Feed Manufacturing &
Distribution Requirements
Including
Good Manufacturing Practices
(GMPs)
Brenda Ball
Compliance Manager
AZ Department of Agriculture
Who Regulates Feed in the U.S.
• States
• FDA Center for Veterinary
Medicine (FDA/CVM)
• AAFCO
• U.S.D.A.
• Other Federal agencies
• Localities (cities), territories,
and tribal partners
Bioterrorism Act of 2002
• Public Health Security & Bioterrorism
Preparedness & Response Act of 2002
• Allow FDA and other authorities to quickly
determine the source and cause of any
deliberate or accidental contamination of
food.
• Food facility registration – food & beverages
or human and animal consumption
Bioterrorism Act of 2002
• Imports – 2 to 8 hour (not more than 5 days)
prior notice to FDA before arrival.
• Food facility registration – domestic & foreign
– all facilities that manufacture, process, pack
or hold food regulated by FDA including
animal feed.
• Traceability – recordkeeping
• Grants for state inspections
• Provides notice to states on imported food
Food & Drug Administration
Amendments Act (FDAAA)
• September 27, 2007 - President George W. Bush
• FDAAA requires increased activities for active
post market risk identification and analysis
particularly those related to tools and methods
for data access and analysis.
• Title X of FDAAA also requires new reporting of
adverse events related to food and new
regulations for pet food labeling, ingredients, and
processing standards.
What defines “Feed”?
• “Food” means “articles used for food or drink
for man or other animals” as defined in
section 201(f) of the federal Food, Drug and
Cosmetic Act and includes raw materials and
ingredients.
• This is the very broad federal definition under
the Food & Drug Administration’s (FDA)
jurisdiction - consider the terms “food” and
“feed” to be synonymous.
What defines “Feed”?
• State Department of Agriculture - usually the
main animal feed control regulatory agency
besides the FDA CVM and USDA who regulates
animal feed and feed ingredients in state.
• Food (for humans) is regulated by FDA, USDA, the
State Department of Agriculture, the Federal and
State Department of Health, and local state
county health departments; cities etc.
• State feed control agencies can and most do have
their own definitions of animal “feed”.
• Within states – city, county, local municipalities
Reportable Food Registry (RFR)
• Electronic portal for reporting when there is
reasonable probability that an article of food will
cause serious adverse health consequences.
• Purpose: To enable the FDA to better protect
public health by tracking patterns and targeting
inspections.
• The RFR applies to all FDA-regulated categories of
food and feed, except dietary supplements and
infant formula.
Who Should Use the Reportable Food
Registry?
• Registered Food Facilities that manufacture, process,
pack, or hold food for human or animal consumption in
the United States under section 415(a) of the FD&C Act
(21 U.S.C. 350d) are required to report when there is a
reasonable probability that the use of, or exposure to,
an article of food will cause serious adverse health
consequences or death to humans or animals.
• Federal, state, and local government officials may
voluntarily use the RFR portal to report information
that may come to them about reportable foods.
Reportable Food
An article of food/feed for which there is a
reasonable probability that the use of, or
exposure to, such article of food will cause
serious adverse health consequences or death
to humans or animals. All foods under FDA's
jurisdiction, including animal feed/food
(including pet food) may be reportable foods,
except for dietary supplements and infant
formula.
Reportable Food Registry (RFR)
When reports are received via the RFR;
notification also goes to the state(s). The
incident depending upon the reported zip
code is sent to the FDA District office, who
then is responsible for notifying the applicable
identified state official(s). The FDA and the
states work together jointly in responding to
these incidents.
Industry Reports to the RFR
• Industry Report – a mandatory report from a
facility that manufactures, processes, packs or
holds human food or animal food/feed
(including pet food) for consumption in the
U.S.
• Food Safety Hazards – any biological,
chemical, or physical agent that may cause a
food/feed to be unsafe for human or animal
consumption.
Reportable Food Safety Hazards
to the RFR
Other Food Safety Hazards:
• Foreign Objects – foreign objects that pose physical hazards
typically are hard or sharp objects that can result in injury, e.g.
choking, lacerations and perforation of tissues of the mouth,
tongue, throat, stomach or intestines. Reportable physical
hazards may include, for example, glass, brittle plastic, and
metal
• Other – food safety hazards other than E. coli O157:H7,
Salmonella, foreign objects, Listeria monocytogenes, or
undeclared allergens/intolerances
• Pathogen – an agent that causes disease. Pathogens of
foodborne origin are typically bacteria, parasites and viruses.
