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MGMT 211 Swim > Chapter 6 > Flashcards

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
Q

4 Benefits to Regulation of business by Agencies?

A

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
Q

Cost of Regulation by Agencies

A
  • used cost-benefit analysis (do costs outweigh benefits)
  • hard to value benefits efficiently
  • rules cost lots of money
27
Q

Criticisms to Agencies

A

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
Q

Freedom of Information Act

A

-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
Q

Government Sunshine Act? What are it’s exceptions

A
  • 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
Q

Regulatory Flexibility Act

A
  • 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
Q

Small Businesses Regulatory Enforcement Fairness Act (SBRERA)

A
  • 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
Q

Sunset Laws

A
  • 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
Q

The Food, Drug and Cosmetic Act of 1938

A
  • 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
Q

Kefauver-Harris Amendments 1962

A
  • 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
Q

Drug Abuse Control Amendments

A
  • gave government more control over amphetamines, barbiturates, hallucinogens
  • lead to creation of DEA
36
Q

Delaney Clause

A
  • 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
Q

Saccharin and the Delaney Clause

A
  • 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
Q

What did the Food, Drug and Cosmetic Act of 1938 do?

A

Expanded power of FDA to:

  • cosmetics
  • therapeutic devices

Gave new enforcement powers
-injunctions

39
Q

FDA is a subdivision of ____

A

Department of Health and Human Services

40
Q

How is FDA organized

A

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
Q

What are the 4 subparts of the Office of the Commissioner

A

Medical Products and Tobacco
Foods
Global Regulatory Operations and Policy
Operations

42
Q

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?

A

Pesticides

  • share regulation with EPA
  • share regulation with USDA

Drinking Water

  • FDA develops label
  • EPA sets national standards
43
Q

Explain the process after you send in a Complaint to the FDA

A

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
Q

True or False:

Companies usually do a voluntary recall to avoid liability and before matters get worse.

A

True

45
Q

Food Safety Modernization Act 2011 (FSMA)

A
  • shift from defensive to offensive
  • try to identify potential outbreaks before they happen
  • prevent contamination of food supply
46
Q

Food Additives Amendment to the Food Drug and Cosmetic Act of 1938

A
  • 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
Q

Food Quality Protection Act (FQPA)

A
  • eliminated zero-risk tolerance standard
  • new “reasonably certain of no harm standard”
  • expand FDA jurisdiction to over 9,000 pesticides
48
Q

Fair Packaging and Labeling Act 1966

A
  • 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

MGMT 211 Swim (17 decks)

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