Midterm Exam Flashcards
Which of the following best describes the Homestead Act?
A) A law passed in 1862 that encouraged US farmers to increase their food production to create a surplus to trade with Europe
B) A law passed in 1862 that allowed individuals to purchase 160 acres from the government for the purpose of farming
C) A law passed in 1862 that solidified Jefferson’s view of America as a country with an agrarian base
D) A law passed in 1862 that gave 160 acres to people who agreed to farm the land
D
T/F: The pandemic has limited impact on overall US agricultural exports.
True
T/F: The consolidation and industrialization of agriculture has had many impacts on rural America including depopulation and reduced economic activity in rural areas.
True
Which of the following best describes the Coronavirus Food Assistance Program (CFAP)
A) A series of programs designed to construct a decentralized food system that would be more resilient in the face of future pandemics
B) A program providing farmers and ranchers with payments to take acreage out of production to prevent further surpluses of food
C) An emergency measure from the USDA providing up to $16 billion to farmers and ranchers to cope with pandemic-related losses
D) A program to provide low-income families with vouchers to offset the increased cost of food products
C
T/F: The loss of jobs across the country during the COVID-19 impact had a devastating impact on farms, particularly those that rely on off-farm income.
True
T/F: Farm incomes are expected to fall by $21.9 billion in 2021 compared to the prior year.
True
Which of the following best defines the phrase “vertical integration” as used in agriculture?
A) The practice of raising multiple livestock or crop species in a single farming enterprise to better protect against market volatilities
B) The control of the stages of production of a single entity
C) A government program intended to streamline food production while providing farmers with better margins
D) A cooperative model among farmers designed to secure better prices for farm products
B
The Constitution provides the judicial branch (courts) with the power to ____ the law.
A) Enforce
B) Discontinue
C) Interpret
D) Create
C
Which of the following best defines the legal concept of judicial precedent?
A) A higher court can sometimes review a lower court’s decision and reverse the outcome. The US Supreme Court is the highest court in the land.
B) A doctrine derived from the Constitution stating that federal laws will preempt or take precedence over any state laws seeking to regulate the same conduct.
C) There are 2 separate court systems that can hear legal disputes: state courts and federal courts.
D) Courts have to follow the reasoning and decisions of courts with greater authority.
D
Which of the following best defines the legal concept of federalism?
A) There are 2 separate court systems that can hear legal disputes: state courts and federal courts.
B) The doctrine that authorizes Congress to regulate interstate commerce.
C) The doctrine that prevents one branch from having too much power or acting beyond the scope of its authority.
D) A doctrine derived from the Constitution stating that federal laws will preempt or take precedence over any state laws seeking to regulate the same conduct.
A
The Constitution provides the Executive Branch with the power to ____ the law.
A) Interpret
B) Modify
C) Revoke
D) Enforce
D
The Constitution provides Congress with the power to ____ the law.
A) Revoke
B) Enforce
C) Create
D) Interpret
C
The Constitution is designed to prevent any one branch of the Federal Government from becoming too powerful. What is this concept called?
A) Judicial Review
B) Federalism
C) Judicial Precedent
D) Checks and Balances / Separation of Powers
D
The current federal GMO labeling statute, enacted in 2016, imposes a ___________ labeling standard for foods containing genetically modified ingredients.
A) Mandatory
B) Intermittent
C) Voluntary
D) Partial
A
Which of the following best defines the legal doctrine of preemption?
A) The doctrine that prevents one branch from having too much power or acting beyond the scope of its authority.
B) There are 2 separate court systems that can hear legal disputes: state courts and federal courts.
C) A doctrine derived from the Constitution stating that federal laws will take precedence over any state laws seeking to regulate the same conduct.
D) The doctrine that authorizes Congress to regulate interstate commerce.
C
Administrative agencies derive their authority and jurisdiction from:
Congress
The FDA will consider a food to be misbranded if its labeling is false or misleading. When determining whether a product’s labeling is misleading, what two factors will the FDA consider?
Representations and omissions of material facts
Which of the following best describes the FDA’s approach to the use of the term “natural” in food labeling?
A) The FDA defines natural the same way that the USDA defines natural.
B) The FDA has issued no guidance or official rule on the use of the term natural in food labeling.
C) The FDA has officially defined natural as foods that do not contain synthetic substances and which have undergone only minimal processing.
