Most relevant in this request is that it is the first request to deregulate a GE plant variety that is intended solely for the use in the production of ethanol. The corn variety is not cultivated for human consumption or livestock feed, but rather is grown to improve the efficiency of converting corn starch to industrial ethanol.
A concern is that there is inadequate scientific data or documentation to evaluate the possible impacts on food and feed should this variety be commingled with commodity corn supplies. Syngenta Seeds said the seed is available for planting for a small number of growers.
By , the seed was available for large-scale commercial planting under contracted, closed production. Trade groups and companies involved in milling, refining, and exporting corn, including the Corn Refiners Association, National Grain and Feed Association, North American Export Grain Association, and North American Millers' Association, also opposed APHIS's approval of this GE corn, citing concerns that its engineered protein could damage food products such as breakfast cereals and snack foods and disrupt exports of such products.
APHIS granted a permit in May to import a eucalyptus tree that is genetically engineered for "cold-tolerance. Eucalyptus is a fast-growing tree that dominates tropical timber plantations. It is not native to the United States and has become invasive in some places. The permit authorizes planting and flowering on 28 sites across seven southern states Alabama, Florida, Georgia, Louisiana, Mississippi, South Carolina, and Texas. The Center for Biological Diversity and other organizations have sued to set aside the approval on grounds that the potential environmental impacts have not been properly evaluated, nor has APHIS complied with congressional mandates enacted in the farm bill P.
In a letter to Secretary of Agriculture Tom Vilsack, the Northwest Horticultural Society has asked that APHIS reject the request, citing concerns about adverse marketing should the apples be permitted into the general market.
Two public comment periods on the deregulation of the Arctic Apple drew more than , comments, almost all opposed to approval. The biotechnology firm is currently engaged in a voluntary food assessment consultation with FDA. FDA also announced at the same time that it would hold a public comment period and a hearing on labeling for the transgenic salmon. Environmental issues associated with potential escape of the GE salmon into the wild are also being considered.
FDA scientists stated in a briefing document that the GE salmon is safe for human consumption and poses no risk to the environment. The meetings were open to the public. Committee members heard from FDA about GE animals generally and about the agency's evaluation and approval process. On the second day, FDA presented data supporting AquaBounty's claim that the fish grew faster than conventionally bred Atlantic salmon.
The comment period on the EA ended April 26, The VMAC is advising FDA officials whether to approve the salmon and make recommendations regarding the need to label the fish, although FDA has already indicated that it is safe for human consumption and would not require labeling. FDA's position is that labeling should not suggest that GE foods are different from other foods. A coalition of 31 organizations and restaurant chefs is demanding that FDA deny approval.
Various environmental organizations are concerned that the GE salmon could escape from fish farms and threaten the wild salmon population. AquaBounty, however, says it would encourage producers to grow the GE Atlantic salmon only at in-land fish farms. Congressional Members have raised concerns about FDA's approval process. The letter stated that the Members had "serious concerns" regarding the process for review and approval of the GE salmon.
In particular, the letter stated that the FDA process was "inadequate" and "sets a dangerous precedent: the environmental review is flawed and the consumer's right to know ignored. Although the company intends to raise the fish at an egg hatchery facility on Prince Edward Island, Canada, and the GE salmon would be sterile, Members expressed their concern that the GE fish could pose threats to the remaining wild Atlantic salmon.
A coalition of 53 consumer and environmental organizations and businesses endorsed the letter from House and Senate Members. The Center for Food Safety, a central actor in opposing federal regulatory standards for biotechnology, and a coalition of allied groups also submitted nearly , comments from individuals opposing the approval.
The U. For example, the European Union EU , Japan, South Korea, New Zealand, and Australia either have or are establishing separate mandatory labeling requirements for products containing genetically modified ingredients; in many of these countries, consumer and official attitudes toward GE foods are more skeptical.
Differing regulatory approaches have arisen at least partly because widely accepted international standards continue to evolve. Incidents, such as those discussed below, have disrupted U. Although several GE varieties of rice have been approved for commercial use "deregulated," in regulatory parlance , none have been marketed, although they have been planted on test plots in the United States.
In August , the Secretary of Agriculture announced that "trace amounts" of an unapproved variety of GE rice had been found in samples of the crop of U.
