Select Committee on European Communities Minutes of Evidence


Supplementary Memorandum from United States Department of Agriculture

US REGULATION: PROCESS

  11. Would you explain the procedure the USDA uses to (a) approve field trials and (b) permit commercialization of a new genetically-modified crop?

    What is the legal status of an "deregulated" or exempted crop? Do you still monitor such crops in any way? Are these "traceable"? If the exempted crop were to prove to be a problem, is there any way of withdrawing the exemption?

Answer:

A. Approve field trials

  The Animal and Plant Health Inspection Service (APHIS) of the USDA, as part of its overall responsibilities to protect American agriculture against pests and diseases, exercises oversight for the importation, interstate movement, and the field testing of most genetically engineered organisms, particularly most new plant varieties, and assures that these new varieties are as safe to use in agriculture as traditional varieties (the term "genetically engineered" means those organisms derived through the use of recombinant DNA techniques).

  The development process for a new test organism typically involves steps in which the new organism (which we call a "regulated article") leaves the lab in which it's developed and is imported or moves interstate or is planted in the open environment. Those actions require permission from APHIS, in essence a certification that the action will be performed in a safe manner. As testing proceeds, an applicant gathers information typically to establish for him/herself that the product has the new intended property, and also gathers information to demonstrate that the organism is safe to grow in the environment. When enough information is gathered, the applicant petitions APHIS for a Determination of Nonregulated Status.

  USDA procedures provide different options for the conduct of field trials. Our regulatory approach incorporates the use of performance standards which focus on results, rather than design standards. For example, APHIS has two options under which applicants can seek regulatory approval to conduct field trials. One is our notification procedure, under which there are clear eligibility criteria for its use and performance standards for assurance of safety. The other is our original, traditional permitting procedure which continues to be required for some field trails that are not covered under notification, such as those involving genes encoding products intended for pharmaceutical use.

  The streamlined notification alternative does not compromise safety. Field tests under either option must be performed at comparable levels of confinement and care, standards that we have spelled out clearly. These standards have been demonstrated to be both sufficient to ensure that field tests are safely conducted and also achievable in practice. The standards have been met in each of the field trials involving transgenic plants that have been conducted in the US and its territories.

  Under notification, it is the applicant's responsibility to certify that he or she will adhere to a set of performance standards. USDA officials, as well as our State counterparts, have the option to inspect test sites at any time to verify that those standards are being met and maintained. We never lose the option of requiring additional information from an applicant about the conduct of the trial if we have some concern that in the particular instance a performance standard may be difficult to meet.

B. Permit (allow) commercialization of new engineered crop

  As a point of clarification, we use the term "permit" for field testing and "petition" for the process of deregulation of an engineered plant.

  As field testing proceeds, an applicant gathers information typically to establish for him/herself that the product has the new intended property, and also gathers information to demonstrate that the organism is safe to grow in the environment. When enough information is gathered, the applicant petitions APHIS for a Determination of Nonregulated Status. APHIS announces receipt of the petition, solicits public comment, and reviews the submitted petition information as well as other scientific information our scientists obtain.

  If we agree, we issue the determination, along with a Finding of No Significant Impact under the main environmental statute in the United States, called the National Environmental Policy Act (NEPA). All Federal regulatory agencies have to comply with NEPA for any regulatory action that they take. Once such a Determination of Nonregulated Status is issued, the new variety or plant line may be treated, from USDA's perspective, like any other variety of the crop: i.e., it may be grown, tested, or enter traditional crop breeding programs without any other special oversight on the part of APHIS. Once any other requirements from other agencies (such as the FDA or EPA) are satisfied, it can enter into commerce and be sold or, if it's a commodity like corn, perhaps mixed in silos with other varieties.

  In the US, therefore, new products destined for commodity streams are grown by farmers, shipped to silos or grain elevators, and shipped either directly to processors, or to container ships and then to processors, with each of those steps again usually based on independent contracts between two independent entities. These steps are only regulated by the standard procedures that govern the shipment of the unmodified commodity.

C. What is the legal standing of a deregulated crop?

  Once such a Determination of Nonregulated Status is issued, the new variety may be treated, from USDA's perspective, like any other variety of the crop: it may be grown, tested, or enter traditional crop breeding programs without any other special oversight on our part. A new variety is not used as food or feed unless the applicant has completed the consultation with FDA. If the plant is pest resistant or herbicide tolerant, EPA approval of the plant, or changes to the list of allowed uses for the particular herbicide, may also be required.

D. Do you monitor such crops?

  To date, no post commercialization monitoring has been found to be necessary and therefore has not been required by USDA.

E. Are these traceable?

  The USDA does not require that applicants provide us any unique molecular tag that would allow identification of a specific engineered seed in a mixture of engineered and nonengineered seeds.

F. If there is a problem with a crop, is there a way of withdrawing the exemption?

  Yes, USDA has the authority to regulate any plant that poses a plant pest risk.

NEW QUESTION

  12. Why did the US decide to use existing laws to regulate the products of biotechnology? Why did the US develop new regulations under these laws?

Answer:

  The United States believes that the use of existing health and safety laws provided more immediate regulatory protection and certainty than was possible with new legislation specific to biotechnology. Moreover, there did not appear to be an alternative, unitary statutory approach because the broad spectrum of products obtained through genetic engineering cuts across many different types of products regulated by different agencies. The United States believes that the new techniques of genetic engineering are an extension of biotechnology in general and, thus, new products developed through these techniques are extensions of existing product classes.

EXEMPTIONS

  13. Could there be any GM plants which would not require surveillance of any kind from the USDA; for example, a flower modified by using a gene gun?

Answer:

  In the sense of "surveillance" as regulatory oversight:

  A regulated article is an organism that has been genetically engineered (using recombinant DNA techniques) from a donor organism, recipient organism, vector or vector agent that is a plant pest or contains plant pest components. Other genetically engineered organisms may be regulated articles if they have been genetically engineered using unclassified organisms or if APHIS determines that the genetically engineered organism is a regulated article.

  Thus, somaclonal variants and protoplast fusion techniques do not meet our definition of "genetically engineered." Some generically engineered plants do not contain any plant pest components. For field testing, however, companies do submit voluntarily for APHIS' approval for field testing of all engineered plants, irrespective of whether they contain plant pest components. To date, all commercialized engineered plants have met the definition of regulated article and have been reviewed by APHIS.

