question
sunset laws
answer
Laws that automatically expire after a given time; lawmakers have to review the need for continuing the law beyond the date.
ONLY FOR STATES NOT FEDERAL
ONLY FOR STATES NOT FEDERAL
question
Eras of Federal Regulatory Agencies
answer
Historical, New Deal, Socially Conscious
question
Historical Era
answer
late 1800s early 1900s
railroads, drug companies, securities
railroads, drug companies, securities
question
New Deal Era
answer
FDR
get country out of depression
get country out of depression
question
Socially Conscious Era
answer
1960s-1970s
Industry activities: pollution control, workplace safety, product safety, and hiring and firing practices in employment
Industry activities: pollution control, workplace safety, product safety, and hiring and firing practices in employment
question
Enabling Statue sets agencies
answer
1) Regulatory mission
2) Organizational structure
3) Enforcement powers
2) Organizational structure
3) Enforcement powers
question
Industry Specific Regulatory Agencies
answer
-Agency was created to regulate one specific type of industry
-Can lead to Regulatory Capture
Examples
-ICC
-SEC
-FCC
-Can lead to Regulatory Capture
Examples
-ICC
-SEC
-FCC
question
Regulatory Capture
answer
The situation that occurs when a governmental regulatory agency ends up being controlled by the industry that it is supposed to be regulating.
question
Economy Wide Regulatory Agencies
answer
regulate problems that are not isolated in one particular industry
-regulate across industry lines
Ex.
FTC
NLRB
EPA
-regulate across industry lines
Ex.
FTC
NLRB
EPA
question
Types of Agencies based on Control
answer
Executive Agencies (Dependent)
Independent Executive Agencies
Independent Regulatory Agencies
Government Corporations
Independent Executive Agencies
Independent Regulatory Agencies
Government Corporations
question
Executive Agencies
answer
-executive branch
-created by executive order/enabling statue
-answer directly to president
-normally one person in charge
-appointed/removed by pres.
- normally confirmed by senate
-created by executive order/enabling statue
-answer directly to president
-normally one person in charge
-appointed/removed by pres.
- normally confirmed by senate
question
Independent Executive Agencies
answer
-not directly under jurisdiction of particular cabinet position
-still under presidential control
-independent dependent
-president still can appoint and remove head
Ex. NASA EPA
-still under presidential control
-independent dependent
-president still can appoint and remove head
Ex. NASA EPA
question
Independent Regulatory Agencies
answer
•Normally created by Congress via Enabling Statute
•Boards and Commissions
•Multiple Members, appointed by President, confirmed by Senate, serve a term of years, only removed for cause
•Supposed to be non-political
•Boards and Commissions
•Multiple Members, appointed by President, confirmed by Senate, serve a term of years, only removed for cause
•Supposed to be non-political
question
Constitutionality of agencies was challenged
answer
during new deal area
question
Schechter Poultry Corp v. US
answer
(1935)
-Congress creates laws, not the president
-NIRA was removed (wanted to stabilize prices and deter cutthroat competition)
-Congress creates laws, not the president
-NIRA was removed (wanted to stabilize prices and deter cutthroat competition)
question
Switch in Time Saved Nine
answer
a saying recalling the actions that saved the supreme court to remain with only 9 seats. came about after NIRA was found unconstitutional
FDR wanted more judges so the judges started agreeing with his policies
FDR wanted more judges so the judges started agreeing with his policies
question
Yakus v. US
answer
Supreme Court ruled that delegation of legislation authority was okay as long as there were standards and powers were limited
effort to control inflation w/ shortage of goods and from the creation of Office of Price Administration
effort to control inflation w/ shortage of goods and from the creation of Office of Price Administration
question
administrative procedures act (APA)
answer
-made organizational structure more uniform
-gives guidance to the agencies
-gives guidance to the agencies
question
Legislative Rule making Powers
answer
- Must follow the APA
- Two types of rule-making procedures
-- Formal **
-- Informal
