Author Archives: Elise Paeffgen

Elise Paeffgen is an associate in the Environment, Land Use & Natural Resources Group. Her practice focuses on environmental enforcement defense; RCRA, CERCLA and SDWA financial assurance; chemicals management; carbon regulation; and shale gas extraction.  Read More

Now Effective: EPA’s Sewer Ban and (in some states) Management Standards for Hazardous Waste Pharmaceuticals

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Today, August 21, 2019, EPA’s Final Management Standards for Hazardous Waste Pharmaceuticals takes effect federally.  The sewer ban component of the new rule applies in all states.  Healthcare facilities are now prohibited from flushing hazardous waste pharmaceuticals, including DEA controlled substances and “pharmaceutical wastage” that are hazardous waste.  This sewering ban may drive many facilities to stop flushing pharmaceuticals entirely (even those that are not hazardous waste), given how complicated it is in practice for healthcare provides to determine which drugs are hazardous [...]Read more

Final Management Standards for Hazardous Waste Pharmaceuticals Released

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On December 12, 2018, the EPA released its long-awaited Management for Hazardous Waste Pharmaceuticals Rule. The EPA addressed industry concerns by amending the hazardous waste listing for nicotine to exclude nicotine replacement therapies (NRTs) in this rulemaking, but challenges remain in the new management standards. Here are a few noteworthy takeaways as we continue to analyze the rule and its implications: The exclusion of NRTs is a big win … so long as states follow suit FDA-approved, over-the-counter NRTs (nicotine patches, gums, and lozenges) have been removed from the P075 hazardous [...]Read more

California’s Drug and Sharps Takeback Bill Triggers Statewide Obligations

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All entities selling drugs and sharps in California should be aware of California’s pharmaceutical and sharps waste stewardship bill, SB 212, which recently passed both houses of the state Legislature. It currently sits on the Governor’s desk awaiting signature. SB 212 requires manufacturers of sharps and pharmaceuticals to create and fund a statewide take-back program covering prescription and OTC drugs. If a manufacturer is not located in the state, responsibility shifts down the chain to the wholesale distributor, then repackager, followed by the owner or licensee of the trademark, and lastly [...]Read more

Food Packaging Alert: Increasing State Scrutiny of PFAs, BPA and BPS

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Washington recently passed legislation that will examine and possibly lead to a ban on perfluorinated chemicals (PFAs) in food packaging.  Under Washington’s Healthy Food Packaging Act (H.B. 2658/S.B. 6396), which takes effect June 7, the Department of Ecology is required to identify safer alternatives to PFAs by January 1, 2020.  If Ecology succeeds in doing so, the law will ban PFAs in paper food packaging two years later, on January 1, 2022.  If Ecology does not find safer alternatives, Ecology will be required to review safer alternatives every year.  When Ecology finds an acceptable [...]Read more

Forthcoming California Phase 2 GHG Emission Regulations Foreshadow Compliance Challenges

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Last August, the U.S. Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA) finalized the more stringent “Phase 2” greenhouse gas (GHG) emission standards and fuel efficiency standards for medium- and heavy-duty engines and vehicles.  As discussed at a CARB hearing on February 6, California will propose its own Phase 2 GHG emission standards this summer, and is predicted to release the proposed rule for public comment in September.  California’s rules are expected to differ from and go beyond the EPA Phase 2 rules.  They will move forward [...]Read more

EPA Confirms Vehicle Emission Standards for 2022-2025

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As expected, on January 12, 2017, the U.S. Environmental Protection Agency (EPA) issued its Final Determination affirming the greenhouse gas (GHG) emission standards for model year 2022-2025 light-duty vehicles.  While EPA had until April 1, 2018 to issue this Final Determination, it did so quickly,  less than two weeks following the close of the public comment period on the agency’s Proposed Determination, detailed in our prior blog here.  This Final Determination makes it much more difficult for the new administration to change course. EPA’s Final Determination was originally anticipated [...]Read more

EPA Releases CERCLA Financial Assurance Rule

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EPA has released its long-awaited proposed CERCLA financial assurance regulations for the hardrock mining industry.  When finalized, these regulations will serve as a model for financial assurance regulations for other industries. Also on December 1, EPA provided notice that its next target industries -  petroleum and coal products manufacturing; chemical manufacturing; and electric power generation, transmission, and distribution.  These developments have major implications for a multitude of companies—both in these industries and in industries that could be future targets. Here are some [...]Read more

EPA Provides Early Affirmation of Vehicle Emission Standards for 2022-2025

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On November 30, 2016, EPA issued a Proposed Determination as part of its Midterm Evaluation of greenhouse gas (GHG) emission standards for model year 2022-2025 light-duty vehicles.  EPA has concluded, in this proposed adjudicatory determination, that these GHG standards, established in 2012, remain appropriate under the Clean Air Act (CAA).  EPA is required by regulation (40 CFR 86.1818-12(h)) to consider factors such as the availability and effectiveness of technology, appropriate lead time for technology, costs to manufacturers and consumers, and the feasibility and practicality of the standards [...]Read more

CARB Launches Rulemaking for Heavy-Duty Engine Low NOx Standard

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On November 3, the California Air Resources Board (CARB) announced plans for a new low-nitrogen oxide (NOx) standard for heavy-duty engines sold in the state.  CARB intends to adopt the new NOx standard—of 0.02 grams per brake horse power-hour (g/bhp-hr)—in 2019.  This standard would apply beginning with 2023 model year engines sold in California.  CARB stated that this new rulemaking will combine amendments to: The heavy-duty engine NOx standards, including a low load certification cycle; The Not-to-Exceed in-use compliance program; The useful life and durability requirements [...]Read more

EPA Commits to Hazardous Waste Retail Strategy, Policy Expected to Address Point of Generation Issues

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On September 12, 2016, the U.S. Environmental Protection Agency (EPA) issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework.  As part of this strategy, EPA will finalize the Resource Conservation and Recovery Act (RCRA) Hazardous Waste Generator Improvements Rule this fall, and is working to finalize the Management Standards for Hazardous Waste Pharmaceuticals Rule, but appears to need additional time to do so.  While EPA states that it is focusing efforts on these rulemakings, it will also issue a Policy on Reverse Distribution and RCRA. EPA recognizes that [...]Read more