RESPONSIBILITIES

  14. Can you explain the different responsibilities of the USDA, the EPA and the FDA when considering the use of GM products? Does an applicant apply to each agency, or is there a central "clearing house" for the product—i.e., does deregulation by the USDA imply clearance for food, feed or drug use?

Answer:

  The Agencies primarily responsible for regulating biotechnology in the United States are the US Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Products are regulated according to their intended use, with some products being regulated under more than one agency.

  Before commercialization, genetically engineered plants/organisms must conform with standards set by State and Federal marketing statutes such as State seed certification laws, the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the Federal Plant Pest Act. There are no national requirements for varietal registration of new crops.

  Each US agency regulates GM products under separate statutory authority. Therefore, firms apply separately to the relevant agency depending on the nature or characteristics of the product.

  Here are some examples of common types engineered plants and which Agency has regulatory responsibility. This information is available at United States Unified Home page for biotechnology at http://www.aphis.usda.gov/biotech/OECD/usregs.htm.


New trait/organismRegulatory review
conducted by
Reviewed for

Viral resistance in food cropUSDA Safe to grow
EPASafe for the environment
FDASafe to eat
Herbicide tolerance in food cropUSDA Safe to grow
EPANew use of companion herbicide
FDASafe to eat
Herbicide tolerance in ornamental crop USDASafe to grow
EPANew use of companion herbicide
Modified Oil content in food cropUSDA Safe to grow
FDASafe to eat
Modified flower color ornamental cropUSDA Safe to grow


A. APHIS responsibilities

  Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting US agriculture from pests and diseases. Under the authority of the Federal Plant Pest Act, APHIS regulations provide procedures for obtaining a permit or for providing notification, prior to "introducing" a regulated article in the United States. Regulated articles are considered to be organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. The act of introducing includes any movement into (import) or through (interstate) the United States, or release into the environment outside an area of physical confinement. The regulations also provide for a petition process for the determination of nonregulated status. Once a determination of nonregulated status has been made, the product (and its offspring) no longer requires APHIS review for movement or release in the United States.

B. EPA responsibilities

  In the area of agricultural biotechnology, EPA currently regulates the following types of products: "plant-pesticides", EPA's term for substances in plants (and the genetic material necessary to produce them) that humans intend to use to prevent, destroy, repel or mitigate a pest; used for example to protect crop plants in the field or for post-harvest protection; plant-pesticides in food; microorganisms used as pesticides; microorganisms used for enhanced nitrogen fixation.

  Plant-pesticides: The term "plant-pesticides" is the designation EPA gives the substances (and the genetic material necessary to produce them), that plants produce for protection against pests. In 1994, EPA made the interpretation that these substances, produced and used in living plants, are pesticides if humans intend to use them for "preventing, destroying, repelling or mitigating any pest".

  EPA regulates use of pesticides, including plant-pesticides, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) through a registration process. No person may distribute or sell in the United States any pesticide that is not registered or exempted from the requirement of registration. Before a pesticide can be registered, it must be shown that when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects to human health or the environment.

  Since 1994, EPA has registered eight plant-pesticides. To date, the plant-pesticides registered by EPA have been insecticidal proteins, of bacterial origin, which are regulated under FIFRA when they are formulated in products to be sprayed/dusted on plants. Under FIFRA, EPA performs an assessment of both risks and benefits associated with use of the pesticide using data submitted to EPA by registrants, and on other available information from scientific literature. Under its approach, EPA registers the plant-pesticide for use in a crop. It does not regulate the plant, per se. For example, EPA has registered a delta-endotoxin from the bacterium Bacillus thuringiensis for use in cotton against certain lepidopteran pests (certain caterpillars and moths).

  EPA is also responsible for regulating plant-pesticides in food under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDDCA). Before food containing a plant-pesticide can be marketed, FIFRA and FFDCA require that EPA establish a tolerance (i.e., a limit on the amount of pesticide residue that may be in food) or establish an exemption for the plant-pesticide from the requirement of tolerance. Food includes articles used for food or drink by humans or other animals. A food containing a plant-pesticide may not be moved in interstate commerce without an appropriate tolerance or an exemption from the requirement of a tolerance.

  EPA is currently using regulations originally drafted for chemical pesticides to regulate plant-pesticides. EPA wishes to issue regulations specifically tailored to plant-pesticides. In 1994, EPA proposed several regulations to begin this tailoring for plant-pesticides. EPA intends to issue these regulations in final form in 1998.

  FIFRA gives EPA the authority to issue "Experimental Use Permits" (EUP) to allow field testing in order to gather the data necessary for registration. Under current regulations, potential registrants apply for a permit when the testing occurs on 10 acres or more of land (or one surface acre of water). EPA has issued a number of EUPs for field testing of plant-pesticides.

  Microorganisms used as pesticides: FIFRA gives EPA the authority to regulate all pesticides, no matter how they were made or their mode of action. The first registration of a microorganism used as a pesticide occurred in the United States in 1948. To date, hundreds of pesticide formulations, based on some 20 different microorganisms, have been registered. Regulations appropriate to the characteristics of microbial pesticides are in place under both FIFRA and FFDCA section 408.

  The FFDCA section 408 requirements apply to microbial pesticides in food. Regulations for field testing of microbial pesticides are in place.

  Micro organisms used for enhanced nitrogen fixation: EPA regulates this type of product under the Toxic Substances Control Act (TSCA) when the micro organism is "new" within the meaning of TSCA. "New" micro organisms are those formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. TSCA excludes from its jurisdiction products covered by FFDCA and FIFRA. Thus, it does not cover pesticides, foods, drugs or cosmetics. In the area of agricultural technology, the only product EPA has reviewed to date are micro organisms used for enhanced nitrogen fixation. EPA has, however, reviewed micro organisms used for other types of applications, e.g., bioremediation and production of speciality chemicals.

  TSCA gives EPA broad authority to gather information on and evaluate the risks of chemical substances and mixtures of chemical substances. It also gives the Agency the authority to regulate identified risks. EPA has made the interpretation that living organisms are mixtures of chemical substances and thus subject to TSCA.

  EPA's regulations for micro organisms under TSCA address both field testing and commercial use.

