Tuesday, June 28, 2011

Summary of Key Provisions of the Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), which signed into law by President Obama on January 4, 2011, amends the Federal Food, Drug, and Cosmetic Act to shift the focus of the Food and Drug Administration (FDA) from primarily reacting to food safety problems to prevention.

A summary of key new provisions and their impact is available on the Institute for Food Laws & Regulations website here.

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius

Monday, June 20, 2011

FDA's Nanotechnology Guidance

Nanotechnology is the science of manipulating materials on the nanoscale.  “Nanotechnology,” “nanoscale,” and related terms lack definitions in U.S. food law. However, common use of the term “nanotechnology refers to the engineering (deliberate manipulation, manufacture, or selection) of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.
Nanotechnology is an emerging technology that has the potential to be used many products, including drugs (e.g., to increase bioavailability) and foods (e.g., to improve food packaging). Nanoscale materials can have different chemical, physical, or biological properties compared to their conventionally scaled counterparts. These materials warrant further regulatory attention because the properties and phenomena of nanoscale materials can affect safety, effectiveness, performance, and quality of the materials. 
Rather than define nanotechnology, FDA issued draft guidance on nanotechnology that defines when the agency increase product scrutiny based on the application of nanotechnology. Specifically, FDA will ask:
1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
2.  Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.
Note that FDA is interested in the engineered nanoscale materials and the application of nanotechnology as distinguished “from those products that contain incidental or background levels of nanomaterials or those that contain materials that naturally occur in the nanoscale range. FDA is particularly interested in the deliberate manipulation and control of particle size to produce specific properties, because the emergence of these new properties or phenomena may warrant further evaluation. This is distinct from the more familiar use of biological or chemical substances that may naturally exist at small scales, including at the nanoscale, such as microorganisms or proteins.”
FDA’s product focused review is similar to the agency’s regulatory policy for recombinant DNA techniques (GMOs). As with GMOs, FDA does not categorize the technology as either benign or dangerous. A product’s final attributes determine the outcome of FDA’s review. However, the agency considers the process of a product’s development as a part of the means for determining the attributes of the final product.

FDA’s draft guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Draft Guidance for Industry (June 2011) is available here

Friday, June 17, 2011

A more sophisticated crisis response

Alberto Alemanno has a thought provoking article regarding the response to the recent E. coli outbreak. Would it have been better if the European Commission had taken on more powers?

The Commission and the European Food Safety Authority (EFSA) could supervise the risk assessments conducted across Europe and coordinate the task of communicating the outcome of those assessments. A central organization could have more sophisticated ability to collate, assess, and distribute information than individual national authorities.

Read more here.

Alberto Alemanno is a guest instructor at the Institute for Food Laws and Regulations at Michigan State University. He is associate professor of law at École des Hautes Études Commerciales (HEC), Paris, adjunct professor of global risk regulation at Georgetown University Law Centre, and editor of the European Journal of Risk Regulation.

Don't eat raw sprouts. That's the best advice for all of us.

Sprouts can carry danger - Fitness - NewsObserver.com

They just look so innocent. It's hard to imagine that a sprout could be a killer.

A few bad sprouts, however, have recently reminded us that these fresh, green frillies have the potential to spread illness and worse. E. coli bacteria in fresh sprouts produced in Germany have in the past few weeks killed 31 people and made more than 3,000 others sick.

It's not new. Sprouts have been involved in this sort of mischief many years.

Read more here.