Kevin Fasken, University of Missouri, Subpart P: Management Standards for Hazardous Waste Pharmaceuticals, Missouri Hazardous Waste Seminar, November 5, 2015

1. A Generator’s Perspective
Kevin Fasken
University of Missouri
Subpart P: Management
Standards for Hazardous
Waste Pharmaceuticals

2. ›What is Covered:
–Background
–Some Select Definitions
–Who is Affected
–Generator Status Implications
–Satellite Accumulation
–The Proposed Sewer Ban
–DEA Intersection with RCRA
Overview

3. ›Pharmaceuticals have potential for
significant environmental impact.
Background

4. ›The sewering of hazardous waste
pharmaceuticals accounts for an
estimated 6400 pounds of waste
introduced into the environment per
year.
›Health care workers generally have
trouble interpreting regulations.
Background (Continued)

5. ›The rule proposes changes to how
generator status is determined for the
affected parties.
›EPA has also acknowledged that
residues in P-listed pharmaceutical
containers are not equivalent to P-listed
residues in a 55 gallon drum, tank, etc.
Background (Continued)

6. ›The rule establishes standards for
pharmaceutical waste Satellite
Accumulation Areas
›It also addresses reverse distribution,
and the intersection of DEA and RCRA
regulations.
Background (Continued)

7. Health Care Facility
Reverse Distributor RCRA Permitted TSDF
Sewer/Non-Compliant Disposal
Pharmaceutical Waste Flow
Manufacturer/RCRA
Permitted TSDF

8. Definitions

9. ›Key terms:
–Pharmaceutical
–Health Care Facility
–Potentially creditable hazardous waste
pharmaceutical
–Non-creditable hazardous waste
pharmaceutical
–Long Term Care Facility
Definitions (Continued)

10. Who is Affected

11. ›Health Care Facilities including (but not
limited to):
–Hospitals, pharmacies, veterinary clinics,
physician’s offices, dentist’s offices,
chiropractors, nursing care facilities,
continuing care retirement facilities, medical
examiners, etc.
›Long Term Care Facilities
›Reverse Distributors
Who is Affected (Continued)

12. ›The rule initially proposes that entities
including (but not limited to) those
identified by the following North
American Industry Classification System
codes would be affected:
–44611, 54194, 6211, 6212, 6213, 6214,
6219, 622, 6231, 623311, Subset of 922219,
Various Reverse Distributor Codes
Who is Affected (Continued)

13. ›Adoption of this rule is mandatory.
Who is Affected (Continued)

14. ›CESQG’s
–CESQG’s are not subject to the proposed rule,
with one exception.
› These facilities are still subject to the proposed
sewer ban.
›Households
–Encouraged to take advantage of take back
programs or household hazardous waste
programs
›Pharmaceutical Manufacturers
›Group homes, independent living facilities,
independent living portions of retirement
communities
Who is Not Affected

15. Generator Status Implications

16. ›Under current regulations a facility that
generates > 1 kg of acutely hazardous
waste per month is an LQG.
›Under Subpart P pharmaceutical waste
will no longer count toward generator
status.
Generator Status Implications
(Continued)

17. ›Only non-pharmaceutical wastes will
determine status, for example:
–Lab wastes
–Facility maintenance wastes
–Research wastes
Generator Status Implications
(Continued)

18. ›It is possible that some LQG’s will
become CESQG’s. Possible benefits for
generators include:
› Longer accumulation times
› Less required training/documentation
› Reduced cost
›In addition, generators will not be
required to report pharmaceutical
wastes on their biennial report.
Generator Status Implications
(Continued)

19. P-Listed Residues

20. ›Under current regulations generation or
accumulation of only 1kg of P-listed
material is enough to force a status
change from CESQG to LQG.
›Containers which formerly held P-listed
residues also count toward generator
status unless they are RCRA empty.
›Generators may choose to only count
the net quantity of P-listed residue.
P-Listed Residues

