MidTerm. Contamination

Why so much regulation?

Consumer protection, shift from home prep to industrial revolution and industrial processing. Added hurdles in mechanization, production volume, and more workers. Major problems: more contamination and more waste.

Why is hygiene more important than state-of-the-art facility?

You cannot rework crappy or contaminated ingredients into a high-quality product

Law vs Regulation

Law: legislation stating 'what to do'

Regulation: how a law is implemented, set of standards/guidelines 'how to do'

Regulations

Set of standards/guidelines more specific than laws, specific to industry, published by enforcement agency (FDA)

FDA and USDA are what type of agencies

enforcement

3 major enforcement agencies in the U. S.

FDA, USDA, EPA

FDA purpose

Enforce FDCA

Control/seize/ destroy adulterated food

Establish and publish GMPs

GMPs

Good Manufacturing Practices

Types of GMPs

Umbrella GMP & Specific GMP

Umbrella GMPs

basic regulations for sanitation, packaging, manufacturing, not specific to one industry

Specific GMPs

supplement umbrella GMPs, industry specific

USDA jurisdiction is based on what three pieces of legislature

FMIA: Federal Meat Inspection Act

PPIA: Poultry Products Inspection Act

EPIA: Egg Products Inspection Act

EPA: four acts

FWPA: Federal Water Pollution Act

CAA: Clean Air Act

FIFRA: Federal Insecticide, Fungicide, Rodenticide Act

RCRA: Resource and Conservation Recovery Act

Ancient food law history

Early Hebrews/ Egyptians: strict meat handling rules

Greeks + Romans: no adulterated (watered down wine), weights + measures for grains/salts/spices

How food law evolved

coincided with industrial revolution, move from rural areas to urban setting (loss of transparency about food origin), inadequate transportation, storage, preservation, etc.

Common regulatory problems during industrial revolution

Toxic colors + preservatives

quack medicines: snake oil

medicine, rampant use of opiates, cocaine, heroine: toxic and not effective

Pre-Wiley Food Law

1784, food not sold as wholesome without buyer knowledge

1800s food law

varied greatly by state and no continuity between states, impacts food travelling across state lines

Harvey Wiley

1900s, chief of Bureau of Chemistry (eventually known as FDA), analyzed chemicals in food, educated customers, poison squad

First federal food law

1906 Pure Food and Drug Act

major industry opposition, legal cases pointed out weaknesses and strengths, adulteration still common, very few purity standards, limited analytical techniques, weak on SAFETY (focused on Pure not safe), burden of proof falls on to regulatory agencies (USDA)

When was The Jungle published

1906, yuck factor in Chicago meat processing facilities

1907 ….. Act

Federal Meat Inspection Act (UDSA), direct response to The Jungle

Federal Meat Inspection Act 1907

Mandated pre-harvest inspection, post-harvest, product, sanitation, FIRST act to allow federal officials to enter a property

Tragic event in 1937

Elixir of Sulfanilamide, commonly prescribed for various conditions, product was re-formulated with diethylene glycol and led to over 200 deaths

1938 Act

Food, Drugs and Cosmetics Act (FDCA)

Changes in FDCA compared to Pure Food & Drug Act

included cosmetics and therapeutic devices, pre-market testing of drugs, toxic substances prohibited in foods (unless unavoidable), more authority for inspectors (shutdown, recall), proof of fraud no longer required, first mention of safe tolerances for pesticide residues , definition on what you can call an item (jelly that has no fruit), crackdown on obvious filth and worker safety

James Delaney pioneered which three amendments

1954: Miller Pesticide Amnd.

1958: Food Additive Amnd.

