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Agricultural publication NCR557 -- New January 1, 1995

Editor's note: This publication is currently not illustrated on XPLOR. Use the XPLOR order form to purchase the printed version of this publication, which includes illustrations.

Regulation of Genetically Engineered Organisms and Products

Glenda D. Webber
Office of Biotechnology, Iowa State University

North Central Regional Publication

Who's minding the store?

Genetically engineered products are big news these days. The agricultural, science and business sections of newspapers and magazines regularly announce the latest advancement in humankind's quest to improve nature's products. Some of these products are on the market and many more are being developed. For the nonscientist, the whole prospect of moving genes among plants and animals can be overwhelming. Consumers want and need to know who is watching out for their interests. Who can tell them whether a genetically engineered product is safe?

The United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and most state governments closely monitor the development and testing of a genetically engineered product and can provide pages of test results concerning its safety. However, in the end, only consumers themselves can decide if using a product, whether it is developed by genetic engineering or traditional methods, is right for them.

What is genetic engineering?

All living organisms are made up of cells that contain a substance called DNA (deoxyribonucleic acid). The structure of DNA molecules, whose units are called genes, contains information that is used by cells as a "recipe" for the organism. That is, the characteristics of any living thing are determined by the information in the DNA of its genes.

In the last twenty years, scientists discovered that DNA is interchangeable among animals, plants, bacteria and other organisms. In addition to using traditional breeding methods of improving plants and animals through crossbreeding and selection, scientists in some cases can now transfer the genes that determine many desirable traits from one plant or animal to another. The transfer of DNA is done by various methods, such as direct injection of cells with DNA or literally shooting cells with DNA-covered particles from a special gun. Another widely-used method is to insert the DNA into specially modified bacteria or viruses that carry it into cells they infect.

Regardless of which method is used, the general process of transferring DNA from one organism to another is called genetic engineering. Almost any desirable trait found in nature can, in principle, be transferred into any chosen organism. A plant or animal modified by genetic engineering to contain DNA from an external source is called transgenic.

What is a genetically engineered product?

A genetically engineered product is one that was developed by modifying DNA in some way. The number of genetically engineered products is increasing rapidly. Genetic engineering is being used in the production of pharmaceuticals, gene therapy, and the development of transgenic plants and animals.

Pharmaceuticals

Human drugs such as insulin for diabetics and tissue plasminogen activator for heart attack victims, as well as animal drugs such as the growth hormones bovine or porcine somatotropin, are being produced by bacteria that have received the appropriate human, cow or pig gene.

Gene therapy

Gene therapy is a new and experimental treatment. In gene therapy, a gene that is missing or is not functioning correctly is replaced with a correct gene.

The first successful gene therapy was used in 1990 to treat an immune system defect called ADA deficiency in children. Blood cells with normal ADA genes were injected into the patients' bodies where they produced enough normal cells to improve their immune systems.

Today, gene therapy clinical trials are underway to treat diseases such as malignant brain tumors, cystic fibrosis and HIV. Gene therapy techniques have captured the public's interest, and new discoveries are regularly reported by the broadcast and print media.

Transgenic plants

Transgenic plants that can tolerate herbicides, resist insects or viruses, or produce modified fruit or flowers are being grown and tested. Copies of genes for these traits have been transferred to the plants by genetic engineering techniques from other unrelated plants, bacteria or viruses. Corn plants that produce an insecticidal protein to resist European corn borers and tomatoes that can ripen longer on the vine before shipping are examples of transgenic plants that have been developed.

Transgenic animals

Transgenic animals are designed to help researchers diagnose and treat human diseases. Several companies have designed and are testing transgenic mammals that produce important pharmaceuticals in the animal's milk. Products such as insulin, growth hormone and tissue plasminogen activator that are currently produced by fermentation of transgenic bacteria may soon be obtained from the milk of transgenic cows, sheep or goats.

Why is the focus on food?

