Transcript fsf II principles of growth and death

Food Legislation
This lecture was originally developed
by Dr. Jennifer McEntire
Enhanced, updated, and expanded
By Dr. Tom Montville
The scope of food
50,000 food establishments
30,000 U.S. food manufacturers and processors
20,000 food warehouses
600,000 restaurants and institutional food
service establishments
235,000 supermarkets, grocery stores, and
other food outlets
http://www.cfsan.fda.gov/~lrd/cfsan4.html
Who cares?
Regulatory agencies
Companies
The Public
The public
Want safe food
Want honesty in labeling
Lobbying groups, as above, plus want to stay
“in business.”
Companies
Want safe food
Includes US producers and our trading partners
Must abide by laws
Want a say in regulations that will affect them
Packaging/labeling
Standard of identity
Health claims
Microbial testing
The Regulators
Want safe food
Must abide by laws, stay within jurisdiction
Regulate US producers and our trading
partners (USDA has granted “equivalency” for
only 9 countries)
Must work with consumers, producers,
politicians, and other regulators
Who are the Regulators
FDA (CFSAN)- all foods, except meat and poultry
Department of Health and Human Services
USDA (FSIS)- meat and poultry
Department of Agriculture – also ARS, ERS
Codex Alimentarius
Globalization, Regulatory Harmonization
EPA pesticides
State and local agencies
Laws divide responsibility and authority
CDC advises but has no regulatory authority
Do ties to industry invalidate a
scientist’s credentials?
History of Food Laws
Why?
Illness
Adulteration
mixing tea leaves with other leaves
mixing chicory with coffee
milk in Mexico
Melamine?
Food regulations is dynamic and
evolutionary
New regulations address new issues,
i.e. biotech
History of Food Law
1784 first food law in Massachusetts
1862 Department of Agriculture formed
1906 Food and Drug Act (Dr. Harvey Wiley, chief
chemist, USDA, preservative safety). Didn’t give
authority to inspect
1938 Federal Food Drug and Cosmetic Act (passed after
100 people died due to diethylene glycol in a medicine)
– “THE ACT” 1958 Food Additives Amendment
1990 NLEA
1994 DSHEA
FDA Facts
Twenty-five cents on every dollar spent in US
is on products regulated by the FDA.
75 percent is spent on foods.
$240 billion worth of domestic food.
$15 billion worth of imported foods.
http://www.cfsan.fda.gov/~lrd/cfsan4.html
FD&C Act (“The Act’)
Definitions
Prohibited acts and penalties
Food
Drugs and Devices
Cosmetics
General Authority
Imports and Exports
What does FDA regulate
Sec. 201. (f) Food: (1) articles used for food
or drink* for man or other animal, (2)
chewing gum, and (3) articles used for
components of any such article
The courts have extended the definition:
“intended for nutrition, taste or aroma”
*Excludes alcoholic beverages, regulated by
Bureau of Alcohol, Fire Arms and Tobacco
USDA regulates meat and poultry
When does FDA have jurisdiction?
Interstate commerce Sec. 201. (b)
commerce between any State or Territory and
any place outside thereof
insect infested flour mill, flour transported to
make bread. Does FDA have jurisdiction over
bread (final product) (alternate scenario)
medical marijuana issue, States Rights v Federal
Is it medical practice, or is it a drug?
What does FDA enforce?
Labeling: all labels and other written, printed,
or graphic matter (1) upon any article or any
of its containers or wrappers, or (2)
accompanying such article
Adulteration
Misbranding
FDA can inspect, usually leaves it up to
states
Sec. 402. Adulteration-
food which…
bears or contains any poisonous or deleterious substance which
may render it injurious to health; includes pesticides and food
additives (safety must be established in advance). StarLink corn
was recalled (2000) not because it was dangerous, but because
it hadn’t been proven safe.
has been prepared, packed or held under insanitary conditions
where by it may have become contaminated with filth, or
whereby it may have been rendered injurious to health.
any valuable constituent has been in whole or in part omitted or
abstracted therefrom.
has inadequate labeling.
contains an unsafe dietary supplement. (Gov must prove unsafe).
Sec. 403. Misbranding
Offered for sale under the name of another
food
Does not conform to standard of identity
Labeling is false or misleading
Where does this leave dietary
supplements?
What is a Dietary Supplement?
Legal definition:

a vitamin,

a mineral,

an herb or other botanical,

an amino acid,

a dietary substance for use by man to
supplement the diet by increasing the total
dietary intake (e.g., enzymes or tissues
from organs or glands), or

a concentrate, metabolite, constituent or
extract.
Dietary Supplements
Sec. 403. (6)
Not regulated as a food nor a drug as long as
labeling is truthful
Can make a claim
Manufacturer must have substantiation that the
statement is truthful and not misleading
Manufacturer must notify FDA within 30 days of
marketing
“This statement has not been evaluated by the Food and
Drug Administration. This product is not intended to
diagnose, treat, cure or prevent any disease.”
Potential Dietary Supplement
Problems
Doesn’t need FDA approval unless it contains
a new dietary ingredient
No standardization
No manufacturing regulations
Data showing effectiveness is not public
No public source of information
Ephedra
Tell the FDA: HANDS OFF my
dietary supplements!
Responsible members of the dietary supplement
industry were all too glad to see ephedra taken off the
market. However the FDA established a new legal
standard that gives it unlimited authority to swoop
down and ban any product it chooses, without proving
that the product is harmful. (Eminent threat)
As you know, dietary supplements, derived from
entirely natural sources, are not drugs. The DSHEA
reflected the consensus that supplements should not
be forced to endure prohibitively expensive and timeconsuming trials before being approved.
With its new ephedra rule, the FDA violated that
agreement. Supplement manufacturers can now be
required to "prove" that the benefits associated with a
particular supplement outweigh its alleged risks.
LipoKinetix
Dietary supplement marketed for weight loss,
supposed to increase metabolism
caused serious liver injuries after 2 weeks -3
months of usage
FDA got involved (Office of Nutritional
Products, Labeling and Dietary Supplements),
warned consumers, sent letter to company
urging them to remove product
“Laws” vs. “Regulations”
FD&C Act is the LAW, passed by Congress,
signed by the President, upheld and
interpreted by the courts.
Regulations – must go through appropriate
legal channels (public comment), authority is
delegated to FDA, have the force of the law.
Guidelines: Agency creates = “best practices.”
New topic, biosecurity
Weapons of
Mass
Destruction
Mass destruction or mass disruption?
Hamilton, NJ Post Office
Closed: October 2001 Opened: October 2005
Remediation costs: $20-50 million
The “experts” have 20/20 hindsight
(only)
Who’d have predicted that men armed with
box cutters could bring down the World Trade
Center?
Prior to the Amerithrax attack
anthrax was considered a poor choice, not
contagious.
mail was never considered as a vehicle.
Bio-terrorism is a Real Concern
Assault on animal agriculture
Assault on agricultural crops
Use of processed food as terror tool
By individual
Organized terrorist group
(Tylinol® tampering)
Bio-terrorism Defined
Osterholm, Emerging Infections 5, p 213, 2001
“the use of biological agents to
intentionally produce disease or
intoxication in susceptible populations
to meet terrorists’ aims”
Morbidity, Mortality, Economic Loss, Sheer Terror
Diffuse Inputs
Diffuse Outputs
Diffuse Inputs
The Food Industry
Diffuse Outputs
Food Bio-terrorism
Low tech
High impact
Inexpensive
Hits “at home”
Easy to transport
Diffuse inputs and outputs
Hard to detect (before or after)
Unlike chemical or radiological threat
“For the life of me, I cannot
understand why the terrorists
have not attacked our food supply,
because it is so easy to do.” —
Secretary of Health and Human
Services Tommy Thompson, in
announcing his resignation.
Accidental:
250,000 cases of salmonellosis
100 cases of listeriosis
Could have just as easily been
caused by bio-terrorist.
Bio-terrorism in Oregon, 1984
Salmonella Typhimurium
751 cases, 45 hospitalizations
Intentional contamination of salad bars
Rajneeshee cult seeking electoral influence
Not identified as bio-terrorism until two years
later
Bacterial Agents
Clostridium botulinum, or its toxin
Staphylococcus aureus, or its toxin
Salmonella enteriditis or typhi
E. coli O157:H7
Bacillus anthracis
Operational Risk Management
(Food Safety and Security: Operational Risk
Management Approach, Nov. 26, 2001;
www.cfsan.fda.gov)
Operational Risk Management
1. Identify the Hazards - what if?
2. Assesses the Risk –hazard x severity
3. Analyze Risk Control Measure,
includes risk/benefit
mitigate, eliminate, delay, transfer
4. Make Control Decision – what will we do?
5. Implement Risk Controls – inform, motivate
6. Supervise and review – inspect, interview, quiz
“Guidance for Industry
Food Producers, Processors,
Transporters, and Retailers:
Food Security Preventive
Measures Guidance” -FDA
Guidance for Industry
Management of food
security
Physical security
Employees
Computers
Raw materials
Air and water
Finished product
Finished Product
Keep track of it – missing or extra stock
Warehouse and transportation security
Monitor food in open display areas
Counterfeiting
Employees
Pre-hiring screening
Daily work assignments
Identification
Restricted access
Personal items
Security training
Unusual behavior 
FDA Food Bioterrorism Act of 2002
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002
Components of the Act
1. Registration of Facilities – by Dec 12, 2003
Factories, warehouses, “establishments,” must register even if regulation
not issued. Food service and nonprofits exempt.
2. Record Keeping – need to ID previous and subsequent
holder of the food. Records allow FDA to address credible threats.
Entities that manufacture, process, pack, transport, distribute, receive,
hold, or import are subject to these rules.
3. Prior notice –
of importation. Various time requirements, but
not more than 5 days, in advance.
4. Administrative detention of product
“FSIS Safety and Security
Guidelines for the Transportation
and Distribution of Meat, Poultry,
and Egg Products”
On the ”Security” side
Assess Vulnerabilities (hazard analysis)
Develop and Implement Procedures (identify &
control vulnerable points) – tracking, recall,
evacuation, shippers, seals
Emergency Operations Procedures
Training and Testing (for response)
Screen and Educate Employees
Security & monitoring of facility, shipping and
receiving, and employees
For the most part, these are common sense things
that we should be doing anyway.
Conclusions and summary
Great strides have been made to improve the
security of the food supply.
BUT
Federal Officials still speak of “when an
attack occurs,” not “if”.
“We” have to succeed 100% of the time.
“They” only have to succeed once.
Be prepared to take care of yourself
for 5-7 days
Stock of canned or shelf-stable ready-to-eat
foods.
Stock of water and/or juices (1 gal/day).
Stock of high energy foods, power bars, nuts, etc.
Gallon of bleach. 16 drops per gallon to disinfect
water.
Have a family emergency plan- communications
and meeting place.
Have a nice day!