Category: Food Safety

Subway Stops Using Azodicarbonamide in Bread Production

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

The Petrie-Flom Center Staff Leave a comment

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.

 

The Impact of FSMA Import Rules on Domestic Suppliers

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By Ching-Fu Lin

The Food and Drug Administration’s (FDA) proposed rule on Accreditation of Third Party Auditors to implement the Food Safety Modernization Act (FSMA) has given rise to many questions on both domestic and international levels.  The proposed rule is intended to establish a program for recognition of accreditation bodies and accreditation of third-party auditors to provide the FDA with a more efficient tool to regulate imported food products.  In this regard, §307 of the FSMA and its implementing rule are generally seen as necessary to assist the FDA in regulating food imported from foreign jurisdictions, as the FDA is currently administratively and financially unable to ensure import safety on its own.

Again, the proposed rule on Accreditation of Third-Party Auditors is designed to cope with import food safety, and works in an inter-related manner to another proposed rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.  However, many have expressed concerns about the possible trend toward  such “import” rules – which embrace private regulatory participation – becoming de facto “domestic” rules.  Although the legal effects of private certification against FDA standards of domestic products are yet to be clarified, the FDA indicated that such an introduction of rules to the domestic sphere may be desirable in the proposed rule on Accreditation of Third-Party Auditors:

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Genetically Modified Crops

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The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops.   While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.

As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s.  Prior to this development, weed management required significant skill and knowledge.  Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices.  Herbicide-resistant crops, by contrast, were effective and easy to use.

During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant.   By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds.  The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.

In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem.  The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance.  Read More

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

The Petrie-Flom Center Staff Leave a comment

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

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

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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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Antibiotics in Livestock

jskopek 1 Comment

Last week, the Food and Drug Administration finalized a long-awaited guidance document that aims to reduce non-therapeutic uses of antibiotics in livestock production and thereby limit the evolution of drug-resistant bacteria.

As I discussed in a previous post, the use of antibiotics in livestock production is often not for the therapeutic purpose of curing disease, but rather for the purpose of speeding growth or increasing feed efficiency.   Current estimates are that livestock production consumes 30 million pounds of antibiotics per year, representing 80 percent of the total volume of antibiotics sold in the United States for any purpose.  The FDA policy that allows non-therapeutic uses of antibiotics in livestock has in recent years been subject to intense scrutiny by outside advocates, former FDA officials, government investigators, and judges.

The FDA has now taken action to address these concerns by finalizing industry guidelines that it first proposed over a year ago.   Under the guidelines, animal pharmaceutical companies would change the labeling of “medically important” antibiotics in two ways.  First, the labeling would no longer list production uses (i.e., growth enhancement and feed efficiency) in the approved uses for the drugs.  Second, the labeling would require veterinary oversight for therapeutic uses (i.e., the prevention, control, or treatment of a disease), rather than allowing over-the-counter distribution.  These changes in labeling would in turn require changes in agricultural use by virtue of other FDA regulations that prohibit off-label use for production purposes.

While the FDA’s action is a step in the right direction toward eliminating non-therapeutic uses of antibiotics in food animals, there are a few features of its strategy that are worth highlighting as they might significantly limit its impact.     Read More

Conflicts of Interest and the FDA’s Determinations of Food Safety

Leslie Francis Leave a comment

By Leslie Francis

At last year’s Petrie-Flom conference on the FDA in the 21st Century, I had an experience that I’ve never really had before in my academic career.  I gave a paper (co-authored, actually) that was met with genuine ire.  The paper dealt with labeling GMO foods.  Several in the audience—including friends—heard me as going over to the dark side of anti-science, irrational skepticism, and downright immoral ignorance of important nutritional and commercial advantages.  I wasn’t buying into such bad science, however.  The written paper (concededly it’s always possible that a lengthy legal argument doesn’t come across in a nuanced way in a short presentation) argued three points:  (1) the FDA has not acted to the full extent of its statutory labeling authority; (2) the present processes for granting market clearance for particular GMO products is highly deferential to industry submissions with respect to safety (the safety of a particular GMO product is a different question from the general question of GMO safety—the FDA’s own example is the unknown allergenic effects of adding peanut genes to other agricultural products); and (3) in a context in which scrutiny of safety is so industry-dependent, there is a case to be made for labeling so that consumers can make their own choices.

In a nutshell, the current FDA process for allowing a particular GMO product to be marketed is a variant of the process for allowing marketing of additives Generally Recognized as Safe (GRAS).  Under the GRAS process, anyone can petition for a determination that an additive is GRAS; industry can also make its own GRAS determinations.  The procedure for clearing GMO foods is a consultative process that is also voluntary and entirely reliant on information from industry.  Unlike the GRAS process, however, it does not even require publication of the information relied on for consultations.

In an article published this week in JAMA Internal Medicine, Neitner et al. demonstrate the extent to which GRAS determinations are riddled with conflicts of interest.  The authors conclude, “The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.”  Given the parallels between the GRAS process and the process applied to GMO foods, one might hypothesize that conflicts of interest are similarly present in the latter.  The FDA should address these concerns, too.  This is not anti-science; it is respect for good science.

[Leslie Francis]

Challenges to Third-Party Food Safety Audits and Certification

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By Ching-Fu Lin

About a month ago, Jensen Farms pleaded guilty to federal criminal charges for introducing adulterated food into the nation’s food supply via interstate commerce.  In 2011, cantaloupes produced by Jensen Farms resulted in a listeria outbreak that spread across 28 states, killed 33 people, and sickened hundreds.  The now bankrupt and out of business owners—brothers Eric and Ryan Jensen—are to be sentenced in January 2014.

The Jensens took responsibility for one of the deadliest food safety outbreaks in the United States, but they also turned around to sue Primus Labs, a food safety audit firm.  The brothers allege that Primus Labs acted negligently, breached its contractual obligations, and engaged in deceptive trade practices in performing third-party audits on the farmlands and packing house.  Merely weeks before the outbreak, Primus Labs sent one of its subcontractors (Bio Food Safety) to Jensen Farms to perform a third-party audit.  After the audit, Bio Food Safety gave Jensen Farms a “superior” rating with an almost impeccable score of 96 out of 100, which was later found by the Food and Drug Administration (FDA) to be “seriously deficient in its inspection and findings.”  As claimed by the Jensens, Bio Food Safety failed to observe several practices that were in violation of Primus Labs’ standards and relevant FDA guidelines or to inform them of any microbiological risk.  Despite these deficiencies, Jensen Farms cantaloupes were “Primus Certified” and entered into the retail market.

The Jensen Farms case raises questions on the credibility of third-party audits and certifications in the area of food safety.

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30 Pound Turkeys, 30 Million Pounds of Antibiotics

jskopek 1 Comment

Since 1960, the weight of an average live domesticated turkey has nearly doubled from around 15 to 30 pounds.   And current estimates are that 30 million pounds of antibiotics are used in livestock production per year (which represents 80 percent of the total volume of antibiotics sold in the United States for any purpose).  These two facts are related.

The use of antibiotics in livestock is often not for the purpose of curing disease, but rather for the purpose of growth promotion—a practice that has arisen with the intensification of livestock farming.  Although the mechanism underpinning their action is unclear, it is believed that the administration of antibiotics at non-therapeutic doses suppresses sensitive populations of bacteria in the intestines, helping animals digest their food more efficiently.

This non-therapeutic use of antibiotics continues despite clear evidence that the overuse of important antibiotics for humans in the livestock industry spreads dangerous antibiotic resistance. Read More