Food Safety Regulation Mitchell Hamline Food Law Seminar - PowerPoint Presentation

Slide1

Food Safety Regulation

Mitchell Hamline Food Law Seminar

November 29,

2016

David P.GrahamSlide2

What Is Food Safety?

How do consumers view food

safety?

Increasing broad definition and long term risk view

clear and accurate labeling

clear information on ingredients and sourcing

no artificial ingredients and less processing

high nutritional contentSlide3

What Is Food Safety? (cont.)

Regulatory view

of

safety

High risk means generally – high short term

pathogenic

or toxic risks

Safety regulations focused on eliminating short term risks

Labeling regulations based on disclosing potential long term health

effects – except allergensSlide4

Definition of Food

"The term food means (1) articles used

for

food

and drink for man or other animals, (

2)

chewing

gum, and (3) articles used

for

components

of any such article."

Food does not include anything that comes

from

food

Includes

animal feedSlide5

FDA Mission

Promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products . . .

Protect public health by

preventing

adulteration

and misbranding Slide6

FDA Jurisdiction

Food except, USDA regulated meat, poultry and egg products

USDA — if 3% meat or poultry

FDA —live animals intended to be used for food

Bottled water, ice and cosmetics

Joint FDA and USDA jurisdiction over food additivesSlide7

FDA Jurisdiction (cont.)

The Federal Food & Drug Act of 1906, 21 U.S.C

.§§

1-5 (Pure Food and Drug Act)

After processing USDA and FDA have joint

jurisdiction over distribution of meat

and

poultry

up to the retail establishment

FDA — governs retail establishments

Alcohol — Department of Treasury (TTP) under FAAA, 27 U.S.C. 201 et seq. Slide8

Statutory Background

1906 — Federal Food and Drug Act Pure

Food

and

Drugs Act (Originally drafted in 1875)

1938 — Food, Drug and Cosmetic Act ("FDCA

")

—

Basic legal framework for food,

drugs,

cosmetics

, tobacco and medical devices

2011 – Food Safety Modernization Act

Regulatory Pillars are Adulteration and

Misbranding Slide9

Parallel State and Local Laws

Addressed local markets in urban centers

Religious practices

Cultural

norms

Adulteration-focused

Development of local boards of health in cities,

counties

and

states in 19th

Century

FDA and USDA partner with state agencies to regulate food safety Slide10

Food, Drug, and Cosmetic Act of 1938

(FDCA) 21 U.S.C. § 301 et seq.

Food standards of identity required "

to

promote

honesty and fair dealing in

the

interest

of consumers"

§401

Imitation food must be labeled as such

Defined "misbranding" 21 U.S.C. § 343

which

included

a false or misleading label "in

any

particular

"

Defined adulteration and primarily concerned with safety and

keeping adulterated food off market Slide11

Food Safety - USDA

Wide Ranging Jurisdiction – includes:

Farm and Foreign Agricultural Services;

Rural

Development

(including housing)

Food, Nutrition Services

Food Safety Inspection Services (PSIS)

Animal, Plant Health Inspection Services (APHIS)

National Organic Program (NOP)

Forest Services

National

Resources Conservation Slide12

Food Law - USDA

USDA

Agencies

include:

Agricultural Marketing Service (AMS)

Strategic assistance marketing Agricultural products in domestic/international markets

Oversees Egg Inspections; National Organic Program

Animal and Plant Health Inspection Services (APHIS)

Health and care of animals/plants their productivity and competition

Includes

Supplemental Nutrition Assistance Program; Women Infants and Children food supplement programSlide13

Food Law

– USDA (cont.)

Food and Nutrition Services

Provides hunger relief, nutrition education and agricultural support

Partners with communities and governments

Includes Supplemental Nutrition Assistance Program; Women Infants and Children food supplement programSlide14

Food Law

– USDA (cont.)

Food Safety and Inspection Services (FSIS)

Provides inspection services for meat, poultry, egg & egg products, and catfish

Looking for wholesome plant and product, correct labeling and packaging

Coordinates U.S. involvement/participation in the Codex Alimentarius Commission

Codex is United Nations’ international standard setting organization for food safety and public healthSlide15

Foreign Agricultural Services

Assists with foreign market access for U.S. agricultureSlide16

Food Law - USDA

Primary food laws enforced by USDA

Federal Meat Inspection Act 21 USC 601 et seq

Poultry Products Inspection Act 21 USC 451 et seq

Egg Products Inspection Act 21 USC 1031 et seq

Perishable Agricultural Commodities Act 7 USC 499a et seq

Organic Foods Production Act of 1990 7 USC 6501 et seq Slide17

Food Law

– USDA (cont.)

