Week 8-CH6

•Primary Tool for Government Regulation
•Called Fourth Branch of Government

they can:
-Implementation of Laws
-Enforcement of Laws

•Historical (late 1800's-early 1900's)
•New Deal (pres. FDR)
•Socially Conscious Era ('60's-'70's)

•Agency was created to regulate one specific type of industry
•Can lead to Regulatory Capture

•Examples
-ICC (went after railroads)
-SEC (security industry)
-FCC (communication industry)

•Goverenment Agency regulates more than one industry
•Has greater impact normally than Industry Specific

•Examples
-FTC (historic era)
-NLRB (new deal era)
-EPA (modern)

•Executive Agencies (Dependent)
•Independent Executive Agencies
•Independent Regulatory Agencies
•Government Corporations

Dependent

•Part of the Executive Department
•Created by Executive Order/Enabling Statute
•Answer directly to the President
•Normally called Departments or Administrations
•Normally one person in charge

the president liking the job you are doing

•independent bc/ Not directly under the jurisdiction of any particular Cabinet position
•Still under Presidential control
•Independent Dependent
-not very many of these

•Examples
-NASA
-EPA

•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
-can be extremely powerful organizations

- Agencies were challenged during the New Deal Era
•Schechter Poultry Corp. v. United States
•Switch in Time Saved Nine
•Yakus v. United States

•Constitutionality is rarely an issue now

(procedural act of administrative agencies)
•Made organizational structure more uniform
•Gives guidance to the agencies

(came through Truman administration)

•Defines purpose of the agency
•Empowers the agency to create rules and regulations
•Often power is stated in broad terms
•Gives great flexibility to the agency

executive order or act of congress

•Must follow APA
•Two types of rule making procedures
-Formal
-Informal

texas code of criminal procedure & criminal law

•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

•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)

•Formal Trial like Hearing
-Record make
-Can introduce exhibits
-Can call witnesses
-Can be used for delay (Up to 10 years)
•Final Draft Published in Federal Register no sooner than 30 days

•Procedural Rules -Informal
•Substantive Rules -Formal
•Regulations -Informal

just write the rule, post in federal register usually for 30 days and then law can go into effect

write rule, post in federal register, must put hearing dates (some can take up to 10 years)

exceptions

•Main job of most agencies
•Types of Investigatory Powers
-Self Reporting requirements
-Hold Hearings
-Subpoena
-Physical Inspection

-going after most powerful ppl so they have to be powerful which makes big business ppl mad

•4thAmendment relaxed (Civil)
•Usually only need reasonable cause to search, only need legitimate governmental interest
•Administrative Warrant
•Sometimes not warrant required

-exceeding their authority
-taking substantive rule & hiding it as either procedural or regulation rule

•Power to force business to comply with the rules/regulations
•Specified by enabling statute

-Threats of public exposure
-Fines
-Court Action
-Others as well, usually a combinatio

•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

•Right is found in the APA
-Must have standing
-Must be timely
•Scope is normally only on questions of law
•Level of Proof is normally Higher in Informal Procedure Rules than in Formal because already had your day in Court in the Hearings

not substantive b/c they already had their time in court

•Regulation can correct an imperfect market system
•Can take some of the burdens off the other three branches of government
•Can handle politically sensitive issues
•Leads to specialization

-they don't have to make money to be beneficial

-innocent person can get wrapped up & destroyed
-it is easy for a politician to blame a regulatory rule

•Always criticism of agencies
•Always calls for reform of agencies

-Accessibility to the Administrative Process
-Lessoning problems for small businesses
-Sunset Laws
-Deregulation

FDA

the jungle by Upton Sinclair
and the Spanish American war

led to Pure Food and Drug Act (1906)

•First Actual Law was during the Mexican War of 1848 concerning adulteration of food
•By 1886, issue was natural foods v. newly created artificial substitute (butter v. oleomargarine)
•Great time of change, moving from local to mass produced
•Needed a National Change

•Also called The Wiley Act
•Forbids interstate and foreign commerce in adulterated and misbranded, making false or misleading label claims, in food & drugs
•Drugs had to abide by standards of purity and quality
•Any variations from standards had to be disclosed on the label

•Administrative Agency for the Federal Government
•Started as Bureau of Chemistry which became the Food, Drug and Insecticide Administration before being called the FDA
•Now, under the Department of Health, Education and Welfare (HEW)

•Terms of the Pure, Food and Drug Act expired in 1930
•FDA fought Congress to renew them but Congress refused
•FDA went on the offensive
•"American Chamber of Horrors"

-Passed after another tragedy, Elixir Sulfanilamide
•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

Thalidomide banned in Europe, not in the United States for causing birth defects to babies
-Led to Kefauver-Harris (greater control by FDA)

-Drug had to be ruled safe by FDA to be sold
-Also had to be effective (maximum response achievable)
-Also gave FDA control over drug advertising

-Gave FDA more control over amphetamine, barbiturates, etc
-Leads to the Drug Enforcement Administration

•Originally only had control over canned goods
-FDA established standards
-Quality
-Fill of the container
•Stated adding nutrients to products
•Leads to controls

•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)

•Greatly expanded the power of the FDA
•Extended power of FDA to
-Cosmetics
-Therapeutic Devices
•Gave new enforcement powers

USDA
not FDA

•Under the Department of Health and Human Services
•Organization
-Office of Commissioner
-Several subparts anwserto Commission
•FDA Regulates many things, not just food and drugs

-foods
-drugs, vaccines
-cosmetics
-vet products
-tobacco produces
-pesticides
-drinking water

•Can be done by:
-Individuals/Consumers
-Health Professionals
-Industry Members themselves

•Process
-File complaint
-FDA investigates and then creates a report

-No Action (no violation found)
-Objectionable conditions found (voluntary changes usually made)
-Serious Objectionable Conditions (Most serious)

•Recalls
•Injunction issued
•Seizure of the subject product
•Fines
•Consent Decree
•Criminal Investigation

-Delaney Clause 1958 (seen earlier)
•Manufacturer had the burden of proof
•Recognized exceptions called GRAS
•Red Dye No. 2 (M&Ms example)

•Changes to reasonable certainty of no harm
•Expanded FDA to cover pesticides

•Only nutritional Labeling from 1941-1966 was for diet products

•Fair Packaging and Labeling Act 1966:
-Labeling had to be honest and informative
-Not consistent, not consider serving size

-Nutritional Labeling more consumer friendly
-Standardize serving sizes
-List amount of servings per package and Calories, Fats and cholestrol
-Standardizes language of nutritional labeling
-Makes manufacturers prove health claims

someone in Chicago was putting cyanide in Tylenol pills and putting them back on the self

this led to
-Federal Anti-Tampering Act

•FDA given jurisdiction over medical devices by the Medical Devices Amendment Act in 1976

•Example: Silicon Breast Implants

•FDA regulates tobacco products

•Family Smoking Prevention and Tobacco Control Act of 2009 controls
-Anti-Smoking Law
-Advertisements
-Outlawed flavored cigarettes
-FDA approval of sale of cigarettes

(one of the newer regulatory agencies, came out in social conscious era)

•Regulated by the States prior to 1967
•Bipartisan Commission of Product Safety
•Led to the Consumer Product Safety Commission in 1972

-Applies to consumer goods
-Can overlap other agencies
-Goal is to prevent deaths, injuries and loss of money

•Independent regulatory agency:
-Five members
-Appointed by President
-7 years terms
-Only takes 3 commissioners to act

•Regulates virtually ALL children's products
•Requires a General Certificate of Conformity (GCC) based on a test of each product

(came about largely bc of imports from china that were hurting children)

•Children's Gasoline Burn Prevention Act
•Federal Hazardous Substances Act
•Child Safety Protection Act
•Flammable Fabrics Act
•Poison Prevention Packaging Act
•Refrigerator Safety Act
•Virginia Graeme Baker Pool & Safety Act

•Information, Collection and Dissemination
•develops Product Safety Standards created by testing
-CPSC can ban the product or Recall the product
-Any interested Party can petition the CPSC to issue, amend or revoke standard (Judicial Review)

-busy during Christmas time

Confirmed the delegation of legislative powers was constitutional. Therefore, Administrative Agencies held to be constitutional

ruled the delegation of legislative power to be unconstitutional

Reasonable ignorance of a government regulation is not a defense to an agency action

-EPA requested on-site inspection of Dow chemical plant
-Dow chemical refused
-EPA hired commercial aerial photographer to get pictures of the plant
-Dow sued & said it violated 4th amendment rights
- Court held that Dow plant was an "open field" and EPA didn't violate 4th amendment rights, only used photographer to enhance human vision

Hazardous industries often have statute expressly providing for warrantless searches

The Supreme Court has held that procedural due process in the levying of a penalty does not require a pre-determinative hearing in an administrative setting

in closely regulated industries, such as liquor and firearms, a warrant is not required to conduct an administrative search. This is because the industry is subject to close supervision and inspection and does not have the same reasonable expectation of privacy that most individuals and businesses share

Unlike federal trial court, defendants are not entitled to a trial by jury
-where the petitioner was fined $600 for having unsafe working conditions, the Supreme Court ruled that the Seventh Amendment's requirement that jury trial is to be "preserved" in "suits at common law" did not extend to statutory proceedings such as administrative adjudications.

the Supreme Court held that statutory language requiring OSHA to promulgate standards necessary to control health hazards "to the extent feasible" did not mean that OSHA was required to conduct a cost-benefit analysis prior to the imposition of such a regulation.

A law that requires all committee-directed federal agencies to conduct their business regularly in public session.

Whenever a new regulation will have a significant impact upon a substantial number of small entities, the agency must conduct a regulatory flexibility analysis.

permits Congress to review federal regulations for at least 60 days prior to their effective date.
-This gives additional time and an additional forum for opponents to present their arguments. It also requires agencies to prepare guides that explain the requirements imposed on small businesses in "plain English."
-permits small businesses to recover their legal expenses from the government when an agency imposes fines or penalties that the court considers excessive.

1966 law that allows citizens to obtain copies of most public records

permitted all workers to join unions of their choice, allowed workers to bargain collectively for wage increases and benefits, allowed workers to go on strike to try to force employers to meet their demands

federal legislation that places limitations on how agencies are run and contains very specific guidelines on rule making by agencies