Thursday, November 26, 2015

US Urges China to Lift Poultry Import Ban

Written by Tyler R. Etter

U.S. Agriculture Secretary Tom Vilsack attended a United States and China Joint Commission on Commerce and Trade to raise the issue of China’s ongoing ban on imports of US poultry. The ban was enacted in response to the outbreak of highly pathogenic avian influenza. The meeting ran from November 21 to 23.

Since no new cases of HPAI have been detected since June 17, Vilsack hoped for China to lower the restrictions on the importation of poultry. Rather than a nationwide ban, Vilsack hoped for restrictions to only be maintained from states or regions where actual infection had occurred. Vilsack commented on the proposal, saying that “International rules suggest a regional approach would be appropriate.”

Before the Joint Commission took place, Vilsack stated that he did not expect the ban to be lifted during the course of the Commission. At the time of this writing, the Commission meeting has concluded, but no information has been released regarding the status of China’s import ban.

Wednesday, November 25, 2015

Insurance Company’s Request For Summary Judgment In Heinz Case Denied

Written by Katharine Richter

U.S. District Judge, Arthur Schwab, denied Starr Surplus Lines Insurance Co.’s (Starr) request for summary judgment against H.J. Heinz Co. regarding an insurance payment dispute.

According to Law360, the lawsuit arose because Starr, as alleged by Heinz Co., “breached its contract in a $25 million-per-occurrence product contamination by refusing to pay for damages after China’s food control agency found high levels of lead in high-protein dry baby cereal sold in China.”  Starr filed a counterclaim, alleging that Heinz misrepresented material facts pertaining to previous contamination incidents, therefore rendering the contract null.  This case is being decided under New York law and coverage cannot be denied to Heinz unless it is found that the misrepresentation by Heinz is material.  Starr claims if they had known about these previous incidents, they would not have extended the policy to Heinz Co.  If Starr is able to establish this, the facts will be considered material.  Heinz argued that any omission of the facts was because Starr failed to ask for it.

Schwab found there were still issues of fact that needed to be resolved which made summary judgment inappropriate.  According to the legalintelligencer, the specific issue that needs to be determined is whether the misrepresentations by Heinz Co., if there were any, were material and should be determined before a jury.  

Tuesday, November 24, 2015

FDA Releases New Voluntary Labeling Guidance for GE Food

Written by Tyler R. Etter

On November 19, the Food and Drug Administration (FDA) released two new guidance documents for genetically engineered (GE) plants and animals for use as food. One document is the finalized guidance on labeling food to indicate if food has or has not been derived from GE plants. The other document is draft guidance on voluntary labeling indicating if food has or has not been derived from GE Atlantic salmon.

The first document, pertaining to plant-derived food products, is meant to assist food and feed manufacturers that wish to apply labels to their products. The FDA’s primary concern is that any label is truthful and not misleading. For foods that do not use GE derived foods, labeling such include a statement in a context that clearly refers to bioengineering, such as “Not bioengineered” or “Not genetically engineered”, among other possibilities. Foods that are derived from GE products must have statements such as “Genetically engineered” or similar declarations. The FDA does not encourage the use of “GMO” or “genetic modification” as such claims are very broad, and encompass a wide variety of alterations, including natural breeding methods.

The second document, pertaining to food derived from GE Atlantic salmon, was released in conjunction with the approval of AquAdvantage Salmon, a GE Salmon from AquaBounty Technologies. The guidance recommends labeling standards similar to the GE plant guidance, with clear context for the labeling directly stating an association or lack thereof with bioengineering.

The new guidance documents are merely recommendations, and are not binding on the FDA or the public. The commenting period on both documents opens on November 24, 2015, and closes after 60 days. Comment for the plant guidance can be made here, and comment for the GE Salmon guidance can be made here.

Monday, November 23, 2015

FDA Issues New Food Safety Rules

Written by Katharine Richter

On November 13, 2015, the United States Food and Drug Administration (FDA) finalized new rules updating the bipartisan Food Safety Modernization Act (FSMA).  The new rules will “establish enforceable safety standards for produces farms and make importers accountable for verifying that imported food meets U.S. safety standards.”  A rule was also established that created third-party certification bodies which will perform food safety audits in foreign food facilities.

The three rules released are “referred to as the Produce Safety rule, the Foreign Supplier Verification Programs rule, and the Accredited Third-Party Certification rule.”  The stream of recent foodborne illnesses that have occurred over the last few years highlighted to the FDA the need for updates to food safety rules.