The Secretary and other USDA officials sought to reassure the rice trade and consumers that the findings posed no human health, food safety, or environmental concerns. Also, "[t]he protein in LLRICE is approved for use in other products" and "has been repeatedly and thoroughly scientifically reviewed and used safely in food and feed, cultivation, import and breeding in the United States, as well as nearly a dozen other countries around the world.
Nonetheless, the discovery unsettled rice markets and rekindled longtime criticisms of U. Exports represent approximately one-half or more of U. Although the United States produces only about 1. Of the 4. Japan was the second-leading market at nearly , MT. Various Central American and Caribbean countries took a total of 1. Much of the long grain crop is produced in southern U.
California grows mainly medium and short grain rice varieties, which are marketed in Asia, including Japan. Japan has indicated that it was suspending shipments of U.
According to a statement by the producer cooperative Riceland Foods, Inc. Riceland then sent a sample to a U. Riceland said it collected samples from several storage locations in May and found positive results that were "geographically dispersed and random throughout the rice-growing area. In August , USDA officials offered few additional details about the cause or extent of the problem. They indicated that they had not been informed by Bayer of the discovery until July 31, after which the department began its own investigation, they stated.
Consumer and environmental advocacy groups were harshly critical of APHIS and USDA, noting that officials waited three weeks to make the discovery public—and still did not know where the samples were grown or how they entered the food supply. One group, the Center for Food Safety, subsequently called for a moratorium on all new field testing permits until oversight can be improved. USDA essentially declared that the new variety was similar to two Bayer varieties that had already been approved.
About 11, farmers in Arkansas, Louisiana, Mississippi, Missouri, and Texas will divide the settlement. Monsanto had asked the U. Some producers wanted to plant the wheat as soon as it became available; others feared rejection by foreign customers of not only GE wheat, but all U. The latter group wanted developers and regulators to wait for more market acceptance before releasing GE wheat varieties.
In early , a group of U. Underlining these concerns, Japanese consumer groups in March reportedly told U. This resistance likely contributed to a decision by Monsanto to discontinue its efforts to win regulatory approval of a genetically modified wheat variety.
Monsanto announced its decision in May FDA subsequently approved the application in July While opposition to GE wheat remains strong among many U. Wheat Associates indicated in that support for planting and exporting GE wheat was growing among some U.
In May , wheat grower associations in the United States, Canada, and Australia issued a joint statement announcing that they intend to "work toward the goal of synchronized commercialization of biotech traits in our wheat crops Organic Consumers Association, and other organizations drafted a statement opposing commercializing GE.
It will have increased drought tolerance, increased yield, and improved nitrogen efficiency. Had the presence of the non-approved wheat been widespread, serious trade impacts could have followed. A similar discovery of GE wheat in Montana was reported in September The United States and its allies further argued that the EU moratorium was violating WTO rules stating that a country's actions to protect health and the environment must be scientifically based, and approval procedures must be operated without undue delay.
The WTO named a panel in March to consider the case. Although the EU effectively lifted the moratorium in May by approving a genetically engineered corn variety, the three complainants pursued the case, in part because a number of EU member states have continued to block approved biotech products. The dispute panel's ruling dismissed several other U. It concluded that the EU had breached its commitments with respect to 21 products, including types of oilseed rape, maize, and cotton.
The parties subsequently agreed to extend the time for EU compliance with the ruling to January The EU missed this deadline in large measure.
Individual countries e. In , France also initiated a temporary national moratorium on GE crops. Spain continues to dominate the EU in GE crop cultivation. If progress is not made, the issue is likely to return to the WTO's dispute settlement body. These could be levied by imposing extra tariffs on EU goods or lifting other WTO agreements regulating agriculture or health and safety.
The WTO case did not involve the EU's new "labeling and traceability" regulations, in effect as of April , to require most food, feed, and processed products from GMOs to be labeled. GE-based products also must be segregated from non-GE products, with documentation. At least one EU country, Germany, has addressed the issue of potential liability from GM crops—passing a law in November that holds farmers who plant GM crops liable for damages to nearby non-GM fields even if the GM farmers adhered to planting instructions and regulations.
Some U. Several EU countries have banned the cultivation of GE crops in their territories or have specific rules on the trade of GE seeds.
The EU's regulatory framework regarding biotechnology is generally regarded as one of the most stringent—and onerous—systems worldwide. To date, few GE varieties have been approved by EU authorities for commercial cultivation.
