, metal halide)
▸ Spent batteries (such as lead acid, mercuric oxide, 
silver oxide, lithium, nickel‐cadmium [Ni‐Cad])
▸ Recalled pesticides and pesticides from collection 
programs
▸ Mercury‐containing equipment

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RCRA Hazardous and Universal Waste Education Seminar

Universal Waste Management
▸Place waste in closed compatible containers 
▸Label the container or item with:
▸ The words “Universal Waste” and the waste 
description (“lamps”, “batteries”, “mercury‐
containing equipment” or “pesticides”) 
▸ The date taken out of service
▸Transport off‐site for proper disposal/recycling or to 
another Universal Waste handler within one year

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RCRA Hazardous and Universal Waste Education Seminar

Universal Waste Management
▸Recommend keeping copies of bills of lading to 
document that waste is properly managed
▸Low mercury content or “green‐tipped” spent 
fluorescent lamps:
▸ May not require management as universal or 
hazardous waste   
▸ Still contain mercury
▸ Breaking or crushing releases the mercury
▸ Must be “disposed of by separated delivery” in New 
York State

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RCRA Hazardous and Universal Waste Education Program

Other Waste Streams that Require
Special Management

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RCRA Hazardous and Universal Waste Education Seminar

Pharmaceutical waste
▸Nicotine, warfarin, some chemotherapy drugs and other 
medications are listed hazardous waste (U‐ and P‐coded 
waste)
▸Pharmaceuticals may also exhibit a characteristic of 
hazardous waste:
▸ Ignitability ‐ Flash point < 140º F, oxidizer or flammable gas
▸ Corrosivity ‐ Strong acid or base
▸ Toxicity ‐ Contains arsenic, barium, mercury, selenium, 
silver, lindane, or m‐cresol 

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RCRA Hazardous and Universal Waste Education Seminar

Pharmaceutical waste
▸Hazardous waste pharmaceuticals that are “potentially 
creditable” currently may be sent to a pharmaceutical 
reverse distributor and do not need to be managed 
under the ordinary RCRA hazardous waste regulations
▸Hazardous waste pharmaceuticals that are not 
“creditable” currently must be managed and 
transported off‐site for proper disposal in accordance 
with RCRA regulations

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RCRA Hazardous and Universal Waste Education Seminar

Discarded consumer electronics 
▸Most contain RCRA hazardous metals 
▸Not regulated as universal waste in New York State
▸Exempted from hazardous waste regulation if:
▸ Prior notification is submitted to the NYSDEC providing 
information on the generating and receiving facilities
▸ The scrap metal pieces are reclaimed
▸ Managed in accordance with Article 27, Title 26  of the 
Environmental Conservation Law (contact the NYSDEC 
at 518‐402‐8706 for more information)

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RCRA Hazardous and Universal 
Waste Education Seminar
Presentation 2
Food Stores – Steps for Compliance
November 17, 2016

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Identify activities that potentially generate solid waste (solid, 
liquid or gas):
• Grocery retail operations
• Pharmacy operations 
• Facility cleaning operations
• Facility maintenance 
• Facility renovation/construction

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Identify solid waste streams generated by each activity:
• Out‐of‐date products
• Broken or damaged products
• Discontinued/recalled products
• Food waste
• Packaging/empty containers
• Expired/unwanted pharmaceuticals
• Spent bulbs, batteries and consumer electronics
• Spill cleanups
• Construction/renovation debris

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Determine which waste streams are regulated under RCRA:
• Identify what materials, products and chemicals comprise 
each waste stream
• Obtain safety data sheets, product information sheets and 
chemical analysis (if available)
• Complete a hazardous waste determination for each solid 
waste stream (including universal wastes)
• Review exemptions and exclusions
• Assign appropriate hazardous waste codes
• Identify all acute hazardous “listed” waste (“P‐coded”)

