REGULATORY LANDSCAPE: UPDATE

Transcription

1 REGULATORY LANDSCAPE: UPDATE Kristin Alstad Manager, Regulatory Compliance Richard Sieg Regulatory Counsel

2 Roadmap Regulatory Landscape Extended Producer Responsibility Existing Challenges Other Considerations Regulatory Developments 2

3 Background DOT DEA/PDMA EPA & STATE Many Regulatory Agencies FDA USDA OSHA 3

4 DOT PHMSA hazardous materials regulations Hazardous Materials DOT Rules Cover CPGs Even When They Are NOT Wastes ORM-D Shipping Allowed Until Dec. 31, 2020 DOT PHMSA Regulates Pre-transportation Functions Transportation Limited Quantities Reduced Regulatory Requirements 4

5 EPA hazardous waste regulations What is Hazardous Waste? Solid Waste Hazardous Waste Exhibits Certain Characteristics Ignitable (Flashpoint < 140 deg. F) Corrosive (2.0 < ph < 12.5) Reactive Toxic (40 Chemicals w/ published regulated concentration) EPA Deems Hazardous Waste (Through Lists) Examples: P List - Nicotine, Warfarin, etc. 5

6 Existing Challenges 6

7 Challenges within hazardous waste regulations EPA Sets the Federal Floor States may be more stringent than EPA regulations State Patchwork of Hazardous Waste Regulations Developed Exemptions/Exclusions to Definition of Waste Waste Characterization Point of Generation of Waste Generator Categories Management of Hazardous Waste Electronic Devices Emphasis on Enforcement in Retail Universal Wastes (Different, but not always more stringent) 7

8 Waste characterization State significant differences from Federal Consumer Product Goods (CPGs) and Rx Significant Less Significant Universal Waste Rule for Pharmaceuticals Note: This map is not intended as legal advice. It is intended for illustrative purposes only. It is intended to cover certain, common consumer products and prescription drugs. It is not intended to cover some consumer products (e.g., electronic devices, etc.), residues from consumer products, and products intended for recycling (e.g., triggering various state exceptions or exemptions to the definition of solid waste or hazardous waste). Any generator should review and apply the state hazardous waste law that applies to the location, in question. 8

9 Patchwork Complicates Compliance Is CPG a solid waste? State adoption of Federal Exemptions/Exclusions Varies State definition of Empty Container Varies Some States differ on Point of Generation of Waste Is CPG a hazardous waste? State adoption of Federal Exclusions Varies Some States Modified Federal Tests for Certain Characteristics Some States Created Different Lists and Tests for Hazardous Wastes States Have Differing Universal Wastes States may have different hazardous waste generator categories States may have more stringent HW management requirements 9

10 California Enforcement Point of Generation Destroy Disposition Toxicity Characteristic - Aquatic Toxicity Test "Drug Facts Labeling Recycling Challenges 10

11 California: Enforcement California settles with Retailer $8.65M Retailer will pay $27.6M million to settle a lawsuit Retailer settles hazardous-waste claims in California $13.75M California settles with Retailer $3.6M Retailer to pay $22.5M to settle hazardouswaste dumping case Failure to Manage Hazardous Wastes Properly from the Point of Generation Failure to Complete Manifest Requirements Failure to Properly Train Employees 11

12 California: Point of generation Critical Issue When and Where Do Returned Pharmaceuticals and CPGs Become Waste? Manufacturer Distribution Center Wholesale Distributors Retailer Consumer Reuse Disposal Reverse Distributors $ Manufacturer Credit Safety Recalls: CA Regulators Do Not Seem To Be Applying to Safety Recalled Products 12

13 California: Aquatic toxicity Aquatic Toxicity Project Funded by Supplemental Environmental Projects (Settlement Funds) Waste Characterization Testing Variety of Products Presumption as Aquatic Toxicity Pass/Fail Manufacturer Opportunity to Rebut Results Cumbersome to Manage Results 13

14 California: "Drug Facts" Potentially Regulated Medical Waste under the Medical Waste Management Act as Pharmaceutical Waste Medical Waste Must be incinerated when disposed Expiration dates drive whether the product can be used for its intended purpose 14

