Transcript RegulatoryPresenceonFarm_JohnFusonx

FDA’s Growing Regulatory
Presence on the Farm
FSMA, Preventive Controls
and FDA Enforcement
The U.S. Food and Drug
Administration
What Is the FDA?
1906
$4.5
billion
14,000
$2 trillion
95
Agency Structure and Authority
CDER
CBER
CDRH
CFSAN
CVM
CTP
What the FDA Is Not: USDA
“FDA is responsible for protecting the public
health by assuring the safety, efficacy and
security of human and veterinary drugs,
biological products, medical devices, our
nation’s food supply, cosmetics, and products
that emit radiation.”
“[USDA] provide[s] leadership on food,
agriculture, natural resources, rural
development, nutrition, and related issues
based on sound public policy, the best
available science, and efficient management.”
The Food Safety
Modernization Act
Origins of FSMA
Change is coming. It’s not going to
be overnight. We’ve got time to
implement this in a thoughtful way.
But we know change is coming …
Testing by
accredited
laboratories
Mandatory
recall
Expanded
administrative
detention
Suspension of
registration
Enhanced
product tracing
abilities
Additional
recordkeeping
for high risk
foods
Importer
accountability
Third Party
Certification
Certification for
high risk foods
Voluntary
qualified
importer
program
Authority to
deny entry
Imports
Authority to
prevent
intentional
contamination
Records access
Response
Mandatory
produce safety
standards
Mandated
inspection
frequency
Inspection and Compliance
Mandatory
preventive
controls for
food facilities
Prevention
Overview of FSMA’s Requirements
The Final Rule on
Preventive Controls for
Human Food
Who Is Covered by the Final Rule?
Registered
Food
Facilities
Any “facility engaged in
manufacturing, processing, packing,
or holding food for consumption in
the United States” must register with
FDA.
A “facility” is any “factory
warehouse, or establishment …
that manufacturers, processes,
packs, or holds food.”
Not included in the definition of facility: restaurants and other retail food
establishments, nonprofit food establishments, fishing vessels, and farms.
What Is a Farm?
Primary Production Farm
• An operation under one management in one general, but not necessarily contiguous, location devoted
to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. It can pack or hold raw agricultural commodities such as fresh
produce and may conduct certain manufacturing/processing activities, such as dehydrating grapes to
produce raisins and packaging and labeling raisins.
Secondary Activities Farm
• An operation not located on the Primary Production Farm that is devoted to harvesting, packing
and/or holding raw agricultural commodities. It must be majority owned by the Primary Production
Farm that supplies the majority of the raw agricultural commodities harvested, packed, or held by the
Secondary Activities Farm.
• FDA provided this definition, in part, so that farmers involved in certain formerly off-farm packing now
fit under the definition of “farm,” as the packing is still part of the farming operation. In addition to
off-farm produce packing operations, another example of a Secondary Activities Farm could be an
operation in which nuts are hulled and dehydrated by an operation not located at the orchard before
going to a processing plant. If the farmer that owns the orchards and supplies the majority of the nuts
is a majority owner of the hulling/dehydrating facility, that operation is a Secondary Activities Farm.
FSMA and
FDA Enforcement
Prohibited Acts Under the Federal Food,
Drug, and Cosmetics Act
Adulteration
Misbranding
Failure to
Register
Failure to
Keep Records
FDA’s Civil Enforcement Toolbox
Form 483
Regulatory
Meeting
Warning Letter
Administrative
Detention
Recall
Seizure
Injunction
The FSMA Game-Changer:
Proactive Versus Reactive Enforcement
Hazard
Analysis
Verification
“[P]revention –
prevention of food safety
problems, prevention of
food-borne illness – is the
fundamental goal of
[FSMA] and of FDA’s
implementation of it.”
Corrective
Actions
Food
Safety
Plan
Preventive
Controls
Monitoring
Prospects for Criminal Indictments
Adulteration
Park
Doctrine
Strict
Liability
Looking Ahead:
What’s Next for FSMA?
Moving Toward Full Implementation
What’s Finished?
What’s Still
to Come?
• Current Good Manufacturing Practice and Hazard Analysis
and Risk-Based Preventive Controls for Human Food
• Current Good Manufacturing Practice and Hazard Analysis
and Risk-Based Preventive Controls for Food for Animals
• Standards for the Growing, Harvesting, Packing, and Holding
of Produce for Human Consumption
• Sanitary Transportation of Human and Animal Food
• Focused Mitigation Strategies to Protect Food Against
Intentional Adulteration
• User Fee Program to Provide for Accreditation of Third-Party
Auditors/Certification Bodies to Conduct Food Safety Audits
and to Issue Certifications
• Food Supplier Verification Programs (FSVP) for Importers of
Food for Humans and Animals
The Veterinary Feed
Directive Regulation
Background to the New Rule
“According to the Centers for Disease
Control and Prevention (CDC), in the
United States alone, at least 2 million
people become infected annually
with bacteria that are resistant to
antibiotics. …
… And at least 23,000 people die each
year as a result of these infections. …
Animal Drug Availability Act (1996)
Rule on Veterinary Feeds Directive
Drugs (2000)
Guidance #209 – Judicious Use
Strategy (2012)
Guidance #213 – Implementation
Recommendations (2013)
… The non-therapeutic use of
antimicrobial drugs in animals that
enter the food supply contributes to
this problem.”
Revised Rule on VFD Drugs (2015)
Core Principles
Judicious Use Strategy:
“The actions the FDA has taken to date
represent important steps toward a
fundamental change in how antimicrobials
can be legally used in food-producing
animals. …
… The VFD final rule takes another important
step by facilitating veterinary oversight in a
way that allows for the flexibility needed to
accommodate the diversity of circumstances
that veterinarians encounter, while ensuring
such oversight is conducted in accordance
with nationally consistent principles.”
--Michael Taylor, June 2, 2015
• Limit medically important antimicrobial
drugs to therapeutic purposes (i.e., those
uses considered necessary for ensuring
animal health);
• Require veterinary oversight or
consultation for such therapeutic uses in
food-producing animals.
Medically Important: antimicrobial drugs
that are considered important for
therapeutic use in humans
Key Terms
Veterinary Feed Directive (VFD)
• A written statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice
that orders the use of a VFD drug in or on an animal feed.
VFD Drug
• An FDA-approved new animal drug for use in or on animal feed.
Veterinarian-Client-Patient Relationship
• A veterinarian has assumed the responsibility for making medical judgments regarding the health of animals
and the need for medical treatment, and the client has agreed to follow the instructions of the veterinarian;
• The veterinarian has sufficient knowledge of the animals to initiate at least a general or preliminary diagnosis
of any medical conditions; and
• The veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of
therapy.
• Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with
the keeping and care of the animals by virtue of examination of the animals, and/or by medically appropriate
and timely visits to the premises where the animals are kept.
Questions?