C. FDA responsibilities

  The FDA is responsible for food safety and labelling for all foods, food ingredients, and additives (domestic and imported), except for meat and poultry products which are regulated by the USDA. Thus, the FDA's responsibility includes all fruits, vegetables, cereals, and by-products such as vegetable oils and food starch; milk; fin fish and shell fish; and flavours, preservatives, sweeteners, and other additives used in food. The FDA also regulates drugs used in animals, including food producing animals (e.g., rBST used to increase milk production) and human drugs and biologicals produced from plants and animals.

D. Does deregulation by the USDA imply clearance for food, feed or drug use?

  FFDCA does not give EPA the authority to delegate its responsibilities for plant-pesticides in food or feed to USDA. EPA has not delegated its responsibility under FIFRA for plant-pesticides or micro organisms to USDA. In the case of FDA, deregulation by APHIS does not imply clearance as food, feed, or drug.

WIDER ISSUES

  16. Does the US only assess products for safety, or would other issues be considered? Could a permit be refused, or growing conditions imposed, if an adverse impact on the environment were thought possible? By whom?

    Would the US take into account the presence of alternative equivalent products already on the market? Does your risk assessment consider the risk to the non-agricultural environment and could a permit be refused if an adverse impact on the environment were thought possible? If this is not the responsibility of USDA—APHIS, whose responsibility is it?

Answer:

A. APHIS

  APHIS' analyses are based on the principle that: the environmental risk that may be posed by a certain use of a particular organism will depend on: the properties of the organism, the way the organism is to be used (including whether the organism is to be used under containment or in the context of an environmental release), and safeguards that are built into experimental design or conditions of use.

  We have worked closely with member countries of the Organisation for Economic Co-operation and Development, the OECD, and in other fora, to bring about international consensus on the safe development, testing, and use of genetically modified plants and microorganisms.

  In performing risk assessments, we have recognised that it is necessary to identify, and focus in on, specific issues that are potential components of risk based on the particular organisms in question or the particular use; for example, plants intended for use in agriculture, or to be eaten as food, or used to make ingredients in food. To identify these risk components, it is necessary to start with a good understanding of the existing traditional knowledge base and of the procedures that are routinely carried out in the course of developing any new crop variety that is released for commercial use. This knowledge serves as a baseline to decide whether any identified risk is significantly changed in potential magnitude from any well-known one that is part of established practice.

  How are environmental risk assessments performed? Broadly speaking, we follow Annex 3 of the UNEP Guidelines for Safety in Biotechnology, which lays out the broad steps in biosafety review. These can be paraphrased as:

    (1)  identifying hazards;

    (2)  assessing actual risks that may arise from the identified hazard;

    (3)  determining how identified risks can be managed and whether to proceed with proposed action;

    (4)  comparing the assessed risks with those posed by actions with comparable organisms.

  In our risk assessment processes, we focus on the key concept of familiarity. In 1989 National Research Council, an arm of the US National Academy of Sciences, published its report entitled, "Field Testing Genetically Modified Organisms." One conclusion reached was that the use of plants modified by classical breeding techniques for field testing has a history of safe use. That crops modified by engineering should pose risks no different from those modified by classical genetic methods or similar traits. Thus, if the genetically modified plant is phenotypically similar to a plant that has been (or could be) bred by traditional breeding techniques this parallel association is called familiarity.The concept of familiarity allows regulators to draw on past experience with introduction of modified plants into the environment. Familiar does not necessarily mean safe. It does mean that the level of risks associated with the introduction of new pest resistance genes into plants by classical methods and the evaluation of new cultivars by national variety registration agencies, has made the introduction into the environment of these types of modified plants of negligible risk. Other important familiarity factors are whether the plant is new to the particular environment where it is intended to grow, the nature of the trait (gene), and that the evaluations should be made on a case-by-case basis. All engineered crop plants that have been commercialised in the United States to date have been grown in the same environment that their nonmodified progenitors were grown in. The OECD has also recognised the concept of familiarity as a basis for evaluation of genetically modified crops.

  What are the sorts of issues that we concern ourselves with, with respect to genetically engineered plant species? The types of safety issues that are raised by these plants are no different in kind from those with which we are already familiar from traditional breeding, though the magnitude of any particular risk may differ. Apart from the case where the introduction of a wholly new species into a specific environment is under consideration, the environmental issues with respect to plants center around their potential for survival, and even more particularly, the potential for enhanced weediness.

  Specifically, do the introduced traits specifically affect the ability of the plant to survive stresses, or to disseminate pollen or other propagules, or to confer increased survival on those propagules, or to resist particular pests known to play a major role in limiting the plant's survival outside of cultivation? Gene movement, however, is not in and of itself a risk. Genes move freely around via pollen, and interbreeding between compatible species is a matter of statistics, wind currents, and pollinators. USDA's focus is on the specific trait, potential recipients of that trait, and the potential effects.

B. EPA

  EPA will refuse to register a pesticide if the Agency determines use of the product could result in an unreasonable adverse effect. EPA also has the authority to make a registration conditional on the use of specified growing conditions. Such conditions would be imposed if the Agency determined that the conditions were needed to ensure that no unreasonable adverse effects occurred. EPA statutes give EPA authority to address all aspects of the environment.

IMPORTS

  17. Do the US agencies accept products without further scrutiny that have undergone safety assessment procedures in other countries? For example, would you accept products from (a) Canada; (b) Mexico; or China?

    NIH Guidelines explicitly indicate that products in confinement would be acceptable if the safety assessments are equivalent to those supposedly done in US laboratories.

Answer:

USDA/APHIS

  USDA/APHIS has allowed commodities that have undergone safety assessments in Canada to enter the US for processing (not for planting). Our approval was based on our experience with similar types products and our analysis of the Canadian decision document on these commodities. Since we have had bilateral negotiation with Canada for more than a decade, and Canada has reviewed many of the same products that we have, we have a deep understanding of the similarities in our review processes. Our approval was contingent on completion of the food safety consultation process for the commodity at FDA (the plants were not engineered to produce a substance with pesticide activity).

  In addition, APHIS has allowed carnations engineered for altered flower color to be imported as cut flowers. In their customary use, these cut flowers are virtually nonviable. Regulated articles must be viable.