Many U. This could become a more contentious issue in the context of the T-TIP negotiations. Also, in January , the European Parliament voted to allow each member country to ban or approve GE crops in their respective countries. This action will likely further complicate T-TIP negotiations on biotechnology policy.
At this time, positions appear to be hardening between the United States and the EU relative to agricultural biotechnology. Any progress toward narrowing the differences between the U. To date, little movement toward a common position has been seen.
However, because its shipments to ratifying countries are affected, it has actively participated in the negotiations over the protocol text and in countries' preparations for implementation. The protocol, which other nations had ratified as of August , permits a country to require formal prior notifications from countries exporting biotech seeds and living modified organisms LMOs intended for introduction into the environment.
The protocol requires that shipments of products that may contain LMOs, such as bulk grains, be appropriately labeled and documented, and provides for an international clearinghouse for the exchange of LMO information, among other provisions. The Protocol further establishes a process for considering more detailed identification and documentation of LMO commodities in international trade.
The United States objected to implementing measures approved during an international conference in Kuala Lumpur in February According to the United States, the measures would mandate overly detailed documentation requirements and potentially expose exporters to unwarranted liability damages if imported GMOs harm the environment or human health. In the United States, many consumers may be wary of GE foods out of fear that introduced genes could prove allergenic, introduce increased toxicity, or otherwise be harmful to human health.
Some critics express concern that FDA is placing all the responsibility on manufacturers to generate safety data, as it does normally under its pre-market approval system, and is reviewing only the conclusions of industry-sponsored studies rather than conducting its own tests.
They also believe that the process lacks transparency and adequate public scrutiny of data. Others counter that additional testing and oversight are unnecessary because all foods must meet the same rigorous federal safety standards regardless of whether they are genetically engineered.
Federal policy also does not require GE-derived foods to be so labeled as long as they are substantially the same as their conventional counterparts. Nonetheless, some consumer groups continue to seek mandatory labeling of all GE foods. These groups argue that U. The food and biotechnology industries generally oppose compulsory labeling. They contend that consumers might interpret GE labels as "warning labels" implying that the foods are less safe or nutritious than conventional foods, whereas the industry believes the preponderance of scientific evidence indicates otherwise.
The industry has also asserted that mandatory labeling would require development of a costly and possibly unattainable supply chain management system to ensure that GE and non-GE foods remain segregated from the farm to the store, with no added benefit to the consumer. The industry has asserted that if consumers want to purchase GE-free products, the market will support a voluntary system, as exists for organic foods where rules already prohibit GE foods from being called "organic".
In fall , Californians voted on Proposition 37, which would have required labeling of all foods containing GE material. Opponents of labeling, including many large food companies and grocery outlets, spent heavily to defeat the proposal. In , Vermont became the first state to pass a mandatory GE labeling law. The law will not be implemented until July Connecticut and Maine also passed mandatory GE labeling laws in and , respectively, but they will not go into effect until five contiguous states also pass mandatory GE labeling laws.
On July 23, , the full House passed a voluntary labeling bill, H. Opponents of labeling have feared that in the absence of a national labeling law, each state could pass its own specific labeling requirements for GE foods, requiring costly management changes in commodity supply chains to comply with different state laws.
Proponents of labeling are unlikely to find the proposed federal labeling law to their liking. Unlike the labeling bills passed by Vermont, Maine, and Connecticut, H. The bill would prohibit a state now or in the future from "directly or indirectly establishing under any authority, or continue in effect, as to any covered products in interstate commerce, any requirement for the labeling of a covered product indicating the product has been produced from, containing, or consisting of a genetically engineered plant" unless the state establishes a voluntary program that is accredited by USDA as identical to the standards established by H.
While this language is aimed at preempting state labeling laws, questions arose concerning whether the preemption language might also end local non-GE protections—for example, Oregon's GE-free zones that protect the state's seed growing regions.
A manager's amendment in the final bill clarified the language as pertaining only to a state regulating a GE food product. This new subtitle is intended to strengthen the objectives of the Coordinated Framework for Regulation of Biotechnology by affirming the safety of foods produced from or containing GE plant material. The voluntary consultative process under FDA's policy guidelines for the introduction of GE foods would continue. Many opponents of GE products have long supported making FDA's voluntary consultation process a mandatory one.
Products developed by GE technologies but used as a food processing aid or enzyme would not require the premarket notification. A "certifying agent" of a state, an official responsible for state agricultural operations, would certify whether food products are produced with or without GE technologies. Food products labeled as not produced with the use of GE technologies would be subject to supply chain process controls to ensure that the producer planting the seed is not using a GE variety.
Further supply chain controls would cover the growth, harvesting, storage, processing, and transportation of the non-GE product. In the case of products from livestock, the livestock, products consumed by the livestock, and the products used in the processing of products consumed by livestock must be produced without the use of GE technology. Producers seeking certification under the non-GE labeling program would be required to submit a food plan addressing their handling and processing procedures.
These food plans would be subject to review by USDA and state certifying agents. The Secretary of Agriculture would also have authority to stipulate other information on the label deemed appropriate. A subsection of the bill prohibits labeling or advertising from suggesting that non-GE food products are safer or of a higher quality than those produced from or containing GE material.
For entities that wish to label their products as deriving from GE materials or containing GE ingredients, a food must be produced and handled in compliance with a GE food plan submitted to USDA and state certifying agents. More than 90 percent of farmers growing biotech crops are resource-poor farmers in developing countries.
ISAAA reports various statistics on the global adoption and plantings of biotechnology derived crops. Please note: These descriptions are not a complete or thorough review of all the activities of these agencies with respect to agricultural biotechnology and are intended as general introductory materials only. For additional information please see the relevant agency websites.
The Federal Government developed a Coordinated Framework for the Regulation of Biotechnology in to provide for the regulatory oversight of organisms derived through genetic engineering. The approach taken in the Coordinated Framework is grounded in the judgment of the National Academy of Sciences that the potential risks associated with these organisms fall into the same general categories as those created by traditionally bred organisms.
Products are regulated according to their intended use, with some products being regulated under more than one agency. All government regulatory agencies have a responsibility to ensure that the implementation of regulatory decisions, including approval of field tests and eventual deregulation of approved biotech crops, does not adversely impact human health or the environment.
APHIS regulations provide procedures for obtaining a permit or for providing notification prior to "introducing" the act of introducing includes any movement into or through the U. Regulated articles are organisms and products altered or produced through genetic engineering that are plant pests or for which there is reason to believe are plant pests. The regulations also provide for a petition process for the determination of non-regulated status.
Once a determination of non-regulated status has been made, the organism and its offspring no longer requires APHIS review for movement or release in the U. The USDA also helps industry respond to consumer demands in the United States and overseas by supporting the marketing of a wide range of agricultural products produced through conventional, organic, and genetically engineered means.
The Agricultural Marketing Service AMS and the Grain Inspection, Packers, and Stockyards Administration GIPSA have developed a number of services to facilitate the strategic marketing of conventional and genetically engineered foods, fibers, grains, and oilseeds in both domestic and international markets. GIPSA provides these services for the bulk grain and oilseed markets while AMS provides the services for food commodities such as fruits and vegetables, as well as for fiber commodities. Evaluation of Test Kits: AMS and GIPSA evaluate commercially available test kits designed to detect the presence of specific proteins in genetically engineered agricultural commodities.
The agencies confirm whether the tests operate in accordance with manufacturers' claims and, if the kits operate as stated, the results are made available to the public on their respective websites. GIPSA evaluates the performance of laboratories conducting DNA-based tests to detect genetically engineered grains and oilseeds, provides participants with their individual results, and posts a summary report on the GIPSA website.
AMS is developing a similar program that can evaluate and verify the capabilities of independent laboratories to screen other products for the presence of genetically engineered material.
Additional AMS Services: AMS provides fee-based DNA and protein testing services for food and fiber products, and its Plant Variety Protection Office offers intellectual property rights protection for new genetically engineered seed varieties through the issuance of Certificates of Protection.
USDA also works to improve and expand market access for U. The Foreign Agricultural Service FAS supports or administers numerous education, outreach, and exchange programs designed to improve the understanding and acceptance of genetically engineered agricultural products worldwide.
Emerging Markets Program : Supports technical assistance activities to promote exports of U. Activities to support science-based decision-making are also undertaken.
Such activities have included food safety training in Mexico, a biotechnology course for emerging market participants at Michigan State University, farmer-to-farmer workshops in the Philippines and Honduras, high-level policy discussions within the Asia-Pacific Economic Cooperation group, as well as numerous study tours and workshops involving journalists, regulators, and policy-makers.