D) The FDA has not defined the term natural, but does not object to its use if the food does not contain added color, artificial flavors, or synthetic substances.
D
T/F: AMS Grading standards are mandatory on USDA regulated food products.
False
Which of the following type of label claims are not required to receive pre-approval from the USDA?
A) Animal production claims, i.e. grass-fed
B) Breed Claims
C) Green Claims/Environmental Claims
D) Raised without Antibiotics
C
In response to the Jack in the Box outbreak, the USDA declared that ________________ is a per se adulterant in raw non-intact ground beef.
A) Salmonella
B) E. coli O157:H7
C) Listeria
D) Norovirus
B
Roughly ________ Americans get sick as the result of foodborne illness each year and roughly _________ Americans die each year as the result of foodborne illnesses.
A) 84 million; 13,000
B) 22 Million; 2,000
C) 48 million; 3,000
D) 100 million, 30,000
C
T/F: Food Product Dating is used to warn consumers about whether a particular food is safe to eat.
False
T/F: Food product dating is a mandatory labeling statement for all FDA-regulated products.
False
Which of the following best defines FSMA’s Foreign Supplier Verification program?
A) Requires food importers to verify that their foreign suppliers have adequate preventative controls in place to ensure that the imported food is as safe as food originating in the US.
B) Requires foreign food companies to receive a verification and authorization from the FDA before sending any food products to the US.
C) Requires the FDA to verify whether a food import shipment was refused by another foreign country.
D) Requires food importers to make physical inspections of foreign food facilities and to personally certify that the foreign food facility produces food as safely as domestic food producers.
D
T/F: FSMA requires food testing to be performed at an accredited laboratory.
True
Under FSMA’s Produce Safety Rule, a farm can obtain a Qualified Exemption from the rule’s requirements if it meets which of the following two factors:
Food sales averaging less than $500,000 per year during the previous three years and farm sales to qualified end-users exceeds sales to all others combined during the previous three years
Which of the following is not one of the five rules included in FSMA’s Produce Safety Rule?
A) Domesticated/Wild Animals
B) Biological Soil Amendments
C) Equipment, Tools, Buildings
D) Health and Hygiene
E) Waiver and Liability
F) Agricultural Water
E
Which of the following is not one of the four core themes of the Food Safety Modernization Act (FSMA)?
A) Import Safety B) Prevention C) Consumer Responsibility D) Enhanced Partnerships
C
T/F: Under FSMA, the FDA does not have authority to detain food imports.
False
FSMA’s Produce Safety Rule does not apply to farms that have an average annual value of produce sold during the previous three-year period of _________ or less.
$25,000
The FDA ______ the interstate sale of raw milk products.
prohibits
What are the 2 legal theories/frameworks, that states generally use to regulate the intrastate sale of raw milk products: (Hint: not the add-ons, just the basic frameworks.)
A) Pasteurized Milk Ordinance and Respondeat Superior B) FSMA and United Milk Producers of America Act of 1975 C) Retail sales and on-farm sales D) Negligence and HACCP
C
Administrative agencies derive their authority and jurisdiction from:
The legislative branch
According to the CDC between ____% of Americans regularly consume raw milk products.
1-3
Which of the following is not one of the agencies involved in administration of the Coordinated Framework?
A) EPA
B) USDA
C) FDCA
D) FDA
C
Define a Regulated Article.
Organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering
Under the Coordinated Framework, what is USDA-APHIS’ key statute and what is the agency’s primary mandate under the statute?
A) FIFRA; Must ensure that the pesticide will not pose unreasonable risks of harm to human health or the environment.
B) PPA; Must prevent the introduction or dissemination of plant pests in the Unites States
C) FIFRA; Must prevent the introduction or dissemination of plant pests in the Unites States
D) FDCA; Must ensure the safety and proper labeling of all plant-derived food and feed, including those developed through genetic engineering.
B
Which of the following is not one of the guiding principles that agencies must observe when interpreting and enforcing the Coordinated Framework?
A) Agencies must take into account public acceptance and social license when considering novel biotechnology products.
B) Agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities.
C) Agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk.
D) Agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it was created.
A
Which country has banned the cultivation and import of GMO crops?
Russia
Under the Coordinated Framework, what is the FDA’s key statute and what is the agency’s primary mandate under the statute?