EPA

  Under FIFRA, no person may distribute or sell in the United States any pesticide that is not registered or exempted from the requirement of registration. Thus, pest resistant, genetically modified seeds being imported into the United States to be planted would need to comply with the registration requirements under FIFRA. Commodities, not intended to be planted (i.e., used as a pesticide) would not have the same requirements under FIFRA as imported seeds.

  Under FFDCA, a food containing pesticide residues may not be moved in interstate commerce without an appropriate tolerance or an exemption from the requirement of a tolerance. Under TSCA, an importer must submit a notice to EPA 90 days before importation commences.

FDA

  The FDA believes that it is prudent practice for firms, both domestic and foreign, to consult with the FDA regarding GM products prior to commercial distribution in the US. Products that comply with the Federal Food, Drug, and Cosmetic Act may be imported into the US. The FDA has published guidance for industry and procedures by which firms may consult with the FDA.

NEIGHBORING COUNTRIES

  18. Is there any procedure for consulting neighboring countries prior to approval for commercialisation? For example, would the US consult Mexico before crops are approved where Mexico is the center of origin?

    Note for questioner: All the maize in the world originates from Mexico and many Mexican plants and weeds are thus related to it. Pollen could blow across the border from the US or farmers could illegally carry plants across the border into Mexico. The chance of the GM maize crossing with Mexican relatives is thus much higher than anything that might happen in the US and it follows that the super weed problem is potentially much greater than, for example, between the US and Canada. "Genetic pollution" is also an issue.

Answer:

  For more than a decade, USDA/APHIS has had yearly bilaterals with Canada and Mexico (individually) on issues related to field testing and commercialization of engineered plants. Other discussions have been held trilaterally as members of NAPPO (North American Plant Protection Organisation). USDA has conducted workshops to share its experiences in reviewing transgenic plants during field testing and commercialization phases.

  For those countries with which the US shares ocean borders, USDA has participated in ongoing bilateral discussions on biotechnology and the environment with Directorate General XI of the European Commission. As a member of the US/EU Biotechnology Technical Working Group, USDA has been very active in sponsored workshops on environmental reviews associated with field testing and commercialisation.

  USDA has also been an active member in APEC, participating in similar workshops on evaluating environmental safety prior to commercialisation of transgenic plants.

  USDA/APHIS provides list of all field tests and plants under review for deregulation at our home page http://www.aphis.usda.gov/biotech/. This list is updated daily.

ZONING

  19. Can a crop be given permission for commercialization in one part of the USA and not in another due to climactic or other scientific reasons?

    What conditions could be applied if this were a federal requirement? Could any individual State refuse to allow cultivation of a GM crop even though permission had been given nationally, or could they impose stricter conditions than those imposed under Federal law.

Answer:

  To date, all USDA approved engineered plants can be grown anywhere in the US. The USDA has authority to restrict movement of plants for scientific-based (e.g., phytosanitary) reasons. The deregulation of an engineered plant by APHIS is just the first step in its ultimate commercialization. EPA can geographically restrict the authorization of pesticides within the United States. Besides EPA and FDA oversight, some plants may have to be further tested under the State variety registration laws. All engineered plants must meet the same State imposed regulation for the specific plants. For example. all engineered potatoes must meet pathogen indexing requirements.

  EPA has issued a registration for a plant-pesticide (in corn) allowing seed containing the plant-pesticide to be sold to farmers in most of the United States for planting, except for some cotton growing areas in the southern United States. This geographic limitation on sales was placed on the registration to reduce selection pressure on an insect pest that feeds on both corn and cotton. This measure was taken to attempt to manage the tendency of insect pests to become resistant to pesticides, in this case resistance to a delta-endotoxin from the bacterium Bacillus thuringiensis (Bt).

AGRICULTURAL BIODIVERSITY

  20. If many farmers choose to grow a GM variety to the exclusion of others, there may be a reduction in agricultural biodiversity. Are you (or the EPA) concerned about this, and what can be done to maintain diversity?

Answer:

  In the early 1970s, the US National Academy of Sciences addressed the question, "How uniform genetically are the crops upon which the nation depends and how vulnerable are they to epidemics? Their answer was that "most major crops are impressively uniform genetically and impressively vulnerable." For example, 53 per cent of the cotton crop is planted to only three varieties and 71 per cent of the corn to six varieties. APHIS believes that most of the major crops are just as genetically uniform, if not more so, than they were 25 years ago. The factors that govern farmer acceptance of new crop varieties are not in any way unique to GM varieties. Rather, the introduction of new genes by engineering could tend to diversify the genetic makeup of major crops in the United States.

APPENDIX

BIOTECHNOLOGY AGRICULTURAL PRODUCTS ON THE MARKET

  Liberty LinkTM Corn (Produced by AgrEvo®—Introduced in 1997, Liberty LinkTM Corn allows growers to apply Liberty herbicide over the top during the growing season. This results in weed control with no effect on crop performance or yield. Liberty LinkTM Corn hybrids are offered by seed company partners; LibertyTM herbicide is offered by AgrEvo®.

  Liberty LinkTM Canola (Produced by AgrEvo)®—Introduced in 1995, Liberty LinkTM Canola allows growers to apply LibertyTM herbicide over the top during the growing season. This results in weed control with no effect on crop performance or yield.

  IMI-CORN® (Produced by American Cyanamid)—Introduced in 1992, imidazolinone-tolerant and—resistant corn allows growers to apply the flexible and environmentally friendly imidazolinone herbicides to corn. Registration of LIGHTNINGTM herbicide, a new imidazolinone specifically for use on IMI-CORN®, was approved by the EPA on March 31, 1997. One post-emergence application of LIGHTNINGTM herbicide provides both contact and residual control of broadleaf and grassy weeds, resulting in maximum yield potential.

  IMITM Canola Seed (Produced by American Cyanamid)—Introduced in 1995, imidazolinone—tolerant canola allows growers to apply environmentally friendly imidazolinone herbicides to canola. In Canada, registration of ODYSSEYTM herbicide, a new imidazolinone for use on imidazolinone-tolerant canola, was approved on April 4, 1997. One post-emergence application of ODYSSEYTM herbicide provides both contact and residual control of hard-to-control broadleaf and grassy weeds, resulting in maximum yield potential.

  Freedom IITM Squash (Produced by Asgrow)—Squash with a natural resistance to plant viruses.

  BXN® Cotton (Produced by Calgene, Inc)—BXN® cotton plants that require less chemical herbicides.

  FLAVR SAVRTM Tomato (Produced by Calgene, Inc)—The Flavr SavrTM is a high-quality, fresh market tomato that has been modified using antisense technology[1] to ripen on the vine.

  Laurical® (Produced by Calgene, Inc)—A less-expensive source of high-quality raw materials for soaps, detergents and cocoa butter replacement fats. Rapeseed plants with more than 35 per cent laurate in oil have been produced.

  Novartis Maximizer TM Hybrid Corn (Produced by Novartis)—This corn is modified to have natural protection against the European corn borer, one of the most devastating insect pests in modern US agriculture.

  DEKALBTM Insect-Protected Hybrid Corn (Produced by DEKALB Genetics Corporation)—Approved in 1997, select DEKALB leader hybrids are now available with built-in protection against the European corn borer.

  DEKALB GR Hybrid Corn (Produced by DEKALB Genetics Corporation)—Approved in 1996, DEKALB GR hybrids provide growers the added weed control benefits of over-the-top glufosinate herbicide application during the growing season.

  FreshWorld Farms® Tomato (Produced by DNAP Holding Corporation)—The FreshWorld Farms® tomato is a premium, fresh market tomato developed through somaclonal variation[2] to have superior color, taste and texture and a 10- to 14-day shelf life.

  FreshWorld Farms Endless Summer® Tomato (Produced by DNAP Holding Corporation)—The Endless Summer® tomato is a genetically engineered version of the FreshWorld Farms® tomato on the market since April 1993 and shares its superior colour, taste and texture. What's new is a greatly extended shelf life of more than 30 to 40 days after harvest. Company scientists used Transwitch® technology to suppress production of ethylene, the hormone that causes tomatoes and other fruits to ripen. It is the company's first whole-food product developed through recombinant DNA technology.

  FreshWorld Farms® Carrot Bites (Produced by DNAP Holding Corporation)—FreshWorld Farms® carrot bites are crisp, juicy baby whole carrots that are peeled and washed, ready-to-eat, in one-pound bags.

  FreshWorld Farms® Sweet Mini-Peppers (Produced by DNAP Holding Corporation)—The FreshWorld Farms® sweet mini-pepper has a novel sweet taste, deep red color and is nearly seedless. It was developed through another culture, an advanced breeding technique that captures and stabilizes preferred characteristics such as taste, texture and low seed count.

  FreshWorld Farms® Cherry Tomatoes (Produced by DNAP Holding Corporation)—The FreshWorld Farms® cherry tomato is specially bred for superior taste, color and texture. It is sold through distributors and supermarket chains in the mid-Atlantic, Northwest and Midwest regions.

  High Oleic Acid Soybeans (Produced by DuPont Agricultural Products)—These soybeans produce an oil containing higher levels of oleic acid, (82-85 per cent) than found in currently available soybean oil (24 per cent) and also containing lower levels of saturated fat. The oil will fit applications that require stability without the need of chemical hydrogenation.

  High pH Tolerant Corn Hybrids (Produced by Garst Seed Company)—These corn hybrids are capable of growing successfully on the severely alkaline soils that characterise the western United States corn belt.

  Gray Leaf Spot Resistant Corn Hybrids (Produced by Garst Seed Company)—Corn hybrids tolerant to the disease Cercospora ~spp., which attacks corn hybrids in the central and southeastern corn belt.

  G-StacTM Corn Hybrids (Produced by Garst Seed Company)—Corn hybrids featuring "stacked" genes providing multi-task capability. For example, hybrids that contain genes for the control of European corn borer (Bt), genes for resistance to Liberty herbicide and genes for resistance to imidazolone herbicide all in the same corn hybrid.

  Chymogen® (Produced by Genencor International and Marketed by Chr. Hansen's)—Chymogen is the biotechnology-produced version of an enzyme (chymosin) found in calves that makes milk curdle to produce cheese. Because it is produced through biotechnology, it is purer, more plentiful and eliminates variability in the quality and availability of calves' stomachs. It is used in approximately 60 per cent of all hard cheese products made today.

  Bollgard® Insect-Protected Cotton (Produced by Monsanto)—Introduced in 1996, cotton with Monsanto's Bollgard gene is protected against cotton bollworms, pink bollworms and tobacco budworms.

  New Leaf® Insect-Protected Potato (Produced by Monsanto)—Introduced in 1995, the NewLeaf potato is the first commercial crop to be protected against insect pest through biotechnology. Thanks to a gene from a variety of the Bt bacteria, the NewLeaf Potato is resistant to the Colorado potato beetle.

  Posilac® Bovine Somatotropin (Produced by Monsanto), Recombinant Bovine Somatotropin, (rBST)—rBST is a naturally occurring protein hormone in cows that induces them to produce milk. rBST improves milk production as much as 10 to 15 per cent and is now used by farmers whose herds represent over 30 per cent of the nation's cows. It was approved by the FDA in 1993.

  Roundup® Ready Cotton (Produced by Monsanto)—Approved in 1996, Roundup Ready cotton tolerates both topical and post-directed applications of Roundup herbicide.

  Roundup Ready® Soybeans (Produced by Monsanto)—Introduced in 1996, Roundup Ready soybeans allow growers to apply Roundup herbicide over the top during growing season. The result is dependable, superior weed control with no effect on crop performance or yield.

  YieldGard® Insect-Protected Corn (Produced by Monsanto)—The YieldGard gene provides control of the European corn borer throughout the corn planting season.

  NatureGard® Hybrid Seed Corn (Produced by Mycogen)—These corn plants express a protein toxic to European corn borer that will allow for less use of insecticides.

  Chy Max® (fermentation-derived) (Produced by Pfizer, Marketed by Chr Hansen's)—Chy Max® is another version of chymosin, an enzyme that causes milk to coagulate. It is an advanced fermentation ingredient that is of higher purity, quality and activity than natural rennet.

  VitroGraft® Grapevine Plants (Produced by Vinifera, Inc, a wholly owned subsidiary of Epitope, Inc)—VitroGraft® grafted grapevine plants represent the highest-quality planting material available to the US grapevine industry. Rootstock and scion materials are in-house disease tested and grafted using proprietary green-grafting techniques.

