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2014 Missouri Hazardous Waste Seminar 
Nov. 4, 2014 
David Shanks, Boeing Policy Analysis 
TAILORED RCRA GENERATOR 
RULES 
PAST EFFORTS AND FUTURE PLANS
1980 Rules - Ideal Generator 
•Drum or bulk quantities 
•Steady production of consistent waste streams 
•Treatment/disposal facilities available to accept all 
wastes within 90 days
Labs Don’t Fit the RCRA Ideal 
 Laboratories generate 
 Numerous waste 
streams 
 Small quantities per lab 
 Unknown characteristics 
of created compounds 
 Are stored reagents 
 Needed for future use? 
 Abandoned in place? 
 Past usable shelf life? 
 In unmarked containers?
Lab Issues with Standard Rules 
 3 day limit on satellite 
accumulation over 55 
gal. or 1 quart for 
acutely hazardous 
waste 
 Forces frequent, but 
irregular removal from 
numerous labs 
 400 labs at University of 
Vermont
More Lab Regulatory Issues 
 In academic labs, 
fragmented 
departments and 
student turnover: 
 Limits depth of RCRA 
training/experience and 
 Inhibits awareness of 
possible reuse or 
recycling in another lab.
Early EPA Efforts for Labs 
 June 2000 
 EPA solicited academic labs to participate in 
Project XL/Labs21 program to gather information 
 2002 
 EPA Report to Congress on Lab Waste 
 April 2004 
 EPA Advance Notice of Proposed Rulemaking 
(ANPRM) soliciting input on needed generator 
rule changes (not just labs)
Laboratory Rulemaking 
 May 23, 2006 Proposed Subpart K Rule 
 “Alternative Requirement for Hazardous Waste 
Determination and Accumulation of Unwanted 
Material for Laboratories Located at 
Colleges/Universities” 
 Requires labeling sufficient to allow a fully RCRA-trained 
person to assign correct waste code 
 Follow written Laboratory Management Plan 
 6 months max. accumulation time in lab-- under 55 gal/1 qt 
 10 days to remove excess (55 gal or 1 qt.) from satellite 
accumulation, rather than 3 days 
 Special rules for central accumulation area and annual lab 
cleanouts (up to 30 days allowed)
Laboratory Rulemaking 
 Non-academic labs submitted comments 
seeking coverage. 
 Other than student turnover, industrial, 
commercial, and (non-teaching) medical labs have 
the same problems with RCRA rules as colleges. 
 EPA allowed teaching hospital labs, but excluded all 
others. 
 Ohio EPA stated that the lab rule is a poor 
substitute for addressing problems in the 
accumulation rules for all generators.
Laboratory Rulemaking 
 Final Subpart K rule published Dec. 1, 2008. 
 In tailoring optional RCRA rules for labs, EPA 
created substantial new and different 
requirements 
 University facility operations also generate non-lab 
hazardous waste. 
 Result: two sets of RCRA rules at the facility 
 Adopted by Missouri Nov. 2011. 
 Eleven years after EPA recognized the problem. 
 Rate of opt-in by Missouri academic labs?
Retailers Don’t Fit RCRA 
Industrial Generator Rules 
Either
Retailers 
Instead of re-examining 
RCRA rules, 
EPA and states 
took an 
Enforcement 
First approach 
to retailer 
noncompliance 
 Multi-million $ RCRA 
penalties (along with CWA, 
FIFRA, etc.) 
 Wal-Mart 
 Target 
 CVS Pharmacy 
 Costco 
 Albertsons grocery chain 
 Home Depot
Retailers’ Situation 
 Products handled by retailers are seldom 
“spent” materials that are obviously waste 
 Containers damaged in handling 
 Spill cleanup 
 Customer returns: held for resale or “discarded” 
not always clear 
 Products in good condition, but not selling 
 Stores often served by “reverse logistics centers” 
 for decisions on whether product can still be sold, 
returned to vendor, donated, recycled, or disposed.
Retailers’ Situation 
 Chains may have thousands of locations in 
multiple states 
 but not thousands of RCRA compliance experts on 
the ground to observe at each store 
 state rule add-ons (MO, CA, WA, others) prevent 
consistent corporate training courses 
 Same problem as industrial generators who operate 
in multiple states 
 Boeing experience with a draft corporate training 
 Developed in Puget Sound by persons accustomed to 
Washington state rules 
 Not just incomplete, but wrong for other states.