Reportable food reports involving pathogens submitted to
date have included Salmonella, Listeria monocytogenes, and
E. coli O157:H7.
Where Should Consumers, Food
Retailers and Food Service Operators
Report a Problem with Food?
• In emergencies, consumers, food retailers and
food service operators should continue to call
FDA at 301-443-1240.
• For less urgent problems, contact the FDA
consumer complaint coordinator in your
geographic area or see Your Guide To
Reporting Problems to FDA.
Pet Event Tracking Network (PETNet)
Pet Event Tracking Network (PETNet)
• State, Federal Cooperation to Prevent Spread
of Pet Food Related Diseases – FDAAA
• August 2008 – FDA’s ``Gateway to Food
Protection'' meeting a.k.a. the ``50-State'‘
meeting – FDA, other Federal agencies, states,
localities, territories, and tribal partners
• Purpose - to address the challenges necessary
to ensure the safety of the U.S. food supply
including companion animals.
Pet Event Tracking Network (PETNet)
• Outbreaks/Food-Borne and Feed-Borne Investigations
Workgroup - created a subgroup consisting of
veterinarians, animal feed regulators, and others
involved with animal health issues.
• Early warning system to identify, track and report foodborne illness outbreaks in companion animals or
contamination incidents concerning pet food or animal
feed.
• Developed in response to the 2007 outbreak that
occurred in companion animals that was associated
with the deliberate adulteration of pet food
components, such as wheat gluten, with melamine.
Pet Event Tracking Network (PETNet)
• Beginning stages - a system for reporting
outbreaks, supported by adequate diagnostic
laboratory facilities and an established
mechanism for conducting national
epidemiological investigations.
• Developed into a system for sharing
information between FDA, other Federal
agencies, and the States .
Pet Event Tracking Network (PETNet)
• A secure, internet-based network comprised of the
FDA, other Federal agencies, and State regulatory
agencies/officials having authority over pet food.
• Provides timely and relevant information about pet
food-related incidents to FDA, states and other
federal gov’t agencies charged with protecting
animal and public health.
• PETNet members receive alerts about pet food
incidents, as well as create alerts when they are
aware of a pet food incident within their jurisdiction.
Pet Event Tracking Network (PETNet)
• Helps state and federal regulators determine how
best to use inspectional and other resources to
either prevent or quickly limit the adverse events
caused by adulterated pet food.
• Many states have regulatory authority beyond
that of the FDA and often can be in a position to
act independently of FDA with the information
they will receive from the Pet Event Tracking
Network.
Pet Event Tracking Network (PETNet)
• Use & reporting of incidents by States to the
FDA is voluntary.
• The PETNet system is housed in Food Shield
(proprietary software system)
• Accessible only to PETNet members via
password.
• Standardized electronic form to collect and
distribute basic information about pet foodrelated incidents.
Pet Event Tracking Network (PETNet)
• Form filled out & submitted by a PETNet member
on FoodShield, at which time it will be available
to other PETNet members - entered and received
by PETNet members in as close to real time as
possible.
• Essential information necessary to alert PETNet
members about pet food-related incidents.
• Laboratory results & other details - PETNet
members can contact the reporting PETNet
member.
Pet Event Tracking Network (PETNet)
PETNet form data elements:
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Species involved
Clinical signs
Number of animals exposed/affected
Animal ages
Date of onset
Name and type of pet food involved
Manufacturer and distributor(s) of the pet food (if known)
State where the incident occurred
Origin of the information
Any supporting laboratory results
Contact information for the reporting PETNet member (i.e.
name, telephone number).
Association of American Feed Control
Officials (AAFCO)
Members:
• State feed control officials
• Food & Drug Administration Center for
Veterinary Medicine (FDA/CVM)
• Animal Feed Industry
• Canada
Association of American Feed Control
Officials (AAFCO)
• Goal: To provide a mechanism for developing and
implementing uniform and equitable laws,
regulations, standards and enforcement policies
for regulating the manufacture, distribution and
sale of animal feeds; resulting in safe, effective,
and useful feeds.