  Increased Pectin Tomatoes (Produced by Zeneca Plant Sciences)—Tomatoes that have been genetically modified to remain firm longer and retain pectin during processing into tomato paste.

Source: BIO Member Survey

AGRICULTURAL BIOTECHNOLOGY PRODUCTS EXPECTED ON THE MARKET WITHIN SIX YEARS

  Genetically Engineered Cotton Fiber (Produced by Agracetus, Inc.)—This biotech product will have enhanced fiber performance, reduce dye-shop pollution and improve textile manufacturing efficiency.

  Liberty LinkTM Soybean, Cotton Canola, Sugar Beet and Rice (Produced by AgrEvo®)—These Liberty Link TM crops will be available in Canada and/or the United States. Like Liberty LinkTM corn, when used together with LibertyTM herbicide, they will allow farmers greater flexibility and environmental soundness in weed control.

  Seed Link Corn (Produced by AgrEvo®)—These plants provide a more reliable pollination control system for corn seed production. The use of the Seed Link System eliminates the need for hand or mechanical detasseling.

  Insect-Protected Corn (Produced by AgrEvo®/Plant Genetics System)—These plants express a protein toxic to various Lepidopteran pests,which allow less insecticide usage. Unlike insect-protected crops on the market today, the toxin in these plants binds to a different site in the insect's mid-gut, providing an advantage to insect-resistance management programs.

  IMITM Wheat Seed (Produced by American Cyanamid)—American Cyanamid is co-operating with universities, public and private laboratories and seed companies to develop wheat varieties tolerant to imidazoline herbicides. Imidazolinone herbicides are flexible, environmentally friendly and provide contact and residual control of weeds common to wheat production, including ones not controlled by currently registered wheat herbicides.

  IMITM Rice Seed (Produced by American Cyanamid)—American Cyanamid is co-operating with universities, public and private seed companies to develop rice varieties tolerant to imidazolinone herbicides. Imidazolinone herbicides are flexible, environmentally friendly and provide superior contract and residual control of weeds.

  IMITM Sugar Beet Seed (Produced by American Cyanamid)—American Cyanamid is co-operating with universities and seed companies to develop sugar beet varieties tolerant to imidazolinone herbicides. Imidazolinone herbicides are flexible, environmentally friendly and provide superior contact and residual control of weeds.

  BXN plus Bt Cotton (Produced by Calgene, Inc)—These cotton plants will require less chemical herbicide and insecticide to lower grower input costs and to achieve greater crop yield. Initial varieties are in field trials. Market introduction is planned for 1998.

  Insect-Protected Tomatoes (Produced by Calgene, Inc)—These tomato plants will require less chemical insecticides to achieve higher yield.

  High-Stearate Oil (Produced by Calgene, Inc)—High-stearate oil is an ingredient in margarine, shortenings and other food ingredients that would not require hydrogenation, thus reducing the expense.

  High-Myristate Oil (Produced by Calgene, Inc)—This will be a less-expensive and more-abundant source of raw materials for soaps and detergents.

  Medium Chain Fatty Acids/Medium Chain Triglycerides (Produced by Calgene, Inc)—This will be a less-expensive source of raw materials for high-performance lubricants, nutritional formulas and high-energy foods.

  High Sweetness Tomato (Produced by Calgene, Inc)—Tomato plants that produce high-flavor tomatoes.

  Disease-Resistant Strawberry (Produced by Calgene, Inc)—Strawberry plants that give improved crop yields and longer shelf life.

  High Sweetness Strawberry (Produced by Calgene, Inc)—High quality fresh strawberries with improved flavor.

  Genetically Engineered Fruits and Vegetables with Longer Post-Harvest Shelf Life (Produced by Agritope, Inc, a wholly owned subsidiary of Epitope, Inc.)—Using ethylene-control technology, Agritope, Inc, has created delayed-ripening, longer-lasting tomatoes, raspberries and strawberries.

  AquaAdvantage® Salmon, Tilapia, Trout, Flounder (Produced by A/F Protein)—The AquaAdvantage® salmon, tilapia, trout and flounder have the capability of growing from egg to market size (eight to 10 lb) in one to one and a half years. Conventional fish breeding techniques require three years to bring a fish to market. This new salmon could make fish more plentiful, decrease overfishing of wild salmon and lower consumer costs. A/F Protein expects to introduce the AquaAdvantage® salmon within four to six years to a public for whom salmon is an increasingly popular food.

  Ripening-Controlled Cherry Tomatoes (Produced by DNAP Holding Corporation)—Using the same technology as in its Endless SummerTM fresh market tomato, the company has developed cherry tomatoes with longer market life, improved flavor and better harvest traits through ripening control.

  Seedless Mini-Melon (Produced by DNAP Holding Corporation)—This mini-melon is specially bred for its convenient single-serve size and flavor.

  Sweeter Peas (Produced by DNAP Holding Corporation)—Sugar snap peas have been modified for sweeter flavor and higher yield by controlling the conversion of sugar to starch using Transwitch® technology. Pea plants are currently in field evaluations.

  Firmer Peppers (Produced by DNAP Holding Corporation)—This sweet pepper has been modified using Transwitch® technology to remain firmer after harvest. Pepper plants are currently in field evaluations.

  Sweeter Peppers (Produced by DNAP Holding Corporation)—This pepper has been modified to be sweeter and tastier by overexpressing a gene for sweetness. Pepper plants are in early stages of seed increase and field evaluation.

  Ripening-Controlled Bananas and Pineapples (Produced by DNAP Holding Corporation)—Using the same ripening control technology as in its Endless SummerTM tomato, the company is developing banana and pineapple varieties with extended market life.

  Strawberry (Produced by DNAP Holding Corporation)—The company is improving the market life of fresh strawberries by using Transwitch® technology to keep fruit firmer after harvest and adding genes to resist disease.

  High-Solids Potato (Produced by Monsanto)—Monsanto has developed a higher-solids (or starch content) potato by introducing a starch-producing gene from a soil bacteria into a potato plant. With the reduction in the percentage of water in the genetically improved potato, less oil is absorbed during processing, resulting in a reduction of cooking time and costs, better-tasting french fries and an economic benefit to the processor.

