Genetic engineering in the United States
Encyclopedia
Genetic engineering
in the United States
is the largest grower of commercial crops in the world and there is some opposition to it.
Monsanto
, based in Creve Coeur, Missouri
in the United States, is the leading producer of genetically engineered
seed; it sells 90% of the world's GE seeds.
, a nonprofit science advocacy group, opposes some types of genetic engineering.
, and a huge percentage of US's seed supply. The company had to pay millions to consumers to settle class action lawsuits for alleged health problems.
, California became the first and only county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority. (See Mendocino County GMO Ban
)
(APHIS) agency within the USDA is concerned with protecting agriculture and the environment from potential pests under the Plant Protection Act
of 2000 (part of the Agriculture Risk Protection Act) and the National Environmental Policy Act
(NEPA). Each transgenic event is regulated separately as the transgene
insertion locus
varies even when using identical construct
s and host genotype
s. This could result in different expression
patterns or could affect the function of other endogenous
genes within the host. The USDA is responsible for approving field trial
s of GM plants under either the notification or permit procedures. The notification procedure is a streamlined process for the simplest or most familiar genetically engineered plants that meet six criteria (is not a noxious weed, the function of the genetic material is known and characterized, stable integration, no significant risk of creating new viruses and that no animal or human pathogen sequences
are present). Most field trials are approved under the notification procedure. The permit procedure is much more elaborate and is required for all genetically engineered organisms that do not meet the notification requirements or any plant-made pharmaceuticals
or plant-made industrial products.
APHIS officials are responsible for inspecting the field trials. At least one inspection is carried out for each state listed on a permit, while inspection of field trials authorized by notification is conducted based on the relative risk of each trial. For field trials of organisms that contain pharmaceutical or industrial compounds, inspections are carried out more frequently (five times during establishment and twice yearly after that). If the inspectors are satisfied that there are no regulatory concerns they issue a Notice of Compliance. If the regulations are not being adhered to the inspectors will issue a Notice of Non-Compliance requesting that the deviations be fixed, or for more serious breaches a warning letter requiring a written response and corrective action to be taken within a given time frame. Formal investigations are carried out on developers who may not be adhering to regulations, permit conditions, or other requirements, which can result in civil penalties or criminal charges.
In 1993, the USDA proposal to remove regulatory oversight
from GM organisms deemed environmentally benign was approved and four GM plants (Flavr Savr tomato, virus-resistant squash, bromoxynil
-tolerant cotton and glyphosphate-tolerant soybean) obtained non-regulatory status that year. Non-regulated status means that permits and notifications are no longer required for introductions of this organism. Applicants can petition APHIS for non-regulated status if the GM organism poses no more of a plant pest risk than an equivalent non-GM organism. APHIS will prepare at least two documents (an Environmental Assessment
and a determination of non-regulatory status) under the NEPA while considering the application.
Four federal district court
suits
have been brought against APHIS challenging their regulation of GM plants. Two involved field trials (herbicide-tolerant turfgrass in Oregon
; pharmaceutical-producing corn and sugar in Hawaii
) and the other two were the deregulation of GM alfalfa
and GM Sugar Beet. APHIS initially lost all four cases, with the judges ruling they failed to diligently follow the NEPA guidelines. However, the Supreme Court overturned the nationwide ban on GM alfalfa and an appeal court allowed the partial deregulation of GM sugar beet crops.
s genetically modified human insulin
(Humulin
) in 1982 and the first commercialized GM whole food, Calgenes Flavr Savr tomato in 1994. When evaluating new GM foods or feed the FDA looks for the presence of any new or altered allergen
s and toxicant
s and examines changes in the levels of nutritional
and anti-nutritional substances. Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent
and is not required to undergo review by the FDA. The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent. However, all GM food and feed currently on the US market have undergone a FDA consultation, where the developer submits the compositional data and FDA scientist compare it to regular food and feed.