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Determine which waste streams are regulated under RCRA 
(cont’d):
• Flammable liquids and solids (D001), such as paint thinner, 
gasoline, solvents, lighter fluid, nail polish and nail polish 
remover and Sterno
• Ignitable compressed gas (D001), such as propane, butane 
lighters and aerosols
• Oxidizers (D001), such as pool/spa shock and some 
disinfectant cleaning products
• Corrosive liquids (D002), such as rust remover, oven and 
drain cleaner, and some other cleaning products

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Determine which waste streams are regulated under RCRA 
(cont’d):
• Toxic materials (waste code varies based on composition), 
such as some paint removers, stainless steel cleaners, spot 
removers, oil‐based paint/stain, moth balls and many 
pharmaceuticals
• Acute hazardous waste pharmaceuticals, such as warfarin 
(P001 ) and nicotine (P075)
• Universal Waste, such as spent bulbs, batteries, 
thermostats and thermometers
• Consumer Electronics, such as computers, televisions, 
electronic equipment

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Calculate monthly hazardous waste generation rates:
• Hazardous waste streams routinely generated
• Routine broken, damaged or out‐of‐date products
• Non‐returnable pharmaceuticals
• Spent bulbs, batteries, mercury containing 
equipment (if not managed as universal waste)
• Consumer electronics (if not managed under scrap 
metal exemption)

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Calculate monthly hazardous waste generation rates 
(cont’d):
• Hazardous waste streams with variable generation 
rates
• Seasonable damaged/unwanted products (e.g., 
charcoal lighter fluid or de‐icer)
• Expired/unwanted, non‐returnable flu vaccine
• Hazardous waste streams generated occasionally 
(“episodic” waste) 
• Maintenance, construction or renovation projects
• Spill cleanup debris

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA? 

• Determine generator status:
• CESQG
• Generate: ≤ 100 kg (220 lbs)/month of hazardous waste 
and ≤ 1 kg (2.2 lbs)/month of acute hazardous waste
• Accumulate: ≤ 1,000 kg (2,200 lbs) of hazardous waste 
and ≤1 kg (2.2 lbs) of acute hazardous waste

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA? 

• Determine generator status (cont’d):
• SQG 
• Generate >100 to <1,000 kg (220 to 2,200 lbs)/month 
of hazardous waste and ≤ 1 kg (2.2 lbs )/month of acute 
hazardous waste  
• Accumulate ≤ 6,000 kg (13,200 lbs) of hazardous waste 
and ≤ 1 kg (2.2 lbs ) of acute hazardous waste

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA? 

• Determine generator status (cont’d):
• LQG
• Generate: >1,000 kg (2,200 lbs)/month of hazardous 
waste or > 1 kg (2.2 lbs)/month of acute hazardous 
waste
• Accumulate: > 6,000 kg (13,200 lbs) of hazardous waste 
or > 1 kg (2.2 lbs) of acute hazardous waste

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA? 

• Determine generator status (cont’d):
• Variable/episodic waste generation may cause a 
temporary change in generator status
• If a facility exceeds the monthly waste generation limit, 
the requirements for the next waste generator category 
apply for that calendar month
• If a CESQG exceeds the monthly limit for an acute 
hazardous waste, the LQG requirements apply for that 
calendar month
• If an SQG or LQG fails to comply with any one of the 
conditions for exemption from having a permit, then that 
generator is operating without a permit

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Prepare compliance plan
• Prepare site‐specific measures to comply with applicable 
facility and waste management requirements based on 
generator status
• Develop site‐specific procedures, checklists and inspection 
reports
• Assign roles and responsibilities
• Determine training requirements for each role

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA? 

• Notify
• Obtain an EPA Identification Number, if required (SQGs 
and LQGs)
• Submit notification to the NYSDEC for recycling consumer 
electronics under the scrap metal exemption 

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Train Employees
• CESQGs –
• Formal RCRA training not required but employees 
must know how to manage hazardous waste to 
maintain CESQG status
• SQGs   ‐
• RCRA training required for employees on proper 
waste handling and emergency procedures, relevant 
to their responsibilities during normal facility 
operations and emergencies

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA?