Retailers’ Situation 
 Hundreds of thousands of employees and 3rd 
party vendors handle merchandise 
 Employees in US 
 Wal-Mart- -1.4 million 
 Target --350,000 
 Seasonal temporary and part-time employees are 
common in retail 
 Even industrial facilities struggle to meet 100% 
annual RCRA refresher training for full-time 
permanent employees, due to Leaves of Absence 
 For retailers, absence from one year to next is issue
2012—EPA Recognizes a Problem 
Some RCRA 
generator 
requirements 
are a poor fit. 
For example, 
RCRA 
presumption 
that waste 
codes will be 
known by in-store 
personnel. 
 2012 Unified Agenda opened 
rulemaking review project 
regarding retailers and RCRA 
 Carried forward in Spring and 
Fall 2013 Unified Agendas
Next EPA Action? 
 Feb. 14, 2014 
 EPA Notice of Data Availability 
 Invites comment on issues and challenges retailers 
face complying with RCRA rules 
 Retail associations submitted 41 page comment 
letter 
 Among others, seeks conditional exemption for 
unsold or returned products managed in a reverse 
distribution system. 
 Most recent EPA Unified Agenda: 
 “Next action undetermined”
Missouri Actions 
 Draft MO rule revisions address some retailer 
concerns with Missouri-unique rules 
 “If a generator determines that labeling a 
container with a capacity of less than one gallon is 
not feasible, the generator shall affix the 
appropriate label(s) to the locker, rack or other 
device used to hold or accumulate such 
container.” 
 Eliminates requirement for DOT packaging during 
entire storage period.
US Dept. of Transportation 
 July 5, 2012. Advanced Notice of Proposed 
Rulemaking (ANPRM) 
 Solicited comment on reverse logistics 
 August 11, 2014. Proposed Rule 
 Define “reverse logistics” 
 “Process of moving goods from their final destination for the 
purpose of capturing value, recall, replacement, proper 
disposal, or similar reason” 
 Modify and reduce packaging, hazard communication, 
and training requirements for reverse logistic shipments. 
Define responsibilities. 
 DOT rulemaking is ahead of EPA 
 Both are needed
Pharmaceuticals Don’t Fit RCRA 
Industrial Generator Rules 
Either
RCRA Listed Pharmaceuticals 
 5-10% of pharmaceuticals 
are on P- or U- waste lists. 
 Warfarin blood thinner, 
nicotine patches, and 
physostigmine are common 
P-listed acute wastes 
 Result of acute hazard? 
 2.2 lb/month generation = 
Large Quantity Generator 
 Empty containers or packaging 
are not RCRA-empty unless 
triple rinsed (or equivalent). 
Rinsate is hazardous by 
mixture rule for listed wastes
P-listed Container Residues 
 Is LQG status 
determined by total 
weight of containers 
or weight of the 
residues? 
 Nov. 4, 2011 EPA 
guidance says weight of 
residues only 
 States are free to 
impose their own rules 
or interpretation
EPA Recognized a Problem 
 On Dec. 2, 2008, EPA proposed a Pharmaceutical 
Universal Waste rule 
 About 634,000 affected health care entities in US 
 Assoc. of State & Territorial Solid Waste Mgt Officials 
suggested simpler rules for safe handling & 
incineration of all pharmaceuticals. EPA rejected. 
 P- and U- listings do not keep up with new drug 
introductions 
 EPA withdrew its proposal in 2012. 
 US Drug Enforcement Agency (DEA) proposed a new 
rule on Dec. 21, 2012 on Disposal of Controlled 
Substances.
DEA Adds Complexity 
 DEA issued its final rule Sept. 9, 2014. 
 Overlap of DEA-controlled and RCRA-hazardous 
drugs is limited, but both rules apply 
 DEA rule concerned with tracking of registrants to 
control diversion of narcotics 
 DEA defers to EPA on methods of destruction & 
RCRA compliance 
 Under DEA voluntary take-back provisions, 
household donors might qualify for RCRA 
household hazardous waste exemption
Further EPA Action 
 Spring 2014 EPA Unified Agenda 
 Projects a Dec. 2014 proposal to set Management 
Standards for Hazardous Waste Pharmaceuticals (not 
as Universal Waste) 
 Focused on reverse distribution system 
 While EPA tried to decide, Florida and Michigan 
adopted Universal Waste standards for 
hazardous pharmaceuticals: 
 Storage longer than 90 days, and weight of 
drugs/residues don’t count toward SQG/LQG status. 
 Applicable only within state boundaries, however.
