demystifying the new epa hazardous pharmaceutical waste rule
TRANSCRIPT
Demystifying the
New EPA Hazardous Pharmaceutical Waste Rule
October 28th 2015
Meet Your Presenter
Steve Todisco, HEM,
CHMM, Six Sigma
Corporate Director of
Healthcare & Pharmaceutical
Waste Management
Triumvirate Environmental Inc.
RCRA Overview
Current Issues
Proposed Rule Overview
6 Major Components
Q&A
Action Plan
Agenda
The Resource Conservation and Recovery
Act of 1976:
Originally conceived as a law
addressing municipal trash
disposal, Subtitle C of RCRA
was included to give the U.S.
Environmental Protection
Agency (EPA) the authority to
regulate hazardous waste. This
includes the generation,
transportation, treatment,
storage, and disposal of
hazardous waste.
RCRA and Healthcare
HSWA continued where RCRA, Subtitle C left off,
including: adding mandates for the regulation of small
quantity generators, restrictions on land disposal of
hazardous waste, regulation of underground storage
tanks (USTs), and corrective action provisions to prevent
RCRA facilities from becoming Superfund sites.
The Hazardous and Solid Waste
Amendments of 1984:
HSWA and Healthcare
Federal Hazardous Waste
Regulations promulgated
by the US Environmental
Protection Agency (EPA)
under 40 CFR. . . . . . and
Derived
Regulations
Generators
Transporters
Treatment, Storage and Disposal Facilities (TSDFs)
• Part 261- Waste Identification
• Part 262- Generator Requirements
• Part 263- Transporter Requirements
• Part 264- 265- TSDF Requirements
• Part 266- Recycling
• Part 268- Land Disposal Restrictions
• Part 270- TSDF Permitting
• Part 271- State RCRA Programs
40 CFR Parts: 260-281
Who’s Covered Under State &
Federal RCRA Regulations?
Characteristic Wastes (D-List)
Listed Wastes from Non-Specific Sources (F-List)
Listed Wastes from Specific Sources (K-List)
Specifically-Listed Unused Chemicals (U-List)
Acutely Hazardous Unused Chemicals (P-List)
SPENT
SPENT
UNUSED
UNUSED
SPENT or UNUSED
Waste Codes:
Organized into Lists
The amount and type of hazardous waste generated in a given calendar month will
determine your “generator status”.
Large Quantity Generators (LQGs)
Small Quantity Generators (SQG)
Conditionally Exempt Small Quantity Generators (CESQGs)
Generator Status
1. Fact Finding• Formulary Characterization
• Reverse Distribution Review
2. Operational• Satellite Accumulation Areas
• Waste Streams
• Containers
3 Major Components to
Pharmaceutical Waste Management
3. Education• Training
• Special Coding Systems /
Education
RCRA Overview
Current Issues
Proposed Rule Overview
6 Major Components
Q&A
Action Plan
Agenda
1. Large Quantity Generator Status for > 1.0 kg of
P-Listed Waste:
• Currently burden “true” SQG and CESQG’s
• Force shorter accumulation times
• Currently triggers biennial reporting requirements
• Increased training and documentation
• Potentially increased costs
Issue #1
2. Residual P-Listed Containers:
• Containers not considered RCRA Empty
• Container must be triple rinsed or collected as hazardous; or
• Cleaned by another method with proven equivalency
• Currently applies to the smallest of containers < 1 ml
• In some states there is still blister pack required collection
• Other “cups” for collection
Issue #2
3. Manufacturer-Oriented Regulations Imposed on Healthcare:
• Many healthcare folks still have little to no RCRA knowledge
• Varying formularies over time
• Thousands of drugs
• Many people identified as a generator
• Many locations throughout hospital
• Pharmaceuticals are unique
Issue #3
4. Pharmaceutical Waste Drain Disposal has become a commonly
used mechanism for disposal by healthcare facilities:
• Which has contributed to pharmaceuticals in surface and
drinking water
• Has been identified as a risk to the environment and human
health
• Are not capable of being treated at local POTW’s
• Flushing is currently allowed for some pharmaceuticals
Issue #4
5. The Intersection of EPA and DEA Regulations:
• Currently there are a few RCRA-regulated pharmaceuticals
that are also regulated under the DEA:
• Chloral Hydrate (U034)
• Fentanyl Sublingual Spray (D001)
• Phenobarbital (D001)
• Testosterone Gels (D001)
• Valium – Injectable (D001)
• Must currently follow both sets of conflicting regulations
• Diversion issues for remaining material
• Case-by-case approval
Issue #5
6. The Regulatory Status of Creditable Pharmaceuticals:
• Creditable Pharmaceuticals currently allow the reverse
distributor to be the generator of the waste
• This is based on the assumption that some
pharmaceuticals will be redistributed
• Creditable Pharmaceuticals are not regulated as waste
even though many are disposed of after a manufacturer’s
credit is processed by a reverse distributor
• Creates a world of a lack of tracking and potential theft
Issue #6
RCRA Overview
Current Issues
Proposed Rule Overview
6 Major Components
Q&A
Action Plan
Agenda
• Pharmaceutical Definitions
• Which Pharmaceuticals are
Covered?