A) FIFRA; Must ensure that the pesticide will not pose unreasonable risks of harm to human health or the environment. B) FDCA; Must ensure the safety and proper labeling of all plant-derived food and feed, including those developed through genetic engineering. C) PPA; Must prevent the introduction or dissemination of plant pests in the Unites States D) FIFRA; Must prevent the introduction or dissemination of plant pests in the Unites States
B
Which of the following best describes the Coordinated Framework for the Regulation of Biotechnology?
A) It reflects the White House's current policies regarding the regulation of biotechnology, including how each agency should apply its existing laws to regulate biotechnology products. B) None of the above. C) It describes a set of voluntary guidelines that federal agencies must consider when evaluating biotechnology products. D) It describes the Federal system for evaluating products developed using modern biotechnology.
D
Which of the following best explains the difference between a Plant-Incorporated Protectant (PIP) and Herbicide-Tolerant (HT) crops.
A) PIP crops contain new genes that allow the crop to withstand herbicides, whereas HT crops are plants that have had genes inserted causing the plants to produce a pesticide inside its own tissues.
B) PIP crops are plants that have had genes inserted causing the plants to produce a pesticide inside its own tissues, whereas HT crops contain new genes that allow the crop to withstand herbicides.
B
Which of the following is not one of the three principle assumptions incorporated in the Coordinated Framework?
A) The approval of products produced using biotechnology should be subject to rigorous agency examination.
B) A commercial product, regardless of its manner of production, should be regulated based on the product’s composition and intended use.
C) The creation of new laws to regulate the products of genetic engineering is unnecessary. Existing laws can address regulatory needs adequately.
D) The process of biotechnology itself poses no unique or special risks.
A
T/F: Since the RFS was enacted, Congress has kept up with the statutory mandated increases in the levels of renewable fuel sources that must be blended into our fuel system.
False
Under the Coordinated Framework, what is the EPA’s key statute and what is the agency’s primary mandate under the statute?
A) FIFRA; Must ensure that the pesticide will not pose unreasonable risks of harm to human health or the environment.
B) PPA; Must prevent the introduction or dissemination of plant pests in the Unites States
C) FIFRA; Must prevent the introduction or dissemination of plant pests in the Unites States
D) FDCA; Must ensure the safety and proper labeling of all plant-derived food and feed, including those developed through genetic engineering.
A
Which of the following is not one of the official reasons Monsanto gives to support its decision to sue farmers who save its seeds.
A) No business can survive without being paid for its product.
B) The loss of this revenue would hinder our ability to invest in research and development to create new products to help farmers. We currently invest over $2.6 million per day to develop and bring new products to market.
C) It would be unfair to the farmers that honor their agreements to let others get away with getting it for free. Farming, like any other business, is competitive and farmers need a level playing field.
D) Asserting intellectual property rights against farmers regardless of their scale and resources sends a clear message to other producers that seed licenses should be taken seriously and respected.
D
T/F: If a certified organic producer’s crop is subject to GMO drift contamination, he or she will lose his or her organic certification.
It depends
Which of the following best defines a nuisance according to general property law principles?
A) A tangible and direct interference with the right to use and enjoy one’s property.
B) A reasonable but unjustifiable use of property, which causes inconvenience or damage to others.
C) A subjective believe that a neighbors’ use of his or her property is an unreasonable and substantial interference with your health, well-being, and property usage.
D) The unreasonable, unwarranted and/or unlawful use of property, which causes inconvenience or damage to others.
D
The FDA regulates human food animals that have been genetically engineered as:
New Animal Drugs
How does US law allocate the burden of drift prevention between GMO cultivators and non-GMO cultivators?
Non-GMO cultivators bear the burden and costs of identifying and preventing GMO contamination.
T/F: The federal government recently adopted the Privacy & Security Principles for Farm Data agreement as the governing law regarding farm data.
False
Which of the following is not an example of reasonable steps that a non-GMO cultivator can take to protect against GMO drift.
A) Obtaining a preliminary injunction to prevent neighboring agricultural operations from engaging in activities that have a high probability of resulting in drift.
B) The use of buffer zones to separate organic from GE crops.
C) Timing planting to stagger flowering of organic and GE crops.
D) Posting signs to notify neighbors of the location of organic fields.
A
Which of the following is not one of the 6 fundamental property rights:
A) Right to Transfer
B) Right to Expand
C) Right to Use
D) Right to Enjoy
B
T/F: The Coordinated Framework was updated routinely after its adoption in 1986 to account for new developments in biotechnology.
False
What is the estimated percentage of food products sold in supermarkets does the USDA says contains genetically modified ingredients?
70%
What is the National Bioengineered Food Disclosure Standard?
Mandatory labeling of bioengineered food products
(GE, GMO, BE, etc)
What is a complaint?
The first document filed with the court to initiate a lawsuit
IDs the parties to the lawsuit and the claims against them
Lists the remedies that the plaintiff(s) is seeking (money, an injunction, a declaration from the court)
What are Unfair Competition Laws?
Designed to protect consumers and businesses from deceptive business practices (JustMayo packaging resembling real mayonnaise and being misrepresentative)
Ex: misappropriation of business secrets, fraud in advertising, and trademark infringements
What is the FDA responsible for?
Assuring that foods sold in the US are safe, wholesome, and properly labeled
What does the FDA regulate?
80% of the food supply
Seafood
Dairy
Produce
Shell eggs
Dietary supplements
Bottled water
Food additives
Infant formula
What does the USDA regulate?
Meat
Poultry
Processed egg products (liquid egg substitutes, dehydrated eggs, egg products in frozen foods, unshelled eggs)
What are the goals of the Food, Drug, and Cosmetics Act?
1) Prevent misbranding
2) prevent adulteration
Information that must be on food product labels are ____.
affirmative labeling requirements
Examples of affirmative labeling requirements
Name of food
Name and place of manufacturer
Ingredients
Net quantity
Nutrient content
How does the FDA determine if information on a product label is misleading?
1) Representations
2) failing to mention material facts
Why are there standards of identity?
To help consumers and to provide consistency and trust
Nutrient content claims are
claims on food products that directly or implicitly characterize the level of a nutrient in a food
Ex. Low fat, sugar free, contains 100 calories
What is a health claim?
any claim made on a label that expressly or impliedly characterizes the relationship of any substance to a disease or health-related condition
Ex. Good source of calcium, reduces risk of heart disease
When does the FDA consider a food misbranded?
When its labeling is false or misleading in any way
T/F: The FDA preapproves food labels.
False
How does the FDA define the term “natural” for food products?
There is no official definition
What is greenwashing?
when marketing is used to promote the perception that an organizations products, aims, or policies are environmentally friendly
How does the USDA define the term “natural” for food products?
A product containing no artificial ingredient or added color and is only minimally processed
What is a class action lawsuit?
A lawsuit brought on by one individual or a group of individuals on behalf of a class of people who were harmed in a similar way.
The labeling of meat and poultry products is governed by:
Federal Meat Inspection Act (FMIA)
Poultry Products Inspection Act (PPIA)
Egg Products Inspection Act (EPIA)
What is the Food Safety and Inspection Service (FSIS)?
agency within the USDA that is responsible for handling the USDA’s duties under the three labeling statutes
How does the USDA approve labels?
web-based software application called LSAS
Production claims are
claims related to how an animal was raised or processed
These must be verified by supporting documentation and approved by FSIS before the label can be used
Ex. No added antibiotics, no hormones added, raised without antibiotics, vegetarian fed
Examples of animal raising claims
Grass fed
Grass finished
100% grass fed
Pastured
Pasture raised
Outdoor access
Cage free
What is country of Origin Labeling (COOL)?
labeling law that requires retailers, such as full-line grocery stores, supermarkets, and club warehouses, to notify their customers with information regarding the source of certain foods
What are the three main purposes of the National Organic Program (NOP)?
1) Establish national standards governing the marketing of certain agricultural products as organically produced products
2) To assure consumers that organically produced products meet a consistent standard
3) To facilitate interstate commerce in fresh and processed food that is organically produced
What is a foodborne illness?
Any illness that results from the ingestion of food
What is a pathogen?
a bacterium, virus, or other microorganism that can cause disease
What statute is under FDA marking responsibility for food safety?
Food, Drugs, and Cosmetics Act
What regulatory authority does the FDA have?
Produce, dairy, seafood, and shell eggs
What statue is under the USDA marking responsibility for food safety?
Federal meat Inspection act
What regulatory authority does the USDA have?
Meat, poultry, processed egg products, and catfish
Define deleterious
causing harm or damage
The meat and poultry industry is the largest segment of US agriculture. These industries comprise ___% of the US GDP.