The appropriate administrative divisions of the USDA and FDA regulate the development of animal and human health products, including those developed through genetic engineering. Genetically engineered vaccines and other pharmaceuticals for humans and animals are being developed, and some, such as diabetic insulin, have been on the market for years.

The entrance of these health-related products into the marketplace usually has not generated the same level of public controversy that surrounds the proposed introduction of genetically engineered foods. For example, on November 5, 1993, the FDA announced approval of the growth hormone bovine somatotropin (bST). The product is sold commercially by Monsanto as an animal drug called POSILAC® for increasing milk production in dairy cows. Controversies concerning milk product labeling, animal health issues and economic impacts followed the FDA approval and received extensive coverage by the media. Calgene Fresh's Flavr Savr^TM tomato received similar media attention when it became the first genetically engineered fruit or vegetable to hit the market in May of 1994.

Companies have requested, or soon will ask for, regulatory approval to market leaner pork from pigs that receive porcine somatotropin (pST), and a multitude of genetically engineered fruits and vegetables, including tomatoes, potatoes, corn, squash, cantaloupe and strawberries.

Consumers need answers about the scientific development, characteristics, cost and safety of genetically engineered foods so they can make their own decisions about their use. The USDA, FDA, EPA and state governments are working with companies to supply those answers.

How does the USDA regulate genetically engineered food plants?

The USDA regulates genetically engineered food plants through one of its divisions called the Animal and Plant Health Inspection Service (APHIS). APHIS administers the Federal Plant Pest Act (FPPA). This legislation authorizes APHIS to regulate interstate movement (between states), importation (into the U.S.), and field testing of "organisms and products altered or produced through genetic engineering which are plant pests or which there is reason to believe are plant pests." (Federal Register, Vol. 58).

Applying the term "plant pest" to a genetically engineered plant means only that the "non-pest" nature of the plant has yet to be demonstrated. All of the many field tests conducted to date have shown that the genetically engineered plants tested have no more "pest-like" qualities than their non-engineered parents.

APHIS regulations provide a list of the organisms regarded as plant pests so applicants know if the development of their product is subject to APHIS regulations. If an organism is not on the list, it still may be subject to APHIS regulations if it is an unclassified organism or there is reason to believe that the resulting organism is or will be a plant pest. An organism that is subject to APHIS regulation is called a "regulated article."

APHIS exercises its regulatory authority through a permit system. A company, academic research institution, or private scientist who wishes to move or field test a genetically engineered plant must obtain the necessary permit(s) before proceeding. This permit system is an extension of the long-standing permitting program used for naturally occurring plant pests.

There are three basic types of permits that an applicant who is developing a genetically engineered plant may be required to obtain. To apply for any of the three permits, an applicant must complete a detailed form (APHIS Form 2000) and send it to the Biotechnology Permits unit of Biotechnology, Biologics, and Environmental Protection (BBEP) within APHIS.

If portions of the application contain trade secret or confidential business information (CBI), the applicant submits two versions of the application, one with CBI marked and included and one with CBI marked and deleted. The CBI deleted version is the version that is circulated for review by officials outside APHIS, for example state departments of agriculture.

If applicants falsify any information on the permit application, they may be fined up to $10,000 and imprisoned for up to five years or both. To help applicants provide accurate and complete applications, APHIS has issued technical bulletin 1783 titled User's Guide for Introducing Genetically Engineered Plants and Microorganisms.

Permit for movement and importation

An APHIS permit and approval of individual state departments of agriculture is required to move any genetically engineered organism that is a potential plant pest into the U.S. or between states. Applicants for a permit must provide APHIS with details about the nature of the organism, its origin, and its intended use.

After the application is reviewed, APHIS makes a preliminary pest risk analysis and sends a letter to the appropriate state departments of agriculture asking them to review the proposed movement. APHIS and state officials will inspect the facility that will receive the organism to be sure that the organism will not be accidentally released into the environment. The inspectors will also evaluate the facilities, personnel, security, and operational procedures of laboratories, growth chambers, and greenhouses to be sure that National Institutes of Health guidelines for good practices are being followed.

Movement permits are issued or denied within 60 days after APHIS receives the application. If granted, the permit is valid for one year from the date of issue and must be renewed if additional plant material is moved after this time. If a permit is denied or revoked, the applicant can appeal the decision.

The process for obtaining an interstate movement or importation permit is depicted in Figure 1.

Figure 1. Permit process for moving or importing genetically engineered plants.

Permit for release into the environment

APHIS also oversees field testing (also called environmental release) of genetically engineered crops. On the APHIS Form 2000, an applicant must provide complete information about the plant, including all new genes and new gene products, their origin, the purpose of the test, the experimental design (how the test will be conducted), and precautions to be taken to prevent the escape of pollen, plants or plant parts from the field test site.

These special precautions routinely include transporting the plants to the field test site in enclosed containers and thoroughly cleaning test plot equipment before and after use. Depending on the plant being field tested, cross pollination is blocked by bagging the flowers, growing crops in cages that keep insects from carrying pollen out, removing the plants' reproductive structures, and isolating the plants from other crops. After harvest, any remaining vegetative material in a field test site is allowed to dry down in the field, followed by cultivation to incorporate remaining plant parts into the soil. The next spring, a field test site typically is treated with herbicide, planted to a different crop, and monitored throughout the growing season. Any volunteer plants that sprout are destroyed.

APHIS personnel review the permit application for completeness and assign it to a scientific reviewer who evaluates the proposed field test. APHIS also notifies state department of agriculture officials in the state where the field test is proposed for their input.

An environmental assessment (EA), a document that analyzes any possible environmental impacts the field test could have, is prepared by APHIS as part of the review process. The EA is required by the National Environmental Policy Act, Council on Environmental Quality regulations, and USDA procedures. One permit application can cover field tests in more than one state and field tests do not have any size limits. However, APHIS officials take the scope and size of a field test into consideration when they prepare the EA.

Written approval or denial of a field test application is sent to the applicant within 120 days. If the field test is approved, APHIS personnel will inspect the field test site near the beginning of the field test, possibly during the test, and after harvest.

The permit process for a field test of a genetically engineered plant is shown in Figure 2.

Figure 2. Permit process for field testing genetically engineered plants.

Before a genetically engineered crop can be sold commercially, a petition must be filed for USDA exemption. This petition requires more information than a field test permit, including environmental product safety information.

Courtesy permit

Applicants may request a courtesy permit from APHIS to move or field test a genetically engineered plant that is not regulated by the agency. Sometimes a non-regulated plant may be similar to one that is regulated by APHIS. Even though it is not required, an APHIS permit may make it easier to move or field test the plant.

An applicant for a courtesy permit completes certain items on the APHIS Form 2000, including a statement of why the applicant believes the plant organism or product is not subject to APHIS regulation. Within 60 days after it receives the application, APHIS will either issue the courtesy permit or advise the applicant that the organism is a regulated article and application for a regular movement or field test permit must be made.

Alternatives to the permit process

Obtaining an APHIS permit is not an easy process, although it is easier for some crops than for others. In the spring of 1993, APHIS offered two alternatives to the regular permit process.

1. Notification process

APHIS streamlined the permit process for importation, interstate movement and field testing of certain genetically engineered crop plants such as corn, soybeans, cotton, potatoes, tomatoes and tobacco. Instead of applying for a permit, applicants can just notify APHIS that the movement or field test is planned.

The notification process is not as simple as it sounds. The planned move or field test must meet certain eligibility criteria and performance standards. If it does not, the more involved regular permit process must be followed. If a field test does qualify for the notification process, APHIS will still require information about the plant, such as the source of any genes used; the method of genetic engineering; and the size, date and location of the field test. APHIS must receive the notification at least 10 days before interstate movement and 30 days before field testing or importation into the U.S. Detailed annual follow-up reports are also required (Biotechnology Notes).

The notification process was based on an extensive history of safe use of the six crop plants in field trials in the United States. On a limited case-by-case basis, APHIS may approve the introduction of other genetically engineered crops under the notification process. If a field test does not meet eligibility and performance standards, the regular field test permit process must be followed.

2. Petition process

This process allows anyone to request, in writing, that a regulated plant should no longer be regulated. Again, this process is not as easy as it seems. The petition must include scientific details about the genetics of the plant, the nature and origin of the genetic material used, information about indirect effects on other plants, and other information required by APHIS, including any information unfavorable to the petition (Biotechnology Notes).

All petitions are printed in the official legal publication of the U.S. Government, the Federal Register. The public has 60 days to comment for or against the petition, and APHIS has up to 180 days to either approve or deny it.

What are the FDA's responsibilities?

The Food and Drug Administration has the primary responsibility for regulating food additives and new foods, except meat and poultry products that are regulated by the USDA. However, the genetically engineered animal growth hormones bST and pST are under FDA regulation because the agency is required to determine the safety and effectiveness of animal drugs. Before allowing drugs for food-producing animals to be marketed, the FDA requires that these drugs be shown to be safe by rigorous scientific studies. Residues of the drug in meat, milk or eggs must be safe for people to eat or the FDA will not approve the drug.

The FDA has very broad authority under the Federal Food, Drug, and Cosmetic Act (FFDCA) to regulate the introduction of new foods, whether they were conventionally produced or developed by genetic engineering. This act gives the FDA two kinds of authority to regulate the safety of foods.

The "adulteration" provisions of the act authorize the FDA to remove unsafe foods from the marketplace and make producers legally responsible for the safety and wholesomeness of the foods they market. Another section of the act requires pre-market approval of food additives, unless they are generally recognized as safe.

Guidelines for genetically engineered foods

In May 1992, the FDA determined that foods derived from new plant varieties produced by genetic engineering essentially will be regulated no differently than foods created by conventional means, unless special circumstances apply (Federal Register, Vol. 57):

Unexpected effects (produces unexpected genetic effects)
Known toxicants (has significantly higher levels of toxicants than present in other edible varieties of the same species)
Nutrients (significantly alters levels of important nutrients)
New substances (differs significantly in composition from such substances currently found in food)
Allergenicity (contains proteins that cause an allergic response)
Antibiotic resistance selectable markers (contains marker genes that theoretically may reduce the therapeutic effects of clinically useful antibiotics)
Plants developed to make specialty nonfood substances (plants developed to make substances such as pharmaceuticals or polymers that will also be used for food)
Issues specific to animal feeds (significant changes in nutrients or toxicants)

The FDA has issued criteria to help developers decide if a substance introduced to a food or altered in a food through genetic engineering requires pre-market approval as a food additive. In general, only genetically engineered food crops that contain substances significantly different that those already in consumers' diets have to earn FDA approval. Currently, these substances are primarily proteins, fats and oils, or carbohydrates.

FDA policy does not require a review of new or modified proteins if they are from food sources or are substantially the same as food substances, are not known to be toxic or raise food safety concerns, and will not be a major part of the diet. New carbohydrates with an unusual structure or function and oils composed of new, unusual fatty acids must be reviewed (Maryanski). If there is reason to believe that certain individuals may be allergic to the new substance or the digestibility or nutritional value has been altered, developers should consult with the FDA.

In fact, because of the serious legal consequences and economic loss that companies could face if a food must be withdrawn from the market, they routinely consult with the FDA before introducing new products, especially those developed through genetic engineering.

Labeling

Currently, there is a controversy concerning whether all genetically engineered foods should be labeled as such. Some consumer and trade organizations believe they should be. Legally, the Federal Food, Drug, and Cosmetic Act requires producers of food products to describe the product by its common name and to reveal all important facts associated with claims made or suggested on the label.

So far, the FDA has not required all genetically engineered food products to be labeled as such solely because they involved genetic engineering. If the FDA ever does decide to require labeling of all food products developed through genetic engineering, an interesting consequence could follow. Some FDA authorities believe that these products would have to be kept separate during all phases of production, storage, processing and distribution. For example, genetically engineered tomatoes could not be dumped into the same vat with conventional tomatoes to produce tomato paste. Likewise, wheat varieties whose development involved genetic engineering could not be mixed with other wheat to manufacture flour. It is also possible that pizzas made with the tomato paste and bread made from the flour would also have to be labeled as the genetically engineered products passed through the food processing chain.

Current FDA policy does recognize that in certain situations consumers should be advised through labeling, such as when the genes for proteins to which some people are allergic are transferred from one species to another. For example, if a gene from peanuts or fish, foods that commonly cause allergic reactions, were inserted into sweet corn, the corn would have to be labeled to alert consumers. The only way a company could avoid labeling the new sweet corn would be to prove to the FDA's satisfaction that the gene taken from peanuts or fish did not transfer anything to the corn that could produce an allergic reaction.

The FDA also could require labeling if the nutritional content of the food is changed. Oranges are an important source of vitamin C. A genetically engineered orange that had a significantly lower vitamin C level would have to be labeled.

Why does the EPA regulate genetically engineered food plants?

The Environmental Protection Agency regulates pesticides under the authority of two acts. The Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) makes the EPA responsible for regulating the distribution, sale, use and testing of pesticides in order to protect humans and the environment. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the EPA to set tolerances or establish exemptions from the requirement of a tolerance for pesticide residues in or on food crops. A tolerance is the amount of pesticide that may legally remain on a crop after harvesting.

Many food plants are being genetically engineered to resist pests. For example, Bacillus thuringiensis, commonly known as Bt, is a bacterium that occurs naturally in the soil. For years, bacteriologists have known that some strains of Bt produce proteins that are lethal to certain insects with alkaline digestive tracts. When these insects ingest the protein produced by Bt, the function of their digestive systems is disrupted, producing slow growth and, ultimately, death. The protein that is toxic to some insects causes no harm to animals with acidic digestive tracts, such as humans.

Genetic engineering makes it possible to locate the gene that produces Bt proteins lethal to insects and transfer the gene into crop plants. Corn that resists European corn borers and potatoes that resist the Colorado potato beetle are two examples of food crops that are being developed through Bt technology.

The EPA is developing a draft policy intended to clarify the regulatory status under FIFRA and FFDCA of pesticidal substances produced by plants (plant-pesticides). Current EPA thinking is that EPA will not regulate plants per se, but instead will regulate certain categories of plant-pesticides. These categories are described in the draft policy. At this time, EPA would propose to focus on plant-pesticides that are most likely to result in new environmental exposures to a pesticidal substance and have the greatest potential for adversely affecting non-target, beneficial organisms. The draft describes the scientific considerations that EPA would use to evaluate those plant-pesticides that the Agency believes warrant review under FIFRA and FFDCA. The draft proposal was presented to a sub-panel of the FIFRA Science Advisory Panel on December 18, 1992. The draft proposal, supporting documents, and the committee's report can be obtained from OPP (Office of Pesticide Programs) public docket No. OPP 00343. The EPA hopes to issue a proposal in the Federal Register in 1994 (Matten).

Red flags for food producers

In its draft proposal, the EPA provides guidance for producers of food plants that produce pesticides. If one or more of the following "red flags" exist, it is a signal for the food producer to consult with the EPA for review under FFDCA.

