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FDA To Conduct Environmental Impact Statement on Draft Produce Rule

FDA announced today that it will conduct an environmental impact statement (EIS) on the draft Produce Safety Rule proposed in January 2013.    An EIS is required under the National Environmental Policy Act for certain government agency actions that may significantly affect the quality of the human environment.  The EIS is a tool used by the agency to tailor the specific action, such as rulemaking, to address environmental concerns.  FDA indicated that it is conducting the EIS “because it has received information through comments and its own analysis that an environmental analysis is needed.”  FDA is also commencing a scoping process to determine the scope of the environmental review.  Comments on the scope of review FDA should undertake are due November 15, 2013, the same day that comments on the substantive provisions of the draft Produce Safety Rule are due.  FDA has indicated that the EIS process is not anticipated

FDA Extends Comment Period on Produce and Human Food Rules

FDA announced today that it is extending by sixty days the deadline for commenting on the proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and the proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.  The new deadline for comments is November 15, 2013, and FDA has indicated that this will be the last extension of time.

The two draft rules were originally proposed in January of 2013 to implement provisions of the Food Safety Modernization Act.  The proposed Human Food rule will, among other things, require hazard analysis and critical control points (HACCP) plans for domestic and foreign facilities that manufacture, process, pack or hold human food.  The proposed Produce Safety Standards are prevention-based standards that require those growing, harvesting, packing or holding produce on foreign or domestic farms to undertake a science-based risk analysis of

Pepsi Settles “All Natural” Litigation Regarding Naked Juice

August 2, 2013

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PepsiCo has agreed to settle a class action lawsuit brought in 2011 related to labeling of certain Naked Juice products as “all natural.”  The litigation alleged that the use of certain synthetic ingredients, including a synthetic fiber, were false and misleading in light of the “all natural” claim.  The ingredients at issue included zinc oxide, ascorbic acid, and calcium pantothenate.  PepsiCo agreed to pay $9 million to settle the lawsuit, and also to remove the “all natural” claim from its Naked Juice products.  Plaintiffs also claim that Naked Juice contains GMO ingredients despite labeling indicating the products are GMO-free, an allegation that PepsiCo denies.  Nonetheless, PepsiCo has announced an intention to seek third party certification of the non-GMO status of Naked Juice product bearing the GMO-free claim.

This suit against PepsiCo is one of dozens of pending lawsuits against food companies for using “natural” or “all natural” claims where

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

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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.

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