The FDA consultation focuses on whether the new food or feed contains any new allergens or toxic substances and whether the nutritional components of the food or feed have increased or decreased. The developer submits documentation to the FDA describing the food or feed and a FDA assigned caseworker can then request additional information on expected dietary exposure, in particular if any risk groups (children, elderly etc) might be exposed. As of 2007, the FDA has not identified any genetically modified foods with unexpected changes in the nutrient composition or levels of allergens or toxic substances. However, allergic proteins have been detected when some GM products have undergone testing. Pioneer Hi-Bred
inserted a gene from the Brazil nut
into transgenic soybean
resulting in soy with an enhanced nutritional profile. The inserted gene did not translate
into a known allergen at the time, but when tested with serum from people who are allergic to Brazil nut the allergenic nature of the protein was discovered. The development of the transgenic soybean expressing a Brazil nut allergen was stopped after these tests. The FDA consultation process is relatively (when compared to the other agencies regulating GM) informal and they do not approve new GM products. Instead they issue a memo stating whether the new food is the same as or different to the non-modified variety.
The Center for Veterinary Medicine
of the FDA regulates genetically modified animals in consultation with Centers at the FDA responsible for regulating pharmaceuticals or other medical products derived from biopharm animals
. The FDA also has extra guidelines that apply to genetically modified animals that will be used in the manufacturing and testing of therapeutic products
and xenotransplantation
. The FDA guidance documents do not establish legally binding laws and are viewed as recommendations, unless specific regulatory or statutory requirements are cited. Any relevant federal, State, or local laws and regulations must also be adhered to.
characteristics, looking at potential threats to human health or the environment. They claim not to regulate the genetically modified plants, but the pesticides produced by the plants or properties that change the usage of applied pesticides . This includes; plants engineered to produce resistance to herbicides (e.g Roundup Ready), plants that produce their own pesticides (e.g BT
) and virus resistant plants. Authority to regulate the pesticide properties in genetically modified organisms was granted in the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and the Federal Food, Drug, and Cosmetic Act
(FFDCA). The EPA published regulations in 1994 and begun acting on them in 1995. In 1994 they proposed the exemption of three categories of genetically modified plants under their regulation. These were plants where the genetic material originated in sexually compatible plants (cisgenic), plants that used physical barriers to prevent the target pest from attaching itself, and plants expressing viral coat protein
s to protect against virus infection. In 2001, rules regarding exemption of cisgenic plants had been finalised. The other two proposed exemptions were still under review in 2010.
The EPA evaluated each submission on a case-by-case basis. The EPA assesses data concerning the characterisation of the end-product of the engineered organism (presently all plants evaluated produce proteins), as well as data on mammalian toxicity, effects on non-target organisms and environmental metabolism. For Bt products the producer must also supply an insect resistance management program. For herbicide resistant plants the EPA co-ordinates with the USDA and FDA, but does not regulate the plant itself. Instead it regulates the herbicide and its use on the new cultivar
. The EPA examines the construct
used to transform the plant and the biology of recipient plant. The sequence of the resulting protein must be described, expression pattern and intencity verified and any modifications to the protein reported. The EPA considers the potential allergenicity of the product, issues surrounding gene flow into wild species, possible effects on non-target organisms, likelihood of it persisting in the environment and the potential for insect resistance developing when assessing submissions.
, California became the first county in the United States
to ban the production of GMOs. The measure passed with a 57% majority. In California, Trinity
and Marin
counties have also imposed bans on GM crops, while ordinances to do so were unsuccessful in Butte
, Lake
, San Luis Obispo
, Humboldt
, and Sonoma
counties. Supervisors in the agriculturally
-rich counties of Fresno
, Kern
, Kings
, Solano
, Sutter
, and Tulare
have passed resolutions supporting the practice.
Genetic engineering
Genetic engineering, also called genetic modification, is the direct human manipulation of an organism's genome using modern DNA technology. It involves the introduction of foreign DNA or synthetic genes into the organism of interest...
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
is the largest grower of commercial crops in the world and there is some opposition to it.
Monsanto
Monsanto
The Monsanto Company is a US-based multinational agricultural biotechnology corporation. It is the world's leading producer of the herbicide glyphosate, marketed in the "Roundup" brand of herbicides, and in other brands...
, based in Creve Coeur, Missouri
Creve Coeur, Missouri
Creve Coeur, derived from French for "heartbreak" , is a second-ring suburb of St. Louis, located in west St. Louis County, Missouri, United States. The city derives its name from Creve Coeur Lake, which is shaped like a broken heart. The population was 17,833 at the 2010 census...
in the United States, is the leading producer of genetically engineered
Genetic engineering
Genetic engineering, also called genetic modification, is the direct human manipulation of an organism's genome using modern DNA technology. It involves the introduction of foreign DNA or synthetic genes into the organism of interest...
seed; it sells 90% of the world's GE seeds.