6
Define adulterated
Food that bears or contains any poisonous or deleterious substance that may be injurious.
Briefly describe the HACCP system
- ID food safety hazards
- ID critical control points (where a food safety measure can be applied)
- Establish minimum and maximum limits for each point
- Monitor for compliance with these limits to ensure each one is under control
- ID corrective actions that will be taken if the limits are exceeded
- Effective recordkeeping of all HACCP activities
- Verify that the system works
Exemptions for USDA meat, poultry, and processed egg product inspection
- Personal use
- Custom (similar to personal use but someone else butchers the animal for you)
- Retail/Restaurant/Central Kitchen
- Religious
T/F: Salmonella is not considered an adulterant under the USDA.
True
Is a food recall voluntary?
Yes, but if a company refuses to recall its products FSIS has legal authority to detain and seize those products in commerce.
Describe a Class I recall
Reasonable probability that eating the food will cause health problems or death
Describe a Class II recall
Remote probability of adverse health consequences from eating the food
Describe a Class III recall
Eating the food will not cause adverse health consequences,
I.e. product is misbranded due to undeclared ingredients
5 main components to the Produce Safety Rule
d1) Water Quality - water that is intended or likely to contact produce or food-contact surfaces is safe and sanitary
2) Biological Soil Amendments - types of treatment, methods of application, and time intervals between application of certain soil amendments and crop harvest
3) Domesticated & Wild animals - waiting periods between grazing or working animal contact and crop harvest - farmers must monitor for wildlife intrusion
4) Worker Training, Health, Hygiene - farm workers must follow hygienic practices and not work when sick
5) Equipment, Tools, & Buildings
PSR does not apply to:
- Produce that is not a raw agricultural commodity (rarely consumed raw)
- Food grains
- Personal use or on-farm consumption
- Farms whose average annual value of produce sold during the previous 3-year period of $25,000 or less.
- Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance
What are the two requirements that would make some farms exempt from PSR’s requirements?
1) The farm has food sales averaging less than $500,000/year during the previous 3-year period
2) The farm’s sales to qualified end-users must exceed sales to all others combined during the previous 3 years.
What is a qualified end-user?
(a) The consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or Indian reservation as the farm or not more than 275 miles away.
What are the FSMA themes?
1) Inspection, Compliance, & Response
2) Traceability
3) Import Safety
4) Enhanced Partnerships
T/F: FSMA requires that food from abroad be as safe as food originating in the US.
True
What is foreign supplier verification?
Importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe
T/F: The FDA cannot refuse entry into the US of food from a foreign facility if the FDA is denied access by the facility or the country in which the facility is located.
False
The FDA CAN refuse food entry into the US
According to the USDA between __% to __% of food in the US goes uneaten.
30-40
T/F: The average American family of four throws out over 1,160 pounds of food a year.
True
T/F: Product dating is not a federally required regulation, except for on infant formula.
True
What is the Pasteurized Milk Ordinance (PMO)?
Model regulation helping states and municipalities have an effective program to prevent milk borne disease.
What is the Renewable Fuel Standard?
Federal program that requires transportation fuel sold in the US to contain a minimum volume of renewable fuels
Describe genetically modified organism (GMO)
result of a laboratory process where genes from the DNA of one species are extracted and artificially forced into genes of an unrelated plant or animal.
Are GMOs and GE products the same?
No
GE is typically used to reference a broader set of biotechnology techniques
What is herbicide tolerance?
Plants that are able to withstand herbicidal products used on them.
What are risks ascribed to GM crops?
- No longer-term testing
- Cross pollination (herbicide resistant crops leading to herbicide resistant weeds)
- Pesticide resistance in insects
- Structural and/or chemical changes to internal organs and reduced fertility in humans
- Inability to maintain complete control of GMO crops once they are placed in the environment
What are benefits ascribed to GM crops?
- Better resistance to weeds, pets, and other diseases
- Producing plants that have larger yields
- Foods with better texture, flavor, and nutritional value
- Longer shelf life
- Helping farmers produce enough food to meet rising global populations and increasing demands
- Creating food security
What three entities are part of the Coordinated Framework?
1) USDA-APHIS (agri & plant health)
2) FDA (food & feed)
3) EPA (pesticides)
Describe the Coordinated Framework for Regulation of Biotechnology.
the federal system for evaluating products developed using modern biotechnology
What are the three principle assumptions of the Coordinated Framework?
1) The process of biotechnology itself poses no unique or special risks
2) A commercial product, regardless of its manner of production, should be regulated based on the products composition and intended use
3) The creation of new laws to regulate the products of genetic engineering is unnecessary
What part does the USDA-APHIS play in the Coordinated Framework?
- Protecting agriculture from pests and diseases
- Creates regulations that carry out the requirements of the Plant Protection Act
What part does the EPA play in the Coordinated Framework?
- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
- Regulates the distribution, sale, use, and testing of pesticidal substances produced in plants and microbes
- Ensuring pesticides will not pose unreasonable risks of harm to human health or the environment
What are Plant-Incorporated Protectants (PIPs)?
Plants that have had genes inserted causing the plants to produce a pesticide inside its own tissues
What are genetically modified microbial pesticides?
Either bacteria, fungi, viruses, protozoa, or algae whose DNA has been modified to express pesticidal properties
What are herbicide-tolerant crops?
crops that contain new genes that allow the plant to tolerate herbicides
What part does the FDA play in the Coordinated Framework?
- Food, Drug, and Cosmetic Act
- Ensuring the safety and proper labeling of all plant-derived food and feed
What does “generally regarded as safe” mean?
- Scientific data and information about the use of a substance must be widely known
- There must be a consensus among qualified experts that the data and information establish that the substance is safe under the conditions of its intended use
What are the key statutes under each of the three members of the coordinated framework?
USDA-APHIS = Plant Protection Act
EPA = FIFRA
FDA = Food, Drug, & Cosmetic Act
What is the primary mandate under the three members of Coordinated framework under their key statues?
APHIS - must prevent the introduction or dissemination of plant pests in the US
EPA - ensure that pesticides will not pose unreasonable risks or harm to human health or the environment
FDA - ensure the safety and proper labeling of all plant-derived food and feed, including those developed through GE
What are key terms to know regarding USDA-APHIS in the Coordinated Framework?
Plant pest
Regulated articles
Non-regulated articles
Authorization
What are key terms to know regarding EPA in the Coordinated Framework?
PIPs
HTs
Bt Corn
What are key terms to know regarding FDA in the Coordinated Framework?
VCP
GRAS
GRAS Notification Program
What is a Limited Use License?
restricts how the purchaser of intellectual property can use it
What is GMO drift?
The unintended transfer of GE crops or plant materials to another location or to non-GE crops
AKA: Genetic crop contamination
How does the NOP define GMO Drift?
physical movement of prohibited substances from the intended target site onto an organic production operation or any portion thereof.
Describe the reasonable steps an organic farming system must do to try and prevent GMO drift?
- Use of buffer zones to separate organic from GE crops
- Testing seeds for GE
- Timing planting to stagger flowering of organic and GE crops
- Forming agreements with neighbors to avoid planting GE crops adjacent to organic crops
- Cutting or mowing alfalfa prior to flowering
- Posting signs to notify neighbors of the location of organic fields
Define plant pest
any living stage of insects, bacteria, fungi, viruses, or various other organisms that can damage or cause injury to plants or plant parts
Define non-regulated articles
A company can petition to have its product deemed a non-regulated article which is not subject to APHIS’ regulation under the PPA
Define authorization
If a GE organism meets the definition of a regulated article and the company plans to import it, move it interstate, or release it into the environment, the company will need to apply for an authorization before proceeding with the activity
Define PIPs
plants that have had genes inserted causing the plants to produce a pesticide inside its own tissues
Define HTs
Herbicide tolerant crops contain new genes that allow the plant to tolerate herbicides intended to kill unwanted weeds
Define Bt Corn
a PIP variety of GE corn engineered with a type of toxin that kills insect larvae feeding on the corn
Define GRAS
Substances that are not subject to the FDA’s pre-approval process
Define GRAS Notification Program
Provides a mechanism whereby a person may inform the FDA of a determination by non-agency qualified experts that the use of a substance is GRAS, rather than petition FDA for affirmation
What is the patent exhaustion doctrine?
Doctrine that limits the extent to which patent holders can control an individual article of patented product after an authorized sale
How does the FDA regulate GE animals?
As new animal drugs under the FDCA
Define New Animal Drug
Any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed
That is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug
