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February 2011

FEDERAL AND STATE ISSUES INTERNATIONAL ISSUES GMA  CONTACTS

 

FEDERAL AND STATE ISSUES

USDA/APHIS Makes Bold Moves on Alfalfa, Sugar Beets and Corn Amylase

Alfalfa: The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) today announced its decision to grant non-regulated status for alfalfa that has been genetically engineered to be resistant to the herbicide commercially known as Roundup. “After conducting a thorough and transparent examination of alfalfa through a multi-alternative environmental impact statement (EIS) and several public comment opportunities, APHIS has determined that Roundup Ready alfalfa is as safe as traditionally bred alfalfa,” Agriculture Secretary Tom Vilsack said. “All of the alfalfa production stakeholders involved in this issue have stressed their willingness to work together to find solutions. We greatly appreciate and value the work they've done so far and will continue to provide support to the wide variety of sectors that make American agriculture successful.” APHIS' deregulation of Roundup ready alfalfa will become effective upon publication of the Agency's determination of nonregulated status in the Federal Register.

Decision on RR alfalfa is available to the public here.

Corn Amylase: The USDA Animal and Plant Health Inspection Service has announced its decision to deregulate corn genetically engineered (GE) to produce a common enzyme called alpha-amylase. The enzyme breaks down starch into sugar, thereby facilitating a vital step in ethanol production. APHIS conducted a plant pest risk assessment and found this line of corn does not pose a plant pest risk, and should no longer be subject to regulation by APHIS. APHIS recognizes that certain milling and food-processing stakeholder groups have concerns about this corn variety being deregulated and potential impacts on wet-milling operations. Syngenta is forming an industry advisory council to review the closed loop (containment) system the company has in place for amylase corn. The new corn variety successfully completed the U.S. Food and Drug Administration’s food/feed safety consultation in August 2007 which said it was safe for food and feed.

The APHIS decision is published in the February 15, 2011 Federal Register.

Sugar Beets: USDA announced to the public their decision to “partially deregulate” Roundup Ready sugar beets developed by the Monsanto Company, designated as event H7-1, in response to a supplemental Monsanto/KWS petition requesting partial deregulation of event H7-1. APHIS has determined that it will, for an interim period of time, grant the petition in part. APHIS will grant a partial deregulation for event H7-1 sugar beet root crop production activities when conducted under certain mandatory conditions. APHIS has decided not to grant partial deregulation for event H7-1 sugar beet seed crop production. Rather, APHIS has decided that event H7-1 sugar beet seed production shall remain regulated under APHIS' regulations governing the introduction of certain genetically engineered organisms. Their decision granting the petition in part on an interim basis is based on their evaluation of data submitted by Monsanto and KWS in its supplemental petition for a determination of “partial deregulation,” their analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the environmental assessment (EA) associated with the supplemental petition for partial deregulation. This partial deregulation is an interim measure until APHIS is able to complete a full environmental impact statement. USDA’s notice also announces the availability of a written decision, final EA, and finding of no significant impact.

Documents referenced in the notice are available here.

More from USDA’s Vilsack on Coexistence

Anticipating widespread controversy regarding the decision last week to fully deregulate Roundup Ready alfalfa, USDA is offering several steps in the direction of coexistence among biotech, conventional and organic crops.

USDA says that it will:

• Reestablish the Advisory Committee on Biotechnology and 21st Century Agriculture (see FCN Jan. 21, Page 6) and the National Genetic Resources Advisory Committee. “These two committees will tackle a broad range of issues, from ensuring the availability of high quality seed, to helping ensure that growers have access to the best tools available to support their production choices, to whether risk management and indemnification options can play a role,” USDA says.
• Conduct research into areas such as ensuring the genetic integrity, production and preservation of alfalfa seeds entrusted to the germplasm system;
• Refine and extend current models of gene flow in alfalfa;
• Request proposals through the Small Business Innovation Research program to improve handling of forage seeds and detection of transgenes in alfalfa seeds and hay; and
• Provide voluntary, third-party audits and verification of industry-led stewardship initiatives.

