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.

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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.]

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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.

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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:

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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.