FDA approves genetically engineered salmon

Posted November 20, 2015

The FDA has approved AquaBounty Technologies’ application for AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-genetically engineered (GE) farm-raised Atlantic salmon, according to the FDA’s press release here. The Washington Post also published an article available here and Reuters here.

The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.  

“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

Five years ago, the FDA first declared the product, made by Massachusetts-based AquaBounty Technologies, to be as safe as conventional farm-raised Atlantic salmon, according to Reuters.

AquaBounty's product will not require special labeling because it is nutritionally equivalent to conventional farm-raised Atlantic salmon, the FDA said on Thursday.

AquaBounty developed the salmon by altering its genes so that it would grow faster than farmed salmon, and expects it will take about two more years to reach consumers' plates.

A Canadian governmental risk assessment issued in 2013 also looked at both safety and escapes, and they described the risk to human health as “low” and the risk to the Canadian environment as “negligible,” according to The Washington Post.

On both of those issues, there will always be some doubt. Safety can’t be proved (we can only infer it from absence of harm so far), and any containment system can fail. So the questions aren’t “Is it safe?” and “Could they escape?” The question is whether the risk in those two areas is outweighed by the benefits.

The FDA will maintain regulatory oversight over the production and facilities, and will conduct inspections to confirm that adequate physical containment measures remain in place. In addition, the Canadian and Panamanian governments will also be conducting inspections of the facilities, according to the FDA.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

House ag committee approves anti-GMO labeling law

Posted July 20, 2014

The House Agriculture Committee has approved a bill that would ban states from requiring the labeling of genetically engineered (GMO) foods, according to an Agri-Pulse article available here. Food Safety News also published an article available here and Reuters here.

The Safe and Affordable Food Labeling Act (HR 1599), which was approved on a voice vote in a 15-minute meeting, could be on the House floor as early as next week. Opponents of the bill on the committee, led by Rep. Jim McGovern, D-Mass., did not request a roll-call vote.

Companies that wished to tout the fact that their products do not contain GMOs, such as with a “GMO-Free” label, would still be able to do so if the bill passed. That process would operate similarly to the U.S. Department of Agriculture’s organic certification, according to Food Safety News.

Maine, Connecticut and Vermont have already passed laws that would require foods containing GMOs to be labeled, and GMO-labeling campaigns are underway in a number of other states.

Groups lobbying for mandatory GMO labeling said they are increasing their efforts to make sure that H.R. 1599, dubbed the Safe and Accurate Food Labeling Act, never becomes law, according to Reuters

"The real fight will be in the Senate," said Scott Faber, executive director of Just Label It, an advocacy group pushing for mandated labeling. "This is from over."

They say the bill is objectionable not only because it would overturn state GMO labeling laws, but because it also prevents state and local governments from regulating GMO crops, and would keep the U.S. Food and Drug Administration from creating a mandatory GMO labeling standard.

"Those states like mine, Maine, which has already passed a law that requires GMO labeling... we would be prohibited from doing it," said U.S. Rep Chellie Pingree, a GMO labeling supporter.

Opponents say mandatory labeling would raise food prices, confuse consumers without cause as GMOs are well regulated and are no less safe or nutritious than foods made with non-GMO ingredients.

As much as 80 percent of packaged foods in grocery stores contains GMO ingredients, according to the Grocery Manufacturers Association, which opposes GMO labeling, according to Food Safety News.

The House is expected to vote on H.R. 1599 later this month.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Greenhouse gas analysis, EPA accepting comments

Posted July 15, 2015

The Environmental Protection Agency (EPA) is inviting comment on its analysis of the greenhouse gas (GHG) emissions attributable to the production and transport of Gossypium spp. seed oil (“cottonseed oil”) feedstock for use in making biofuels such as biodiesel, renewable diesel, and jet fuel.

The document explains their analysis of the feedstock production and transport-related components of the lifecycle GHG emissions of biofuel made from cottonseed oil, including both direct and indirect agricultural and forestry sector emissions.

