Laws And Regulations - USDA Flashcards
What is a regulatory environment?
Consists of laws, regulations, and guidances developed by federal, state, and local governments in order to exert control over business practices
What factors affect passage of laws?
1) Political: legislature, president/governors, courts
2) Public opinion: large effect on marketability of a product
3) Industry: lobbying, government affairs
- some political action groups are funded by pharmaceutical companies + organic farming groups lobby to show
What is true if of laws or regulations?
A) laws are enforceable while compliance with regulations is voluntary
B) regulations are written by congress to provide details on how laws will be implemented by federal agencies
C) state laws have power or precedent over contradictory federal laws
D) proposed state laws require approval by the President of the United States before they can be implemented
E) the successful passage of laws can be influenced by public opinion and industry lobbyists
E) the successful passage of laws can be influenced by public opinion and industry lobbyists
With the publication in 1986 of the Coordinated Framework for the Regulation of Biotechnology (CFRB) as the formal policy for regulating biotechnology activities and products, which agency or agencies will be involved in reviewing rice which is genetically engineered to produce higher amounts of vitamins?
A) USFA, EPA, and FDA
B) USDA and FDA only
C) USDA only
D) FDA and EPA only
E) USDA and EPA only
B) USDA and FDA only
The USDA requires a permit for the introduction of regulated organisms. Introduction is of three types. From the USDA regulations, which one is not included as a type of introduction?
A) Release of the regulated organism from a laboratory and into the environment for field testing
B) Transport of regulated organism from Florida to Georgia
C) Importation of non-radioactive sunflower from the US to Russia
D) Interstate transport of the regulated article from Texas to California
E) Importation of a regulated organism from Japan and into the US
C) Importation of non-radioactive sunflower from the US to Russia
What is not true about the Animal and Plant Health Inspection Services’ (APHIS) permit system for GMO testing?
A) APHIS must be notified within 24 hrs of accidental release of GMO
B) Precautions must be taken to prevent accidental spread of GMOs
C) Permit is required for a company before field testing of new GMO plant.
D) Permit is required for a UH Natural Science and Mathematics researcher before field testing of new GMO plant.
E) Permit must be submitted 30 days before the planned field testing of the genetically engineered plant
E) Permit must be submitted 30 days before the planned field testing of the genetically engineered plant –> must be submitted 120 days before planned release
Which law is used by the USDA’s Animal and Plant Health Inspection Service to hold, seize, quarantine or destroy genetically engineered plants which are being tested, used, or marketed, in violation of regulations?
A) Virus, Serum Toxin Act (VSTA)
B) Plant Protection Act
C) Recombinant DNA Advisory Act
D) Plant Pest Act
E) Plant Health Act
B) Plant Protection Act
When a developer has collected enough evidence that a GE organism poses no more of a plant pest risk than an equivalent non-GE organism, the developer may _________ APHIS to determine ___________ status for the GE organism.
A) Injunction:permit
B) Permit:release
C) Petition:non-regulated
D) permit:introduction
E) Petition:introduction
C) Petition:non-regulated
The development of a marketed GM plant takes close to 9 years. The regulatory responsibilities of USDA begins with:
A) Initial field trials
B) experiments on the isolation and characterization of the gene that will be introduced into a plant
C) backcross breeding to remove extra unwanted sequences
D) Transforming the plant with the gene construct
E) product release to the market
A) Initial field trials
What is one of the 2013 goals of the Advisory Committee on Biotechnology 21st Century Agriculture (AC21)?
A) Help evaluate the effectiveness of practices for coexistence of GMO, organic, and non-GMO crops.
B) Promote the consumption of non-genetically engineered crops over genetically-engineered ones
C) Promote the use of organic fertilizers and pesticides for agricultural crops
D) Evaluate the effect of an engineered protein on food digestibility
E) Discourage the coexistence of GMO, organic and non-GMO crops
A) Help evaluate the effectiveness of practices for coexistence of GMO, organic, and non-GMO crops.
What is the daily official publication of the US government where all newly proposed and final federal rulemaking (including regulations) can be accessed, and where the public can comment on proposed laws?
A) electronic Code of Federal Laws
B) International Conference on Harmonization
C) Library of Congress
D) Federal Register
E) Public law
D) Federal Register
The Electronic Code of Federal Regulations (eCFR) is a compilation of CFR material and Federal Register amendments which are organized into 50 titles. What is title 21 on?
A) Food and Drugs
B) Agriculture
C) Commodities and Securities Exchanges
D) Public Health
E) Protection of the Environment
A) Food and Drugs
In 1971, Paul Berg successfully combined E. coli DNA with the DNA from the virus, SV40, that causes cancer in apes. To address human health and environmental concerns with similar experiments in the future, the National Institutes of Health formed the ___________ in 1974.
A) Office of Science and Technology (OST)
B) Recombinant DNA Advisory Committee (RAC)
C) Biotechnology Advisory Division (BAD)
D) U.S. Department of Agriculture (USDA)
E) Food and Drug Administration (FDA)
B) Recombinant DNA Advisory Committee (RAC)
Current regulations on recombinant DNA activities apply only to federally-funded research; industries that do not receive federal funding are exempt from the regulations.
False
What does not apply to the CFRB and CFRB policies?
A) A Pseudomonas strain engineered with a gene from Agrobacterium is considered to be a new organism
B) CFRB policies are intended to ensure the safety of biotech research and products
C) CFRB policies are based on verifiable scientific risks
D) CFRB intends to assign jurisdiction on regulation of biotech products to the FDA, EPA, and or USDA based largely on the intended use of the product
E) CFRB stands for Coordinated Framework for the Regulation of Biotherapeutics
E) CFRB stands for Coordinated Framework for the Regulation of Biotherapeutics
