1. Overview of Animal Food Regulatory Program
Padmakumar B. Pillai, MVSc., PhD, DACAN
FDA – Center for Veterinary Medicine, Rockville, Maryland
April 29, 2014
American Society of Animal Science Webinar Series

2. Focus of the Webinar Define food/feed Regulatory authority
Regulatory entities
Animal food regulatory processes; pre-market
Information to address each of these processes
Post-market regulatory processes
Food Safety Modernization Act

3. What are Feed Substances?
In FDA’s regulatory framework, feed or animal food is in the same definition as human food.
Legal definition - Food is “articles used for food or drink for man or other animals”
Food for animals (or people) are substances
That provide nutrition (nutritive value), taste, or aroma
Affect the characteristics of food
May indirectly become a component of food through processing, packaging, etc.

4. Animal Food Animal food includes Livestock feed Pet food
Companion animal food
Exotic animal food
Aquaculture feed

5. Regulatory Authority Federal Food, Drug and Cosmetic Act (FFDCA)
Basic food and drug law in the U.S.
Code of Federal Regulations (CFR) explains the requirements of laws
Says food must be …
Safe to eat
Produced under sanitary conditions
Free of harmful substances
Truthfully labeled
Prohibits interstate distribution of adulterated and/or misbranded articles

6. Adulteration Defective Unsafe Unapproved Filthy, putrid, or decomposed
Produced under unsanitary conditions

7. Misbranding Addresses product labels and labeling
False or misleading labels and labeling
Failure to provide required label information

8. Who Regulates Animal Food
Food and Drug Administration (FDA)
Composition and labeling
Manufacturing facility registration
State agencies
Often through the State’s Department of Agriculture
State regulation is through individual state’s commercial feed laws and regulations

9. Who else is Involved? Environmental Protection Agency (EPA)
Pesticide tolerances
Department of Agriculture (USDA)
Meat
National Organic Program
Federal Trade Commission (FTC)
Advertising
Customs and Border Protection (CBP)
Import and export

10. What is Regulated as Food?
Substances that
Provide nutrition (nutritive value), taste, or aroma to the animal
Affect the characteristics of food
May directly or indirectly become a component of food through processing, packaging, etc.

11. What Constitutes Animal Food?
Food/Feed
Unprocessed grains, grasses, or hays
Generally recognized as safe (GRAS) as source of nutrients
Other “ingredients” or “articles”
Are component part or constituent or any combination/ mixture added to and comprising an animal food
Includes many different substances for various uses

12. Food - by Itself Food – e.g. corn or hay, is presumed safe
Does not require approval by FDA prior to entering commerce (being offered for sale).
Manufacturer/Distributor
Is responsible for the product being safe and otherwise acceptable for the intended use.
Is responsible for ensuring that product labeling is compliant with federal and state laws and regulations.

13. Other “Articles” from FFDCA
Are component part, ingredient, constituent or any combination/ mixture added to and comprising an animal food
Includes many different substances for various uses
Multiple regulatory processes available

14. Regulatory Classes Food additive
Listed in 21 CFR 573
Substance generally recognized as safe for intended use (GRAS)
Partial list in 21 CFR 582
Affirmed GRAS by FDA in 21 CFR 584
Self determination by qualified experts
FDA concurrence is not required

15. Regulatory Classes (cont.)
Color additive
Colors the food itself or the tissues, milk or eggs from animals consuming the additive
Listed in 21 CFR 73
New animal drug
Intended for diagnosis, cure, mitigation, treatment or prevention of disease,
Affects the structure or function of the animal other than by providing nutrition, taste, or aroma,
Improves animal productivity, such as growth rate, milk production, carcass leanness
Listed in 21 CFR 558

16. State Regulatory Defined ingredient
Published in Official Publication of Association of American Feed Control Officials (AAFCO)
Administered by AAFCO
FDA acts as scientific consultant
FDA recognizes common and usual name of ingredients
CPG

17. Dietary Supplements for Animals?
Regulatory class for people established by Dietary Supplement Health and Education Act (DSHEA)
Does NOT apply to animal food
1996 Federal Register (FR) Notice 61:17706
Many supplements may be animal drugs based on their intended use
Claim determines whether a substance will be considered food or drug

18. How is New Substance for Animal Food Approved or Recognized?
Food additive petition - 21 CFR 571
Color additive petition - 21 CFR 71
New animal drug application - 21 CFR 514
……………………………………………………
GRAS notification to CVM FR notice 75:31800
Bioengineered plant FR notice 57:22984
Consultation process with FDA
AAFCO ingredient definition process
CVM is science advisor under Memorandum of Understanding

19. Animal Food Regulatory Requirements
No pre-market approval for foods
New articles must be shown to be safe
Approved food additive or GRAS substance is for a specific intended use
Not proprietary
Animal food articles cannot have drug claims
If a food article affects structure or function of body, it must do so only through nutrition
DSHEA does not apply to animal food

20. Food Additives FFDCA defines a food additive as:
“any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food”
Very broad definition, can include:
Vitamins, proteins, fiber, emulsifiers, sequestrants, anti-caking agents, enzymes, packaging materials, irradiation, etc.