This notice also describes how EPA may apply this analysis in the future to determine whether biofuels produced from cottonseed oil meet the necessary GHG reductions required for qualification as renewable fuel under the Renewable Fuel Standard program. Based on this analysis, they anticipate that biofuels produced from cottonseed oil could qualify as biomass-based diesel or advanced biofuel if typical fuel production process technologies are used.

Comments are accepted until before August 13, 2015.

For more information, the Federal Register is available here.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Interim final rule issued for Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program

Posted July 13, 2015

The Rural Business-Cooperative Service (Agency) is publishing an interim final rule for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program, formerly the Biorefinery Assistance Program, incorporating changes required in the Agricultural Act of 2014 (2014 Farm Bill) and addressing comments received on the interim final rule published on February 14, 2011 (76 FR 8404).

This rule establishes provisions for the loan guarantees available for Biorefineries to support the production of Advanced Biofuels and Renewable Chemicals and for Biobased Product Manufacturing facilities.

This interim rule is effective August 24, 2015. Comments on the rule and the information collection under the Paperwork Reduction Act of 1995 must be received by August 24, 2015.

For more information, the Federal Register is available here.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Federal judge rules Maui County GMO ban invalid

Posted July 2, 2015

A federal judge ruled that a Maui County ban on the cultivation of genetically engineered (GMO) crops is pre-empted by federal and state law and invalid, according to a Capital Press article available here. Honolulu Civil Beat also published an article available here and ABC News here.

The county’s ordinance exceeded the county’s authority, U.S. District Court Chief Judge Susan Oki Mollway said in her order.

The county, which is a major center for research on GMO crops, will abide by the decision, spokesman Rod Antone said. Monsanto Co. and Dow Chemical Co. unit Agrigenetics Inc. both have research farms in the county.

Mollway emphasized that the ruling is not a statement on whether genetically modified organisms are beneficial or detrimental, according to Honolulu Civil Beat.

“The court recognizes the importance of questions about whether GE activities and GMOs pose risks to human health, the environment, and the economy, and about how citizens may participate in democratic processes,” she said. “But any court is a reactive body that addresses matters before it rather than reaching out to grab hold of whatever matters may catch a judge’s fancy because the matters are interesting, important, or of great concern to many people.”

Mark Sheehan, one of five citizens who sponsored the ballot initiative, said his group would appeal the order. He expressed disappointment that Mollway ruled on what he called procedural issues instead of addressing the substance of their argument, according to Capital Press.

Monsanto said in a statement after the ruling that it welcomes "the opportunity to continue to have conversations" with the community, according to ABC News.

"We're listening and we've heard the concerns some people have about GMOs and today's farming practices. Our commitment to ongoing dialogue with our neighbors doesn't stop today," said John Purcell, vice president and Monsanto's lead for business and technology in Hawaii.

There has been little scientific evidence to prove that foods grown from engineered seeds are less safe than their conventional counterparts. But fears persist in Hawaii and elsewhere. In the islands, these concerns are compounded by worries about the companies' use of pesticides.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Syngenta rejects second Monsanto offer

Posted June 11, 2015

Syngenta has rejected a second takeover bid from Monsanto, which included a $2 billion breakup fee if the proposed $45 deal failed to meet regulatory muster, according to an Agri Pulse article available here. The New York Times also published an article available here and Wall Street Journal here.

As stated in Monsanto's letter, their offer “represents the same inadequate price, same inadequate regulatory undertakings to close, same regulatory risks and same issues associated with dual headquarters' moves" as in its original offer in April, Syngenta said in a statement. "The only change by Monsanto is to add a wholly inadequate reverse regulatory break fee."

If accepted, Monsanto would create the world’s largest supplier of crop seeds and chemicals. They are already the world’s largest seller of seeds and a leader in biotechnology, while Syngenta is the top seller of pesticides, fungicides and herbicides, according to The Wall Street Journal.