• Who is Affected / Covered?
• Where do the New Regulations
Live?
• State Adoption
• Six Major Component
Solutions
Proposed Rule
Overview
Any chemical or biological product that is intended for use in the diagnosis,
cure, mitigation, care, treatment, or prevention of disease or injury of a
human or other animal; or
Any chemical or biological product that is intended to affect the structure or
function of the body of a human or other animal
The definition includes but is not limited to:
• Dietary supplements as defined by the FD&C Act
• Prescription drugs
• Over-the-counter drugs
• Residues of pharmaceuticals remaining in containers
• Personal Protective Equipment contaminated with pharmaceuticals, and
• Clean-up material from spills of pharmaceuticals
Pharmaceutical Definitions
Additional Information Pertaining to the Proposed Rule:
• The definition includes all dose forms including tablets, capsules, gums,
lozenges, liquids, ointments, lotions, IV’s, antiseptics, patches, etc.
• At commenters request is much broader than Universal Pharmaceutical
Waste
• Takes from the FDA definition of what a drug is
• General Rule of Thumb – If the FDA requires a Drugs Fact label then it’s a
pharmaceutical
• Does not include waste sharps
Pharmaceutical Definitions
• …Only pharmaceuticals that are already
considered hazardous waste.
• The proposed rule DOES NOT propose to
increase the number of pharmaceuticals
that are considered hazardous waste.
• It only changes how hazardous waste
pharmaceuticals must be managed.
• The EPA wishes to encourage healthcare
facilities to manage all waste
pharmaceuticals under the new rule.
Which Pharmaceuticals
are Covered?
• Healthcare facilities that generate Hazardous Waste
Pharmaceuticals
• Proposed definition of Healthcare Facility is any person that:
• (I) Provide preventative, diagnostic, therapeutic, rehabilitative,
maintenance or palliative care, and counseling, service,
assessment or procedure with respect to the physical or
mental condition, or functional status, of a human or animal
or that affects the structure or function of the human or
animal body; or
• (II) sells or dispenses over the counter or prescription
pharmaceuticals
Who Is Covered?
*Does not include Drug Manufacturers
Who Is Covered?
• All pharmaceutical reverse distributors
• Proposed Definition of a reverse pharmaceutical distributor is:
• Any person that receives and accumulates potentially creditable
hazardous waste pharmaceuticals for the purpose of facilitating or
verifying manufacturer’s credit
• Any person, including forward distributors and pharmaceutical
manufacturers, that processes pharmaceuticals for the facilitation or
verification of manufacturers credit is considered a pharmaceutical
reverse distributor
*Some drug manufacturers may operate as pharmaceutical
reverse distributors
Who Is Covered?
40 CFR Part 266 – Standards for
the management of specific
hazardous wastes and specific
Types of Hazardous Waste
Management Facilities
Part 266 Subpart P – Management
Standards for Hazardous Waste
Pharmaceuticals
Where Do the
Regulations Live?