  Roundup Ready® Canola (Produced by Monsanto)—Roundup Ready canola allows growers to apply Roundup® herbicide over the top of the crop during the growing season, for superior weed control with enhanced crop safety.

  Roundup Ready® Sugar Beets (Produced by Monsanto)—Roundup Ready sugar beets are tolerant of Roundup Ready® herbicide and provide growers with a new weed-control option while the crop is growing.

  Roundup Ready® Corn (Produced by Monsanto)—Roundup Ready corn allows over-the-top applications of Roundup® herbicide during the growing season for superior weed control.

  New-Leaf® Y Insect- and Virus-Protected Potatoes (Produced by Monsanto)—These potatoes protect themselves against the Colorado potato beetle and the potato virus Y.

  Second-Generation Bollagard® Insect-Protected Cotton (Produced by Monsanto)—This cotton controls insect pests, like the original Bollagard cotton, but uses a different mode of action to help growers manage insect-resistance concerns.

  High-Stearate Soy Oil (Produced by Monsanto)—This is a functional oil with healthier properties for margarines and shortenings. High-stearate oil requires no hydrogenation and contains no trans-fatty acids, which increase cholesterol.

  Bt Sunflower, Soyabeans, Canola and Wheat (Produced by Mycogen Corp.)—These crops will express a protein toxin providing protection against various caterpillar and beetle pests.

  Fresh Market Tomato (Produced by Zeneca Plant Sciences)—Zeneca is modifying the tomatoes for enhanced flavor, color and increased antioxidant vitamin content.

  Banana (Produced by Zeneca Plant Sciences)—Zeneca is developing an inherent resistance to Black Sigatoka and modifying ripening characteristics in bananas. This will reduce the need for chemical fungicides as well as improve the agronomics of production and the quality to the consumer.

  Modified Lignin in Paper Pulp Trees (Produced by Zeneca Plant Sciences under separate agreements with Shell Forestry and Nippon Paper)—By making lignin easier to remove from cellulose—the primary ingredient in paper—paper makers can make high quality paper with less energy and bleaching, which results in benefits to both the paper processor and the environment.

Source: BIO Member Survey

BIOPESTICIDES, HERBICIDE RESISTANCE AND NATURAL PROTECTIONS FOR PLANTS

BIOPESTICIDES

  Several biopesticides[3] are in use today. Biopesticide products are based on natural agents such as microorganisms and fatty acid compounds. They are toxic only to targeted pests (such as the European corn borer) and do not harm humans, animals, fish, birds and beneficial insects. In addition, because biopesticides act in unique ways, they can control pest populations that have developed tolerance to chemical pesticides.

  One of the most common microorganisms used in biologically based pesticides is the Bacillus thuringiensis, or Bt bacterium. Several of the proteins produced by the Bt bacteria, principally in the coating the bacteria forms around itself, are lethal to individual species of insects. By using Bt bacteria in pesticide formulations, target insects can be eliminated without relying on chemically based pesticides.

  It is also possible to use pheromones in pest control. Pheromones are naturally occurring substances that insects produce to attract mates. In pest control, pheromones are used to attract insects away from crop plants. In recent years, for example, pheromone-based traps were used to control fruit fly infestations in California. European corn borers, one of the most prevalent pests, costs the nation $1.2 billion in crop damage each year.

HERBICIDE RESISTANCE

  Planting conditions good for crop plants will also sustain unwanted weeds that can reduce crop yield. To prevent this, herbicides are sprayed on crops. Often, herbicides must be applied several times during the growing cycle, at great expense to the farmer and possible harm to the environment.

  Using biotechnology, it is possible to make crop plants tolerant of specific herbicides. When the herbicide is sprayed, it will kill the weeds but have no effect on the crop plants. This lets farmers reduce the number of times herbicides have to be applied and reduces the cost of producing crops and damage to the environment.

NATURAL RESISTANCE TO PESTS AND VIRUSES

  We can, today, transplant the genetic information that makes a given bacterium—such as the Bt bacterium—lethal only to a specific insect (but not to humans or animals) into plants on which that insect feeds. The plant that once was a food source for the insect now kills. This process, which has no effect whatsoever on humans or other species, means that it becomes less necessary to spray crops with chemical pesticides to control infestations.

BIOPESTICIDE PRODUCTS CURRENTLY ON THE MARKET

  LaginexTM Bioinsecticide (Produced by AgraQuest, Inc)—This product is effective for controlling a wide range of mosquito larvae in rice, wetlands and other bodies of water.

  Disease Free KleentekTM (Produced by Crop Genetics International)—This product increases yield of sugar per acre.

  Spod-XTM (Produced by Crop Genetics International)—Spod-XTM uses a naturally occurring insect virus to control the beet armyworm. The beet armyworm is becoming resistant to many chemical insecticides. Spod-XTM is safer to use and better for the environment.

  AspireTM (Produced by Ecogen)—AspireTM is a biofungicide used to protect fresh produce from post-harvest rot. It is used on citrus, pome fruits, berries and grapes. The active ingredient is a naturally occurring yeast that is harmless to all nontargeted organisms.

  Condor® Bioinsecticide (Produced by Ecogen)—This product is effective against the tobacco budworm, cotton bollworm, the soybean looper, velvetbean caterpillar, green clover worm, gypsy moth and spruce budworm.

  Cutlass® Bioinsecticide (Produced by Ecogen)—This is a broad-spectrum bioinsecticide effective against the beet armyworm, cabbage looper, diamondback moth, cabbage webworm and imported cabbageworm.

  Otinem® Insecticide, Bee-scent® and No-Mate® (Produced by Ecogen).

  AQ-10® (Produced by Ecogen)—AQ-10® is a biofungicide that protects crops from powdery mildew. It is used on strawberries, grapes, tomatoes, cucurbits and ornamentals. It reduces the use of conventional fungicides.

  Mattch® (Produced by Mycogen)—Controls broad spectrum of caterpillars in vegetables, field crops, nuts, grapes, turf, stored grain, and ornamental and nursery crops.

  MVP® (Produced by Mycogen)—This product is used on tree fruits and nuts, vines, cotton and vegetables to control leaf-eating caterpillar pests.

  M-PerilTM (Produced by Mycogen)—This product is used on corn to combat the European corn borer.