- Two types of rule-making procedures
-- Formal **
-- Informal
question
Informal Rule-Making Steps
answer
-agency recognizes the need for rule
-agency promulgates draft of the proposed rule
-gives notice required by APA of printing in the federal register
-public can send in written comments (30 days)
-agency can revise or completely ignore
-final draft published in the federal register and take effect in 30 days
Procedural Rules or interpretive rules aka regulations
-agency promulgates draft of the proposed rule
-gives notice required by APA of printing in the federal register
-public can send in written comments (30 days)
-agency can revise or completely ignore
-final draft published in the federal register and take effect in 30 days
Procedural Rules or interpretive rules aka regulations
question
Formal Rule Making Steps
answer
-Agency identifies need for Rule
-Agency promulgates proposed rule
-Must publish "Notice of Proposed Rule-Making" in Federal Register including
-Hearing Dates, Time, Place and nature of the proceedings
-Legal Authority
-Description of issues
-Minimum of 30 days notice (can be longer)
Required for Substantive Rules
-Agency promulgates proposed rule
-Must publish "Notice of Proposed Rule-Making" in Federal Register including
-Hearing Dates, Time, Place and nature of the proceedings
-Legal Authority
-Description of issues
-Minimum of 30 days notice (can be longer)
Required for Substantive Rules
question
Enforcement/Investigatory Powers
answer
-Main job of most agencies
Types of Investigatory Powers
-Self Reporting requirements
-Hold Hearings
-Subpoena
-Physical Inspection
Types of Investigatory Powers
-Self Reporting requirements
-Hold Hearings
-Subpoena
-Physical Inspection
question
Subpoena
answer
a court order requiring appearance and/or testimony or produce documents
question
Don Chemical Co v US
answer
) EPA had asked for an on-sight inspection of Dow's chemical plant
ii) Dow Chemical refused the request
iii) EPA hired a commercial aerial photographer to take photos of the Dow plant
iv) Dow claimed a violation of its 4th Amendment rights
v) Supreme Court held it to be "open field
ii) Dow Chemical refused the request
iii) EPA hired a commercial aerial photographer to take photos of the Dow plant
iv) Dow claimed a violation of its 4th Amendment rights
v) Supreme Court held it to be "open field
question
Adjudicatory Powers
answer
-Can be very controversial
Hearing before an Administrative Law Judge
-Independent
-Can still be replaced/re-assigned
-Agency is both prosecutor and judge
-No jury
Hearing before an Administrative Law Judge
-Independent
-Can still be replaced/re-assigned
-Agency is both prosecutor and judge
-No jury
question
Types of Regulatory Reforms
answer
-Accessibility to the Administrative Process
-Lessoning problems for small businesses
-Sunset Laws
-Deregulation
-Lessoning problems for small businesses
-Sunset Laws
-Deregulation
question
Federal Food and Drug Administration (FDA)
answer
The federal agency with jurisdiction over foods, drugs, and all products that come in contact with the skin or are ingested
question
Pure Food and Drug Act (Wiley Act)
answer
original act dealing with food and drug prior to FDA creation, Bureau of Chemistry
Forbids interstate and foreign commerce (Commerce Clause) in adulterated and misbranded food and drugs
Forbids interstate and foreign commerce (Commerce Clause) in adulterated and misbranded food and drugs
question
Food, Drug, and Cosmetic Act of 1938
answer
Passed after another tragedy, Elixir Sulfanilamide (antifreeze)
•Manufacturer's had to prove that drug was safe before it could be used and required FDA approval
•Required doctor's prescription of drugs, prescription v. over the counter drugs
•Manufacturer's had to prove that drug was safe before it could be used and required FDA approval
•Required doctor's prescription of drugs, prescription v. over the counter drugs
question
Kefauver-Harris Amendment of 1962
answer
requires all medications in US to be pure safe and effective
gave FDA control over drug advertisements
after Thalidomide incident with deformed babies
gave FDA control over drug advertisements
after Thalidomide incident with deformed babies
question
Drug Abuse Control Amendments of 1965
answer
required accounting for drugs with a potential for abuse such as barbiturates and amphetamines.