Monsanto intends to rename their company and place its headquarters in the United Kingdom, according to details of its proposal released on Monday by Syngenta, which could lower the tax rate of the combined firm.

Syngenta said Monsanto’s bid undervalued Syngenta’s prospects and underestimated “the significant execution risks, including regulatory and public scrutiny at multiple levels in many countries,” according to The New York Times.

On Monday, Syngenta said that they did not believe that the regulatory concerns would be resolved by “a pre-agreed and pre-announced package of horizontal divestitures, which is Monsanto’s proposed approach.”

Monsanto has said that it would sell Syngenta’s seed business and other overlapping businesses.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

USDA Creates GMO-Free Certification Label

Posted May 18, 2015

The U.S. Department of Agriculture (USDA) has developed a new government certification and labeling for foods that are free of genetically modified ingredients, according to a U.S. News article available here. The New York Times also published an article available here and ABC News here.

Consumers groups have been pushing for mandatory labeling of the genetically modified organisms (GMO).

The certification is the first of its kind, and it would be voluntary, however, companies would have to pay for it. If approved, the foods would be able to carry a "USDA Process Verified" label along with a claim that they are GMO free.

Agriculture secretary, Tom Vilsack, outlined the new certification in a May 1 letter to department employees, saying it was done at the request of a “leading global company,” which was not identified, according to The New York Times.

The government said GMOs on the market now are safe, so mandatory labels are not needed, but consumer groups say shoppers still have a right to know what is in their food.

Vilsack said the USDA certification is being created through the department's Agriculture Marketing Service, which works with interested companies to certify the accuracy of the claims they are making on food packages, such as "humanely raised" or "no antibiotics ever." Companies pay the Agricultural Marketing Service to verify a claim, and if approved, they can market the foods with the USDA process verified label, according to ABC News.

"Recently, a leading global company asked AMS to help verify that the corn and soybeans it uses in its products are not genetically engineered so that the company could label the products as such," Vilsack wrote in the letter. "AMS worked with the company to develop testing and verification processes to verify the non-GE claim."

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

U.S. District Court Allows Vermont GMO Law to Stand

Posted April 29, 2015

U.S. District Court Judge Christina Reiss ruled against the Grocery Manufacturers' Association (GMA) and other industry groups in their request for a preliminary order to block a genetically modified (GMO) food law from going into effect, according to a U.S. News and World Report article available here. Agri-Pulse also published an article available here and WRAL here.

The Vermont law could make the state the first in the country to require labeling of GMO foods and would go into effect July 1, 2016.

The judge partially granted and partially denied the state's motion to dismiss the industry lawsuit, which means the case could go to trial, according to WRAL.

The Grocery Manufacturers Association said it was pleased the court "found us likely to succeed on several of our claims" but was disappointed at the denial of its request for a preliminary injunction.

"Manufacturers are being harmed, and they are being harmed now," the association said in a statement. "Act 120 is unconstitutional and imposes burdensome new speech requirements on food manufacturers and retailers."

The Center for Food Safety (CFS) hailed the federal court’s decision, according to Agri-Pulse.

“This important ruling affirms the constitutionality of genetically engineered food labeling, as well as the rights of Vermonters and U.S. citizens across the country,” said

George Kimbrell, senior attorney for Center for Food Safety (CFS) and counsel. “Americans are demanding right to know if their food is produced through genetic engineering, for health, environmental and many other reasons. This decision is a crucial step in protecting those rights.”

CFS also noted that, in the denying the Plaintiffs' injunction, Judge Reiss declared, “Because the State has established that Act 120's GE disclosure requirement is reasonably related to the State's substantial interests, under Zauderer, Act 120's GE disclosure requirement is constitutional.”

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Regulators Approve GMO Apples, Resist Browning

Posted February 17, 2015

U.S. regulators have approved two genetically engineered apple varieties designed to resist browning, according to an Ag Professional article available here. The Des Moines Register also published an article available here and Reuters here.

