Review of the FDA Progress on Phasing out Certain Antibiotics: Promise and Problems

By Kuei-Jung Ni

Faced with increasing concerns about the misuse and overuse of antibiotics for food animals’ growth enhancement, which has caused serious antimicrobial resistance, FDA finally took action in December 2013 by issuing guidelines that ask antibiotics makers to remove the labeling of antibiotics for growth effects on a “voluntary” basis. FDA officials believe that voluntary participation “is the fastest, most efficient way to make these changes.”

As the restriction of antibiotics only applies to growth promotion and disease preventive uses are still permitted, critics argued that the new policy will create a loophole and no guarantee for the decrease of antibiotics’ usage by farmers. Further, without giving FDA any authority to require drug companies to release sales data of antibiotics, some said it remains illusory to monitor and verify the actual usage of the drugs.

According to the FDA’s strategy plan, pharmaceutical companies may respond with their intention of voluntary compliance within three months after the notice. In March 2014, FDA announced that 25 of the 26 drug makers affected have agreed to follow the voluntary withdrawal.  In effect, these food animal producers can only use the companies’ drugs sold in the market for therapy purposes. Indeed, the predominant support by industry signals an encouraging and good starting point for implementing the FDA policy. Nevertheless, it leaves some legal questions unsolved, which may trigger further disputes in the future.

Continue reading

Review of the FDA Progress on Phasing out Certain Antibiotics: Promise and Problems

Faced with increasing concerns about the misuse and overuse of antibiotics for food animals’ growth enhancement, which has caused serious antimicrobial resistance, FDA finally took actions on December, 2013 by issuing guidelines that ask drug makers to remove the labeling of antibiotics for growth effects on a “voluntary” basis. FDA officials believe the voluntary participation “is the fastest, most efficient way to make these change.”

As the restriction of antibiotics only applies to growth promotion and disease preventive uses are still permitted, critics argued that the new policy will create a loophole and no guarantee for the decrease of antibiotics’ usage by farmers. Further, without giving FDA an authority to require drug companies to release sales data of antibiotics, some said it remains illusory to monitor and verify the actual usage of the drugs.

According to the FDA’s strategy plan, pharmaceutical companies may respond their intention of voluntary compliance within three months after the notice. On March, 2014, FDA announced that 25 of the 26 drug makers affected have agreed to follow the voluntary withdrawal. In effect, food animal producers can only use the companies’ drugs sold in the market for therapy purpose. Indeed, the predominant support by industry signals an encouraging and good starting point for implementing the FDA policy. Nevertheless, it leaves some legal questions unsolved, which may trigger further disputes in the future.

Continue reading

FSMA Conference Part 5: International Issues and Trade Implications

[Ed. Note: On Friday, February 21, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This is the final installment in a series of blog posts from the event; video will follow shortly.]

Continue reading

FSMA Conference Part 4: Benefits, Challenges, and Gaps in FSMA’s Approach

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jeffrey Skopek

Lewis Grossman, Washington College of Law, American University – New Governance, New Challenges

Professor Grossman opened the panel by locating FSMA in the context of the “new governance” movement that has arisen in response to the limits of command and control regulation.   Continue reading

TOMORROW: “New Directions in Food Safety” conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

Subway Stops Using Azodicarbonamide in Bread Production

By Kuei-Jung Ni

In response to the petition launched by a food blogger, FoodBabe, Subway, a big fast food chain, announced the removal of Azodicarbonamide (ADA) in bread production on February 6. As an ingredient for dough conditioner, the chemical is also used to make yoga mats and shoe rubber. Apart from Subway, other food companies, like McDonald’s, Starbucks, Kraft and Chick-fil-A have been targeted for using the chemicals.

In North America, ADA is a legal additive for food processing as long as the residual does not surpass the safe level. In the United States, it has been listed in the “Generally Recognized as Safe (GRAS)” category that exempts additives from a more restrictive premarket approval by the Food and Drug Administration (FDA).  According to the Codex Alimentarius Commission (Codex) that decides international food safety standards, the safe limit of ADA is up to 45 ppm. The United States and Canada permit the use of the additive at the same levels.

