The document summarizes recent and proposed changes to RCRA regulations that will impact hazardous waste generators. Key changes include the finalized revised definition of solid waste rule from 2015, the upcoming electronic manifest system rolling out in 2018, a proposed generator improvements rule with comments due in December 2015, a proposed rule on managing hazardous waste pharmaceuticals with comments due in November 2015, and a proposed rule on hazardous waste export and import revisions with comments due in December 2015. The changes affect generators of various sizes and types of wastes across multiple industry sectors. Proper implementation will require generators to carefully track the various effective dates and overlapping scope of these new and revised regulations.

1. The Changing Landscape for
RCRA Generators
Region V Midwest Environmental Compliance Conference
October 29, 2015
Liane Hetherington-Ward
Senior Consultant
Schreiber, Yonley & Associates / Trinity Consultants

2. What did 2015 bring to RCRA generators?
Definition of Solid Waste - final rule 1/13/2015
Electronic Manifest – final rule 2/7/2014, rollout 2018
Proposed Hazardous Waste Generator Improvements Rule –
comments due 12/24/2015
Proposed Hazardous Waste Pharmaceuticals Rule –
comments due 11/24/2015
Proposed Hazardous Waste Export-Import Revisions –
comments due 12/18/2015

3. Revised Definition of Solid Waste
What regulations changed?
 40 CFR 260 and 261
Who was / is affected?
 Any user of a hazardous waste recycling exemption
Timing?
 Went into effect on 7/13/2015 in any state without authorization
 Illinois adopted already
 Remaining states in Region V are in process

4. 5 Major Changes in This Rule
Sham Recycling and Legitimacy
Revisions to Solid Waste variance process and non-
waste determination process
Generator Controlled Recycling Exclusion revised
New Verified Recycler Exclusion replaces Transfer Based
Exclusion
New Solvent Remanufacturing Exclusion

5. Sham Recycling and Legitimacy
Sham Recycling defined:
“Recycling that is not legitimate recycling”
Legitimate Recycling Factors (must meet all four)
1. Useful contribution to product
2. Valuable product or intermediate
3. Managed as valuable commodity
4. Comparable to a legitimate product or intermediate
5

6. New Requirements for Solid Waste Variances
If using a DSW variance, must provide an initial notification
and at change in circumstances
Re-notification every 2 years
10 year fixed term (at which point, users must re-apply)
For non-waste determination (260.34), demonstrate that
existing exclusions would not apply
Currently applies only to exemptions/variances dating from
2008 and later
7

7. Three exclusions
Generator Controlled Exclusion
 Adds recordkeeping and notifications to existing exclusion
Verified Recycler Exclusion
 Replaces transfer-based exclusion
 Adds recordkeeping and notifications for the Generator
 Adds conditions for the Verified Recycler
Remanufacturing Exclusion
 For remanufacture of 18 specific solvents in select industries
 Requires joint notifications, plans, recordkeeping, and reporting

8. Electronic Manifest
A CENTRALIZED SYSTEM FOR ELECTRONIC
SUBMITTAL, INSPECTION, AND RECORDS
RETENTION FOR HAZARDOUS WASTE MANIFESTS
 Final rule published 2/7/2014
 Effective date 8/6/2014
 BUT: deferred until e-manifest system is in place
 Affected regulations: 40 CFR 260, 262, 263, 264, 265, 271
 Separate User Fee Rule in development
 EPA Goal: E-Manifest System fully online no later than Spring, 2018

9. Who is Affected?
Affected entities: anyone using a hazardous waste
manifest
Hazardous waste generators, transporters, TSDFs
Some HSM handlers (recyclers, reclaimers)
Handlers of any other waste (or exempted material)
required to be shipped using a hazardous waste manifest
 Illinois: special waste
 Michigan: liquid industrial waste, PCB waste

10. What Will Change from Current System?
Four data entry options
Web Service
Mobile App Paper
Centralized system
Recordkeeping and Documentation procedures
Manifest fees
Goal is to replace paper manifests – but –
 Paper “replacement” is required if e-manifest use is interrupted
 One paper copy still required on vehicle to meet DOT HazMat laws

11. State Implementation
 Effective date IN ALL STATES same as national e-manifest
system
 States cannot impose inconsistent requirements
 Supersedes less stringent or inconsistent requirements
 Applies to all requirements affecting content or use
 States cannot establish their own system or require different formats
 EPA will implement & enforce until state programs are revised
 State program modification deadline was 7/1/2015 (or 7/1/2016 if
statutory change required)
 Adopted: Illinois