The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) approved the new apples that were developed by the Canadian biotech company Okanagan Specialty Fruits Inc., as “unlikely to pose a plant pest risk to agriculture.”

The apples, Arctic Granny and Arctic Golden, are identical to their conventional counterparts except that they will not turn brown.

Neal Carter, president and founder of Okanagan, said he is confident that apple growers and consumers will accept the apples, according to The Des Moines Register.

“It looks like an apple, tastes like an apple and grows like an apple,” said Carter. Critics “can say whatever they want but we got the evidence. It's an apple in every way.”

The Organic Consumers Association (OCA) petitioned the USDA to deny approval, and said the genetic changes that prevent browning could be harmful to human health, and pesticide levels on the apples could be excessive, according to Reuters.

The Food and Drug Administration, which has no mandatory review process for genetically engineered foods, is examining the new apples through a voluntary consultation with Okanagan.

Okanagan said its apples have undergone “rigorous review,” and are “likely the most tested apples on the planet.”

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Syngenta Considering Counterclaims in Corn Biotech Lawsuits

Posted February 17, 2015

Syngenta AG may file counterclaims against some of the 750 plus U.S. grain farmers and exporters who have sued them over sales of biotech corn seed that disrupted trading with China last year, according to an Ag Professional article available here. STL Today also published an article available here and Reuters here.

Syngenta, the world's largest crop chemicals company, is “assessing the scope for potential counterclaims” in response to lawsuits over Agrisure Viptera corn, also known as MIR 162.

Last year, global grain handlers Cargill Inc. and Archer Daniels Midland Co., along with hundreds of farmers, sued Syngenta for damages from China rejecting shipments of U.S. crops that contained Viptera corn, according to STL Today.

At the time, the trait was approved for planting in the United States, but it was not approved for import by China, a major corn buyer.

As of Jan. 28, 762 lawsuits had been filed, according to Syngenta’s SEC filing on Thursday, and the company claims the suits are without merit.

Syngenta counterclaiming is "a lot of puffery," said lawyer Paul Hanly of Simmons Hanly Conroy, which is representing clients suing the seed maker, according to Reuters.

“I'm really hard-pressed to see what the theory would be, other than some sort of disparagement claim,” he said, adding that he believes a disparagement counterclaim would be baseless.

Lawsuits against Syngenta have been consolidated in Syngenta AG MIR162 Corn Litigation, U.S. District Court, District of Kansas, No 14-md-02591. (Reporting by Tom Polansek; Editing by Paul Simao)

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

NASDA Supports National GMO Labeling, Groups Send Letter to Urge Congress

-->

Posted February 11, 2015

The National Association of State Departments of Agriculture passed a resolution to support a national uniform labeling policy for genetically modified foods (GMO), according to an Ag Week article available here. WNAX also published an article available here.

The measure does not specifically support the bill introduced by Rep. Mike Pompeo, R-Kan., which would limit food labeling with GMO ingredients to those with which Food and Drug Administration (FDA) finds a food safety problem. Louisiana Agriculture and Forestry Commissioner Mike Strain said supports the bill.

“The whole issue is we need a uniform labeling system based on sound science,” said Strain. “We don’t need a non-uniform, disjointed system.”

South Dakota Agriculture Secretary Lucas Lentsch stated a national standard is needed to overcome the problems stemmed from different and diverse state regulations that obstruct biotechnology, according to WNAX.

Lentsch said that GM0 foods are completely safe and fit in well with our present food system, which is the safest in the world, and having a national standard would enhance that safety.

Agriculture Secretary Tom Vilsack said the Pompeo bill is an “end run” around labeling, and that he is not sure supporters can get it through Congress, according to Ag Week.

Vilsack also said that he has a “commitment to coexistence” between organic and conventional crops, and he plans to reconvene the Advisory Committee on Biotechnology in the 21st Century, known as AC21, in March to continue work on how both industries can thrive.

