feed manufacturing & distribution requirements including good manufacturing practices (gmps)...

Feed Manufacturing & Distribution Requirements

Including Good Manufacturing Practices

(GMPs)Brenda Ball

Compliance ManagerAZ 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.

http://www.localwin.com/julie/system/files/lu10/Ingredients_Healthy_Food.jpg

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.

• 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.

Who Should Use the Reportable Food Registry?

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)


• 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.


• 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 food-borne 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.


• 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 .


• 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.


• 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.


• 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 food-related incidents.


• 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.


PETNet form data elements: – 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


• 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.


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.


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.


• 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”.


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.


• 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

http://www.afco.org/

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 IngredientsFeed 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. Food Additive Petition – 21 CFR 5732. Generally Recognized As Safe (GRAS) Notification3. AAFCO Ingredient Definition Process4. 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

AdulterationThe 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)


• 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’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.


• 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)


• 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


• 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


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


Packaging


Packaging• Maintains identity & minimizes risk of

adulteration• Cleanout procedures or prohibit reuse of bags

& totes• Recordkeeping (1 year) - from date of

disposition

http://www.google.com/aclk?sa=l&ai=C6IktEAbeTK__G4agsAOx6NSCCcqo_9sB0pXouRSOsP4JCAAQASCTrPsFUJuLvY0HYMm-yYbEo8gXoAH-ysDyA8gBAaoEG0_Q38ZwTMBWbibZJr-60soHmXAm8nrzlkKnFQ&sig=AGiWqtzONWuNSiz7obbNG0iBDGMu_k7DVg&adurl=http://shop.tcrpackagingsupplies.com/shop/C1.aspx


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


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


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


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 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 ManagerArizona Department of Agriculture

(602) [email protected]

feed manufacturing & distribution requirements including good manufacturing practices (gmps)...

Documents

federal food

human food

article of food

pet food

terms food

imported food slide

reportable food reports

reportable food safety