  M-PedeTM (Produced by Mycogen)—M-PedeTM is used on fruits, vegetables, grapes and ornamentals to resist soft-body insects and powdery mildew.

  DeMosstm (Produced by Mycogen)—This product is used on roofs, buildings, sidewalks and greenhouses to resist moss, algae and lichens.

  Thinex® (Produced by Mycogen)—This product is used for blossom thinning in apples, pears and fruits.

  M/C®(Produced by Mycogen)—MC is used on vegetables to control various caterpillar pests.

Source: BIO Member Survey

BIOPESTICIDE PRODUCTS EXPECTED ON THE MARKET WITHIN THREE YEARS

  QST 153 Biofungicide (AgraQuest, Inc.)—For diseases of grapes, vegetables and fruit (downy mildews, bunch rot, gray mold and brown rot).

  QST 177 Biofungicide (AgraQuest, Inc.)—For diseases of grapes, other fruits and vegetables, turf and ornamental (powdery mildew, gray mold, scab and damping off).

  QST 776 Insect Repellent (AgraQuest, Inc.)—Natural product for repelling mosquitoes, ticks, and other biting insects.

  EcologixTM Cockroach Bait (Produced by Dominion Biosciences)—This is the first commercial product developed from a unique insect growth regulator technology. It is highly effective in eliminating insect populations, yet completely nontoxic to users, pets and the environment.

  LeoneTM Biofungicide (Produced by Dominion Biosciences)—This product controls a number of plant diseases by relying on highly active, antimicrobial redator bacteria. These naturally derived biochemicals offer a new mode of action for effective and safe control of disease-causing micro-organisms.

  CrymaxTM (Produced by Ecogen)—CrymaxTM is a genetically engineered bioinsecticide that is very effective against a broad range of pests. It will be used on vegetables, trees, nuts and vines.

  EG7826TM (Produced by Ecogen)—This will be a genetically modified insecticide that will control the fall armyworm, a major insect pest affecting sweet corn.

  ScytheTM Herbicide (Produced by Mycogen)—This is used for horticulture and landscape management to combat a broad spectrum of weeds.

Source: BIO Member Survey.

BT-BASED AND OTHER BIOLOGICAL CONTROL AGENTS

  A number of products are in development that will control insects as well as conventional insecticides, thereby reducing the use of these products.

  Bt technology is used to develop and specially formulate a line of biotoxin and fatty acid-based products for field testing in the poultry and livestock industries.

  Mycogen, Ecogen and Ciba Geigy Ag Group are three of the companies developing these products.

  Biculovirus Insecticides (Produced by American Cyanamid)—These products express insect-specific toxins and control Lepidopteran pests at levels similar to chemical insecticides.

  Agree® (Produced by Ciba Geigy Ag Group—Ciba Crop Protection)—This is a Bt-based bioinsecticide designed to control pests that affect tobacco, corn and soybean plants.

  Design® (Produced by Ciba Geigy)—Design® is a Bt-based bioinsecticide for cotton and soybeans.

  Exhibit® (Produced by Ciba Geigy)—Exhibit® is a parasitic nematode for control of insects on ornamental plants and turf.

  M-Press (Produced by Mycogen)—This product will be used to control the fall army worm in sweet corn and other vegetable crops.

Source: The Biotechnology Industry Organisation

INSECT-, VIRUS- AND HERBICIDE-RESISTANCE PLANTS UNDER DEVELOPMENT

  Herbicide-Tolerant Plants (Produced by American Cyanamid)—American Cyanamid is working within universities, public and private laboratories and seed companies to develop a number of crop plants to tolerate imidazolinone herbicides. This tolerance lets farmers use flexible, environmentally friendly herbicides while achieving cost-effective contact and residual control of weeds.

Crops under development for tolerance to imidazolinone herbicides

    Wheat

    Rice

    Sugar beets

  Herbicide-Tolerant Plants (produced by Monsanto)—Monsanto has genetically modified a number of crop plants to tolerate its Roundup® herbicide. This natural tolerance lets farmers reduce herbicide applications while achieving cost-effective broad-spectrum weed control using a product well known for its favourable environmental characteristics.

Crops tolerant to Roundup® Herbicides

    Canola/Oilseed Rape

    Corn

    Sugar beets

  Bt Cotton, Alfalfa, Canola and Sunflower (Produced by Mycogen)—Plants that express a protein toxic to various insect pests, which will allow for less use of insecticides.

HOW AGRICULTURAL BIOTECHNOLOGY IS REGULATED

  Since combining specific genes from donor and host plants does not alter the basic nature of the host plant, the result of genetic modification is predictable and can be carefully controlled. As with any new variety of food, the developers test extensively for safety, quality and other factors.

  The Food and Drug Administration (FDA) is responsible for approving the safety of all foods and new food ingredients. In addition, all producers are required to ensure the safety and quality of anything they introduce into the food supply.

  The US Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) impose safety requirements and/or performance standards on the development of pesticides, herbicides and genetically modified test crops. Examples of tests include crops with improved disease resistance and animal vaccines produced from biotech microorganisms.

  The EPA regulates the use of chemicals, including pesticides in the environment. With this authority, EPA must approve any field test of biotech products with new properties.

  The FDA may require that genetic modifications that significantly alter the nutritional value of the host food, use genetic material from outside the traditional food supply or use known allergens be subject to strict premarket testing and regulatory oversight.

  The FDA also requires that any genetically modified food product that significantly alters the host food's nutritional value or uses material from a known allergen be clearly labeled. For example, any product that used a gene from a peanut, which is a potential allergen, would be subject to testing and labeling requirements. The FDA also has the authority to order unsafe products off the market.



1   Antisense technology involves taking the gene in the tomato that is responsible for softening, creating a duplicate of that genetic sequence in reverse and inserting it in the tomato. The new genetic information effectively turns off the softening process, which allows the tomato to ripen longer on the plant. Back

2   Somaclonal variation is a biotechnology process that involves breaking a plant sample down to its individual cells, putting the cells in a growth medium and regenerating new plant clones from the cells. The new plants will have a broad diversity of characteristics. The new plants with the desired characteristics are then used to create new plant lines through traditional breeding techniques. Back

3   A biopesticide is any material of natural origin used in pest control derived from living organisms, such as bacteria, plant cells or animal cells. Back


 
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