Chapter 6 Flashcards

1
Q

Why were Agencies created?

A
  • business became too complex

- Government could not oversee everything

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2
Q

First Agency created ever was?

A

Interstate Commerce Commission

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3
Q

What were the 3 Eras of agencies

A

Historical 1887 to 1932

  • regulated specific industries
  • railroads, Drug Companies, Securities

New Deal
-Franklin D. Roosevelt’s Administration
-created many diff agencies
to get out of Great Depression

Socially Conscious 1960s and 1970s

  • product safety
  • pollution control
  • hiring/firing processes
  • workplace safety
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4
Q

Goal of Agencies

A
  • want to better Industry/companies
  • NOT public interest
  • Usually run by experts in business industry
  • leads to bias
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5
Q

FTC regulates what? In what era was it established?

A

Federal Trade Commissions

  • regulate advertising
  • created during Historical Era
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6
Q

NLRB regulates what? In what era was it established?

A

National Labor Relations Board

  • regulates management of companies in industries
  • created during New Deal Agency
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7
Q

What are the 4 Types of Federal Bureaucratic Agencies?

A

Executive Agencies
Independent Executive Agencies
Independent Regulatory Agencies
Government Corporations

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8
Q

Executive Agencies

A
  • created by Executive Order by President
  • under Executive branch
  • answer directly to president
  • one person in charge (head)

EX: Department of Labor

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9
Q

Independent Executive Agencies

A
  • executive branch
  • don’t answer directly to president

EX: NASA, EPA

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10
Q

Independent Agencies

A
  • Created by congress
  • members appointed by President
  • advice and consent by congress
  • appointed for terms
  • CAN’T be dominated by only one political party
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11
Q

Schechter Poultry Corp. v. United States

A
  • New Deal Era
  • said FDR giving Agencies legislative powers was unconstitutional
  • FDR was pissed
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12
Q

Yakus v. United States

A
  • declares giving legislative powers to Agencies is constitutional
  • reverses Schechter Poultry Corp. V. United States
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13
Q

Administrative Procedures Act (APA)

A
  • set standard of rules for agencies to follow

- made more uniform

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14
Q

What is an Enabling Statue?

A
  • Basically mission statement of an agency
  • gives powers to create legislation
  • is broad to create flexibility in powers
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15
Q

Informal Rule-Making process of an Agency

A

Agency defines need

  • by public demand
  • by congressional mandate
  • by industry request

Agency announces rough draft of Proposed rule

Prints proposed rule in Federal Register

  • required by APA
  • public can comment on it for 30 days
  • can revise/ignore

Final Draft of Rule published in Federal Register
-takes effect in 30 days

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16
Q

Formal Rule-Making Process of an Agency

A

Agency defines need for a rule

Proposed Rule is announced

Proposed Rule printed in Federal Register

  • hearing time
  • date
  • time
  • place
  • must describe issue and people involvedd

Formal trial

  • is of record
  • can have witness and cross examination of witnesses
  • interested party(affected party) can delay or draw out approval of rule
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17
Q

Informal Rule-Making V.S. Formal Rule-Making

A
Formal Rule Making
 -required for substantive rules
 -mandated by APA
Informal Rule Making
 -required for procedural rules
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18
Q

4 types of Investigatory Powers of Agencies

A

Require Businesses to self report

Hold Hearing

Physical Inspection of Businesses

  • may/may not need warrant
  • warrants are not probable cause warrants

Subpoena Power

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19
Q

Dow Chemical Co. V. United States

A
  • EPA wants to search Dow Chemical but they say no
  • EPA hires photographer to take pictures instead
  • “Open Fields Doctrine” allows them and doesn’t violate 4th amendment
  • Photographer used equipment that was available to the public
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20
Q

4th Amendment and Agencies searching businesses?

A
  • 4th amendment relaxed
  • only need legitimate government interest
  • some business require no warrant (EX: liquor stores)
21
Q

What are the two things that constitute legitimate government interest in order for an agency to search a business?

A
  • Violation of Rule or Regulation

- Valid Public Interest

22
Q

2 Types of Enforcement powers of an Agency

A

Threat of Public Exposure
-informal method
EX: EPA shows public how you make suasage to sell

Fines

  • violater can appeal fine
  • Agency can appeal to Federal District Court
  • Agency gets court order to comply with fine regarding violater
  • if violater still reffuses…. then criminal charges
23
Q

Explain Adjudicatory Powers and Procedures of Agency

A
  • controversial power of Agency
  • is court system for agencies
  • Administrative Law Judge (ALJ) conducts hearing
  • ALJ is employee of agency (potential conflict of interest)
  • ALJ pride themselves on being “independent but not really the case
  • just like regular court with witnesses and all that BUT
  • no right to attorney if cannot afford one
  • no jury
24
Q

Can someone appeal after the Administrative Law Judge’s opinion?