Nevertheless, the World Health Organization has linked the substance to respiratory issues, allergies, and asthma as workers experience environmental exposure where the chemical is manufactured or used. Of course, one would expect that risks would be different for people who consume food containing very small amounts of the chemical; the Center for Science in the Public Interest (CSPI) observes small or negligible risks from consumption, but still urges FDA to ban use or raise the safe level on the grounds that the chemical is an unnecessary additive. Many countries that take a precautionary approach, including UK, the European Union and Australia, outlaw ADA in food production.

Continue reading

2/21: “New Directions for Food Safety” — conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

 

ICYMI: Bi-weekly Petrie-Flom Center Newsletter, 1/10/14

The latest edition of the Petrie-Flom Center’s bi-weekly e-newsletter is now available. Check it out for news and announcements from the Center, new scholarship from our affiliates, updates on upcoming events, and job and fellowship opportunities in health law and bioethics!

REGISTER NOW: “New Directions for Food Safety” conference at Harvard Law School

This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.

Speakers include:

  • KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective

Continue reading

New Book: “Science and Technology in International Economic Law”

I am pleased to post that my new book, “Science and Technology in International Economic Law: Balancing Competing Interests” (co-edited with Professor Bryan Mercurio at the Chinese University of Hong Kong), was recently published by Routledge. In addition to the introduction, the book includes thirteen articles written by scholars from the Asia-Pacific region, Middle East, and Europe. It is the first attempt to explore the status and interaction of and between science, technology and international economic law (namely, trade and investment) with a view to seeking a proper balance between promoting trade/investment liberalization and ensuring that decisions are soundly based and that technological advancement is not hampered.

On the issue of food safety, scientific evidence and trade disputes, I contributed a paper, titled ”Does Science Speak Clearly and Fairly in Trade and Food Safety Disputes? The Search for an Optimal Response of WTO Adjudication to Problematic International Standard-Making,” which appeared previously in the Food & Drug Law Journal, Vol. 68, pp. 97-114 (2013).

The following reveals a brief background and objective of the book:

Continue reading

GM Food Labeling: An Unfinished Battle

By Kuei-Jung Ni

In Washington state, a proposal (Initiative 522) to require labeling of genetically modified (GM) or engineered (GE) foods was defeated recently by votes of 45.17% in favor and 54.83% against. The state law would have implemented mandatory labeling requirements on food composed of 0.9% or more of GM ingredients, measured by weight. Prospects for passage of the proposal were quite promising when it was first introduced. But, the scenario shifted when GM food companies, including General Mills, Nestle USA, PepsiCo, Monsanto, etc., launched a multi-million dollar advertisement campaign challenging the justification for GM labeling.

The downfall of the proposal, while disappointing consumer groups, is not likely to stop the labeling movement. Actually, there have been many other attempts to regulate GM foods on a state level. California Proposition 37, which would have imposed labeling requirements similar to the Washington proposal, was put to a vote last year, but failed to pass. According to Just Label It, a NGO, more than 20 state laws were introduced about GM labeling this year.

Many scientists trust the safety of GM foods, and the benefits brought by the development of GM agriculture are obvious. GM crop production can reduce the use of pesticides and enhance yields. By contrast, in addition to possible new allergies caused by the consumption of GM foods, some worry about their potential harm to the environment and ecological system. On the federal level, three agencies are competent to regulate GM crops and foods: the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), which use existing rules to regulate. Yet, the inadequacy of their oversight has been disclosed. Until now, no specific federal law has been enacted to regulate GM food production and consumption.

Continue reading

Government Shutdown Compromises Food Safety

By Kuei-Jung Ni

It has been over a week since the federal government shutdown started on October 1 and concerns over food safety due to the lack of essential food inspections have increased. The impasse on the budget constitutes a big challenge facing federal agencies responsible for monitoring food safety and protecting the public from such risks.

