Food and Drug Law Journal

Food and Drug Law Journal This is the official page of the Georgetown Law Ed. Board of the Food & Drug Law Journal. Follow us on Twitter: https://twitter.com/FoodandDrugLJ

This is the official page of the Georgetown Law Editorial Board of the Food and Drug Law Journal (FDLJ). Follow the Journal on twitter @FoodandDrugLJ (https://twitter.com/FoodandDrugLJ). The Journal was first published in March 1946 as the Food-Drug-Cosmetic Law Quarterly. As of February 2015, in its 70th year of publication, the Food and Drug Law Journal is now co-published by Georgetown Law, FDLI, and the O'Neill Institute. FDLJ promotes the exchange of ideas from all sides of an issue, and as an scholarly journal does not take a position on issues; it remains neutral and upholds its neutrality as a means to nurture an open, balanced marketplace of ideas. The mission of the Food and Drug Law Journal is to provide the food, drug, life sciences, and health law communities with articles that inform, educate, and challenge legislation, regulations, court decisions, and public policies affecting the development, manufacture, marketing, and the use of foods, drugs, biologics, cosmetics, tobacco, and medical devices. It has always been a principle of this preeminent publication to ensure that the Journal presents information both from the perspective of the practicing bar and from a scholarly, public policy perspective. It is the Journal's goal to continue to provide a forum for scholarly debate and analysis of the highest standards.

11/04/2016

Thank you to everyone who made it out to the Symposium today. Overall, we had a great showing; especially for the Keynote Address. The Symposium was recorded, and we'll provide a link soon. Otherwise, be sure to check out the Twitter feed "Food & Drug L.J." for pictures and a play-by-play of the Symposium.

11/04/2016

Be sure to check out the "Food & Drug L.J." Twitter feed for live updates on what is happening at the Symposium.

11/04/2016

Margot J. Pollans, Assistant Professor of Law and Faculty Director, PACE-NRDC Food Law Initiative, Pace University, will also be joining us today for Session 2: Shaping Agency Priorities – Responses to Emerging Forces at 11:00AM. Journal Staff Member Tiffany Weston profiles Pollans and her paper, "FDA and USDA as Environmental Regulators: Food Regulation, NEPA Compliance, and Environmental NGOs."

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Professor Margot Pollans received her J.D. from New York University Law School and L.L.M. in advocacy from Georgetown University Law Center. She was an academic fellow at UCLA School of Law's Resnick Program for Food Law and Policy and a Clinical Teaching Fellow at GULC's Institute for Public Representation. She currently teaches at Pace University and is the Faculty Director of Pace-NRDC Food Law Initiative. Professor Pollans also has published works in publications such as the NYU Law Review and Harvard Environmental Law Review.

In presenting Incorporating Environmental Ethics Into Food and Drug Safety Regulation, Professor Pollans discusses the role of the Food and Drug Agency (FDA) in regulating environmental factors in food and drugs. The recent passing of the Food Safety Modernization Act (FSMA) gives the FDA the ability to regulate agriculture practices for the first time. With the separation of the regulation of food and environmental effects to the FDA and EPA respectively, there are problems with the limits it places on providing effective regulatory schemes for the food system supply chain. The National Environmental Policy Act (NEPA) requires the FDA to identify environmental effects of regulatory actions and gives some authority to consider the effects in making decisions. However, Professor Pollans argues the FDA underutilizes this opportunity.

Over three parts, Professor Pollans argues for a broader definition of food and drug safety, how the narrower definition limits the FDA's ability to solve direct safety problems, and how the FDA has existing authority to consider environmental issues. Part I looks to the definitions provided by Congress and the FDA. Part II addresses the passing of the FSMA and its effects on the policy and regulations of the FDA. Part III explores the scope of the FDA's ability to regulate environmental harms through legislative actions such as FSMA and NEPA. Professor Pollans addresses the concerns about the lack of regulation for environmental factors with food and drug safety. The paper encourages the FDA to take environmental issues into consideration through effective use of statutes when making regulatory decisions.

11/03/2016

The Symposium is less than 2 days away now. Cheng Zeng LLM'17 profiles Ching-Fu Lin, Assistant Professor of Law, National Tsing Hua University, Taiwan, who co-authored "Assessing the Relative Influence and Efficacy of Public and Private Food Safety Regulation Regimes: Comparing Codex and Global GAP Standards" with Sam Halabi, Associate Dean of Faculty Development, University of Tulsa. We hope you're as excited as we are for the Symposium and look forward to seeing you this Friday, November 4.

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Ching-Fu Lin (林勤富) is an Assistant Professor of Law at Institute of Law for Science and Technology, National Tsing Hua University, Taiwan, where he teaches international health law and food safety law and policy. He is also a researcher at Asian Center for WTO & Int’l Health Law and Policy, National Taiwan University. Professor Lin earned his S.J.D. and LL.M. from Harvard Law School, and also received a double degree in law (LL.B.) and chemical engineering (B.S.) from National Taiwan University. His legal scholarship in food and drug law and international law has appeared in numerous journals and edited collections, including Virginia Journal of International Law, Columbia Science and Technology Law Review, Food and Drug Law Journal, and Journal of World Trade.

In his symposium article, Professor Lin mentioned that the exponential increase in food safety incidents across the globe in the past decades have resulted in mushrooming regulatory initiatives, including new standards and requirements from national governments, international organizations (i.e. Codex), and private actors (i.e. GlobalGAP). The article examines the durability and strength of private sector standard setting in the food safety system, and the desirability of that system as an alternative (or perhaps complement) to formal, governmental processes embodied in the standards adopted by the Codex Alimentarius Commission and implemented by national governments through analyzing textual and process differences in the Codex and GlobalGAP standards applicable to two specific sectors – fish and crops, and then evaluates the relative influence of Codex and GlobalGAP standards on farming practices in Honduras, Thailand, and the United States. In conclusion, Professor Lin points out that the legitimacy deficit of private governance models (including GlobalGAP) limits their roles and therefore public standards and approaches would seem to remain indispensable, and proposes that mechanisms that will seamlessly combine the strengths of market-driven approaches with the legitimacy that public sector regulation often provide should be created.

10/29/2016

Dena Kirpalani LLM'17 & Colleen Hespeler JD'17 introduce the Symposium Keynote Speakers: Laurie Beyranevand, Senior Faculty Fellow for Food Law and Policy and Professor of Law, Vermont Law School, and Emily Broad Leib, Assistant Clinical Professor of Law, Harvard.

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Laurie Beyranevand

Professor Beyranevand completed her Bachelor of Arts at Rutgers College and received her Juris Doctor from Vermont Law School. Professor Beyranevand is a Senior Faculty Fellow for Food Law and Policy at the Center for Agriculture and Food Systems (CAFS) and a Professor of Law at Vermont Law School. CAFS trains new food and agriculture advocates. CAFS aims to create innovative legal tools exploring fresh ways to think about food.

Professor Beyranevand directs several grant funded projects for CAFS. One of her recent projects is the Blueprint for a National Food Strategy. The Blueprint is a research project jointly conducted by Harvard’s Food Law and Policy Clinic and CAFS. It aims to develop a detailed and comprehensive blueprint to inform policy reform proposals of food system stakeholders. The project will look at developing a healthful, equitable, environmentally friendly and economically sustainable food system. Professor Beyranevand’s other projects include the website, labelsunwrapped.org, which aims to assist consumers navigate food labels and make informed food choices about the products they buy.

Before joining the faculty at Vermont Law School, Professor Beyranevand was a Staff Attorney at Vermont Legal Aid where she appeared in a number of individual cases and class action suits involving health law issues. She also clerked in the Environmental Division of the Vermont Attorney General's Office and also served as a law clerk to the Honorable Marie E. Lihotz in New Jersey.

Professor Beyranevand teaches courses in Food Regulation and Policy and Legislation and Regulation. She is also an appointed member of the Academic Programs Committee for the Food and Drug Law Institute, and formerly served as an Executive Committee Member of the Agriculture and Food Law Section of the American Association of Law Schools.

