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

EPA Opens Environmental Crimes Office in North Dakota

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The Environmental Protection Agency (EPA) opened a Criminal Investigation Division (CID) office in North Dakota at the end of July. North Dakota has seen its oil production increase to over 1 million barrels a day over the last decade. The Bakken shale, located in the western part of the state, holds almost 11 billion barrels of oil, and production is increasing. EPA’s office is staffed by four agents who plan to investigate operations in the state’s western oil patch, ranging from drilling rigs to disposal sites and everything in between. EPA’s closest offices have been in Montana and Colorado [...]Read more

BOEM Issues ANPR to Update Financial Assurance Requirements for Outer Continental Shelf Operations

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The Bureau of Ocean Energy Management (BOEM) issued an advanced notice of proposed rulemaking (ANPR) on Risk Management, Financial Assurance, and Loss Prevention in an effort to update its financial assurance regulations for industrial operations on the Outer Continental Shelf (OCS). BOEM intends to develop more robust financial assurance requirements to address what the agency perceives as increasingly complex financial, commercial, functional, and business risks involving leases, Rights-of-Use and Easements (RUEs), Pipeline Rights-of-Way (ROWs) and facilities on the OCS. BOEM is soliciting [...]Read more

Oral Arguments Held in PhRMA v. Alameda Co., California

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On August 28, 2013 the U.S. District Court for the Northern District of California upheld the Alameda County Safe Drug Disposal Ordinance (“the Ordinance”), the first pharmaceutical extended producer responsibility law in the United States. Three pharmaceutical industry associations brought a dormant Commerce Clause challenge to the Ordinance, but the court held that the Ordinance treats all drug companies alike and does not discriminate against those located outside of the county. PhRMA filed an appeal on September 12, 2013 and last Friday, July 11, 2013, the U.S. Court of Appeals for the [...]Read more

Working Group to Address Radioactive Waste Regulations

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The Conference of Radiation Control Program Directors (CRCPD) established a working group of multiple state agency officials to develop recommendations for improved state regulations governing the handling, storage and disposal of technologically enhanced naturally occurring radioactive material (TENORM) from hydraulic fracturing. The working group is expecting to push states to move away from regulations based solely on picocuries per gram (pCi/g) of TENORM, to regulations based on exposure. Further, a dose-based, rather than risk-based, standard is preferred by the group. The working group also [...]Read more

King County Adopts Fee Schedule for Drug Take Back Program

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The King County Board of Health adopted a fee schedule as part of the requirements of its Secure Medicine Return Regulations. The scheduled fees include an annual operating fee, as well as plan review fees for: • Review of a proposed stewardship plan; • Resubmittal of a proposed stewardship plan; • Review of changes to an approved stewardship plan; • Submittal of an updated stewardship plan at least every four years; and • Review of any petition for approval to use alternative final disposal technologies. As we previously mentioned here, the total cost for each of [...]Read more

EPA’s Forthcoming RCRA Regulations May Threaten Reverse Distribution of Pharmaceutical Waste

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In February, the Environmental Protection Agency (EPA) issued a Notice of Data Availability (NODA) seeking information on ways to more effectively regulate hazardous waste—including pharmaceuticals—in the retail sector under the Resource Conservation and Recovery Act (RCRA). The healthcare industry has already submitted comments expressing concern that EPA may modify the “reverse distribution” system currently in place for disposal of outdated or unsold pharmaceuticals. Under the reverse distribution system, retailers send expired and unsold pharmaceuticals to a central [...]Read more

King County Announces Fee Schedule for Drug Take Back Program

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The King County Board of Health released its proposed fee schedule as part of its Secure Medicine Return Regulations. As part of the regulations, producers will be required to cover King County’s costs of administering and enforcing the regulations. The fees are based on the number of drug producers expected to participate in the program. One hundred sixty-one (161) drug producers have submitted their notice to participate in the stewardship plan. Although King County has delayed implementation of its drug take back program until a decision is issued by the Ninth Circuit regarding a [...]Read more

EPA to Review Consent Decrees To Ensure Compliance

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EPA is increasing oversight of its open consent decrees. First as part of EPA’s FY 2014-2018 Strategic Plan, the agency has set the goal of maintaining reviews of the overall compliance status of 100 percent of open consent decrees by 2018.  EPA claims that it reviewed 91 percent in FY 2013, a drop from 100 percent in 2009. While EPA may have reviewed most consent decrees, it did not address not all instances of noncompliance, and likely does not have the means to do so. While some may hope that lax enforcement continues, the petroleum refining sector (at minimum), should take action now to [...]Read more

Updates on the Pharmaceutical Waste Legislative and Regulatory Efforts

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California California State Sen. Hannah-Beth Jackson’s (D-Santa Barbara) bill, SB 1014, which would implement a statewide pharmaceutical drug take-back program, failed to pass the Senate Business, Professions and Economic Development Committee. Jackson’s legislation was modeled after an Alameda County ordinance, which is currently pending review in the Ninth Circuit. The bill would have required drug manufacturers to develop and finance a statewide system for collecting and disposing of unwanted pharmaceuticals. Despite approval by 100 local government and environmental groups, the pharmaceutical [...]Read more

Regulations Forthcoming Regarding Disposal of Controlled Substances

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The Department of Justice (DOJ), Drug Enforcement Administration (DEA) has set a final action date of March, 2014 to implement the Secure and Responsible Drug Disposal Act of 2010. The legislation, which amends section 302 of the Controlled Substances Act (21 U.S.C. 822), became public law in October 2010. The Act gives the Attorney General authority to develop new regulations, under the Controlled Substances Act, to govern the disposal of controlled substances by DEA registrants and ultimate users. The rule will restructure existing regulations concerning disposal (including those applicable [...]Read more