As predicted, Andrew Kimbrell, executive director of the Center for Food Safety, describes USDA's promises as a “stale gesture” toward organic and other industry groups that had worked with the department on its proposed option for partial deregulation of RR alfalfa. The organic industry’s Christine Bushway, executive director of the Organic Trade Association, says OTA “is willing to engage in any way that it can to protect farmer and consumer choice, including working to see that these advisory committees truly represent the range of stakeholders affected by GE commercialization decisions. Going forward, it is imperative that USDA take action to respect the rights of all agricultural sectors under its jurisdiction as well as consumer choice. This will require measures that address the questions of liability and compensation for losses that result to non-GE farmers from the actions of GE plantings, the costs for testing and practices to prevent commingling, the need to protect the genetic diversity of seeds, and also the labeling of GE crops and product ingredients.”

State Legislatures Call for Ban/ Labeling of Biotech Salmon

Alaska senators Mark Begich (D) and Lisa Murkowski (R) reintroduced a bill to block the sale of genetically engineered salmon. The two senators introduced the same bill late last year. The legislation, and a companion bill that would require labeling of GE fish, are in response to an application to commercialize GE salmon by AquaBounty Technologies currently under consideration by FDA's Center for Veterinary Medicine.

Begich said in a news release, “Genetically-modified salmon, the first such hybrid to be considered for human consumption, is risky, unprecedented and unnecessary. I am strongly opposed to the FDA approval of genetically engineered salmon. It is completely irresponsible for the FDA to even consider this action without evaluating the impacts on Alaska's wild salmon fisheries,” Murkowski said. “The FDA has not studied the environmental effects, let alone the economic impacts on the salmon and seafood markets that would result from approval.” In September, Begich and Murkowski were among a group of 10 senators who sent a letter to the FDA questioning the review process and the safety of a genetically engineered animal for human consumption.

California Assemblyman Jared Huffman (D-San Rafael) introduced a bill (AB 88) that would require all genetically engineered salmon sold in the state to include clear and prominent labeling. “The federal agency charged with protecting our food supply is failing us yet again,” says Rebecca Spector, CFS West Coast director. “Consumers have the right to know that the food they consume and feed their families is safe. Until FDA does an adequate environmental and human health review of genetically engineered salmon, it is up to individual states to protect consumers and their families. The assembly member's proposed bill will protect Californians through labeling, which restores consumer confidence and choice.”
 

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INTERNATIONAL ISSUES

EFSA Reviews the Risk of GM Mammals and Birds

A project was undertaken to provide EFSA with a scientific and technical report on (1) scientific disciplines and fields of expertise that might feed an environmental risk assessment (ERA) of GM mammals and birds to be commercially released into the EU environment; (2) research institutes and academics having expertise on the subject and on (3) relevant criteria to be considered when performing an environmental risk assessment of GM mammals and birds. An extensive review of the literature on GM mammals and birds was completed. A limited number of mammals and birds have been identified as in current development for release. In contrast, an extremely large number of animals are used in contained use for fundamental research. It was not feasible to cover all the literature on contained use in the same detail so a subset of these was identified using a statistical methodology and a short report produced on this. In order to facilitate the development of criteria for risk assessment, seven (hypothetical) species-traits case studies were identified for detailed examination. The case studies identified were cattle-disease tolerance, sheep-increased herding behaviour, pigs-“Enviropig”, chicken egg production, cat- increased longevity and/or neoteny, pigeon-disease resistance and rabbit sterility. The potential for these species to establish feral populations in Europe and to influence the environment was explored. Given the limited current development for commercial release of GM mammals and birds, there are few examples that can be evaluated to aid in defining a risk assessment. Risk assessment criteria were developed such that any subsequent risk assessment protocol can be used to properly assess any combination of species and GM trait(s). The current EFSA draft guidance document for GM plants provides a framework for risk assessment that was followed when setting the criteria for mammals and birds, however, the issues involved with mammals and birds are often quite different from those with plant species so there is limited ‘read across’.

Click here for more information.


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GMA BIOTECHNOLOGY REGULATORY CONTACTS

Jeffrey Barach, PhD,Vice President of Science Policy, New Technologies (202/639-5955, .(JavaScript must be enabled to view this email address))

Regina Hildwine, Senior Director of Science Policy, Labeling and Standards (202/639-5926, .(JavaScript must be enabled to view this email address))

Kevin Koshute, Associate Scientist, Science Operations
(202/639-5908, .(JavaScript must be enabled to view this email address))

Peggy Rochette, Senior Director, International Affairs
(202/639-5921, .(JavaScript must be enabled to view this email address))

Christie Gray, Manager of Science Policy, Labeling and Standards
(202/637-8064, .(JavaScript must be enabled to view this email address))
 

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