Digest

Main Content

FDA Issues Guidance on “Gluten Free” Labeling

FDA issued a final rule today on the voluntary use of “gluten-free” on food labels, as directed by the Food Allergen Labeling and Consumer Protection Act.  In summary, FDA set a threshold for gluten of less than 20 parts per million in foods that are labeled “gluten-free,” “no gluten,” “free of gluten,” and “without gluten.”  Food manufacturers will have one year to bring their labeling into compliance with the new regulation.  After that one year implementation period, any food labeling “gluten-free” or a similar claim with gluten more than 20 parts per million will be considered misbranded.  A threshold of 20 parts per million was selected because that is the lowest level of gluten that can currently be detected with validated methodology, and, as stated by FDA, “some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of

French Court Overturns Ban on GMO Maize

August 1, 2013

Categories

A French administrative court today overturned a 2012 ban on Monsanto’s MON810 genetically modified maize.  The Conseil d’Etat stated that such a ban could only be imposed in the case of an emergency or a serious health or environmental risk.  In a preliminary hearing earlier this month, the Conseil d’Etat had already found that there was no scientific justification for the ban.

In response to the ruling, French Agriculture Minister Stephane Le Foll reiterated that France “is not in favour of GM, especially MON810 which is a corn that is resistant to herbicides.”

FDA Publishes Draft Food Import Rules

FDA today announced two new draft rules to further implement the Food Safety Modernization Act, both impacting the import of food.  One rule, relating to Foreign Supplier Verification Programs, requires importers to verify that their suppliers meet the same safety standards as domestic producers.  A second rule relates to the accreditation of third party auditors to issue certifications for foreign food production facilities.  The rules will be published in the Federal Register on July 29, 2013, and comments are due within 120 days of publication.

FDA Issues Draft Egg Safety Rule Guidance for Producers Who Give Hens Outdoor Access

July 23, 2013

Categories

FDA issued draft guidance Egg Safety Rule today, which can be found here.  From FDA’s press release:

FDA is issuing draft guidance with practical and reasonable food safety controls to help egg producers who provide their laying hens with outdoor access comply with the Egg Safety Rule and thereby prevent Salmonella Enteritidis (SE) in shell eggs. FDA believes the draft guidance will help clarify how the Egg Safety Rule applies to their operations so the egg producers can confidently and efficiently implement the appropriate food safety measures.

The draft guidance describes different types of poultry houses and outdoor access areas and offers practical measures to control for SE by preventing wild birds, rodents, and other animals from entering the outdoor access areas and advice on conducting environmental sampling for SE.  It also discusses considerations related to vaccination of laying hens.

Meat Industry Sues USDA over Country of Origin Labeling

On July 8, 2013, a number of meat industry trade organizations filed suit against the USDA in the United States District Court for the District of Columbia challening USDA’s new country of original labeling (“COOL”) regulations.  A copy of the complaint can be found here.  In May of 2013, USDA issued immediately-effective revised COOL regulations requiring, among other things, that meat labeling make a distinction between where an animal was born, raised and slaughtered.  These regulations were issued in response to a World Trade Organization dispute between the United States, Mexico and Canada over then-existing COOL regulations in the United States.  Mexico and Canada have asserted that the May 2013 regulations only exacerbated the dispute.  More background on the WTO dispute can be found here.

Plaintiffs assert three causes of action.  First, they argue that the COOL regulations violate the First Amendment because they compel certain commercial speech

FDA Publishes Guidance on Proposed FSMA Produce Rule

July 15, 2013

Categories

In support of FDA’s proposed produce rule implementing portions of the Food Safety Modernization Act, FDA issued today several publications to help small- and medium-sized growers understand their future obligations under the proposed rule.  FDA has been creating fact sheets to to describe requirements such as the obligation to assess potential routes of microbial contamination of produce.  The new publications include a fact sheet on the proposed agricultural water standards, which is one of those potential routes of microbial contamination.  FDA also issued a second fact sheet on alternatives and variances under the proposed produce rule, which will help producers develop alternative standards to comply with the rules.

FDA’s proposed produce rule remains open for public comment until September 16.  Like the proposed rule, FDA will accept comments on the fact sheets.