• Train Employees (cont’d)
• LQG –
• Formal RCRA training required ‐ Classroom or on‐
the‐job training required with annual updates 
• All  –
• Employees handling or managing universal waste 
must be informed of proper handling and emergency 
procedures
• Employees preparing or signing waste manifests with 
DOT regulated materials must receive DOT hazmat 
training with updates every three years

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA? 

• Implement facility compliance plan
• Implement site‐specific compliance measures
• Develop and maintain a compliance binder 
• Waste determinations
• Monthly hazardous waste generation rates
• Training records
• Hazardous waste manifests, LDRs and bills of lading 
(SQGs and LQGs, recommended for CESQGs)
• Exception Reports (SQGs and LQGs)
• Annual Reports (LQGs)

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RCRA Hazardous and Universal Waste Education Seminar

What are the Steps to Comply with RCRA? 

• Implement facility compliance plan (cont’d)
• Develop a compliance calendar
• Check compliance on a regular basis 
• Revise compliance plan and/or retrain employees, as 
needed

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1

Pilot Pharmaceutical Take-Back Program

November 17, 2016

Thomas R. Snow, Jr., New York City Watershed Coordinator


2

2016-2017 State Budget -


• Included funding for NYSDEC to:
“maximize the availability of drug collection programs for
communities throughout the state, including to local law
enforcement agencies for the purchase and distribution of
tamper proof drug collection boxes, and other federally
approved drug collection programs.”
3

What is DEC proposing?


Establish a pilot
pharmaceutical take-back
program at pharmacies and
retail establishments with a
pharmacy.
4

Why is NYS proposing this pilot program?


• One U.S. citizen dies every 14 minutes from
a drug overdose, leading to 100 deaths per
day across the country.

• Today, unintentional prescription opioid


overdose kills more Americans than cocaine
and heroin combined.

• Drug abuse has surpassed motor vehicle


accidents as the leading cause of injury
death.

• Federal government has declared this public


health threat an epidemic.
5

Why is NYS proposing this pilot program?


• Pharmaceuticals are not
removed during
conventional wastewater
treatment process.
• Concerns about their
presence in drinking water
supplies.
• Adverse impacts on aquatic
organisms.
6

Overview of how we envision proposed


program being implemented?

1. DEC will purchase medication collection box and provide


disposal via a contractor.
2. Vendor will ship medication collection box to participating
pharmacy and provide for the pick up, transportation and
destruction of waste drugs.
3. Participating pharmacy will install, operate and maintain
medication collection box.
7

What cost(s) will be covered?


• Purchase of a DEA-
compliant medication
collection box/receptacle
• The pick-up, transport and
destruction of waste
pharmaceuticals for a
period of two (2) years.
8

DEC responsibilities:
• Directly overseeing the pilot program.
• Soliciting pharmacies to participate through an application
process.
• Reviewing and scoring applications based on specific
criteria.
• Selecting participating pharmacies.
• Selecting vendor.
• Pay for medication box and disposal costs.
9

Pharmacy responsibilities:
• Must install medication
collection box according
to DEA regulations.
 Securely anchored
 Located in an area that
is accessible by general
public
 Can be continuously
monitored by
Pharmacist and/or staff
10

Pharmacy responsibilities:
• Must also operate and
maintain medication
collection box according to
DEA regulations.
 Two employees must
empty box
 Arrange for drug pickup
11

What will pharmacy need to do in order to


participate?
• Must be a DEA-authorized collector – very easy
registration process that takes a couple of minutes;
can be done online.
 www.deadiversion.usdoj.gov
 Go to Registration Support and click on
“Registration for Disposal of Controlled
Substances”
 Enter your login information – all found on your
existing DEA registration certificate
 Select your collection method – collection
receptacle
 Sign and certify your collector status
registration electronically
 Save and print copy of your new registration
certificate
12

Vendor will:
• Need to be a DEA-reverse distributor.
• Ship medication collection box directly to participating pharmacy.
• Provide replacement inner liners, pre-labeled for shipping on a
scheduled basis.
• Either pick up, transport and destroy waste drugs directly or
provide for via common carrier.
• Provide overall technical assistance to participating pharmacy.
• Provide online tracking system and progress reports of drug
disposals.
13

When will program be implemented?