• AAFCO promotes new ideas and innovative
procedures and urges their adoption by member
agencies, for uniformity.
Association of American Feed Control
Officials (AAFCO)
Purpose and Function of AAFCO:
• Establish & maintain an Association through which
officials of any state, dominion, federal or other
governmental agency and employees thereof charged
with a responsibility in enforcing the laws regulating
the production, labeling, distribution, or sale of animal
feeds or livestock remedies may unite.
• Explore problems encountered in administering such
laws.
• Develop just and equitable standards, definitions and
policies to be followed in enforcing such laws.
Association of American Feed Control
Officials (AAFCO)
Purpose and Function of AAFCO:
• Promote uniformity in laws, regulations and
enforcement policies.
• Cooperate with members of the industry
producing such products in order to promote
the effectiveness and usefulness of such
products.
Association of American Feed Control
Officials (AAFCO)
• Feed Ingredient Definitions and Feed Terms in the
AAFCO Official Publication (AAFCO OP).
• AAFCO defines “feed(s)” as “edible materials
which are consumed by animals and contribute
energy and/or nutrients to the animals diet.”
• Therefore, basically anything that you give to an
animal to eat which contributes energy and/or
nutrients to the animals diet, whether it be a
vitamin/mineral supplement, a cookie or a treat;
even if it makes no guaranteed analysis under the
snack or treat exemption, would still be
considered a “commercial feed”.
Association of American Feed Control
Officials (AAFCO)
The AAFCO Official Publication (OP):
• Contains model regulations or guidelines a state
can use as a template to make laws specific to the
production of animal feeds or animal feed
ingredients.
• A state may adopt all of the AAFCO OP, part of
the AAFCO OP or none of the AAFCO OP.
• Some states under state law may merely
reference portions of the AAFCO OP model
regulations.
Association of American Feed Control
Officials (AAFCO)
• Model Bill and Model Regulations
• Model Good Manufacturing Practices for Feed
and Feed Ingredients
• Model Regulations for Pet Food and Specialty Pet
Food
• Model Guidance Documents (Feed Labeling
Guide; Model Feed Safety Program; Model
National Medicated Feed Program; Voluntary
Self-Inspection Program; BMPs; Enforcement;
Bio-Security; Emergency Response Preparedness;
Analytical Variations (Check Sample Program)
• Website: www.afco.org
• Membership Directory – states & Canada
• Regional FDA Directors
Federal Cooperative Agreements
with States
Bioterrorism Act and FDAAA
• Many (not all) state Department’s of Agriculture
(animal feed control agencies) have cooperative
agreements with the FDA CVM to regulate feeds
and feed ingredients under the federal regulations.
• Examples - Bovine Spongiform Encephalopathy (BSE);
Medicate Feed Mill inspections
Federal Cooperative Agreements
with States
• States oftentimes have more restrictive
regulations and broader authority than FDA (on
farm, records, enforcement).
• State cannot enforce the federal regulations
(unless adopted or referenced under state law).
State conducts inspections using federal FDA
credentials.
• If violations are observed specific
to federal regulations, FDA CVM has
to enforce them and take any
enforcement actions.
State Feed Regulations
• Licensing requirements
• Registration of products
and/or ingredients
• Tonnage reporting and fees
• Feed Labeling Requirements AAFCO labeling requirements
– most states
• Approved feed ingredients
• Misbranding
• Adulteration
• Animal Drug / Animal
Remedy regulations
Approved Feed Ingredients
Feed ingredients are basically any ingredient in which the
intended use is to provide nutritive value; aroma and/or taste.
Options for approval of a feed ingredient:
1.
2.
3.
4.
Food Additive Petition – 21 CFR 573
Generally Recognized As Safe (GRAS) Notification
AAFCO Ingredient Definition Process
Approval at the state level under Model Bill Reg. 6(a) –
assuming the product did not enter interstate commerce.
• FDA New Animal Drug Applications are required for any
ingredient making drug/medicinal, structure, function or
productivity claims.
Food Additive Petition – 21 CFR 573
• Manufacturer submits a petition to FDA for a
particular ingredient.
