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

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

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

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

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

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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

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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

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

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

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

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

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

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)

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

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)

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

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

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

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

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

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”

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

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

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, …

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

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

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

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.)

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.

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

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

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

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.

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

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

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

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!

Questions?

Liane Hetherington-Ward

Senior Consultant

Schreiber, Yonley & Associates / Trinity Consultants

708/737-7162

lianehw@syaeng.com