12. RCRA Generator Improvements Rule
Proposed 9/25/2015
Comments due 12/24/2015
Affected regulations: 40 CFR 260 – 265, 268, 270, 273, 279
 >60 changes to the regulations, plus about 30 technical corrections
Affected entities:
 All CESQGs
 All SQGs
 All LQGs

13. Reorganization
“VSQG” (Very Small Quantity Generator) replaces “CESQG”
Moving all Generator Provisions to 40 CFR 262
 § 262.13 – Generator Category, moved from § 261.5(c) – (e)
 § 262.14 – VSQG (formerly CESQG), moved from § 261.5(a), (b), (f)
– (g)
 § 262.15 – Satellite Accumulation, moved from § 262.34(c)
 § 262.16 – SQG, moved from § 262.34(d) – (f)
 § 262.17 – LQG, moved from § 262.34(a), (b), (g) – (i), (m)

14. VSQG (CESQG) Consolidation Option
VSQG can consolidate waste at an LQG under control of the
same person
VSQG Responsibility
 Mark and label containers as “VSQG Hazardous Waste”
LQG Responsibility
 Notification (via Site ID Form)
 Recordkeeping
 Manage as LQG hazardous waste
 Include in Biennial Report

15. Episodic Generators
Generators can retain existing (VSQG, SQG) category during
episodic generation, provided:
 Comply with streamlined set of requirements
 Allowed one episode per year, with ability to petition for second
 Must notify EPA prior to initiating a planned episode, or within
reasonable timeframe for unplanned episode
 Must complete the episode within 45 days (30 day extension
possible)

16. Episodic Generators, cont.
SQG streamlined requirements: comply with existing SQG
regulations and maintain records of episodic event
VSQG streamlined requirements
 Obtain RCRA ID Number
 Hazwaste manifest and transporter to ship to RCRA TSDF or recycler
 Minimize potential for accident or release
 Label episodic waste containers
 Identify an emergency coordinator
 Maintain records

17. Numerous changes and clarifications
LQG Contingency Plans must include executive summary
Must document that arrangements have been made with
local authorities
Document waste determination for solid waste determined
to be non-hazardous
Changes to labeling requirements
Satellite Accumulation Provisions clarified

18. More changes and clarifications
Waiver allowed for 50-Foot prohibition for ignitable &
reactive wastes, with fire department approval
Closure requirements (as landfill) for LQGs that cannot clean
close
Clarification of generator categories for mixtures of
acute/non-acute or of haz/non-haz wastes
Corrections/clarifications/new definitions/deleting outdated
and obsolete provisions

19. Notification / Recordkeeping
SQGs required to re-notify every 2 years
 Electronic option available
Biennial Report (rules updated to be consistent with current
guidance)
 LQGs must report all hazwaste generated in a calendar year, even
when it is managed the next year
 LQGs must report for all months in the year, even if SQG for some of
those months
 Recycling facilities must report waste not stored prior to recycling

20. Implementation
Expected to be finalized in 2016
 Effective date 6 months after final rule – probably 2017
State Implementation
 Authorized states required to adopt provisions more stringent than
current state regulations
 States not required to adopt the less stringent provisions
 VSQG (CESQG) consolidation
 Episodic generation
 Waiver from 50-foot rule

21. What should be done now?
EPA Website has lots of useful information, including an FAQ
and the Webinar slides
 http://www2.epa.gov/hwgenerators/proposed-rule-hazardous-waste-
generator-improvements#rule-history
Comments on the rule are due December 24, 2015
 EPA is requesting comment on “practically every component of the
generator regulatory program”

22. Hazardous Waste Pharmaceuticals Rule
Proposed 9/25/2015
Comments due 11/24/2015
Affected regulations: 40 CFR 261, 262, 266, 268, 273
Affected entities:
 Healthcare facilities / pharmacies
 Pharmaceutical reverse distributors
Affected wastes:
 Existing universe of hazardous waste pharmaceuticals

23. Background and History
Unique category of waste
 Very low volume, very high frequency of generation
 “Reverse distribution” management arrangement
 DEA and FDA requirements
 Higher than average percentage of P-listed wastes
 Huge variability and constant change in chemicals involved
2008 Universal Waste proposed rulemaking
 Inadequate for this waste category
 This proposed rulemaking replaces the 2008 Universal Waste option

24. Pharmaceutical Hazardous Wastes
Hazardous waste pharmaceutical means a pharmaceutical
that is a solid waste, as defined in § 261.2, and is listed in
part 261, subpart D, or exhibits one or more characteristics
identified in part 261, subpart C.
Pharmaceutical: anything requiring an FDA drug facts label
 Prescription and over-the-counter
Includes all dose forms
 Pill, tablet, ointment, liquid, gel cap, tablet, inhaler, …