EPA Considers this to more stringent than current regulations
• Not voluntary – all states will be required to adopt the final rule
• Regulated parties will be required to use the final rule
The Sewer Ban – HSWA Provision
• Will be effective in all states on the effective date for the final rule,
even before the state adopts it
Current Universal Pharmaceutical Waste Programs
• Florida and Michigan will have to replace their UPW programs
State Adoption
RCRA Overview
Current Issues
Proposed Rule Overview
6 Major Components
Q&A
Action Plan
Agenda
1. The Proposed Solution – Hazardous Waste
Pharmaceuticals no longer count toward an
institution’s generator status:
• No longer an SQG or LQG delineation
• All Hazardous Waste Pharmaceuticals are managed the same
• No monthly generation rate tracking
• Allows comingling of acute and non-acute
• Reduces episodic generation
• Removes the dis-incentive to manage hazardous and non-
hazardous separately
Solution #1
2. The Proposed Solution – Residues addressed via
exemptions:• Unit dose containers = exempt
• Dispensing bottles and vials (up to 1L or 1000 pills) = exempt
• If all contents removed – now considered RCRA empty
• RCRA empty containers may now be disposed of as non-hazardous
• Original packaging must be disposed and destroyed
• Dispensed syringes = exempt
• All other devices still need to be managed as hazardous if applicable, such
as:
•IV bags, tubing, aerosols, nebulizers, ointments, gels, creams
Solution #2
3. The Proposed Solution – 40 CFR Part 266 Subpart
P:
• Utilize sector-specific standards specific to hazardous waste
pharmaceuticals generated at healthcare facilities and reverse distributors
• No more SQG and LQG requirements
• SAA and CAA regulations specific to pharmaceuticals
• One-time notification
• Performance-based training
• No biennial reporting due to pharmaceuticals
Solution #3
4. The Proposed Solution –The new rule bans
sewering hazardous waste pharmaceuticals:
• Ban applies to all healthcare facilities
• Ban applies to all reverse distributors
• Ban applies to CESQG’s
Solution #4
5. The Proposed Solution – Hazardous Waste
Pharmaceuticals also regulated by the DEA
would be exempt from RCRA:
• Must be managed in accordance with all DEA
regulations
• Must be combusted at a permitted/interim
status:
• Municipal Solid Waste Combustor
• Hazardous Waste Incinerator
Solution #5
6. The Proposed Solution – The point of generation
for pharmaceuticals sent to a reverse distributor
will now be the healthcare facility and not the
reverse distributor:
• Will allow for more tracking of shipments of creditable
hazardous waste pharmaceuticals from generator to reverse
distributor
• Through notification allows the reverse distributors to have
better oversight of what they receive
• If the pharmaceutical is legitimately reused or recycled then it
is not considered a solid waste and/or hazardous waste and is
not covered under the new rule
Solution #6
• Reverse distributors would now be considered a new type of
management facility like a TSDF
• They would only be capable of accepting hazardous waste that is
potentially creditable
• They aren’t required to have a RCRA storage permit
• They are regulated the same as the generator
• The standards are similar to Large Quantity Generators
(Notification, Inventory, Security)
Reverse Distribution
• Proposed definition of “Potentially Creditable”
• A hazardous waste pharmaceutical that has the potential to receive
manufacturer’s credit and is:
• Unused or un-administered; and
• Unexpired or less than 1 year past expiration
• This definition does not include:
Evaluated HW Pharmaceuticals
Residues remaining
Contaminated PPE
Clean up material from a spill
Reverse Distribution
• What is NOT creditable
• A scenario where there is no reasonable expectation for a credit:
• When you have a sample
• When you are trying to return a generic drug
• Is more than 1 year past expiration
• If it has been removed from the original container and
repackaged
• Was generated during patient care or refused by a patient
Reverse Distribution
• Pharmaceuticals must be evaluated by the RD within 21 days of arrival
to determine if:
• It’s moving on to another RD for further evaluation (Max 2)
• It’s moving to a permitted Hazardous Waste TSDF
• If the RD accidentally receives Hazardous Waste “Non Creditable”:
• They must prepare an “Unauthorized Waste Report” that goes
to the shipper and to the EPA
• They must manage the waste appropriately
• Only allowed 90 days of accumulation time
• Other rules similar to satellite and central accumulation apply
Reverse Distribution
RCRA Overview
Current Issues
Proposed Rule Overview
6 Major Components
Q&A
Action Plan
Agenda
Publication of the final rule in the CFR• Administrator has already signed the proposed rule on 8/31/15
• This was published on 9/25/15; 80 FR58014
There is a 60 Day Comment Period• That has been extended to 12/24/15
• There has already been many requests for extension
Review of Public Comment• After review the EPA will begin to finalize the rule
EPA will to proceed or modify in a couple of specific areas• Expanding what pharmaceuticals are hazardous
What Should I Do Now?
QUESTIONS?
Epinephrine Salts that are not considered P-Listed wastes
RCRA Online Memo # 14778; October 15th 2007
Residues in partially used syringes are not listed Wastes
RCRA Online Memo # 14788; April 14th 2008
Nicotine patches, gum, lozenges are P-Listed when unused
RCRA Online Memo # 14817; August 23rd 2010
Limited fix for containers with P-Listed pharmaceutical residues
RCRA Online Memo # 14827; November 4th 2011
Phentermine Salts are not P- Listed Wastes
RCRA Online Memo # 14831; February 17th 2012
Additional Information
Household Pharmaceuticals collected during take back events
RCRA Online Memo # 14833; September 26th 2012
E-Cigarettes are P075
RCRA Online Memo # 14850; May 8th 2015
Nicotine patches, gum, lozenges are P-Listed when unused
RCRA Online Memo # 14817; August 23rd 2010
Nicotine containing Smoking cessation products
RCRA Online Memo # 14851; May 8th 2015
Household pharmaceuticals collected in DEA collection receptacles
Not online yet; October 2nd 2015
Additional Information
Thank You For Attending!
Steve Todisco, HEM, Six Sigma
339-226-0524
www.Triumvirate.com
Contact: