Elise Paeffgen is an associate in the firm’s Environment & Land Development Group and also assists clients of the Food, Drug & Device Group. She counsels companies regulated by EPA, FDA, and related state authorities. Elise’s practice focuses on environmental enforcement defense, carbon transactions, shale gas extraction, chemicals management, and drug, device and cosmetic regulation.
Elise received her J.D., magna cum laude, from Vermont Law School, where she was articles editor of the Vermont Journal of Environmental Law and a member of the Trial Advocacy Moot Court Team. Elise earned a Masters in environmental management from Yale University, School of Forestry and Environmental Studies, with concentrations in climate change and corporate environmental management. Her Masters work on the personal care industry culminated into a case study, taught at the Yale School of Management. During her joint degree program, Elise worked for the U.S. EPA Office of Enforcement & Compliance Assurance. Elise received a B.A. in environmental studies and politics from Oberlin College, and was awarded high honors for her research on sustainability in the cosmetics industry. Prior to joining the firm, Elise served as operations executive at the Carbon War Room, where she focused on market-based mechanisms for forest conservation.
-
“EPA’s Enforcement of RIN Fraud Violations Starts to Bring Stability Back to the Market,” BNA’s Environment Reporter, May 3, 2013.
May 3, 2013
Publications
-
This advisory discusses the U.S. EPA’s recent prosecution of renewable identification number (RIN) fraud violations and how law enforcement’s reaction to this problem, albeit delayed, has started to bring stability back to the renewable fuel standard (RFS) program and to the market.
February 28, 2013
Advisories
-
On July 27, 2012, the California Department of Toxic Substances Control (DTSC) proposed stringent “Safer Consumer Products” regulations to implement California’s Green Chemistry program.
January 8, 2013
-
The Pesticide Registration Improvement Renewal Extension Act of 2012 (PRIA 3) (S. 3552), like PRIA and PRIA 2, has been lauded by industry because it sets time frames for the pesticide registration process. Not only does PRIA 3 provide greater certainty and agency accountability through mandated review time frames, but it also enhances the tracking of these time frames by funding improvements to the U.S. Environmental Protection Agency’s information management system. Despite broad support, there is a possibility of some difficulties ahead for manufacturers of conditionally registered pesticides and those with contested labels.
November 8, 2012
Publications
-
California's Safer Consumer Products regulations, currently in draft form and set for implementation in early 2013, pose a serious challenge to US over-the-counter (OTC) drug manufacturers by imposing a new layer of bureaucratic oversight on top of what already exists through federal statutes. There is a high potential for contradictory labeling and information requirements as well as greater liability exposures—even an outright ban on sale of OTCs in the state. Nevertheless, there is little awareness of the extent of the threat. To date the pharmaceutical industry has been largely missing from the dialogue.
November 1, 2012
Publications
-
This advisory discusses the California Department of Toxic Substances Control’s (DTSC) recent issuance of the fourth iteration of its Safer Consumer Products draft regulations. These stringent regulations, implementing California’s Green Chemistry program, have a broad reach and impact across the industrial spectrum. Although concern is widespread across industries that make consumer products sold in California, the pharmaceutical industry is largely missing from the dialog. On first blush, the regulations, like the federal Toxic Substance Control Act (TSCA), appear to exempt drug, devices and food—products regulated by the United States Food and Drug Administration (FDA). However, the regulations only exempt “dangerous drugs,” a term defined to include prescription (Rx) drugs, but not over-the-counter (OTC) drugs. Therefore, the entire gamut of OTC drug products and their packaging—from aspirin to sunscreen—is susceptible to regulation. Although the pharmaceutical industry has a strong argument that the Safer Consumer Product regulations, as they apply to OTC drugs, are preempted by FDA regulations, it should act quickly to raise these concerns by October 11, 2012, the close of the public comment period.
September 10, 2012
Advisories
-
July 13, 2012
Blog Posts
-
“Risky Business: 3 Circuits Affirm CWA Simple Negligence,” Law360, June 15, 2012.
June 15, 2012
Publications
-
January 2012
Publications
-
September 1, 2011
Publications
-
“Finding the Magic Pipe: Do Seamen Have Constitutional Rights When a U.S. Coast Guard Boarding Turns Criminal?” 22 U.S.F. MAR. L.J. 23 (2010).
2010
-
“Clorox Inc.: Was the Company's Jump into "Green" Personal Care a Smart Move or a Strategic Misstep?” YALE CASE 09-028 (2009).
2009
Past Events
-
November 13, 2012
Seminar
- Vice Chair of the ABA Environmental Enforcement and Crimes Committee
- Environment, Energy and Natural Resources Section of the D.C. Bar
- US District Court for the District of Columbia