Essential Points of Laws

Specified Business Entities or Individuals Affected

Food and/or Food Sources Affected by the Laws

Food Safety, Sanitation and Labeling

Record

Keeping

Violations, Penalties and Due Process Slide18

USDA - FMIA

Products covered:

Cattle, sheep, swine, goats, horses, mules and other equines

Businesses covered:

"Official establishment" - a registered facility where on-site USDA- authorized inspections are maintained over processes

Meat Brokers — buyer, sellers and negotiator of products

Renderers

Animal Food Manufacturers

NOT PRODUCERS Slide19

USDA – FMIA (cont.)

Primary Focus:

"Adulterated"

Meat or meat food substance:

bearing or containing any poisonous or

deleterious substance

which may render meat or meat

food

product

injurious to health

contains added poisonous or deleterious

substance

when

animal was alive

containing unapproved or unsafe food additives,

color additives

or pesticide chemicals Slide20

USDA – FMIA (cont.)

(FMIA) Inspections:

Required for meat examination pre- and post- slaughter

Looking for evidence of disease, inhumane slaughter techniques

Also applies to post-slaughter meat and meat products, carcasses and parts

Inspectors mark/label - approval or condemnation - of meat, carcasses and parts

Under supervision of an inspector

FD&CA labeling standards apply

No "false or misleading" labels — right to appeal inspector's determination Slide21

USDA – FMIA (cont.)

Take place at establishments for

slaughtering

,

meat-canning

,

salting

,

packing

,

rendering

,

non-retail storage

and

handling

facilities

Inspectors have access at any time to:

examine establishment for sanitary conditions

look at meat for adulteration or improper labelingSlide22

USDA – FMIA (cont.)

Inspector

authority:

Can refuse to inspect premises if any owner is:

A convicted felon

Convicted of multiple violations of food law.

Can administratively detain adulterated or misbranded food for human use

Can seize and/or condemn animal(s) or carcass or parts which are adulterated,

misbranded or in violation of the FMIA laws. Slide23

USDA – FMIA (cont.)

Can enjoin operation of establishment or refuse to inspect due to violations

Can cite owner or establishment for minor violations

Due process is available to owner

Can extend inspections to reindeer and dairy exports Slide24

USDA – FMIA (cont.)

Violation penalties include:

Seizure and condemnation of violative product

Destruction of product at owner's expense

Injunctions

Fines and imprisonment Slide25

USDA –

Poultry Products

Inspection Act (PPIA)

Similar Regulatory Regimen to FMIA

Exemptions

to requirements and inspections

:

Retailers which cut up poultry for consumers

Slaughter, processing and handling required by "recognized

religious

dietary laws" i.e. Kosher, Halal

Poultry raised, slaughtered by owner for exclusive personal,

family

or employee use

Custom slaughter of owner's poultry for owner's use Slide26

USDA –

PPIA (cont.)

Slaughter, processing of poultry raised by poultry producer

on

producer's

premises for local distribution (products must be

fit for

human food; limit 20,000 poultry/year)

Pizzas containing poultry products if those products are

prepared

, inspected and passed in cured/cooked RTE form

and

served

in non-profit institutions

Adulteration and misbranded requirements still apply to above Slide27

USDA MPIA and PPIA Regulations

HACCP

(§417)

Hazard Analysis and Critical Control Points

Required for all "official establishments"

Objective: Food safety and sanitation

processes

for

avoidance of adulteration

Analyze establishment for food safety hazards

that

can

occur

Before, during and after entry of food product

into

establishment Slide28

USDA MPIA and PPIA Regulations

Recall

Establishment must prepare and maintain procedures

for

recall of meat, meat food, poultry or

poultry

products

they produce or ship, including:

recall

determination

how

recall will be effected

Upon establishment "belief or reason to believe" that

a

product

is adulterated or misbranded,

establishment

must

contact FSIS within 24 hours of that knowledge

All records relating to recalled product production,

HACCP

plans, SSOPs, and other standard requirements

must

be made available for FSIS review and copy Slide29

USDA Food Safety Inspection Service (FSIS)

MISSION:

The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

http:// ww.fsis.usda.goviwpsiportal/informationaliaboutisisSlide30

USDA Egg Products Inspection Act (EPIA)

Products covered:

Shell

eggs

of domesticated chickens, turkeys, ducks, geese or

guinea

Egg Products —

dried, frozen, liquid eggs, with or without added

ingredients. Exceptions:

Products with relatively small proportion of egg or not considered

by

consumers

to be egg products

Freeze-dried

, imitation or substitute egg products, cake mixes, noodles Slide31

USDA Perishable Agricultural Commodities Act (PACA)

Law passed in 1930

Actions leading to law:

Unfair or discriminatory business and finance practices affecting perishable commodity growers and others

Fraudulent or deceptive marketing of fruits and vegetables

Flooded markets and wrongful destruction of food

Consumer deceptionSlide32

USDA Perishable Agricultural Commodities Act (PACA) (cont.)

Directed by USDA Agricultural Marketing

Service (AMS)

Function: Administer programs that facilitate

e

fficient, fair marketing of U.S. agricultural products, including food, fiber, and specialty cropsSlide33

USDA PACA

Products covered

Fresh fruit and vegetables – Perishable Agricultural Commodities (PAC)

Including those frozen or packed in ice

Shipped in interstate or foreign commerceSlide34

USDA PACA

(cont.)

Businesses covered

Commission Merchants

Receive PAC for sales on commission or for or on behalf of another

Dealers

Buyers or sellers of wholesale or jobbing quantities

Can include retailers who sell direct to consumers

DOES NOT INCLUDE

:

produce selling own product

buyers for retail sales

<$

230,000/year

to

a limited extent, buyers of PAC for canning or processing

Slide35

Food Safety Modernization Act Slide36

Overview

Relates to FDA regulation primarily

Covers

approximately 80% of all

food

consumed

Designed to build a "scientifically/risk

based“ food

borne illness preventative regime

Increases FDA's access to records

Registration requirements Slide37

FSMA at a Glance

Records

Inspection

Registration of

Facilities

Preventive

Controls

Performance

Standards

Food Defense

Sanitary

Transportation

Allergy

Management

Port Shopping

Inspection

Resources

Laboratory

Accreditation

Integrated Lab

Networks

Surveillance

Mandatory Recall

Admin. Detention

of Food

Training of

Officials

Improving RFR

Foreign Supplier Verification

Voluntary Qualified Importer Program

Import

Certification

Prior Notice

Capacity of

Foreign Gov..

Inspection of

Foreign Facility 3

rd

Party Auditor Accreditation

Smuggled Food

Funding

Employee

Protections

Jurisdictions/

Authorities

International

Agreements

Budgetary Effects Slide38

Overview

Facility Registration

FDA Inspections

Increased Access to Records

Hazard analysis and risk-based prevention

controls

Additional Record keeping Regulations

FDA mandatory recall authority

Imported foods and foreign food suppliers

Employee whistleblower protections Slide39

Overview (cont.)

Proactive vs. Reactive

Focus on prevention

More Requirements

Inspections

Recordkeeping

Imports

More FDA Authority

Response

Rulemaking/Guidance

Programs Slide40

FDA Inspections

Section 201

Based on “Scientifically” determined "Risk Profile"

Must target "high-risk" facilities

FDA must report annually to Congress

on

inspections

Effective

immediately b

ut

subject to appropriations Slide41

FDA Inspections (cont.)

Domestic Facilities

High-risk facilities

Once in first five years, then once every

three

years

Non-high risk facilities

Once in first seven years, then once every five y

ears

States may inspect more often Slide42

FDA Inspections (cont.)

Foreign

Facilities

FDA must inspect at least 600 within one year

Then, for five years, inspect at least twice as many

as the previous year

19,200 facilities by 2016 Slide43

Mandatory Recall Authority

Section 206

"Reasonable probability that an article of food is

adulterated or misbranded and will cause

serious adverse health consequences or death"

FDA to provide opportunity for "responsible

party to cease distribution"

If not, FDA will order stoppage and notify chain

of distribution

Allows for a hearing within 2 days Slide44

Administrative Detention of Food

Section 207

Standard changes to allow for detention of

food is FDA reasonably believes an article of

food is adulterated or misbranded

Lower than current standard "threat of

serious adverse health consequences. . . .

"

Could apply to labeling violations Slide45

Whistleblower Protection

Section 402

No discrimination or retaliation against:

Employees engaged in manufacturing processing, packing, transporting, distributing,

receiving, holding or importing food

For making a disclosure protected by the Act,

including reports of violations

Whether at employee's initiative or in

ordinary

course

of duties Slide46

What FSMA Does Not Do

No registration fees or

additional civil

fines (exception:

failure

to

comply with recall order)

No criminal penalties

Food Safety Accountability Act. S. 216

Up to 10 years for knowingly contaminating food

supply with intent to mislead, defraud or

endanger consumers

No full pedigree traceability

No single, unified food safety agency Slide47

Industry Trends Driven by FSMA

Software-as-a-service to document program management, organize work flows and distribute notifications for corrective and preventative actions

Increased availability of risk assessment tools

Intersection of mobile devices and electronic recording keeping and verification

Increased demand for more effective and frequent trainingSlide48

Industry Trends Driven by

FSMA (cont.)

Targeted monitoring and verification activities

Availability of new self-assessment tools for updating food safety systems

Dedicated staff to support compliance efforts

More communication on FSMA food safety related topics as regulations have rolled out