-->

Update: In a letter to House offices, 373 producer groups, processors, biotech providers, and food companies representing the Coalition for Safe and Affordable Food asked Congress members to support a bill that would provide federal food labeling standards for genetically engineered (GMO) products, according to Agri-Pulse.

Reps. Mike Pompeo, R-Kans., and G.K. Butterfield, D-N.C., introduced H.R. 1599, the Safe and Accurate Food Labeling Act, on March 25, to establish a voluntary, national labeling law for foods derived from GMO ingredients, which “will ensure food labeling in the United States is uniform and science based,” said the groups.

The bill also requires FDA to evaluate all genetically engineered foods before they enter the market, pre-empting any state mandatory laws for GMO labeling. 

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Syngenta Counsel Announced

Posted February , 2015

The United States District Court in Kansas has named a team of four attorneys to lead the multi-district litigation cases filed against Syngenta, according to an Ag Professional article available here.

The entire co-lead counsel team includes Gray, Ritter & Graham’s Don Downing; Gray Reed & McGraw’s William Chaney; Hare, Wynn, Newell & Newton’s Scott Powell; and Stueve Siegel Hanson’s Patrick Stueve.    

Syngenta faces over 360 lawsuits filed in courts across the country by corn farmers, grain handlers, exporters and others.

The lawsuits are combined per the law firms’ following description. “The case filed in U.S. District Court, Eastern District of Missouri (St. Louis) is Wilson Farm Inc. et al v. Syngenta AG et al, No.4:14-cv-01908. The case filed in U.S. District Court for the State of Kansas (Kansas City, Kan.) is Five Star Farms et al v. Syngenta AG et al, No. 2:14-cv-02571. The Judicial Panel on MultiDistrict Litigation has recently ordered all cases against Syngenta to be consolidated in coordinated proceedings before the Honorable Judge John W. Lungstrum in the U.S. District Court for the District of Kansas (Kansas City). That venue was one of the choices of venues supported by the firms.”

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

USDA Approved New Monsanto GMO Seeds

Posted January 21, 2015

Monsanto has received approval from the U.S. Department of Agriculture (USDA) for new genetically modified cotton and soybean seeds, according to  an ABC News article available here. Capital Press also published the article here, and The Wall Street Journal also published an article available here and.

GMO seeds are used to decrease pest and weed damages and increase yields and herbicide tolerance. But many crops can develop a resistance to herbicides so companies must develop a new version.

The new soybean and cotton seeds are designed to tolerate glyphosate exposure as well as dicamba, according to The Wall Street Journal.

The U.S. Environmental Protection Agency (EPA) is “nearing completion of its concurrent review” of a new dicamba and glyphosate formulation.

Environmental and consumer groups opposing the new formulation have argued that stronger weed killers pose more of a threat to the public’s health.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

China Approves Syngenta Corn, GMO Trait MIR 162

Posted December 22, 2014

U.S. Agriculture Secretary Tom Vilsack announced that Chinese officials have approved imports of Syngenta GMO corn trait MIR 162 and two varieties of biotech soybeans, according to a Farm Futures article available here. The Wall Street Journal also published an article available here, Star Tribune here, and Chicago Tribune here.

The country already has rejected more than 1.2 million tons of U.S. corn since the ban was imposed.

This change could resume stronger corn trade with China after they started rejecting U.S. shipments with any traces of Viptera, according to Star Tribune.

The genetically engineered corn seed, MIR 162, protects corn against damage from more than a dozen insect species.

Syngenta has previously stated that several major corn importing countries other than China approved the seed, because it was commercialized “in full compliance with regulatory and legal requirements.”

Each country has a regulatory system to “gauge the safety and appropriateness" of each product, according to the Chicago Tribune.

"The key would be for us to have greater alignment between our regulatory systems and their regulatory systems. Not that we would dictate what conclusions they would reach, but that we would better synchronize, or time, what we do. The Chinese have been reluctant to do that," said Vilsack.