question
Drug Enforcement Administration (DEA)
answer
1970s
1980s
-AIDS
-Generic drug
-speedier approval of drugs
-recalls
1980s
-AIDS
-Generic drug
-speedier approval of drugs
-recalls
question
Delaney Clause in 1958
answer
-FDA assumed control over food additives
-Banned carcinogenic, (cancer causing) additives
-Zero risk standard meant ANY showing of cancer meant the additive could NOT be used (will be changed)
-Banned carcinogenic, (cancer causing) additives
-Zero risk standard meant ANY showing of cancer meant the additive could NOT be used (will be changed)
question
General Powers of the Food, Drug and Cosmetic Act of 1938
answer
-expanded power of FDA to cosmetic and therapeutic devices
-meat still exempt
-meat still exempt
question
FDA reports results in
answer
-no action
-objectionable condition found (voluntarly changes made)
-serious objectionable conditions found ( enforcement)
-objectionable condition found (voluntarly changes made)
-serious objectionable conditions found ( enforcement)
question
Enforcement of FDA
answer
Recalls
•Injunction issued
•Seizure of the subject product
•Fines
•Consent Decree
•Criminal Investigation
•Injunction issued
•Seizure of the subject product
•Fines
•Consent Decree
•Criminal Investigation
question
Food Quality Protection Act
answer
set pesticide limits in food
Changes to reasonable certainty of no harm
Changes to reasonable certainty of no harm
question
Hatch-Waxman Act
answer
Drug Price Competition and Patent Restoration Act of 1984
Allowed FDA to approve generic versions of brand-named drugs
Allowed FDA to approve generic versions of brand-named drugs
question
MedWatch
answer
This is the FDA reporting service for adverse effects that occur from use of approved drugs.
question
Medical Devices Amendment Act in 1976
answer
gave FDA jurisdication over medical devices
Ex. silicon breast implants Dow Corning Case
Ex. silicon breast implants Dow Corning Case
question
Family Smoking Prevention and Tobacco Control Act of 2009
answer
gave FDA jurisdiction over tabacco products
-anti smoking law
-advertisements
-outlaws flavored cigs
-anti smoking law
-advertisements
-outlaws flavored cigs
question
Consumer Product Safety Act (CPSA) in 1972
answer
Only applies to consumer products, products produced or distributed for "personal use, consumption or enjoyment in a household, in school, or in recreation"
-toys
-furniture
-household chemicals
-toys
-furniture
-household chemicals
question
what does the appellate court harshish to?
answer
procedural and regulatory
question
first administration agency
answer
interstate commerce commission (regulate railroads)
question
NRLB
answer
National Relations Labor Board
governs the organizing and bargaining rights of labor unions in virtually all industries.
governs the organizing and bargaining rights of labor unions in virtually all industries.
question
NIRA
answer
1933 National Industrial Recovery Act.
Created NRA to enforce codes of fair competition and established price setting boards
Created NRA to enforce codes of fair competition and established price setting boards
question
Atlas Roofing Company, Inc. v. Occupational Safety and Health Review Commission
answer
said Seventh Amendment's requirement that jury trial does not extend to administrative adjudications
question
timeless
answer
grieved party cannot appeal the case until all remedies within the agency have been exhausted, including the appeal to the review board within the agency.
question
standing
answer
to assure that the parties challenging the administrative action are in a true adversarial relationship to the agency.
question
de novo
answer
court will examine the issue as if the agency had not yet acted
question
FDA was originally in what department
answer
Department of Agriculture then Federal Security Agency and now in the Department of Health, Education, and Welfare
question
Meat is under what department
answer
nited States Department of Agriculture.
question
Food Safety Modernization Act (FSMA)
answer
FDA focus more on preventing food contamination
2011 from Obama
2011 from Obama
question
Federal Anti-Tampering Act
answer
After the Tylenol scare in Chicago when bottles of the drug were laced with cyanide, the FDA issued tamper-resistant packaging regulations
question
Consumer Product Safety Act (CPSA)
answer
first direct control of product safety by the federal government. The CPSA applies only to consumer products, which are defined as products produced or distributed for "personal use, consumption or enjoyment, in a household, in school, or in recreation.
question
Consumer Product Safety Commission (CPSC)
answer
Consists of five members, appointed by the President, for staggered seven-year terms. No more than three commissioners may belong to the same political party.
usually only 3 on
usually only 3 on
question
CPSC is empowered to issue two types of product safety standards
answer
Performance Standards
Labeling Standards
Labeling Standards
question
Accessibility to Administrative process
answer
Freedom of Information Act (1966)
Government in the Sunshine Act (1976)
Government in the Sunshine Act (1976)
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