Opposition
Numerous organizations based in the US oppose genetic engineering for various reasons. The Union of Concerned ScientistsUnion of Concerned Scientists
The Union of Concerned Scientists is a nonprofit science advocacy group based in the United States. The UCS membership includes many private citizens in addition to professional scientists. James J...
, a nonprofit science advocacy group, opposes some types of genetic engineering.
Health concerns
Some human health problems have occurred in the US due to genetically engineered crops. One of the largest food recalls in US history, was the Starlink scandal, where a Bt corn plant not approved for human consumption due its risk as an allergen, had contaminated food products like the tacos at Taco BellTaco Bell
Taco Bell is an American chain of fast-food restaurants based in Irvine, California. A subsidiary of Yum! Brands, Inc., which serves American-adapted Mexican food. Taco Bell serves tacos, burritos, quesadillas, nachos, other specialty items, and a variety of "Value Menu" items...
, and a huge percentage of US's seed supply. The company had to pay millions to consumers to settle class action lawsuits for alleged health problems.
Regulation
The USA is the largest commercial grower of genetically modified crops in the world. For a genetically modified organism to be approved for release it is assessed by the USDA, the FDA and the EPA. USDA evaluated the plants potential to become weeds, the FDA reviewed plants that could enter or alter the food supply and the EPA regulated the genetically modified plants with pesticide properties. Most developed genetically modified plants are reviewed by at least two of the agencies, with many subject to all three. Final approval can still be denied by individual counties within each state. In 2004, Mendocino CountyMendocino County, California
Mendocino County is a county located on the north coast of the U.S. state of California, north of the greater San Francisco Bay Area and west of the Central Valley. As of the 2010 census, the population was 87,841, up from 86,265 at the 2000 census...
, California became the first and only county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority. (See Mendocino County GMO Ban
Mendocino County GMO Ban
Mendocino County, California was the first jurisdiction in the United States to ban the cultivation, production or distribution of genetically modified organisms . The ordinance, entitled Measure H, was passed by referendum on March 2, 2004...
)
US Department of Agriculture
The Biotechnology Regulatory Services program of the Animal and Plant Health Inspection ServiceAnimal and Plant Health Inspection Service
Animal and Plant Health Inspection Service is an agency of the United States Department of Agriculture responsible for protecting animal health, animal welfare, and plant health. APHIS is the lead agency for collaboration with other agencies to protect U.S. agriculture from invasive pests and...
(APHIS) agency within the USDA is concerned with protecting agriculture and the environment from potential pests under the Plant Protection Act
Plant Protection Act
The Plant Protection Act is a US statute relating to plant pests and noxious weeds introduced in 2000. It is currently codified at 7 U.S.C. 7701 et seq...
of 2000 (part of the Agriculture Risk Protection Act) and the National Environmental Policy Act
National Environmental Policy Act
The National Environmental Policy Act is a United States environmental law that established a U.S. national policy promoting the enhancement of the environment and also established the President's Council on Environmental Quality ....
(NEPA). Each transgenic event is regulated separately as the transgene
Transgene
A transgene is a gene or genetic material that has been transferred naturally or by any of a number of genetic engineering techniques from one organism to another....
insertion locus
Locus (genetics)
In the fields of genetics and genetic computation, a locus is the specific location of a gene or DNA sequence on a chromosome. A variant of the DNA sequence at a given locus is called an allele. The ordered list of loci known for a particular genome is called a genetic map...
varies even when using identical construct
DNA construct
A DNA construct is an artificially constructed segment of nucleic acid that is going to be "transplanted" into a target tissue or cell...
s and host genotype
Genotype
The genotype is the genetic makeup of a cell, an organism, or an individual usually with reference to a specific character under consideration...
s. This could result in different expression
Gene expression
Gene expression is the process by which information from a gene is used in the synthesis of a functional gene product. These products are often proteins, but in non-protein coding genes such as ribosomal RNA , transfer RNA or small nuclear RNA genes, the product is a functional RNA...
patterns or could affect the function of other endogenous
Endogenous
Endogenous substances are those that originate from within an organism, tissue, or cell. Endogenous retroviruses are caused by ancient infections of germ cells in humans, mammals and other vertebrates...
genes within the host. The USDA is responsible for approving field trial
Field trial
A field trial is a competitive event at which hunting dogs compete against one another. There are field trials for retrievers, pointing dogs and flushing dogs. Field trials are usually organized by kennel clubs or other gun dog organizations...