Emily Broad Leib

Emily Broad Leib is an Assistant Clinical Professor of Law, co-founder and Director of the Harvard Food Law and Policy Clinic, and the Deputy Director of the Harvard Law School Center for Health Law and Policy Innovation. Her scholarship focuses on increasing access to healthy foods, assisting small-scale and sustainable food producers in participating in food markets, and reducing food waste. She was ranked No. 1 on Food & Wine’s “Most Innovative Women in Food and Drink” list, which highlighted her work fighting against the hunger epidemic by focusing on legislation regarding labeling and making donating simpler. Ms. Broad Leib has published scholarly articles in publications including the Wisconsin Law Review, the Harvard Law & Policy Review, and the Journal of Food Law & Policy. Her work has also been featured in media outlets such as CNN, The Today Show, MSNBC, TIME Magazine, and the Washington Post. Ms. Broad received her B.A. from Columbia University and J.D. from Harvard Law School.

In the fall of 2015, the Harvard Food Law and Policy Clinic launched an 18-month long project in partnership with The Center for Agriculture and Food Systems (CAFS) at Vermont Law School called The Blueprint for a National Food Strategy. The initiative aims to examine the potential role for a national food strategy in ensuring a healthful, equitable and environmentally and economically sustainable food system. The project is creating a report that overviews the benefits and critiques of a national food strategy, discusses the processes by which other countries have developed national food strategies, and analyzes other U.S. national strategies and legal mechanisms for coordination. In addition, the project is creating an interactive, educational version of the report for the general public and interested stakeholder groups.

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We look forward to seeing you at the Symposium on November 4th!

Below are Laura Malave's LLM'17 notes on Scott Faber, who will be moderating Session 2 - "Shaping Agency Priorities – Re...
10/27/2016
Journal Symposium - Law and Food Systems: Institutional Pathways toward a New Paradigm? – Food and Drug Law Institute

Below are Laura Malave's LLM'17 notes on Scott Faber, who will be moderating Session 2 - "Shaping Agency Priorities – Responses to Emerging Forces." (http://www.fdli.org/conferences/fdlj16/#agenda) He is joined by exciting guests like Valerie Madamba, Food Regulatory Counsel, Blue Apron, and Margot J. Pollans, Assistant Professor of Law and Faculty Director, PACE-NRDC Food Law Initiative, Pace University.
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Scott Faber is native of Massachusetts. He completed his Bachelors Degree in Clark University and his Juris Doctor in Georgetown University. Professor Faber is currently an adjunct Professor of Law in Georgetown University Law Center and is the Senior Vice President of Government Affairs for the Environmental Working Group, a national environmental organization. He leads the team working to improve food and farm legislation, chemicals policy and a host of other issues important to EWG and its supporters.

Prior to joining EWG, Professor Faber was vice president for federal affairs for the Grocery Manufacturers Association, where he spearheaded efforts to enact the Food Safety Modernization Act, which sets new food safety standards for food manufacturers and farmers. From 2000 to 2007, he was a food and farm policy campaign manager for the Environmental Defense Fund, where he led efforts to reform farm policies in the 2002 and 2008 farm bills. From 1993 to 2000, he was the senior director for public policy for American Rivers. As a Professor, he teaches the Farm Law and Policy Seminar. Professor Faber has frequently testified before Congress as an expert on farm and food policies.

Food law and policy is one of the fastest growing legal academic fields in the U.S., and the issues in this complex area are gaining significant traction in the public sphere. The food industry, consumers, attorneys, and policy practitioners face a fragmented set of rules, authorities, and institut...

10/27/2016

Nick Prust JD'18 profiled another of our Symposium speakers - Professor Allison Peck. He also introduces her paper, "Re-Framing Biotechnology Regulation."
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Professor Alison Peck is a graduate of Yale Law School and received an LLM in agricultural law from the University of Arkansas-Fayetteville. She currently teaches and writes in the area of sustainable development, including environmental and trade law, with a special focus on agriculture and food law, at West Virginia University College of Law.