21. Food Additives (cont.) Must be approved prior to marketing
Food additive petition process
When petition approved, publication of food additive regulation in CFR
Process described in 21 CFR 571
Regulatory definitions are in 21 CFR 570
Food additives are not proprietary
Any firm can market if product meets requirements of pertinent regulations

22. What is Needed for Approval?
Areas that must be addressed in petition:
Identity and composition
Manufacturing methods and controls
Intended use, use level, and labeling
Data establishing intended effect
Physical, nutritional, or other technical effect
Analytical methods
Safety evaluation
Target animal
Human food, including tolerance for residues if needed
Environmental assessment
Proposed regulation
Label

23. Identity and Composition
Data to identify additive
Manufacturing
Complete description of methods used
Final additive specifications
Stability testing
Mixability studies
Detailed description of method(s) used to determine strength, purity, and quality
Analytical method validation data

24. Intended Use Intended use varies with type of additive and its purpose
Petition must address:
Species, life stage of target animals, type of food (eg. complete diet vs treat)
Use rate
Intended effect
Data to demonstrate additive achieves effect in target animals

25. Safety Legal standard Safety is defined in 21 CFR 570.3(i)
“Reasonable certainty of no harm”
Safety is defined in 21 CFR 570.3(i)
Two major aspects of safety
Target animal safety
Human food safety

26. Target Animal Safety
Demonstrate safety under intended conditions of use in target animals
Guidance for Industry (GFI) #185, Target animal safety for veterinary pharmaceutical products VICH GL43

27. Target Animal Safety (cont.)
Appropriate toxicity (safety) studies
Adverse effects identified in toxicity studies are not expected to occur under conditions of use
Addressing animal safety is complex
Cross-species extrapolation difficult
Animal safety studies in individual target species are often necessary

28. Human Food Safety
Demonstrate safety of human food products obtained from animals consuming additive
Impact of potential residues in tissues, milk, eggs
Three areas must be addressed (toxicology, residue chemistry, microbial food safety)
GFI #3, General principles for evaluating the safety of compounds used in food-producing animals

29. Human Food Safety (cont.)
Toxicology: General study recommendations
CVM GFI #149
Residue Chemistry
May need to establish tolerance levels
Microbial Food Safety for antimicrobials
Microbiological acceptable daily intake (mADI) may be needed if adverse impact on:
Development of antimicrobial resistance
Human intestinal flora
CVM GFI #152 ; CVM GFI #159

30. Environmental Safety
Potential environmental impacts, positive or negative, must be addressed
Additive manufacture, use, and disposal
21 CFR 25

31. Regulation and Label
Regulation addresses how additive can be safely used in animal food
Will be published in the CFR
Label that contains all the required sections should be included
GFI #221, Recommendations for Preparation and Submission of Animal Food Additive Petitions

32. GRAS GRAS = Generally Recognized as Safe
Substances are GRAS for specific intended uses
Two parts to establish that use of a substance is GRAS
“Safety” as defined in 21 CFR 570.3(i)
Reasonable certainty of no harm
“General Recognition” as stated in 21 CFR
Safety evidence to be generally available and generally accepted by qualified experts

33. Basis for GRAS status Evidence of safety based on:
Experience from common use in animal food prior to 1958
Data and information must be generally available
Need to show common use
No longer very common
Scientific procedures
Requires the same quality and quantity of scientific evidence as required for approval of food additive petition
Most frequently used

34. GRAS Determination & Notification
Companies can self-determine GRAS status for products
No FDA notification required
GRAS Notification
Informs FDA of notifier’s determination of GRAS
Voluntary program
Submitted to FDA for evaluation
FDA response by letter will be ..
No questions, or
Notice does not provide sufficient basis for notifier’s determination

35. GRAS Notification Proposed rule published April 17, 1997
Changing from petition to notification process
Publication date of final rule is unclear
CVM implemented pilot program
June 4, 2010 FR Notice
Inventory of GRAS notices and FDA responses at:

36. AAFCO Ingredient Definitions
Process used for substances that present no apparent safety concerns for intended use
Target animal
Human food
Environment
Process outlined in New and Modified Ingredient Definitions: A Guide in AAFCO OP
AAFCO investigator is contact for definition request, not CVM

37. AAFCO Definition Process
Request for new definitions must include:
Firm and contact person
Summary
Ingredient name, intended use, and rationale for request
Proposed definition
Description of ingredient
Prior Sanctioned use
Common use in United States pre 1958 and/or
Historical regulation of ingredient
General description of manufacturing processes
Purpose of ingredient