25. Key Components
Prohibits disposal of hazardous waste pharmaceuticals via
the sewer
Provides an alternate strategy for managing pharmaceutical
hazardous wastes
 Creates new sector specific regulation at 40 CFR 266, Subpart P
 For this industry sector only, 40 CFR 262 generator regulations are
replaced with 40 CFR 266, Subpart P regulations
 Designed to encourage management of non-hazardous
pharmaceuticals together with hazardous

26. Reverse Distribution
Imposes controls on reverse distribution practice
 Expired, unused, or un-administered pharmaceuticals sent to reverse
distributors for credit, prior to final disposition
 Potentially Creditable:
 Potential to receive manufacturer’s credit, and is unused or un-administered,
and is unexpired or < one year past expiration date.
 Non-Creditable
 Not expected to be eligible for manufacturer’s credit
 Evaluated
 Evaluation has been made whether credit will be issued

27. Subpart P Provisions
Healthcare facility must make waste determination for each
stream
 Alternately, healthcare facilities can elect to manage all solid waste
pharmaceuticals as hazardous waste pharmaceuticals
Accumulation up to 365 days allowed without a permit
Clearly marked with the phrase “Hazardous Waste
Pharmaceuticals”
Hazardous waste codes not required on manifests
Generation of >1 kg P-waste will not trigger LQG status

28. Subpart P Provisions, cont.
Generator facility personnel require some basic training
Specific allowances for management at reverse distributors
 “Creditable” wastes have lesser requirements, until evaluated
Biennial Report
 Not required for non-creditable hazardous waste pharmaceuticals
managed under Subpart P (with exceptions)
 Allows management of combined non-hazardous & hazardous waste
pharmaceuticals.
Additional provisions (recordkeeping, reporting, labeling, container
standards, LDR, rejected shipments, etc.)

29. Applicability
All pharmaceutical reverse distributors are subject to the
proposed rule
CESQG healthcare facilities: remain subject to requirements
at § 261.5, plus prohibition on disposal to sewer
SQG and LQG healthcare facilities: must comply with
requirements of § 266 Subpart P.

30. Implementation
EPA expects final rule in 2016
 Effective date 6 months after final rule – probably 2017
State Implementation
 Sewer Ban is HSWA: Effective in all states on date of final rule
 The rest of the rule is considered to be more stringent than existing,
so authorized states are required to adopt the final rule
 Universal Waste is not considered protective enough for
pharmaceuticals.
 FL and MI will have to replace their UW programs with this one

31. What should be done now?
EPA Website has lots of useful information, including an FAQ
and the Webinar slides
 http://www2.epa.gov/hwgenerators/proposed-rule-management-standards-
hazardous-waste-pharmaceuticals#additional-resources
Comments on the rule are due November 24, 2015
 EPA requests numerous comments on a variety of specific concerns
in the rule

32. Hazardous Waste Export-Import Revisions
Proposed 10/19/2015
Comments due 12/18/2015
Affected regulations: 40 CFR 260 – 267, 271, 273
Affected entities: Importers and Exporters of Hazardous
Wastes
Addressing issues raised in
 2013 Commission for Environmental Cooperation report; and
 2015 EPA Office of Inspector General report

33. What changes?
Requires use of international movement documents for each
international shipment of hazardous wastes
 Includes universal wastes
 Includes Part 266 spent lead acid batteries
Mandatory electronic annual reporting of hazardous waste
exports
Links hazardous waste export consent with the U.S. Customs
exporter declaration.

34. Additional Changes
Increases tracking of individual shipments
 Matches consent numbers with manifest information
Requires EPA ID Numbers for all SQG and LQG hazardous
waste exporters and importers
 Includes traders arranging for export or import
Reorganizes the exporter, importer, transporter, and
receiving facility requirements into 40 CFR 262 Subpart H

35. Implementation
Expected to be finalized in Fall, 2016
 Effective date no later than 12/31/2016
State Implementation
 Becomes effective immediately in all states
 Authorized states required to adopt the final provisions into their
regulations

36. What should be done now?
EPA Website
 http://www2.epa.gov/hwgenerators/proposed-rule-hazardous-waste-
export-import-revisions#rule-summary
Comments on the rule are due December 18, 2015

37. RECAP
5 Different Rules
5 (or more) Different Timeframes and Effective Dates
All rules overlap with some or all of the others
The rules affect overlapping waste categories
The rules affect overlapping generators
END RESULT: Complicated rulemaking processes and
complicated implementation for generators!

38. Questions?
Liane Hetherington-Ward
Senior Consultant
Schreiber, Yonley & Associates / Trinity Consultants
708/737-7162
lianehw@syaeng.com