The pesticide is not derived from a known food source. Bt is an example of this type of pesticide since it is derived from a bacteria.
The pesticide is derived from a known food source and is introduced into a known food source, but the way humans are exposed to it in their diets changes. Perhaps the food now contains more of the pesticide than it did before. Maybe a widely consumed food, such as potatoes, is modified to produce a pesticidal substance that it did not have before. Another possibility is that a pesticide normally expressed in the inedible parts of a plant now is in the parts that are eaten. Or perhaps a pesticide derived from a food that's cooked or processed before consumption is now introduced into a food plant that is eaten raw.
The pesticide has a different structure, function or composition than its counterpart that already occurs in food. For example, the structure of a protein pesticide that already occurs in food could be altered significantly.

EPA options

The EPA has two options when it determines that a food plant does need to be reviewed under FFDCA. It can set a tolerance for the particular pesticide, meaning that food containing amounts of the pesticide at or below the tolerance level is deemed safe for consumption.

The other option is to exempt a pesticide from the requirement of a tolerance, if such an exemption does not already exist. Currently the EPA is considering exempting the coat proteins of viruses from tolerance levels.

Agency interactions

The USDA has consulted with EPA when reviewing applications to test genetically engineered crops on a small scale. The EPA will most likely formally review a product when a company decides to move into large-scale testing. As with traditional pesticides, an Experimental Use Permit (EUP) may be required for tests that exceed 10 acres total in the U.S.

After receiving the EUP, a company follows a process that involves extensive testing of the crop to ensure food and environmental safety before the crop is commercialized. In addition, it is likely that some applicants also will consult the FDA before a pest-resistant food crop is commercialized, even though a recent FDA policy proposal emphasized that such products fall under the EPA's jurisdiction and are not subject to FDA pre-market approval.

How do individual states regulate genetically engineered foods?

In general, state legislatures have the authority to determine what products can and cannot be sold in a state. For example, many states ban the sale of fireworks for safety reasons. Exercising this legislative authority, some states in the upper Midwest declared a temporary moratorium on the sale and use of bST in dairy cows about three years ago.

States also have the right to monitor the development of a genetically engineered product. Required inspections and permits are two mechanisms states can use.

Genetically engineered plants

State regulation of genetically engineered plants, including food crops, varies from state to state. In general, state departments of agriculture become involved in the process when a genetically engineered plant is moved into or out of the state or when it is ready to be field tested in the state. APHIS is required to notify a state regulatory agency, usually agriculture, when a company, university or private researcher has applied for a movement or environmental release permit.

Applicants for an importation or movement permit can expect to have the receiving facilities for the plant inspected by either federal and/or state authorities before the plant arrives. Applicants for an environmental release permit are told that federal representatives will inspect the field test site near the beginning of the field test and shortly after harvest and possibly at some time during the field test. State officials may also inspect the field test site.

An example of state regulation

Some states have established formal procedures for dealing with genetically engineered plants within their borders. Iowa is one example. The state's rich soil makes it a prime site for field tests of many genetically engineered crops. To handle the growing number of requests to move and field test these plants, Iowa's Department of Agriculture and Land Stewardship (IDALS) has developed a review process.

Iowa has established a State Biotechnology Advisory Committee whose members currently include representatives from the Iowa Department of Natural Resources, the Iowa Department of Public Health, Iowa State University, the University of Iowa, and Grinnell College. The Iowa Department of Agriculture chairs the committee.

The first step in Iowa's review process begins when the USDA-APHIS sends a permit application to the Iowa Department of Agriculture for review. Depending on the type of application, officials at IDALS may send it on to the members of the Biotechnology Advisory Committee for their comments. These comments may include questions about the design of a field test, safety precautions or any other area of concern. The comments are forwarded to the USDA-APHIS for their consideration during the permit approval process.

In Iowa, the purpose of the State Biotechnology Advisory Committee is to provide expert advice to the IDALS. Neither the Committee nor the IDALS has any legal authority to issue permits in the state. Any required permits for moving or field testing genetically engineered plants are issued by APHIS.