There are mainly three units managing food safety at the federal level: (1) the Food Safety Inspection Service (FSIS) of the United States Department of Agriculture (USDA); (2) the Food and Drug Administration (FDA); and (3) the Centers for Disease Control and Prevention (CDC). FSIS is responsible for supervising the production of meat, poultry, and eggs. FDA regulates non-meat food safety. CDC aims to control and prevent foodborne illnesses. In response to the shutdown, according to the New York Times’ report, there was no coherent decision among the agencies about to what extent competent officials will keep working. The discrepancy will affect the efficiency of coordination and communication between the organs.

Although states remain functional to oversee local food safety, foodborne disease outbreaks or other food safety emergencies at a multi-state or national level would be a serious health problem as centralized coordination and federal support would be lacking. The recent ongoing Salmonella outbreak that has inflected 278 people in 17 states raises a grave worry about whether the government shutdown will make the situation worse. It was reported that CDC will continue to investigate and watch the diseases and has decided to bring 30 employees back from furlough. Yet, it seems unreasonable and unsustainable to require staffs to maintain the same quality of performance without pay. The shortage of sufficient professional workers will also cast a doubt on whether potential and new outbreaks can be detected and investigated in a timely way.

Another critical issue relating to food safety and security is the delay of inspections on imported food. FDA has halted services, among others, on the monitoring of imported foods and drugs. Considering that about 15 percent of American food supply is imported, the potential risks here are quite substantial.

The Response of WTO Members toward the Codex Alimentarius Commission’s 50th Anniversary

By Kuei-Jung Ni

The Codex Alimentarius Commission (Codex) that governs the making of international standards on food safety will reach its 50th anniversary in October 2013. The international institution was established in 1963 under the auspice of the World Health Organization (WHO) and the United Nations Food and Agriculture Organization (FAO). Its mandate is to approve food standards with a view to ensuring food safety and promoting food trade by harmonizing national food regulations. As of 2013, the Codex consists of 186 members.

Compliance with Codex standards used to be on a voluntary basis; the standards initially gave nations guidance in building up their food safety regulatory regimes without exerting legally binding force. However, the status of the standards has been drastically changed in the wake of the effectiveness of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organization (WTO) in 1995. That agreement explicitly requires WTO members to base their SPS measures on international standards, including those of Codex, and gives national measures that comply with Codex standards a presumption of SPS-consistency. Since then, the Codex has gained much weight, especially in the determination of the legality of WTO members’ disputable measures.

From a global governance perspective, WTO and Codex institutionally should be in a cozy and mutually supportive relationship. Thus, it is not surprising to see the SPS Committee of the WTO, at its recent session, send the Codex a quite polite and encouraging message, calling for continued support for the body, and for trade measures to be based on science. The US, Argentina, Australia, New Zealand, Canada, Belize, Russia, Chile, Senegal, the EU, Burkina Faso, Pakistan, Switzerland, Norway, South Africa, Argentina, Dominican Rep, China, Cuba and Lebanon (a WTO observer) echoed the key message mainly articulated by Brazil in praise of Codex’s work.

Yet, not all WTO members were overwhelmed by the message. In particular, the European Union (EU), even while it agreed that the tasks of the Codex are significant, maintained that Codex standards are not one size fits all, and emphasized that countries still have the right to adopt appropriate measures that deviate from Codex. Continue reading

Introducing Guest Blogger Kuei-Jung Ni

Kuei-Jung Ni will be a contributor at Bill of Health during his time as a Visiting Scholar at the Petrie-Flom Center in the 2013-2014 academic year. His current research explores the systems of governmental food safety regulation in the United States and Europe, with the goal of developing a suitable regulatory system for the Taiwanese government. Ni is visiting the Center with support from a Fulbright grant and the Top University Strategic Alliance (TUSA) of Taiwan.

Professor Ni holds an LL.M. from the University of California, Berkeley, School of Law, and a Ph.D. in Law from the University of Edinburgh School of Law. He is currently on leave from his role as Professor and Director at the Center for Technology Law, National Chiao Tung University, Taiwan.