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FSMA Final Rule on Preventive Controls for Human & Animal Food

September 25, 2015

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On September 17, 2015, the FDA announced two new final rules for the Food Safety Modernization Act (“FSMA”) (Pub. L. 111-353). The two new final rules are: (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food.

Covered facilities, which exclude farms, must create and implement a food safety systems that includes:

  • Hazard analysis: identification of known or reasonably foreseeable biological, chemical, and physical hazards
  • Preventive controls: measures that assure identified hazards can be minimized or prevented
  • Monitoring, verification, and corrective action plans for use of preventive controls; additionally, each animal food facility with a preventive control in place must develop a recall plan

For animal food facilities, Current Good Manufacturing Practices (“cGMP”) are being established for the first time. The animal food rule contains FDA’s baseline

FDA Extends Menu Labeling Rule Compliance Date Until December 1, 2016

This morning, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor announced that FDA is extending the compliance date for the menu labeling rules one year, making the new compliance date December 1, 2016.  Since finalizing the menu labeling rules in December of 2014, FDA states that it “has had extensive dialogue with chain restaurants, covered grocery stores and other covered businesses, and answered numerous questions on how the rule can be implemented in specific situations.”  Certainly, businesses impacted by the rule have been grappling with the substance and logistics of implementing the menu labeling rules, including working with suppliers to obtain additional information about products.  This alone can be a tricky proposition for items like alcohol and craft beers, where nutritional information required by the menu labeling rules is not always readily available.  The extension will allow all parties impacted by the menu labeling rules – a group

The Demise of Country of Origin Labeling (COOL)

The Demise of Country of Origin Labeling (COOL)

May 26, 2015

Authored by: Sara Ahmed and Brandon Neuschafer

Digest has been tracking the U.S. Country of Origin Labeling (“COOL”) rules that the WTO decided last year violate international fair trade rules.  It was the third time the WTO found COOL to be unfairly discriminatory.

In response to the threat of retaliation by Canada and Mexico, last week, the House Agricultural Committee voted to repeal a portion of COOL.  Under the bill, beef, pork, and chicken products will likely no longer state where the animals were born, slaughtered, and packaged.  The USDA had previously tried to no avail to revamp the rules upon the WTO’s prior rulings.

The U.S. National Farmers Union’s President, Roger Johnson, has been vocal in his feelings against the move to repeal portions of COOL and stated: “The House Agriculture Committee has succumbed to lobbying and scare tactics from foreign governments and multinational meatpackers and inserted itself prematurely into the WTO process by voting for a bill

FDA Proposes Draft Guidance on Mandatory Recall Authority

One key element of the 2011 Food Safety Modernization Act was the Act’s grant to FDA of powers to force a product recall.  Prior to FSMA, FDA had no such authority, and was required to use other authorities to “lean” on companies to conduct a recall.  Now, FDA may force a recall where it finds that there is a reasonable probability that food is adulterated or misbranded and the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.  In addition to satisfying this fairly substantial threshold, the responsible party must refuse to voluntarily conduct a recall.  The result is that FDA has initiated its mandatory recall authority only a couple of times, notably with respect to Kasel Associates Industries, Inc.’s pet treats and dietary supplements manufactured by USPLabs.

FDA recently issued draft nonbinding guidance regarding its mandatory recall authority.  The draft

USDA Approves Genetically Modified Apples, But Will They See The Shelves?

February 22, 2015

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On  February 13, 2015, the Department of Agriculture’s Animal and Plant Health Inspection Service approved the Arctic apple, a genetically modified strain of apple developed to resist browning.  A Canadian company, Okanagan Specialty Fruits Inc., first filed its petition for deregulation nearly three years ago.  The technology works by “turning off” the production of a certain enzyme that is produced when an apple is cut or bruised.  The Arctic apple is the one of the first deregulated genetically modified products designed to promote consumer-preferred traits, as opposed to traits like herbicide tolerance that promote certain production practices.

Notwithstanding APHIS’s approval, the question still remains of whether and how widely producers and consumers will adopt the technology in today’s environment surrounding GMOs.  Because it will be at least five to seven years before Arctic apple trees can bear fruit that can be marketed, producers will be required to do some significant

WTO Rules on Country of Origin Labeling

WTO Rules on Country of Origin Labeling

October 23, 2014

Authored by: Sara Ahmed and Brandon Neuschafer

You may recall prior Digest posts regarding the World Trade Organization’s evaluation of the validity of the US Country of Origin Labeling (“COOL”) law.

On Monday, the WTO decided against the United States and has held that the COOL violates international fair trade rules. This is the third time the WTO has found COOL to be unfairly discriminatory and it is instigating Canada and Mexico to prepare to impose trade sanctions on US products such as wine and chocolate.

Consumer groups have also voiced their disappointment about the recent decision. Renee Hunt, a spokeswoman for the Ohio Ecological Food and Farming Association, an organic advocacy group, said: “It comes at the expense of consumers and American livestock farmers…Consumers want to have the choice of where their meat comes from, but, instead, Big Ag’s interests are protected.”  Chris Waldrop, policy director at

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