Even the six crop plants that can now be imported, moved interstate, or field tested under the notification process (see USDA section) are still subject to state inspection. In these cases, when applicants notify APHIS of their intent to move or field test one of these six crops, APHIS in turn notifies Iowa within five business days.

Iowa's State Biotechnology Advisory Committee has the same opportunity to provide comments for movement or field tests of these six crops as it does for other genetically engineered plants. The state is currently developing guidelines for applicants to follow when APHIS determines that notification is all that is required.

Is regulating genetically engineered food plants a public process?

The Freedom of Information Act allows members of the general public to obtain copies of APHIS permit applications for moving or field testing genetically engineered plants. Copies of environmental assessments of field tests are also available. Confidential business information may be deleted from the copies. For more details about requesting permit application copies, individuals should contact: Freedom of Information Act Coordinator; USDA, APHIS, LPA, PI; 6505 Belcrest Road, Room 613 FB; Hyattsville, MD 20782.

References

Biotechnology Notes, "APHIS Amends Biotech Regulations," USDA, Vol. 6, No. 4, April/May 1993, p. 1-2.

Federal Register, Vol. 51, No. 123. "Office of Science and Technology Policy: Coordinated Framework for Regulation of Biotechnology; Announcement of Policy and Notice for Public Comment. Part II". Thursday, June 26, 1986, p. 23302-23350.

Federal Register, Vol. 52, No. 115. "Plant Pests; Introduction of Genetically Engineered Organisms or Products; Final Rule." Part II, Department of Agriculture, Animal and Plant Health Inspection Service. 7 CFR Parts 330 and 340. Tuesday, June 16, 1987, p. 22892-22915.

Federal Register, Vol. 57, No. 104. "Statement of Policy: Foods Derived from New Plant Varieties; Notice." Part IX, Department of Health and Human Services, Food and Drug Administration. Friday, May 29, 1992, p. 22984-23005.

Federal Register, Vol. 58, No. 60, "Genetically Engineered Organisms and Products; Notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status; Final Rule." Part X, Department of Agriculture, Animal and Plant Health Inspection Service. 7 CFR Part 340. Wednesday, March 31, 1993, p. 17044-59.

Human Gene Therapy Research Institute. Personal communication. Iowa Methodist Medical Center, Des Moines, Iowa.

King, Jackie. "Engineering for a Healthy Life." Des Moines Business Record, Week of February 14, 1994, p. 1.

Maryanski, James H.; Flamm, Eric L.; Kahl, Linda S. "FDA's Policy on Foods Derived from New Plant Varieties." Probe -- Newsletter for the USDA Plant Genome Research Program, Fall 1992, p. 1-3.

Matten, Sharlene R. Personal communication. Office of Prevention, Pesticides, and Toxic Substances, EPA.

Matten, Sharlene R.; Schneider, William R.; Slutsky, Bernice I.; and Milewski, Elizabeth A. "Biological Pesticides and the U.S. Environmental Protection Agency." In Advanced Engineered Pesticides, p. 327-336. Edited by Leo Kim. New York: Marcel Dekker, Inc., 1993.

Office of Technology Assessment. A New Technological Era for American Agriculture. August 1992. 460-page report. Free summary and cost information for the complete report available from Publications Ordering, U.S. Congress - OTA, Washington, D.C. 20510-8025. Telephone (202) 224-8996.

Stoltenow, C. R. Personal communication. Iowa Department of Agriculture and Land Stewardship.

Sudduth, Mary Alice. "Genetically Engineered Foods -- Fears and Facts. An Interview with FDA's Jim Maryanski." FDA Consumer, January-February 1993, p. 11-14.

User's Guide for Introducing Genetically Engineered Plants and Microorganisms. United States Department of Agriculture, Animal and Plant Health Inspection Service. Technical Bulletin No. 1783. June 1991.

To order, request NCR557, Regulation of Genetically Engineered Organisms and Products ($2).

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