1960: Color Additive Amnd.

implications for GRAS

Delaney Clause

1958, 3 major FDCA changes wrapped into one, GRAS, Pesticide, Food Additives, Color Additives, ZERO tolerance for carcinogens

1959 Incident

Cranberry recall two weeks before thanksgiving due to exposure to a zero-tolerance weedkiller

Silent Spring

1962: The Jungle but for the environment, exposed impact of pesticides, bioaccumulation of DDT

What did Clinton do

1996 Delaney Clause abolished, cancer is caused over time not by one molecule (zero tolerance is useless).

Risk Cup: how much exposure could you have to a chemical throughout your entire life

Lower residues in edible particles (skin vs flesh of fruit, flash has lower tolerance

Current Delaney Clause Replacement

1996 Food Quality Protection Act (FQPA)

NIOSH

National Institute for Occupational Safety and Health

is for employee safety

CPSA

Consumer Product Safety Act

(food packaging)

FIFRA

Federal Insecticide, Fungicide, and Rodenticide Act

pre-market testing of icides and fertilizers

Burden of proof shifted away from…

FDA to companies due to lack of manpower

CFR

Code of Federal Regulations

Title 21: Food and Drug Why so much regulation?

Consumer protection, shift from home prep to industrial revolution and industrial processing. Added hurdles in mechanization, production volume, and more workers. Major problems: more contamination and more waste.

Why is hygiene more important than state-of-the-art facility?

You cannot rework crappy or contaminated ingredients into a high-quality product

Law vs Regulation

Law: legislation stating 'what to do'

Regulation: how a law is implemented, set of standards/guidelines 'how to do'

Regulations

Set of standards/guidelines more specific than laws, specific to industry, published by enforcement agency (FDA)

FDA and USDA are what type of agencies

enforcement

3 major enforcement agencies in the U. S.

FDA, USDA, EPA

FDA purpose

Enforce FDCA

Control/seize/ destroy adulterated food

Establish and publish GMPs

GMPs

Good Manufacturing Practices

Types of GMPs

Umbrella GMP & Specific GMP

Umbrella GMPs

basic regulations for sanitation, packaging, manufacturing, not specific to one industry

Specific GMPs

supplement umbrella GMPs, industry specific

USDA jurisdiction is based on what three pieces of legislature

FMIA: Federal Meat Inspection Act

PPIA: Poultry Products Inspection Act

EPIA: Egg Products Inspection Act

EPA: four acts

FWPA: Federal Water Pollution Act

CAA: Clean Air Act

FIFRA: Federal Insecticide, Fungicide, Rodenticide Act

RCRA: Resource and Conservation Recovery Act

Ancient food law history

Early Hebrews/ Egyptians: strict meat handling rules

Greeks + Romans: no adulterated (watered down wine), weights + measures for grains/salts/spices

How food law evolved

coincided with industrial revolution, move from rural areas to urban setting (loss of transparency about food origin), inadequate transportation, storage, preservation, etc.

Common regulatory problems during industrial revolution

Toxic colors + preservatives

quack medicines: snake oil

medicine, rampant use of opiates, cocaine, heroine: toxic and not effective

Pre-Wiley Food Law

1784, food not sold as wholesome without buyer knowledge

1800s food law

varied greatly by state and no continuity between states, impacts food travelling across state lines

Harvey Wiley

1900s, chief of Bureau of Chemistry (eventually known as FDA), analyzed chemicals in food, educated customers, poison squad

First federal food law

1906 Pure Food and Drug Act

major industry opposition, legal cases pointed out weaknesses and strengths, adulteration still common, very few purity standards, limited analytical techniques, weak on SAFETY (focused on Pure not safe), burden of proof falls on to regulatory agencies (USDA)

When was The Jungle published

1906, yuck factor in Chicago meat processing facilities

1907 ….. Act

Federal Meat Inspection Act (UDSA), direct response to The Jungle

Federal Meat Inspection Act 1907

Mandated pre-harvest inspection, post-harvest, product, sanitation, FIRST act to allow federal officials to enter a property

Tragic event in 1937

Elixir of Sulfanilamide, commonly prescribed for various conditions, product was re-formulated with diethylene glycol and led to over 200 deaths

1938 Act

Food, Drugs and Cosmetics Act (FDCA)

Changes in FDCA compared to Pure Food & Drug Act

included cosmetics and therapeutic devices, pre-market testing of drugs, toxic substances prohibited in foods (unless unavoidable), more authority for inspectors (shutdown, recall), proof of fraud no longer required, first mention of safe tolerances for pesticide residues , definition on what you can call an item (jelly that has no fruit), crackdown on obvious filth and worker safety

James Delaney pioneered which three amendments

1954: Miller Pesticide Amnd.

1958: Food Additive Amnd.

1960: Color Additive Amnd.