The Produce Safety rule “establishes science-based standards for growing, harvesting, packing, and holding produce” which are designed to minimize risk of illness when consuming contaminated produce.  The Foreign Supplier Verification Programs rule requires food importers in the U.S. that have received imported foreign foods, that these foods are meeting U.S. safety standards and meet the same standards of food safety as domestic farms.  The importers are required to conduct various verification activities.  The Accredited Third-Party Certification creates a program where “third-party certification bodies…conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.”

Friday, November 20, 2015

FDA Approves Genetically Engineered Salmon

Written by Stephen Kenney

On Thursday November 19th, U.S. health regulators decided that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon.  This approval was the first such approval for an animal whose DNA had been scientifically modified.  The FDA also will not require companies to label the genetically modified food.

AquAdvantage Salmon is a product of AquaBountyTechnologies.  The AquAdvantage Salmon are Atlantic salmon that reach market size more quickly than non-GE farm-raised Atlantic Salmon.  AquaBounty claims that the salmon can grow to market size in half the time required for conventional salmon.  The genetically modified fish is an Atlantic salmon with a Pacific salmon gene for faster growth and a gene from the eel-like ocean pout that promotes year round growth.

Five years ago, the U.S. Food and Drug Administration (FDA) first began the evaluation of GE salmon.  The Salmon can only be raised in land-based hatchery tanks in two specific facilities that are located in Canada and Panama.  The FDA ultimately approved the safety of the fish because the data demonstrated that the “inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s (AquaBounty) claim about faster growth.”  The FDA also assessed the environmental impacts of the fish and found that there would not be a significant impact on the environment because of the containment measures that will be put into place at the hatcheries.  The agency also found that there is not a risk of the fish reproducing with wild fish because the GE fish are sterile.

Activist groups and grocers are not convinced that the GE fish is a safe alternative.  Activist groups are concerned that the genetically modified food may pose a risk to the environment or public health.  Kroger, a national grocery chain, said that it has “no intention of sourcing or selling genetically engineered salmon.”  Trader Joe's and Whole Foods Market Inc. also do not intend to carry the modified fish.

Thursday, November 19, 2015

West Virginia Lifts Ban on Poultry Exhibits

Written by Tyler R. Etter

On November 10, 2015, West Virginia Commissioner of Agriculture Walt Helmick announced that he was
lifting the ban on gatherings of live poultry. West Virginia is the first state to lift its ban on these

The ban has been in place since May of 2015 in response to the outbreak of avian influenza. Ohio and
Pennsylvania enacted similar bans, which are still in place. Spokesperson at the Pennsylvania
Department of Agriculture stated that the ban will be re-evaluated next year, and the Ohio Department
of Agriculture has also stated that it will potentially reevaluate the ban at the beginning of the next year.

The West Virginia Ag Director is continuing to urge the exercise of caution and biosecurity habits, due to
the possibility of reappearance due to exposure from wild birds. Poultry is West Virginia’s most valuable
agricultural sector, valued at $355 million.

Wednesday, November 18, 2015

Following Ninth Circuit Decision, EPA Orders Ban On Sulfoxaflor Sales

Written by Katharine Richter

On September 10, 2015, the United States Court of Appeals for the Ninth Circuit decided in favor of various “commercial bee keepers and bee keeping organizations” who challenged the Environmental Protection Agency (EPA) approval of “insecticides containing sulfoxaflor, which initial studies showed were highly toxic to honey bees.”  As a result of the decision, the EPA issued a cancellation order on November 12, 2015, for “all previously registered Sulfoxaflor products.”  As part of the order, “all distribution or sale by the registrant of cancelled sulfoxaflor products is prohibited, unless such distribution or sale is for the purpose of disposal or export.”

In the opinion, the Ninth Circuit Court begins by discussing the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which “prohibits the use or sale of pesticides that lack approval and registration by the Environmental Protection Agency (EPA),” 7 U.S.C. § 136a(a).  FIFRA uses a cost-benefit analysis to determine whether a pesticide will cause unreasonable risk to people or the environment.  After a new pesticide has been submitted to the EPA for approval, the EPA can either conditionally or unconditionally accept.  Unconditional acceptance would require sufficient data to show there are no unreasonable risks associated with the pesticide.  Conditional acceptance would require more data submitted after a period of use of the pesticide. 

In this case, Dow Agrosciences LLC (DOW) applied for approval of three pesticides, all containing sulfoxaflor as the main ingredient.  In January 2013, the EPA announced it would conditionally register the sulfoxaflor, but “less than seven months later, on May 6, the EPA decided to “unconditionally” register sulfoxaflor.”  This occurred even though DOW “never completed the requested additional studies” and “the EPA acknowledged the insufficiency of the data to support unconditioned registration.” 

The Ninth Circuit Court vacated the EPA’s “unconditional registration of sulfoxaflor, and remanded for the EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees, as required by EPA regulations.”