• The ingredient and related information can be
proprietary and confidential.
• Under the petition, a risk with regards to the feed
ingredient and its intended use has been
identified.
• FDA’s main focus and priority in the review of
feed ingredients is safety. FDA will make a
determination based on the petition and takes
responsibility as to the ingredients safety.
Generally Recognized As Safe (GRAS)
Notification
• GRAS ingredients are substances whereby no risk
has been identified with the intended use for the
intended species.
• The firm makes a “self-determination” that an
ingredient or substance is GRAS based upon
supporting data for the ingredient or substances
“intended use for an intended species”.
• Under the GRAS Notification Process, data and
information cannot be kept confidential.
• The firm uses qualified experts to make this
safety determination about the
ingredient/substance.
Generally Recognized As Safe (GRAS)
Notification
• This is an informal process. The firm can (not required)
send the GRAS notification to FDA who will review the
supporting documentation and make a safety
determination.
• FDA’s main focus and priority in the review of feed
ingredients is safety. Assuming the evidence supports
the safety of the ingredient for the intended use and
species; the FDA CVM will issue the firm an
“Enforcement Discretion Letter”.
• GRAS ingredients - the firm accepts responsibility for
the safety of the ingredient and its intended use.
AAFCO Feed Ingredient
Definition Process
AAFCO Feed Ingredient Definition process
is not a formal process, it is recognized by FDA
although it is not specifically in regulation.
FDA Approval
Coloring Additives
& Bioengineered Plants
• Any coloring additives must be approved under
the FDA Color Additive Petition 21 CFR 71.
Ingredients making drug/medicinal, structure,
function or productivity claims must be approved
by FDA CVM under the New Animal Drug
Application Process 21 CFR 514.
• Use of bioengineered plants as feed ingredients
must be pre-approved under Federal Register
notice and consultation with FDA.
Misbranding
• Truth in labeling
• False or misleading
statements
• Meet label guarantees
• Guaranteed Analysis
• Feed Terms
• Words, statements, designs,
graphics
Adulteration
Adulteration
The presence of any poisonous or deleterious
substance at a level that may render feed and/or
feed ingredients injurious to human or animal
health. (AAFCO)
• Biological – microbiological; parasites; prohibited
mammalian protein; decomposition
• Chemical – drugs; pesticides; industrial
contaminants; toxins (including plant toxins);
heavy metals; minerals, unapproved feed
ingredients or food additives
• Physical – stones, wood, metal, glass, plastic
The Inspection Process
The Inspection Process
• Authority – state, federal, local
• Credentials – identification – federal, state
• Notice of Inspection – why are they there i.e. routine
or suspected violations (RFR; PETNet)
• Sampling
• Suspected violations – describe
• Accompany inspector
• Records / recordkeeping
• Confidential business information – formulas; cost;
pricing etc.
• Closing Conference – identify inequities or violations
Enforcement Actions
• Depends upon state or federal
authority
• Federal 1st time warning
• Opportunity to correct
• History
• Stop Sale / Cease & Desist
Orders
• Seizure / Destruction of
material
AAFCO Model Good Manufacturing
Practices (GMPs)
• Prerequisite to a Voluntary Hazard Analysis &
Critical Control Point (HACCP) Plan
• GMPs and HACCP - Feed safety program
development
• HACCP – develop written standard operating
procedures (SOPs)
AAFCO Model Good Manufacturing
Practices (GMPs)
• Definitions – “adulteration”; “establishment”;
“pest”
• Personnel – good hygiene; minimize risk of
adulteration; training in areas of responsibility
• Establishments – construction; design; size;
facilitate routine maintenance & cleaning;
maintenance of grounds; minimize pest
infestations
AAFCO Model Good Manufacturing
Practices (GMPs)
• AAFCO’s GMPs are specific
to animal feeds and animal
feed ingredient production,
whereas 21 CFR Part 110 is
much broader and
encompasses human and
animal feeds.