21. ›REGFORM 11/04/2013:
P-Listed Residues Continued

22. ›Under Subpart P:
–Residues in containers, dose cups,
dispensing vials/bottles (up to 1000 pills or 1
liter) are considered “RCRA empty” when
fully dispensed.
› Dispose as non-hazardous waste.
› Crush or otherwise render the containers non-
recognizable.
–Dispensed syringes are considered empty as
well
› Manage as sharps.
P-Listed Residues

23. Satellite Accumulation

24. ›No stricter no sooner would have
removed accumulation time limits for
hazardous waste pharmaceuticals.
–Volume limits of 55 gallons of hazardous
waste or 1 Kilogram of acutely hazardous
waste would have been in effect.
Satellite Accumulation
(Continued)

25. ›REGFORM 11/04/2014:
Satellite Accumulation
(Continued)

26. ›Subpart P proposes requires different
management strategies for drugs based
on their potential value.
–Potentially creditable drugs will be managed
less stringently than non-creditable drugs.
Satellite Accumulation
(Continued)

27. ›Potentially Creditable Hazardous Waste
Pharmaceuticals
–No specific labeling requirements
–No specific container requirements
–No accumulation time limits
› Drugs must be unexpired or less than 1 year past
expiration date
–Security is not specifically required, but
assumed to be present because of the
potential value
Satellite Accumulation
(Continued)

28. ›Potentially Creditable Hazardous Waste
Pharmaceuticals (Continued)
–May be shipped to a Reverse Distributor
–Records of shipment to RD must be
maintained for 3 years
› No Hazardous Waste Manifest is required
› Notification to RD of pending shipment
› Notification from RD of receipt of shipment
Satellite Accumulation
(Continued)

29. ›Non-Creditable Hazardous Waste
Pharmaceuticals
–Must be labeled as “Hazardous Waste
Pharmaceuticals”
› RCRA Codes are not required on the container
–1 year accumulation time limit
–Containers must be secure – performance
based standard to prevent theft.
Satellite Accumulation
(Continued)

30. ›Non-Creditable Hazardous Waste
Pharmaceuticals
–Wastes which cannot be incinerated must
be collected separately
–Must be shipped to a TSDF
–Must use a Hazardous Waste Manifest
› Not required to report RCRA codes on
manifest
Satellite Accumulation
(Continued)

31. Proposed Sewer Ban

32. ›At one time sewering was considered an
acceptable method of disposal.
–It was convenient for health care workers.
–Easily avoided any potential for theft or
diversion for DEA regulated materials.
Proposed Sewer Ban
(Continued)

33. ›Subpart P would ban sewering of all
Hazardous Waste Pharmaceuticals.
›The DEA is no longer allowing sewering
as a means of destruction for DEA
regulated materials.
›It is strongly encouraged that this
practice is extended to all waste
pharmaceuticals, not just those that are
RCRA or DEA regulated.
Proposed Sewer Ban
(Continued)

34. DEA Regulated Materials

35. ›Prescription drug abuse is a serious
problem
–46,000 Americans die each year from drug-
related deaths. – DEA.gov
›The DEA recently completed it’s 10th
prescription drug take back effort
–In one weekend 702,365 pounds of drugs
were collected. Over 5,000,000 pounds
have been collected in total.
DEA Regulated Materials
(Continued)

36. ›Under Subpart P pharmaceuticals which
are both RCRA and DEA regulated will be
exempt from RCRA regulations provided:
–They are managed in accordance with DEA
regulations; and
–They are combusted in a municipal solid
waste combuster or hazardous waste
combuster.
DEA Regulated Materials
(Continued)

37. ›In addition comingling of non-hazardous
and hazardous waste pharmaceuticals
will be permitted, provided all other DEA
regulations are observed.
›This helps make it easier for institutions
to sponsor drug take back programs
which help reduce societal burden.
DEA Regulated Materials
(Continued)

38. ›The comment period was originally
proposed to end 11/24/15, but has been
extended to 12/24/15.
Comment Period Extension

39. Kevin Fasken
Environmental Affairs Professional
faskenk@missouri.edu
Questions?