s of GM plants under either the notification or permit procedures. The notification procedure is a streamlined process for the simplest or most familiar genetically engineered plants that meet six criteria (is not a noxious weed, the function of the genetic material is known and characterized, stable integration, no significant risk of creating new viruses and that no animal or human pathogen sequences
Séquences
Séquences is a French-language film magazine originally published in Montreal, Quebec by the Commission des ciné-clubs du Centre catholique du cinéma de Montréal, a Roman Catholic film society. Founded in 1955, the publication was edited for forty years by Léo Bonneville, a member of the Clerics...
are present). Most field trials are approved under the notification procedure. The permit procedure is much more elaborate and is required for all genetically engineered organisms that do not meet the notification requirements or any plant-made pharmaceuticals
Molecular farming
Molecular farming is the use of genetically engineered crops to produce compounds with therapeutic value. These crops will become biological factories used to generate drugs and other difficult or expensive products...
or plant-made industrial products.
APHIS officials are responsible for inspecting the field trials. At least one inspection is carried out for each state listed on a permit, while inspection of field trials authorized by notification is conducted based on the relative risk of each trial. For field trials of organisms that contain pharmaceutical or industrial compounds, inspections are carried out more frequently (five times during establishment and twice yearly after that). If the inspectors are satisfied that there are no regulatory concerns they issue a Notice of Compliance. If the regulations are not being adhered to the inspectors will issue a Notice of Non-Compliance requesting that the deviations be fixed, or for more serious breaches a warning letter requiring a written response and corrective action to be taken within a given time frame. Formal investigations are carried out on developers who may not be adhering to regulations, permit conditions, or other requirements, which can result in civil penalties or criminal charges.
In 1993, the USDA proposal to remove regulatory oversight
Deregulation
Deregulation is the removal or simplification of government rules and regulations that constrain the operation of market forces.Deregulation is the removal or simplification of government rules and regulations that constrain the operation of market forces.Deregulation is the removal or...
from GM organisms deemed environmentally benign was approved and four GM plants (Flavr Savr tomato, virus-resistant squash, bromoxynil
Bromoxynil
Bromoxynil is a nitrile herbicide, trade names include Brominal, Bromotril, Bronate, Buctril, Certrol B, Litarol, M&B 10064, Merit, Pardner, Sabre, and Torch. It is used for post-emergent control of annual broadleaf weeds. It is especially effective in the control of weeds in cereal, corn,...
-tolerant cotton and glyphosphate-tolerant soybean) obtained non-regulatory status that year. Non-regulated status means that permits and notifications are no longer required for introductions of this organism. Applicants can petition APHIS for non-regulated status if the GM organism poses no more of a plant pest risk than an equivalent non-GM organism. APHIS will prepare at least two documents (an Environmental Assessment
Environmental impact assessment
An environmental impact assessment is an assessment of the possible positive or negative impact that a proposed project may have on the environment, together consisting of the natural, social and economic aspects....
and a determination of non-regulatory status) under the NEPA while considering the application.
Four federal district court
United States district court
The United States district courts are the general trial courts of the United States federal court system. Both civil and criminal cases are filed in the district court, which is a court of law, equity, and admiralty. There is a United States bankruptcy court associated with each United States...
suits
Lawsuit
A lawsuit or "suit in law" is a civil action brought in a court of law in which a plaintiff, a party who claims to have incurred loss as a result of a defendant's actions, demands a legal or equitable remedy. The defendant is required to respond to the plaintiff's complaint...
have been brought against APHIS challenging their regulation of GM plants. Two involved field trials (herbicide-tolerant turfgrass in Oregon
Oregon
Oregon is a state in the Pacific Northwest region of the United States. It is located on the Pacific coast, with Washington to the north, California to the south, Nevada on the southeast and Idaho to the east. The Columbia and Snake rivers delineate much of Oregon's northern and eastern...
; pharmaceutical-producing corn and sugar in Hawaii
Hawaii
Hawaii is the newest of the 50 U.S. states , and is the only U.S. state made up entirely of islands. It is the northernmost island group in Polynesia, occupying most of an archipelago in the central Pacific Ocean, southwest of the continental United States, southeast of Japan, and northeast of...