China does not start the process until the U.S. has completed its process, which could delay a product’s availability "by a matter of years," he said.

Ethanol producers could benefit the most as China’s approval allows for resumed purchases of distillers’ dried grains, a byproduct of ethanol production used for animal feed, according to John Payne, senior market analyst at Daniels Trading. Chinese livestock producers are one of the biggest purchasers of feed, according to The Wall Street Journal.

“The bigger win is in the ethanol [industry],” said Mr. Payne.

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

 

North Carolina Launches AgBio[sphere]

Posted November 24, 2014

North Carolina launched an economic development platform branding the state as the “AgBio[sphere], the complete ecosystem for ag biotechnology,” according to a Southeast Farm Press article available here. WRAL Tech Wire also published an article available here.

The initiative is intended to “educate prospective agricultural biotechnology ventures about North Carolina’s ag biotech assets while streamlining market entry for research and business interests.”

“North Carolina’s agricultural roots, diverse assets and industry advantages position this state as the best global location for any ag biotech venture,” said Dr. Richard Linton, dean of North Carolina State University’s College of Agriculture and Life Sciences. “This new engagement platform further solidifies our global leadership and commitment to supporting and serving organizations looking for a new home. It’s a great way to welcome folks to North Carolina—the complete ecosystem for ag biotechnology,” Linton added.

AgBio[sphere] will provide a branded identity to North Carolina’s “complete value package for all facets of the industry,” including academic research, workforce development, business support programs, a strong agricultural sector and a huge $59 billion-a-year biotech industry involving some 650 companies with more than 80 firms being ag biotech, according to WRAL Tech Wire.

Steve Troxler, commissioner of the North Carolina Department of Agriculture and Consumer Services, stated that the state’s $78 billion economy-leading ag industry has grown from its “hardscrabble subsistence plots of a century ago” with the help of research and technology.

“Technology and education will drive us again,” said Troxler, “and thanks to the Biotechnology Center and all these partnerships represented here today, there’s nothing else like this anywhere.” He predicted the state’s increasingly technology-driven ag economy “is not that far away from reaching $100 billion a year.”

For more information on biotechnology, please visit the National Agricultural Law Center’s website here.

Nov. 19 Webinar Addresses Mandatory GMO Food Labeling Laws

Posted October 27, 2014

On November 19, from 2:30 - 3:30 (EST), the Agricultural & Food Law Consortium will host a free webinar that focuses on GMO labeling laws, proposals, and initiatives titled, Mandatory GMO Labeling Laws: Overview and Status of Current Legal Issues.

Ross Pifer, (J.D., LL.M.) Director of the Agricultural Law Resource Reference Center at Penn State Law, will be the presenter. 

The Consortium is a first-of-its-kind multi-institutional collaboration designed to enhance and expand the development and delivery of authoritative, timely, and objective agricultural and food law research and information.  The Consortium is funded in part by a $750,000 multi-year grant provided by the USDA Agricultural Research Service, National Agricultural Library.  Led by the National Agricultural Law Center, the Consortium is a multi-year partnership that includes the following members:

·  The National Sea Grant Law Center at the University of Mississippi School of Law;

·  The Agricultural Law Resource and Reference Center at Penn State Law; and

·  The Agricultural & Resource Law Program at The Ohio State University. 

Within the past decade, ballot initiatives and legislative proposals addressing the labeling of “Genetically Modified Organisms,” commonly known as “GMOs,” have been proposed in several states across the country, as well as on the federal level.  Recently, voters in two states considered legislation and others are sure to arise in the future.  This program is designed for anyone interested in learning more about this active area of law and policy, specifically including non-attorneys and students.  As time permits, there will be a Q&A session. 

Shortly before the webinar begins, click here (https://uaag.adobeconnect.com/gmolabeling/) and sign in as a guest using your full name, or the name you wish to use for purposes of the webinar. Before viewing the webinar, please visit this link to confirm your ability to connect to the server.