A
  • can appeal to review board of Agency
  • after that, losing party can appeal to U.S. Court of Appeals

-Final Ruling sets Precedent
(sometimes used to set a rule without having to go through whole rule making processes)

25
4 Benefits to Regulation of business by Agencies?
Free Market System -regulation allocates resources efficiently Takes burden of 3 branches of Government Used to handle politically sensitive issues Congress doesn't want to deal with Leads to Specialization by hiring experts in their fields - EPA biologists and chemists - FTC economists - FAA aeronautical engineers
26
Cost of Regulation by Agencies
- used cost-benefit analysis (do costs outweigh benefits) - hard to value benefits efficiently - rules cost lots of money
27
Criticisms to Agencies
Bureaucratic workers are lazy Adjudication Processes disatisfaction Agencies are too fast/slow to act on things Have outlived usefulness Agencies act to protect businesses and not public
28
Freedom of Information Act
-Agencies must make all information known to any person who asks for it - can refuse under several exceptions - agency can be forced to disclose information
29
Government Sunshine Act? What are it's exceptions
- applies to agencies headed by two or more people appointed by president - must hold "every portion of every meeting" out in the open EXCEPTIONS - day to day activities don't apply - agency can close a meeting by majority vote - decision is reviewed by U.S. District Court
30
Regulatory Flexibility Act
- if agency is about to pass rule/regulation affecting many businesses - then must measure costs to business - consider less burdensome ways to solve problem - must alert business before they pass rule/regulation
31
Small Businesses Regulatory Enforcement Fairness Act (SBRERA)
- allows congress to review regulation 60 days prior to it's effective date - more time for adversaries to present arguments - more time for adversaries to fight regulation
32
Sunset Laws
- state laws NOT federal laws - set time for agencies to "expire" and no longer have any authority/power - agency must convince Texas Legislature it is doing what is necessary to live on
33
The Food, Drug and Cosmetic Act of 1938
- Requires FDA approval to sell product - have to prove drug is safe before you can sell - required some drugs to only be given with Doctor Prescription
34
Kefauver-Harris Amendments 1962
- was an amendment to the Food, Drug, and Cosmetic Act - says drug now has to be safe in order to be approved by FDA - made manufacters of drug prove effectiveness of drugs and list side effects
35
Drug Abuse Control Amendments
- gave government more control over amphetamines, barbiturates, hallucinogens - lead to creation of DEA
36
Delaney Clause
- zero-risk tolerance standard - said product couldn't be sold if it even caused cancer a little bit - very strict, covers lots of products
37
Saccharin and the Delaney Clause
- FDA banned Saccharin for causing cancer - Congress overruled and allows it to be sold - Led to Nutrition Labeling and Education Act - revolutionized FDA requirement standards of nutritional information - allows some things that cause cancer if you do waaayyy too much
38
What did the Food, Drug and Cosmetic Act of 1938 do?
Expanded power of FDA to: - cosmetics - therapeutic devices Gave new enforcement powers -injunctions
39
FDA is a subdivision of ____
Department of Health and Human Services
40
How is FDA organized
Has an Office of Commissioner 4 offices answer to Commissioner - Chief Counsel - Attorney for the FDA - Office of Chief Scientists (give expertise) - Office of the Counselor to the Commissioner (gives leadership during crisis)
41
What are the 4 subparts of the Office of the Commissioner
Medical Products and Tobacco Foods Global Regulatory Operations and Policy Operations
42
FDA regulates a lot of things, including veterinary products, electronic products, vaccines, and blood products. What 2 things does it share regulation in and with whom?
Pesticides - share regulation with EPA - share regulation with USDA Drinking Water - FDA develops label - EPA sets national standards
43
Explain the process after you send in a Complaint to the FDA
FDA responds immediately -contacts complainer or complained about company FDA investigator goes to company - observes - ask questions - some industries have detailed manual how to carry out investigation FDA publishes report to public -part of Freedom Informations Act Company can respond - within 15 days - only if bad stuff was discovered Enforcement - injunction - recall - fines, etc.
44
True or False: Companies usually do a voluntary recall to avoid liability and before matters get worse.
True
45
Food Safety Modernization Act 2011 (FSMA)
- shift from defensive to offensive - try to identify potential outbreaks before they happen - prevent contamination of food supply
46
Food Additives Amendment to the Food Drug and Cosmetic Act of 1938
- called Delaney Clause - prevents additives shown to cause cancer - manufacturer had to prove safe - zero-risk tolerance ONLY Exception was GRAS (Generally Recognized as Safe)
47
Food Quality Protection Act (FQPA)
- eliminated zero-risk tolerance standard - new "reasonably certain of no harm standard" - expand FDA jurisdiction to over 9,000 pesticides
48
Fair Packaging and Labeling Act 1966
- applies to interstate commerce products - label had to be honest - label had to be informative - no standard serving size - confusing words reg. ppl don't know