• Once program is officially announced DEC will establish an
application process and establish a deadline.
• DEC will review application and select participating
pharmacies
• An Invitation for Bid will go out to select vendor.
• DEC will establish contract with successful bidder.
• Depending on program announcement and contractual
approval process, we expect program to be implemented
within the next year or sooner.
14

Additional Information
• Product Stewardship’s
“How to Guide” can be
found at www.bit.ly/drug-
take-back
15

My contact information -
Thomas R. Snow, Jr.
New York City Watershed Coordinator
625 Broadway
Albany, NY 12233-1040
thomas.snow@dec.ny.gov
(518) 402-9395
RCRA Hazardous and Universal Waste 
Education Seminar
Presentation 4
Management Standards for Waste 
Pharmaceuticals
November 17, 2016
RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Pharmaceutical 
Management
New draft federal “Subpart P” regulations propose 
streamlined standards for management of hazardous 
waste pharmaceuticals that apply to:

• Healthcare facilities, including: 
• Pharmacies
• Retailers of over‐the‐counter (OTC) medications

• Pharmaceutical reverse distributors 
• Receive, evaluate and accumulate potentially 
“creditable” hazardous waste pharmaceuticals

1
RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Pharmaceutical 
Management
• The proposed rule excludes hazardous waste 
pharmaceuticals managed pursuant to subpart P from 
the hazardous wastes that must be counted when 
determining whether a facility is a LQG, SQG or CESQG
• However, the proposed rule requires healthcare 
facilities to determine their initial generator status 
based on the total amount of hazardous waste 
generated per month, including hazardous waste 
pharmaceuticals as well as other hazardous wastes

2
RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Pharmaceutical 
Management
• Following that initial determination, the proposed rule 
allows healthcare facilities managing their hazardous 
waste pharmaceuticals pursuant to subpart P to exclude 
those hazardous waste pharmaceuticals when re‐
determining their generator status
For example, if a healthcare facility was a LQG because it 
generated over 1 kg of a P‐listed hazardous waste 
pharmaceutical per calendar month as well as some 
amount of other hazardous wastes and the hazardous 
waste pharmaceuticals are managed under subpart P, 
then the healthcare facility only needs to consider the non‐
pharmaceutical hazardous wastes to re‐determine its 
generator status
3
RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Pharmaceutical 
Management
Hazardous waste pharmaceuticals include: 
• Potentially “creditable” hazardous waste pharmaceuticals
• “Non‐creditable” hazardous waste pharmaceuticals 
• “Evaluated” hazardous waste pharmaceuticals

Potentially creditable hazardous waste pharmaceuticals:
• Have the potential to receive manufacturer’s credit
• Are unused or un‐administered
• Are unexpired or less than one year past the expiration 
date

4
RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Pharmaceutical 
Management
• Non‐creditable hazardous waste pharmaceuticals 
include:
• Residues of pharmaceuticals remaining in containers 
• Contaminated PPE
• Pharmaceutical spill clean‐up debris
• Pharmaceutical samples
• Generic pharmaceuticals
• Pharmaceuticals more than one year past expiration
• Pharmaceuticals removed from original container and 
repackaged for dispensing
• Pharmaceuticals partially administered/refused by a 
patient
5
RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Pharmaceutical 
Management
Evaluated hazardous waste pharmaceuticals:
• Potentially creditable hazardous waste 
pharmaceuticals evaluated by a pharmaceutical 
reverse distributor 
• Will not be sent to another pharmaceutical reverse 
distributor for further evaluation or verification

6
RCRA Hazardous and Universal Waste Education Seminar

Hazardous Waste Pharmaceutical 
Management
• A healthcare facility may accept creditable and non‐
creditable hazardous waste pharmaceuticals from 
an off‐site CESQG healthcare facility provided that:
• The healthcare facility is under the control of the same 
person as the CESQG healthcare facility
• The healthcare facility has a contractual relationship to 
provide pharmaceuticals to the CESQG 
• The healthcare facility is operating under Subpart P and 
manages non‐creditable hazardous waste 
pharmaceuticals in compliance with the requirements of 
Subpart P
• The healthcare facility keeps records for three years of all 
shipments received
7
RCRA Hazardous and Universal Waste Education Seminar

Standards for managing potentially 
creditable hazardous waste pharmaceuticals
• Conduct a hazardous waste determination on all 
potentially creditable solid waste pharmaceuticals 
• All potentially creditable solid waste 
pharmaceuticals can be managed under Subpart P
• Hazardous waste, other than potentially creditable 
hazardous waste pharmaceuticals, cannot be sent to 
a reverse distributor and must be managed in 
accordance with RCRA regulations

8
RCRA Hazardous and Universal Waste Education Seminar

Standards for managing potentially 
creditable hazardous waste pharmaceuticals
• Maintain the following records for at least three 
years for each shipment of potentially creditable 
hazardous waste pharmaceuticals:
• A copy of the advance notification provided to the 
reverse distributor
• The confirmation of delivery
• The shipping papers or bill of lading

9
RCRA Hazardous and Universal Waste Education Seminar

Prohibition of discharging hazardous 
waste pharmaceuticals to a sewer system
• All healthcare facilities and reverse distributors are 
prohibited from discharging hazardous waste 
pharmaceuticals to a sewer system connected to a 
publicly‐owned treatment works

The exclusion from the definition of solid waste for 
mixtures of domestic sewage does not apply!

10
RCRA Hazardous and Universal Waste Education Seminar

Management of hazardous waste 
pharmaceutical residues in containers
• Dispensing bottle, vial or ampule (≤ 1 liter or 1,000 
pills) or unit‐dose container is considered empty 
and not regulated as hazardous waste if:
• All pharmaceuticals have been removed using 
practices commonly employed 
• Original manufacturer product packaging is 
destroyed to prevent further use of the container

11
RCRA Hazardous and Universal Waste Education Seminar

Management of hazardous waste 
pharmaceutical residues in containers
• Residue remaining in dispensing syringes is not 
regulated as a hazardous waste if:
• The syringe has been used to administer the 
pharmaceutical to a patient AND
• The syringe is placed in a sharps container and 
managed in accordance with applicable federal, 
state and local medical waste requirements

12
RCRA Hazardous and Universal Waste Education Seminar

Shipping potentially creditable hazardous 
waste pharmaceuticals
• Provide advanced notice (paper or electronic) to the 
pharmaceutical reverse distributor of the intent to 
ship potentially creditable hazardous waste 
pharmaceuticals before each shipment 
• If delivery confirmation is not received within seven 
days, the healthcare facility must contact the 
transporter and the reverse distributor to determine 
the status

13
RCRA Hazardous and Universal Waste Education Seminar

Shipping non‐creditable hazardous waste 
pharmaceuticals
• If potentially creditable hazardous waste 
pharmaceuticals are exported to a reverse 
distributor in a foreign country, additional 
requirements apply

14
RCRA Hazardous and Universal
Waste Education Seminar
Presentation 5
Environmental Audit Incentive Program
November 17, 2016

1
RCRA Hazardous and Universal Waste Education Seminar

Environmental Audit Incentive Program

• NYSDEC has recently identified potentially significant hazardous


waste compliance issues statewide with respect to the retail
pharmacy sector
• In addition, unused/unwanted pharmaceuticals are finding their way
into the groundwater, rivers, lakes and streams throughout New York
State and the nation due to improper management/disposal
• Accordingly, NYSDEC wishes to foster industry‐wide compliance in
this market sector…statewide
• To achieve this goal, the Department has elected to take a “two‐
pronged” approach:
• Utilize Commissioner’s Policy No. 59 – Environmental Audit Incentive
Policy
• Support the collection of unused/unwanted drugs from consumers by
providing limited financial support for a pilot pharmaceutical “take‐
back” program

1
RCRA Hazardous and Universal Waste Education Seminar

Environmental Audit Incentive Program

The NYSDEC Audit Agreement….How do I participate? How


does it work?
• You or your organization will receive correspondence from
the NYSDEC explaining the statewide RCRA hazardous waste
pharmaceutical compliance issue, as well as how they wish
to address it
• As discussed in that letter, you have 90 days to review the
associated Audit Agreement and sign it, which allows you to
participate in the program
• By signing the Audit Agreement, both you and NYSDEC
agree to do certain things

2
RCRA Hazardous and Universal Waste Education Seminar

Environmental Audit Incentive Program

The NYSDEC Audit Agreement….How do I participate? How


does it work?
• You commit to do the following:
• Proactively adopt best practices
• Audit your operations
• Disclose any violations to NYSDEC and take corrective action
• Comply with the “streamlined” requirements of 40 CFR
Subpart P for managing waste pharmaceuticals
• For pharmacies, commit to make a good faith effort to adopt a
system to collect waste pharmaceuticals from consumers

3
RCRA Hazardous and Universal Waste Education Seminar

Environmental Audit Incentive Program


The NYSDEC Audit Agreement….How do I participate? How
does it work?
• In turn, NYSDEC commits to do the following:
• Defer inspection of any facility covered by the Agreement
during this timeframe
• Allow pharmacies/food stores to develop and implement a
compliance plan prior to conducting audits:
• Up to 6 months to develop compliance plan;
• Up to an additional 6 months to implement the compliance
plan;
• Up to an additional 2 months to audit and disclose
compliance issues; and
• Up to an additional 4 months to fix compliance issues.

4
RCRA Hazardous and Universal Waste Education Seminar

Environmental Audit Incentive Program

The NYSDEC Audit Agreement….How do I participate? How


does it work?
• In turn, NYSDEC commits to do the following (cont’d):
• Waive the monetary penalties typically associated with NYSDEC
compliance inspections/enforcement actions for violations
identified during the audits
• Allow entities to comply with the streamlined requirements
found in proposed federal rule Subpart P, 40 CFR Part 266 for
waste pharmaceutical management, although not yet adopted
by the U.S. Environmental Protection Agency or New York State

5
RCRA Hazardous and Universal Waste Education Seminar

Environmental Audit Incentive Program

Pilot Pharmaceutical “Take‐Back” Program


• Make a good faith effort to adopt a program to collect waste
pharmaceuticals from consumers
• Consider participation in the NYSDEC‐sponsored Pilot “Take‐Back”
Program:
• Fill out the on‐line application by the deadline
• Participating pharmacies will receive a DEA‐compliant
medication drop box from the NYSDEC
• NYSDEC will retain a DEA‐registered vendor to pick up,
transport and destroy collected pharmaceuticals for two years

6
RCRA Hazardous and Universal Waste Education Seminar

Environmental Audit Incentive Program

Please remember you have 90 days from the date of the


NYSDEC’s letter to sign up for the Environmental Audit
Incentive Program

At the close of the 90‐day “sign‐up” period the NYSDEC


may re‐institute compliance inspections

7
Richard M. Walka
Senior Vice President
516-364-9890 ext. 3006
rwalka@db-eng.com

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