Cochran Fellowship Program : Supports short-term training in biotechnology and genetic engineering. Since the program was created in , the Cochran Fellowship Program has provided education and training to international participants, primarily regulators, policy makers, and scientists.
Borlaug Fellowship Program : Supports collaborative research in new technologies, including biotechnology and genetic engineering. Since the program was established in , the Borlaug Fellowship Program has funded fellowships in this research area. Pollen with the genes for a desired trait is transferred from plants of one crop variety to the flowers of another variety with other desirable traits. Eventually, through careful selection of offspring, the desired trait will appear in a new variety of plants.
Traditional plant breeding has produced numerous highly successful new varieties of crops over the centuries. There have also been many less than successful crosses made. In traditional breeding, crosses are often made in a relatively uncontrolled manner. The breeder chooses the parents to cross, but at the genetic level, the results are unpredictable. DNA from the parents recombines randomly, and desirable traits such as pest resistance may be bundled with undesirable traits, such as lower yield or poor quality.
The parent plants must be closely related to produce offspring. Traditional breeding programs are time-consuming, often taking decades to produce new viable crop varieties, and labor-intensive. A great deal of effort is required to separate undesirable from desirable traits, and this is not always economically practical.
Many potential benefits are lost along the way, as plants that fail to demonstrate the introduced characteristics are discarded.
Traditional plant breeding takes on average years to produce a new crop variety. Classical Breeding with Induced Mutation. Genetic Engineering of Organisms. The basic structure of DNA is identical in all living things.
In all organisms, different characteristics are determined by the sequence of the DNA base pairs. Biotechnology has developed to the point where researchers can take one or more specific genes from nearly any organism, including plants, animals, bacteria, or viruses, and introduce those genes into the genome of another organism. This is called recombinant DNA technology Watson et al. In , the first commercial product arising from the use of recombinant DNA technology gene transfer was synthetic insulin.
Pig and cattle pancreatic glands were previously the only way of producing insulin for human use. In , chymosin known as Rennin was the first enzyme produced from a genetically modified source-yeast-to be approved for use in food. Previously this enzyme for cheese production was obtained from cows' stomach linings. In agricultural biotechnology, changes are made directly to the plant's genome.
Once the gene that determines a desirable trait is identified, it can be selected, extracted, and transferred directly into another plant genome Figure 3. Plants that have genes from other organisms are referred to as transgenic. The presence of the desired gene, controlling the trait, can be tested for at any stage of growth, such as in small seedlings in a greenhouse tray.
A breeder can thus quickly evaluate the plants that are produced and then select those that best express the desired trait. Producing new varieties of crops through genetic engineering takes about 10 years on average. Figure 3: The process of genetic engineering in papaya. The process of genetic engineering in papaya. This is the first fruit tree ever genetically engineered for resistance to a virus that kills papaya plants , conducted by Land Grant Universities University of Hawaii and Cornell University in the USA, and licensed to the Hawaii papaya industry for use and distribution.
Crops produced through genetic engineering are sometimes referred to as genetically modified organisms. The term genetic modification, and so-called genetically modified organisms GMOs is frequently misused.
All types organic, conventional of agriculture modify the genes of plants so that they will have desirable traits. The difference is that traditional forms of breeding change the plant's genetics indirectly by selecting plants with specific traits, while genetic engineering changes the traits by making changes directly to the DNA.
In traditional breeding, crosses are made in a relatively uncontrolled manner. DNA from the parents recombines randomly. In contrast, genetic engineering permits highly targeted transfer of genes, quick and efficient tracking of genes in new varieties, and ultimately increased efficiency in developing new crop varieties with new and desirable traits.
As with the development of any new technology there are concerns about associated risks, and agricultural biotechnology is no exception. Despite there being a wide range of foods—GMO and non-GMO—available to consumers, there is some confusion around what GMOs are and how they are used in our food supply.
PDF KB. A GMO genetically modified organism is a plant, animal, or microorganism that has had its genetic material DNA changed using technology that generally involves the specific modification of DNA, including the transfer of specific DNA from one organism to another.
Scientists often refer to this process as genetic engineering. This term is not generally used to refer to plants or animals developed with selective breeding, like the common garden strawberries available today that were created from a cross between a species native to North America and a species native to South America. The Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.
Most GMO crops are used in food for animals like cows, chickens, and fish.
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