AAFCO Model Good Manufacturing
Practices (GMPs)
• Maintenance & Housekeeping – good repair;
clean; pest control - minimize risk of
adulteration
- Chemicals, lubricants, pesticides,
fertilizers & cleaning compounds – secure
storage away /separate - minimize risk of
adulteration (cross-contamination)
AAFCO Model Good Manufacturing
Practices (GMPs)
• Equipment – size; design; precision; accuracy
(scales/metering); intended purpose –
minimize risk of adulteration
• Routine inspection & cleaning of equipment minimize risk of adulteration
• Tested for accuracy & capability to produce a
homogeneous product
• Recordkeeping (one year) - testing
AAFCO Model Good Manufacturing
Practices (GMPs)
• Receiving & Storage for further manufacture
• Inspect received feeds & feed ingredients; check
labeling
• Proper storage & identification – minimize risk of
adulteration
• Establish & implement clean-out procedures
• Inventory practices – rotate inventory stock
• Recordkeeping (one year) – previous source,
quantity, type/name, & date received
AAFCO Model Good Manufacturing
Practices (GMPs)
Manufacturing
• Use of adulterated feeds or feed ingredients
prohibited unless made safe for intended use.
• Establish procedures for minimizing risk of
adulteration – description of the manufacturing
operation; formulation; mixing and production
practices
• Measures in place to minimize adulteration i.e.
cleanout procedures (flushing etc.); minimize
physical adulterants (metal etc.)
• Recordkeeping (1 year) – production history
AAFCO Model Good Manufacturing
Practices (GMPs)
Packaging
AAFCO Model Good Manufacturing
Practices (GMPs)
Packaging
• Maintains identity & minimizes risk of
adulteration
• Cleanout procedures or prohibit reuse of bags
& totes
• Recordkeeping (1 year) - from date of
disposition
AAFCO Model Good Manufacturing
Practices (GMPs)
Labeling
• Label or unique identifier affixed to or
accompanying feed or ingredient – to facilitate
safe & effective use.
• Store, handle & use labels in a manner that
minimizes errors.
• Discard obsolete labels promptly.
• Lot Numbers – production code; lot specific
preferably in case of recall
AAFCO Model Good Manufacturing
Practices (GMPs)
Storage of Finished Feed and/or Feed
Ingredients –
• Clearly identify bins, bulk tanks etc.; avoid
commingling materials, if possible.
• Establish and implement inventory practices –
inventory rotation
AAFCO Model Good Manufacturing
Practices (GMPs)
Transportation of Feed and/or Feed Ingredients
• Inspect conveyances used for transport for
cleanliness & structural integrity.
• Avoid cross-contamination of
feeds, feed ingredients or other
materials by avoiding loading onto
the same conveyance or implement
measures to minimize risk.
• Recordkeeping (1 year) –
recipient; quantity; type/name;
unique identifier; date shipped
AAFCO Model Good Manufacturing
Practices (GMPs)
Voluntary Recalls / Withdrawal
• Recordkeeping (1 year) – identity and
disposition of feed and/or feed ingredients to
permit the rapid and effective recall from the
marketplace or withdrawal from feeding if a
feed or feed ingredient is found to be
adulterated.
• FDA Voluntary Recall Guidance
AAFCO Model Good Manufacturing
Practices (GMPs)
• AAFCO Guidance Framework for Best
Management Practices for Manufacturing,
Packaging & Distributing Animal Feeds and
Feed Ingredients
• Compliance Checklist available
• Advantage in obtaining certificate of free sale
in combination with state certification of a
company GMP program.
Do the feed regulations apply
to my facility?
• Federal GMPs under 21 CFR Part 110
CURRENT GOOD MANUFACTURING PRACTICE
IN MANUFACTURING, PACKING, OR HOLDING
HUMAN FOOD apply nationally regardless of
where a manufacturer is located and
regardless of whether it is animal or human
food.
• Determine who the state feed control agency
is for the state(s) within which facilities are
located.
Do the feed regulations apply
to my facility?
• Has the state feed control agency within which
the manufacturing facility resides adopted the
AAFCO model GMPs in whole or in part?
• If not, does the state animal feed control agency
have a cooperative agreement in place with FDA
to conduct and/or enforce GMPs under the
federal law 21 CFR Part 110?
• Has the state feed control agency adopted any or
all of the federal law 21 CFR Part 110 into their
own state laws? Or does the state feed control
agency
QUESTIONS?
Brenda Ball – Compliance Manager
Arizona Department of Agriculture
(602) 542-0986
bball@azda.gov