Lessons Learned 
 Tailoring RCRA rules to non-industrial waste: 
 May take a decade or more 
 especially if EPA’s starting point is the text of 
existing RCRA rules 
 May result in tailored rules that address some 
issues, but increase complexity 
 Subpart K lab rules 
 States may choose not to adopt, adopt only 
slowly, opt for a Universal Waste approach, or 
muddle through with guidance or enforcement 
discretion

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Shanks,David, Boeing, Tailored RCRA Generator Rules--Past Reports and Future Plans, at 2014 Missouri Hazardous Waste Seminar, November, 4, 2014, Columbia, MO

  • 1. 2014 Missouri Hazardous Waste Seminar Nov. 4, 2014 David Shanks, Boeing Policy Analysis TAILORED RCRA GENERATOR RULES PAST EFFORTS AND FUTURE PLANS
  • 2. 1980 Rules - Ideal Generator •Drum or bulk quantities •Steady production of consistent waste streams •Treatment/disposal facilities available to accept all wastes within 90 days
  • 3. Labs Don’t Fit the RCRA Ideal  Laboratories generate  Numerous waste streams  Small quantities per lab  Unknown characteristics of created compounds  Are stored reagents  Needed for future use?  Abandoned in place?  Past usable shelf life?  In unmarked containers?
  • 4. Lab Issues with Standard Rules  3 day limit on satellite accumulation over 55 gal. or 1 quart for acutely hazardous waste  Forces frequent, but irregular removal from numerous labs  400 labs at University of Vermont
  • 5. More Lab Regulatory Issues  In academic labs, fragmented departments and student turnover:  Limits depth of RCRA training/experience and  Inhibits awareness of possible reuse or recycling in another lab.
  • 6. Early EPA Efforts for Labs  June 2000  EPA solicited academic labs to participate in Project XL/Labs21 program to gather information  2002  EPA Report to Congress on Lab Waste  April 2004  EPA Advance Notice of Proposed Rulemaking (ANPRM) soliciting input on needed generator rule changes (not just labs)
  • 7. Laboratory Rulemaking  May 23, 2006 Proposed Subpart K Rule  “Alternative Requirement for Hazardous Waste Determination and Accumulation of Unwanted Material for Laboratories Located at Colleges/Universities”  Requires labeling sufficient to allow a fully RCRA-trained person to assign correct waste code  Follow written Laboratory Management Plan  6 months max. accumulation time in lab-- under 55 gal/1 qt  10 days to remove excess (55 gal or 1 qt.) from satellite accumulation, rather than 3 days  Special rules for central accumulation area and annual lab cleanouts (up to 30 days allowed)
  • 8. Laboratory Rulemaking  Non-academic labs submitted comments seeking coverage.  Other than student turnover, industrial, commercial, and (non-teaching) medical labs have the same problems with RCRA rules as colleges.  EPA allowed teaching hospital labs, but excluded all others.  Ohio EPA stated that the lab rule is a poor substitute for addressing problems in the accumulation rules for all generators.
  • 9. Laboratory Rulemaking  Final Subpart K rule published Dec. 1, 2008.  In tailoring optional RCRA rules for labs, EPA created substantial new and different requirements  University facility operations also generate non-lab hazardous waste.  Result: two sets of RCRA rules at the facility  Adopted by Missouri Nov. 2011.  Eleven years after EPA recognized the problem.  Rate of opt-in by Missouri academic labs?
  • 10. Retailers Don’t Fit RCRA Industrial Generator Rules Either
  • 11. Retailers Instead of re-examining RCRA rules, EPA and states took an Enforcement First approach to retailer noncompliance  Multi-million $ RCRA penalties (along with CWA, FIFRA, etc.)  Wal-Mart  Target  CVS Pharmacy  Costco  Albertsons grocery chain  Home Depot
  • 12. Retailers’ Situation  Products handled by retailers are seldom “spent” materials that are obviously waste  Containers damaged in handling  Spill cleanup  Customer returns: held for resale or “discarded” not always clear  Products in good condition, but not selling  Stores often served by “reverse logistics centers”  for decisions on whether product can still be sold, returned to vendor, donated, recycled, or disposed.
  • 13. Retailers’ Situation  Chains may have thousands of locations in multiple states  but not thousands of RCRA compliance experts on the ground to observe at each store  state rule add-ons (MO, CA, WA, others) prevent consistent corporate training courses  Same problem as industrial generators who operate in multiple states  Boeing experience with a draft corporate training  Developed in Puget Sound by persons accustomed to Washington state rules  Not just incomplete, but wrong for other states.