15 California: Recycling challenges Current rule places constraints on recycling Facilities receiving items for recycling must be registered to receive such items even if they aren t the facility engaged in the recycling activity Sustainable solutions are limited 15

16 Legislative and Rule-Making developments

17 Ongoing and recent developments EPA Notice of Data Availability (NODA): Hazardous Waste in Retail EPA Second Notice of Proposed Rulemaking: Management of Pharmaceuticals as Universal Waste DOT Reverse Logistics Proposed Rule DOT Lithium Battery Final Rule State Level Activity California Legislative Efforts Connecticut DEEP Working on Similar Pharmaceutical Rulemaking New York 17

18 Epa s notice of data availability: Hazardous waste in retail 1980: EPA Federal Floor Being Adjusted? 2011: President Obama 2014: EPA Publishes NODA 2015: EPA Site Visits Establishes One Size Fits All Federal Approach to the Nation's Waste Problem Signaled Approach likely would not be a good fit in all situations Executive Order 13563: Improving Regulation and Regulatory Review Inmar's Comments Available at Regulations.Gov, Docket ID: EPA-HQ- RCRA , v/#!documentdetail;d=ep A-HQ-RCRA Expect Framework Spring

19 U.S. EPA second notice of proposed rulemaking: Management of pharmaceuticals as universal waste Kristin Fitzgerald, US EPA HQ, Hazardous Waste Pharmaceuticals Proposed Rulemaking, 17 th Annual California Unified Program Training Conference, Feb. 3,

20 U.S. EPA second notice of proposed rulemaking: Management of pharmaceuticals as universal waste Proposed Rule was sent to Office of Management and Budget on March 19, 2015 and a draft will likely be published this summer EPA Fall Regulatory Agenda: Second Notice of Proposed Rulemaking is Expected June 2015 First Notice of Proposed Rulemaking in 2008 Died Stakeholder Concerns Lack of Tracking for Shipments of HW Pharmaceuticals Could Lead to Diversion Lack of Notification by Most Handlers Sector-Based Proposal (Healthcare facilities, Pharmacies, Reverse Distributors) EPA Estimate for Final Rule: FY 2016; Significant Outreach Activities (Webinars, etc.): Extend into FY 2017 (EPA OSWER, Draft FY National Program Manager s Guidance (Pub. Nr: 530P15001), Feb. 23, 2015) 20

21 Environmental Protection Agency Use EPA's Enforcement and Compliance History Online website to search for facilities in your community to assess their compliance with environmental regulations. echo.epa.gov 21

22 DOT / PHMSA reverse logistics proposed rule DOT: Align Requirements with Actual Risks Two Proposed More Stringent Requirements Use of Absorbent Mandatory Shipping of Equipment Inmar Comments Available At Regulations.Gov, Docket ID: PHMSA (HM-253), MSA

23 Lithium battery final rule Original Effective Date: February 6, 2015 After Deadline Passed, DOT PHMSA Extended Deadline (Except Shipping by Air) 6 Months to August 6, 2015 Impact on Retail Tracking Data on Batteries Not Currently Tracked Li-ion vs. Li-metal Watt-hours and weight (grams) Small, Medium and Large Batteries Systematic Solution Not Readily Feasible Reduced Requirements for Small & Medium Size Cells / Batteries Labeling and Marks Hazard Communication Paper

24 Connecticut Established a Pharmaceutical Universal Waste Stakeholders Group Sector-based Management of Hazardous Waste Pharmaceuticals Developed Framework for Program State is in its Deliberative Process of Rulemaking Connecticut CR04, CR05 Wastes 24

25 California: Retailers' working group Department Toxic Substances Control (DTSC) Spent 2014 Learning about Reverse Distribution Manufacturer Meetings Summer 2014 Retail & Inmar Facility Tours Steering Committee Reengaged This Year Building Consensus on Areas of Agreement Interpretation Not the Desired Solution Legislative Solution Desired 25

26 Legislative Efforts : SB 423 California Senate Bill Introduced 2 Year Bill Environmental Committee Hearing Summer 2015 Point of Generation Drug Fact Label not Medical Waste After Financial Reconciliation/ Evaluation of Credit Incineration not required Disposal based upon content or hazardous characteristics 26