) and the other two were the deregulation of GM alfalfa
Alfalfa
Alfalfa is a flowering plant in the pea family Fabaceae cultivated as an important forage crop in the US, Canada, Argentina, France, Australia, the Middle East, South Africa, and many other countries. It is known as lucerne in the UK, France, Australia, South Africa and New Zealand, and known as...
and GM Sugar Beet. APHIS initially lost all four cases, with the judges ruling they failed to diligently follow the NEPA guidelines. However, the Supreme Court overturned the nationwide ban on GM alfalfa and an appeal court allowed the partial deregulation of GM sugar beet crops.
Food and Drug Administration
The FDA is responsible for the safety and security of human and animal food and drugs, including any that are genetically modified. The FDA was responsible for approving the first commercialized GMO, GenetechGenetech
Genetech is a fictional corporation in the Marvel Comics universe. It is located in Sayville, Long Island in the state of New York.Genetech is involved in many scientific endeavors and appears as both an ally and an adversary of the superhuman team the New Warriors. Genetech should not be confused...
s genetically modified human insulin
Insulin
Insulin is a hormone central to regulating carbohydrate and fat metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle....
(Humulin
Humulin
Humulin is the brand name for a group of biosynthetic human insulin products, originally developed by Genentech in 1978 and later acquired by Eli Lilly and Company, the company who arguably facilitated...
) in 1982 and the first commercialized GM whole food, Calgenes Flavr Savr tomato in 1994. When evaluating new GM foods or feed the FDA looks for the presence of any new or altered allergen
Allergen
An allergen is any substance that can cause an allergy. In technical terms, an allergen is a non-parasitic antigen capable of stimulating a type-I hypersensitivity reaction in atopic individuals....
s and toxicant
Toxicant
A toxicant is a chemical compound that has an effect on organisms.A distinction can be drawn between "toxic" and toxin, with the latter being a subcategory of the former....
s and examines changes in the levels of nutritional
Nutrient
A nutrient is a chemical that an organism needs to live and grow or a substance used in an organism's metabolism which must be taken in from its environment. They are used to build and repair tissues, regulate body processes and are converted to and used as energy...
and anti-nutritional substances. Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent
Substantial equivalence
Substantial equivalence is a concept, developed by OECD in 1991, that maintains that a novel food should be considered the same as and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food. Substantial equivalence is important from a...
and is not required to undergo review by the FDA. The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent. However, all GM food and feed currently on the US market have undergone a FDA consultation, where the developer submits the compositional data and FDA scientist compare it to regular food and feed.
The FDA consultation focuses on whether the new food or feed contains any new allergens or toxic substances and whether the nutritional components of the food or feed have increased or decreased. The developer submits documentation to the FDA describing the food or feed and a FDA assigned caseworker can then request additional information on expected dietary exposure, in particular if any risk groups (children, elderly etc) might be exposed. As of 2007, the FDA has not identified any genetically modified foods with unexpected changes in the nutrient composition or levels of allergens or toxic substances. However, allergic proteins have been detected when some GM products have undergone testing. Pioneer Hi-Bred
Pioneer Hi-Bred
Pioneer Hi-Bred is the largest U.S. producer of hybrid seeds for agriculture.- History :In 1926, farm journal editor and future U.S. Vice President Henry A. Wallace, along with a group of Des Moines, Iowa businessmen, founded the "Hi-Bred Corn Company". At the time, most corn farmers saved part of...
inserted a gene from the Brazil nut
Brazil Nut
The Brazil nut is a South American tree in the family Lecythidaceae, and also the name of the tree's commercially harvested edible seed.- Order :...
into transgenic soybean
Transgenic soybean
Genetically modified soybean is a soybean that has had DNA introduced into it in a way other than the combination of male and female gametes...
resulting in soy with an enhanced nutritional profile. The inserted gene did not translate
Translation (genetics)
In molecular biology and genetics, translation is the third stage of protein biosynthesis . In translation, messenger RNA produced by transcription is decoded by the ribosome to produce a specific amino acid chain, or polypeptide, that will later fold into an active protein...
into a known allergen at the time, but when tested with serum from people who are allergic to Brazil nut the allergenic nature of the protein was discovered. The development of the transgenic soybean expressing a Brazil nut allergen was stopped after these tests. The FDA consultation process is relatively (when compared to the other agencies regulating GM) informal and they do not approve new GM products. Instead they issue a memo stating whether the new food is the same as or different to the non-modified variety.