  • 14. Retailers’ Situation  Hundreds of thousands of employees and 3rd party vendors handle merchandise  Employees in US  Wal-Mart- -1.4 million  Target --350,000  Seasonal temporary and part-time employees are common in retail  Even industrial facilities struggle to meet 100% annual RCRA refresher training for full-time permanent employees, due to Leaves of Absence  For retailers, absence from one year to next is issue
  • 15. 2012—EPA Recognizes a Problem Some RCRA generator requirements are a poor fit. For example, RCRA presumption that waste codes will be known by in-store personnel.  2012 Unified Agenda opened rulemaking review project regarding retailers and RCRA  Carried forward in Spring and Fall 2013 Unified Agendas
  • 16. Next EPA Action?  Feb. 14, 2014  EPA Notice of Data Availability  Invites comment on issues and challenges retailers face complying with RCRA rules  Retail associations submitted 41 page comment letter  Among others, seeks conditional exemption for unsold or returned products managed in a reverse distribution system.  Most recent EPA Unified Agenda:  “Next action undetermined”
  • 17. Missouri Actions  Draft MO rule revisions address some retailer concerns with Missouri-unique rules  “If a generator determines that labeling a container with a capacity of less than one gallon is not feasible, the generator shall affix the appropriate label(s) to the locker, rack or other device used to hold or accumulate such container.”  Eliminates requirement for DOT packaging during entire storage period.
  • 18. US Dept. of Transportation  July 5, 2012. Advanced Notice of Proposed Rulemaking (ANPRM)  Solicited comment on reverse logistics  August 11, 2014. Proposed Rule  Define “reverse logistics”  “Process of moving goods from their final destination for the purpose of capturing value, recall, replacement, proper disposal, or similar reason”  Modify and reduce packaging, hazard communication, and training requirements for reverse logistic shipments. Define responsibilities.  DOT rulemaking is ahead of EPA  Both are needed
  • 19. Pharmaceuticals Don’t Fit RCRA Industrial Generator Rules Either
  • 20. RCRA Listed Pharmaceuticals  5-10% of pharmaceuticals are on P- or U- waste lists.  Warfarin blood thinner, nicotine patches, and physostigmine are common P-listed acute wastes  Result of acute hazard?  2.2 lb/month generation = Large Quantity Generator  Empty containers or packaging are not RCRA-empty unless triple rinsed (or equivalent). Rinsate is hazardous by mixture rule for listed wastes
  • 21. P-listed Container Residues  Is LQG status determined by total weight of containers or weight of the residues?  Nov. 4, 2011 EPA guidance says weight of residues only  States are free to impose their own rules or interpretation
  • 22. EPA Recognized a Problem  On Dec. 2, 2008, EPA proposed a Pharmaceutical Universal Waste rule  About 634,000 affected health care entities in US  Assoc. of State & Territorial Solid Waste Mgt Officials suggested simpler rules for safe handling & incineration of all pharmaceuticals. EPA rejected.  P- and U- listings do not keep up with new drug introductions  EPA withdrew its proposal in 2012.  US Drug Enforcement Agency (DEA) proposed a new rule on Dec. 21, 2012 on Disposal of Controlled Substances.
  • 23. DEA Adds Complexity  DEA issued its final rule Sept. 9, 2014.  Overlap of DEA-controlled and RCRA-hazardous drugs is limited, but both rules apply  DEA rule concerned with tracking of registrants to control diversion of narcotics  DEA defers to EPA on methods of destruction & RCRA compliance  Under DEA voluntary take-back provisions, household donors might qualify for RCRA household hazardous waste exemption
  • 24. Further EPA Action  Spring 2014 EPA Unified Agenda  Projects a Dec. 2014 proposal to set Management Standards for Hazardous Waste Pharmaceuticals (not as Universal Waste)  Focused on reverse distribution system  While EPA tried to decide, Florida and Michigan adopted Universal Waste standards for hazardous pharmaceuticals:  Storage longer than 90 days, and weight of drugs/residues don’t count toward SQG/LQG status.  Applicable only within state boundaries, however.
  • 25. Lessons Learned  Tailoring RCRA rules to non-industrial waste:  May take a decade or more  especially if EPA’s starting point is the text of existing RCRA rules  May result in tailored rules that address some issues, but increase complexity  Subpart K lab rules  States may choose not to adopt, adopt only slowly, opt for a Universal Waste approach, or muddle through with guidance or enforcement discretion