27 New York New York Retail Compliance Initiative Announced Informational Stage: Nov Voluntary Compliance Stage : Pending Encourage Compliance by Retailers Letters to Retailers Bring Into Compliance Seek Assistance through DEC s new Environmental Audit Incentive Policy 2013 Prioritizing Items Like: Nail polish remover Paint thinner Household cleaning products (bleach) 27

28 Extended producer responsibility laws Typically holds manufacturers responsible for funding the handling and disposal of certain consumer products and Rx Electronic devices Pharmaceuticals Pharm. Research & Mfrs. Of Am. v. Cnty. Of Alameda Before U.S. Supreme court First of kind ordinance Requires drug producers to establish and pay for drug take back program Constitutional challenge commerce clause If upheld, could lead to a wave of similar laws and could extend to other consumer products 28

29 Other considerations Commercial chemical products (CCPs) Stakeholder participation in rulemaking Public policy 29

30 Commercial chemical product (CCP) Do not treat CCPs in a waste-like manner USEPA Checklist to Assist in Evaluating Whether Commercial Chemical Products Are Solid and Hazardous Waste under the Resource Conservation and Recovery Act, May 14,

31 Commercial chemical products Are Stored Materials Being Treated Like a Waste? Housekeeping Matters! Labeling Matters! USEPA Checklist to Assist in Evaluating Whether Commercial Chemical Products Are Solid and Hazardous Waste under the Resource Conservation and Recovery Act, May 14,

32 Other considerations retail example Commercial Chemical Product (CCP) Exemption EPA: CCPs Are Excluded As Solid Waste When Sent for Reclamation or Speculatively Accumulated Encourages Sustainable Reuse of CCP Not All States Adopted this Exemption Most Consumer Product Goods are CCPs Huge Opportunities for Recycling These in Many States More Difficult for Other States See Inmar s White Paper, Hazmat 102, for a Detailed Summary of the Requirements For Managing Hazardous Wastes and Hazardous Materials in Retail

33 Agency rule-making Agency deliberative process Stakeholder participation important Agency explains rationale Retail industry must ensure agencies have clear, accurate picture of its perspective. For example, for the hazardous waste (HW) rulemaking effort: Actual risks do not justify regulatory burdens created in HW regulation created for industry The unique challenges in retail Benefits associated with reverse logistics Impacts on the environment by creating overly restrictive requirements for retail Sustainable uses and reuses of CPGs disincentivized Landfills meet capacity earlier 33

34 Public policy Similarity Between Sustainability and RCRAReduce, Reuse, Recycle Initiative Most preferred Reduce Reuse Recycle Least preferred Dispose Government Goal is Waste Reduction 34

35 Reverse logistics approach v points of control Regulatory Schemes May Force Management of Unsalables as Waste at the Store 1000 Points of Control = Store by Store Management Compare Reverse Logistics Model to Store by Store Management Which Framework Best Enables Waste Reduction? Reduce and/or Reuse Data Collection on Unsaleables Liquidation Donation Recycling Recycling is easier to facilitate through reverse distribution versus store-by-store management of returns 35

36 Public policy Look at Safety Recalls Must Show Effectiveness of Recall Reverse Logistics Plays Major Role Showing Effectiveness at the Store Level would be a Huge Challenge 36

37 Suggested actions Manufacturer Retailer Collaborate with Manufacturers and Reverse Distributors Sustainable End Life Uses of CPGs (Revisit Destroy Dispositions) Monitor Regulations for Changes Participate in Rule-making 37

38 Hazardous waste has evolved Past Present Future Federal hazardous waste rule Rule Targeted Industrial Waste Retail Not on Radar Screen Low Awareness of Potential Applicability to Retail Not Enforced Against Retailers State level regulations Focused inspections Differing enforcement standards Increased awareness of regulations State & Federal Retailer Enforcement Alignment of Burdens w/ Actual Risks Collaboration Creative and Sustainable Solutions Reduce Destruction 38

39 Kristin Alstad Richard Sieg

40 Click the survey button found on the session page.

41 Appendix A Selected Federal Agency Regulatory Agendas 41

42 Hazardous waste management and the retail sector: providing and seeking information on practices to enhance effectiveness to the RCRA program 42

43 Hazardous Materials: Reverse Logistics 43

44 Management standards for hazardous waste pharmaceuticals 44

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