The Center for Veterinary Medicine
Center for Veterinary Medicine
The Center for Veterinary Medicine is a branch of the U.S. Food and Drug Administration that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs...
of the FDA regulates genetically modified animals in consultation with Centers at the FDA responsible for regulating pharmaceuticals or other medical products derived from biopharm animals
Pharming (genetics)
Pharming is a portmanteau of farming and "pharmaceutical" and refers to the use of genetic engineering to insert genes that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes. As a consequence, the host animals or plants then make the...
. The FDA also has extra guidelines that apply to genetically modified animals that will be used in the manufacturing and testing of therapeutic products
Pharming (genetics)
Pharming is a portmanteau of farming and "pharmaceutical" and refers to the use of genetic engineering to insert genes that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes. As a consequence, the host animals or plants then make the...
and xenotransplantation
Xenotransplantation
Xenotransplantation , is the transplantation of living cells, tissues or organs from one species to another. Such cells, tissues or organs are called xenografts or xenotransplants...
. The FDA guidance documents do not establish legally binding laws and are viewed as recommendations, unless specific regulatory or statutory requirements are cited. Any relevant federal, State, or local laws and regulations must also be adhered to.
Environmental Protection Agency
The EPA regulates substances with pesticidePesticide
Pesticides are substances or mixture of substances intended for preventing, destroying, repelling or mitigating any pest.A pesticide may be a chemical unicycle, biological agent , antimicrobial, disinfectant or device used against any pest...
characteristics, looking at potential threats to human health or the environment. They claim not to regulate the genetically modified plants, but the pesticides produced by the plants or properties that change the usage of applied pesticides . This includes; plants engineered to produce resistance to herbicides (e.g Roundup Ready), plants that produce their own pesticides (e.g BT
Bacillus thuringiensis
Bacillus thuringiensis is a Gram-positive, soil-dwelling bacterium, commonly used as a biological pesticide; alternatively, the Cry toxin may be extracted and used as a pesticide. B...
) and virus resistant plants. Authority to regulate the pesticide properties in genetically modified organisms was granted in the Federal Insecticide, Fungicide, and Rodenticide Act
Federal Insecticide, Fungicide, and Rodenticide Act
The Federal Insecticide, Fungicide, and Rodenticide Act , et seq. is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. It is administered by the Environmental Protection Agency and the appropriate...
(FIFRA) and the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
(FFDCA). The EPA published regulations in 1994 and begun acting on them in 1995. In 1994 they proposed the exemption of three categories of genetically modified plants under their regulation. These were plants where the genetic material originated in sexually compatible plants (cisgenic), plants that used physical barriers to prevent the target pest from attaching itself, and plants expressing viral coat protein
Capsid
A capsid is the protein shell of a virus. It consists of several oligomeric structural subunits made of protein called protomers. The observable 3-dimensional morphological subunits, which may or may not correspond to individual proteins, are called capsomeres. The capsid encloses the genetic...
s to protect against virus infection. In 2001, rules regarding exemption of cisgenic plants had been finalised. The other two proposed exemptions were still under review in 2010.
The EPA evaluated each submission on a case-by-case basis. The EPA assesses data concerning the characterisation of the end-product of the engineered organism (presently all plants evaluated produce proteins), as well as data on mammalian toxicity, effects on non-target organisms and environmental metabolism. For Bt products the producer must also supply an insect resistance management program. For herbicide resistant plants the EPA co-ordinates with the USDA and FDA, but does not regulate the plant itself. Instead it regulates the herbicide and its use on the new cultivar
Cultivar
A cultivar'Cultivar has two meanings as explained under Formal definition. When used in reference to a taxon, the word does not apply to an individual plant but to all those plants sharing the unique characteristics that define the cultivar. is a plant or group of plants selected for desirable...
. The EPA examines the construct
DNA construct
A DNA construct is an artificially constructed segment of nucleic acid that is going to be "transplanted" into a target tissue or cell...
used to transform the plant and the biology of recipient plant. The sequence of the resulting protein must be described, expression pattern and intencity verified and any modifications to the protein reported. The EPA considers the potential allergenicity of the product, issues surrounding gene flow into wild species, possible effects on non-target organisms, likelihood of it persisting in the environment and the potential for insect resistance developing when assessing submissions.
GMO foods
In 2004, Mendocino CountyMendocino County, California
Mendocino County is a county located on the north coast of the U.S. state of California, north of the greater San Francisco Bay Area and west of the Central Valley. As of the 2010 census, the population was 87,841, up from 86,265 at the 2000 census...