38. Definition Process (Cont.)
Use limitations, if any
Data and observations to support intended use
Controlled feeding trials, if necessary
Summary of safety assessment
Reports of available safety studies
Target animal safety, toxicity, carcinogenicity, mutagenicity, and chronic effects
Levels of known impurities and/or potential contaminants
Explanation of how to assure ingredient safety
Statement of risk for target animals
Statement of risk for human food
Statement of environmental safety
List of Cited Literature

39. Definition Process (Cont.)
AAFCO investigator
Reviews definition request for completeness
Sends to CVM for concurrence
CVM reviews material, responds to AAFCO
Proposed definition reviewed and voted on by state feed control officials
Final definition is published in AAFCO Official Publication
Publication is revised and published annually

40. Ingredients and FDA
Memoranda of Understanding defines FDA and AAFCO roles in ingredient definition process
CVM serves as scientific advisor to AAFCO
MUpdates/ucm htm
FDA_MOU_2012.pdf
FDA recognizes AAFCO as standard setting body
21 CFR 10.95

41. Ingredients and FDA (Cont.)
FDA recognizes AAFCO feed ingredient definitions as establishing common or usual name of ingredients
Compliance Policy Guide Common or Usual Names for Animal Feed Ingredients
AAFCO Official Publication contains most comprehensive list of substances accepted in the United States for use in animal food

42. Official Lists for Animal Food
Code of Federal Regulations (
Approved food additives: CFR 573 & 579
GRAS substances (partial list): 21 CFR 582 & 584
Association of American Feed Control Officials “Official Publication”

43. Post-market Regulatory Activities
Animal feed manufacturing compliance program
Feed contaminants compliance program
Scientific support for enforcement actions
Recalls and Diversion of food
FSMA implementation

44. Compliance Programs Feed manufacturing compliance program
Licensure of animal feed manufacturing facilities
Inspection of licensed facilities
Type A medicated article compliance program
Post-approval monitoring of facilities that manufacture type A medicated articles

45. Compliance Programs (Cont.)
Feed contaminants compliance program
Feed sampling assignments
Analysis
Pesticides, industrial chemicals
Dioxin
Elements (Pb, Se, etc.)
Mycotoxins
Microbes (Salmonella)
Antimicrobials

46. Salmonella Surveillance
Objectives
Determine the prevalence of Salmonella
Determine the serovar, genetic fingerprint, and antimicrobial susceptibilities of isolates
Take action for controlling the presence of Salmonella
Compliance Policy Guide (CPG) Sec Salmonella in Food for Animals
July 16, 2013; 78 FR 42451

47. Diversion and Recalls
Diversion of adulterated or contaminated food to animal use
CPG – Diversion of adulterated food to acceptable feed use
CPG – Diversion of contaminated food for animal use
Diversion requests may include information about reconditioning the adulterated food prior to diversion
Recall of animal food
Until recently voluntarily done by recalling firms
Need a Health Hazard Evaluation (HHE) to determine and justify the recall classification

48. Mandatory Recalls
Food Safety Modernization Act (FSMA) of 2011 gave the FDA new authority to:
Increase inspections of food processing facilities
Force companies to recall tainted food
Mandatory recall authority is for food that can cause serious adverse health consequences or death to humans or animals

49. Food Safety Modernization Act
Current food safety system has challenges, is reactive
Historic changes to the food safety system through FSMA
Shift from response to prevention
Involves creation of a new food safety system
Broad prevention mandate and accountability
New system of import oversight
Emphasizes partnerships
Emphasizes farm-to-table responsibility
Developed through broad coalition

50. FSMA Implementation Implementation already underway
Proposed rules published on October 29, 2013
Comment period closed on March 31, 2014
Final rule(s) to be published in 2015
Animal Preventive Control (PC) rules establishes cGMPs
Does not include allergens as hazard

51. Conclusions CVM is responsible for animal food safety regulations
FDA is charged with enforcement of FFDCA which requires that animal food, including pet foods, are“safe, wholesome, sanitary, and properly labeled”
FSMA will modernize the way food/feed is produced

52. Additional Information
Food additive petition
21 CFR 571; GFI #221: Recommendations for Preparation and Submission of Animal Food Additive Petitions
GRAS and notification process
21 CFR 570
April 17, 1997 Federal Register notice 62:18937
June 4, 2010 Federal Register notice 75:31800
AAFCO ingredient definition process
AAFCO Official Publication

53. Additional Information (Cont.)
CVM internet site
Animal food and feeds
New animal drugs

54. Additional Information (Cont.)
FDA internet site
Bioengineered plants
Color additives
AAFCO internet site

55. Human Food Safety Guidance
General recommendations
GFI #149, Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to testing VICH GL33
Microbial food safety
GFI #152, Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern
GFI #159, Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI

56. Thank you