In Re-Framing Biotechnology Regulation, Professor Peck reexamines the federal biotechnology framework which has struggled to navigate the rapid changes in biotechnology. Professor Peck finds that federal policies, laid out in the Coordinated Framework for Regulation of Biotechnology, are outdated and ill suited to handling the health, safety, and environmental concerns of the day. Specifically, she has three primary objections to the current system. First, many technologies are left unregulated. Innovations in biotechnology have made it possible to directly modify host DNA and are not covered by current regulatory paradigms in which the introduction of foreign DNA is the trigger for federal regulation. Second, the maze of regulations involving many different agencies is a major barrier to smaller biotechnology companies whose importance in the development of new technologies has grown in recent years. Finally, amidst great public distrust of genetic engineering, the Coordinated Framework has done little to engage the public or to allay their legitimate concerns.

Professor Peck proposes a new system of federal oversight aimed at addressing the current problems. In contrast with the Coordinated Framework, which regulates new biotechnology on the basis of products with given traits, for example, “plants that contain pests,” regulation would be based on the product itself, “plants.” While a single agency would take the lead in regulating a given product, communication between agencies would take advantage of the breadth of institutional experiences in assessing new issues. This would allow comprehensive analysis to be combined with a simplified approval process. The degree of scrutiny in the approval process would be determined by an agency assessment of risk. Recognizing that such assessments “will not be an exact science,” Professor Peck advocates public inclusion in the debate to determine a “socially accepted level or risk tolerance.” Professor Peck’s article describes a biotechnology revolution with potentially momentous benefits to human health, agriculture, and the environment, but also incompletely understood consequences. Her proposed system provides a comprehensive framework that seeks to harness its potential and mitigate its risks.

Register for the 2016 Food & Drug Law Journal Symposium at http://www.fdli.org/conferences/fdlj16/#registration. Navigat...
10/26/2016
Journal Symposium - Law and Food Systems: Institutional Pathways toward a New Paradigm? – Food and Drug Law Institute

Register for the 2016 Food & Drug Law Journal Symposium at http://www.fdli.org/conferences/fdlj16/#registration. Navigate to the middle of the page, and click the red "RSVP" link, which will take you to a SurveyMonkey survey. Registration is FREE for Georgetown students.

Food law and policy is one of the fastest growing legal academic fields in the U.S., and the issues in this complex area are gaining significant traction in the public sphere. The food industry, consumers, attorneys, and policy practitioners face a fragmented set of rules, authorities, and institut...

10/26/2016

We have a number of incredible speakers joining us for the 2016 Symposium on November 4th, including Emilie Aguirre. Julia Kuelzow LLM'17 profiles Ms. Aguirre and her paper. To hear and learn more about Ms. Aguirre's democratic experimentalist approach of international cooperation to combat anti-microbial resistance, join us at the Symposium!

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Emilie Aguirre is a food and health lawyer and, currently, an Academic Fellow at the Resnick Program for Food Law and Policy at UCLA. She researches the impact of agricultural policy, international trade rules, and corporate law on food systems and human health. She has written several articles on how the European Union's agricultural policy influences the price, availability, and, addition of sugars to processed foods--contributing to excessive sugar consumption and, thereby, non-communicable illnesses like diabetes and heart disease. This semester, Emilie leads a seminar that addresses companies' role in industrialized food production and identifies potential legal tools from corporate law to improve public health.

Whereas her prior work may exact policy solutions, Emilie's symposium paper proposes a democratic experimentalist approach of international cooperation to combat anti-microbial resistance (AMR)--a pressing problem marked by scientific uncertainty, further exacerbated by unsettled legislative mandate. Under this model, a central institution sets a common goal and then delegates its fulfillment to local institutions. Institutions experiment in approach and share data on performance, pooling and comparing results to assess performance. She notes the model's successful application in prior regulatory approaches, like the US Food Safety Modernization Act, and argues the current glut in AMR expertise, lack of data tracking the antibiotic use in the US, and uncertain epidemiology of animal-to-human antibiotic-resistant bacteria transmission, engenders such experimentation at both the national and international levels. Above all, the democratic experimentalist approach affirms and stresses the imperative for the global community act, even when solutions are not yet clear, to halt the progression towards a post-antibiotic world.

Emilie was a Fulbright Schuman Scholar and a Harvard Knox Fellow at the University of Cambridge, where she earned a Masters of Law and worked as a Research Associate at the Center for Diet and Activity Research. She is a graduate of Harvard Law School and Princeton University.

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