, California became the first county in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
to ban the production of GMOs. The measure passed with a 57% majority. In California, Trinity
Trinity County, California
Trinity County is a large, rugged and mountainous, heavily forested county located in the northwestern portion of the U.S. state of California, along the Trinity River and within the Salmon/Klamath Mountains. It covers an area of over two million acres , and as of the 2010 census its population...
and Marin
Marin County, California
Marin County is a county located in the North San Francisco Bay Area of the U.S. state of California, across the Golden Gate Bridge from San Francisco. As of 2010, the population was 252,409. The county seat is San Rafael and the largest employer is the county government. Marin County is well...
counties have also imposed bans on GM crops, while ordinances to do so were unsuccessful in Butte
Butte County, California
Butte County is a county located in the Central Valley of the US state of California, north of the state capital of Sacramento. As of the 2010 census, it had a population of 220,000. The county seat is Oroville. Butte County is the "Land of Natural Wealth and Beauty."Butte County is watered by the...
, Lake
Lake County, California
Lake County is a county located in the north central portion of the U.S. state of California, north of the San Francisco Bay Area. It takes its name from Clear Lake, the dominant geographic feature in the county and the largest natural lake wholly within California...
, San Luis Obispo
San Luis Obispo County, California
San Luis Obispo County is a county located along the Pacific Ocean in the Central Coast of the U.S. state of California, between Los Angeles and the San Francisco Bay Area. As of the 2010 census its population was 269,637, up from 246,681 at the 2000 census...
, Humboldt
Humboldt County, California
Humboldt County is a county in the U.S. state of California, located on the far North Coast 200 miles north of San Francisco. According to 2010 Census Data, the county’s population was 134,623...
, and Sonoma
Sonoma County, California
Sonoma County, located on the northern coast of the U.S. state of California, is the largest and northernmost of the nine San Francisco Bay Area counties. Its population at the 2010 census was 483,878. Its largest city and county seat is Santa Rosa....
counties. Supervisors in the agriculturally
Agriculture
Agriculture is the cultivation of animals, plants, fungi and other life forms for food, fiber, and other products used to sustain life. Agriculture was the key implement in the rise of sedentary human civilization, whereby farming of domesticated species created food surpluses that nurtured the...
-rich counties of Fresno
Fresno County, California
Fresno County is a county located in the Central Valley of the U.S. state of California, south of Stockton and north of Bakersfield. As of the 2010 census, it is the tenth most populous county in California with a population of 930,450, and the sixth largest in size with an area of . The county...
, Kern
Kern County, California
Spreading across the southern end of the California Central Valley, Kern County is the fifth-largest county by population in California. Its economy is heavily linked to agriculture and to petroleum extraction, and there is a strong aviation and space presence. Politically, it has generally...
, Kings
Kings County, California
Kings County is a county located in the Central Valley of the U.S. state of California. It is located in a rich agricultural region. Kings County is also home to NAS Lemoore, which is the U.S. Navy's newest and largest master jet air station. The county seat is Hanford...
, Solano
Solano County, California
Solano County is a county located in Bay-Delta region of the U.S. state of California, about halfway between San Francisco and Sacramento and is one of the nine San Francisco Bay Area counties. The county's population was reported by the U.S. Census to be 413,344 in 2010...
, Sutter
Sutter County, California
Sutter County is a county located along the Sacramento River in the Central Valley of the U.S. state of California, north of state capital Sacramento. Sutter County is part of the Greater Sacramento CSA....
, and Tulare
Tulare County, California
Tulare County is a county located in the Central Valley of the U.S. state of California, south of Fresno. Sequoia National Park is located in the county, as are part of Kings Canyon National Park, in its northeast corner , and part of Mount Whitney, on its eastern border...
have passed resolutions supporting the practice.
See also
- Environmental issues in the United StatesEnvironmental issues in the United StatesAs with many other countries there are a number of environmental issues in the United States.-Climate change:The United States is the second largest emitter, after China, of carbon dioxide from the burning of fossil fuels. The energy policy of the United States is widely debated; many call on the...
- Agriculture in the United StatesAgriculture in the United StatesAgriculture is a major industry in the United States and the country is a net exporter of food. As of the last census of agriculture in 2007, there were 2.2 million farms, covering an area of , an average of per farm.-History:...
- Diamond v. ChakrabartyDiamond v. ChakrabartyDiamond v. Chakrabarty, , was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.-Background:...
- Flavr Savr