#241 
 
Guidance for Industry 
 
Small Entity Compliance Guide 
 
What You Need to Know About the FDA Regulation: 
Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals 
(21 CFR Part 507) 
 
Submit comments on this guidance at any time.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  All comments should be identified with the Docket No: FDA-2011-N-0922 listed in the 
notice of availability that publishes in the Federal Register. 
 
Additional copies of this guidance document may be requested from the Policy and Regulations 
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Place, Rockville, MD 20855, and may be viewed on the Internet at either 
http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
October 2016  Contains Nonbinding Recommendations 
Table of Contents 
 
 
I.  INTRODUCTION .............................................................................................................. 4 
II.  OVERVIEW OF THE RULE ............................................................................................. 5 
A.  Key Requirements ........................................................................................................ 5 
B.  Who Must Comply With the Rule? .............................................................................. 5 
C.  Definitions .................................................................................................................... 6 
D.  Who Is Exempt From the Requirements for Hazard Analysis and Risk-Based 
Preventive Controls for Animal Food or Subject to Modified Requirements? ...................... 7 
E.  When Do I Have to Comply With the Rule? ................................................................ 9 
III.  WHAT ON-FARM LOW-RISK ACTIVITIES BY SMALL OR VERY SMALL 
BUSINESSES ARE EXEMPT FROM HAZARD ANALYSIS AND PREVENTIVE 
CONTROLS? ............................................................................................................................ 10 
A.  On-Farm Packing or Holding of Animal Food ........................................................... 10 
B.  On-Farm Manufacturing/Processing .......................................................................... 11 
IV.  INFORMATION FOR QUALIFIED FACILITIES ......................................................... 12 
A.  How Can I Tell if My Business is a Qualified Facility? ............................................ 12 
B.  How Do I Tell FDA That My Business is a Qualified Facility? ................................ 12 
C.  What Other Information Must I Provide FDA? .......................................................... 13 
D.  When Must I Tell FDA That My Business is a Qualified Facility? ........................... 13 
E.  Withdrawal of a Qualified Facility Exemption .......................................................... 14 
V.  CURRENT GOOD MANUFACTURING PRACTICE (CGMP) .................................... 14 
A.  Personnel .................................................................................................................... 14 
B.  Plant and Grounds ...................................................................................................... 15 
C.  Sanitation .................................................................................................................... 16 
D.  Water Supply and Plumbing ....................................................................................... 17 
E.  Equipment and Utensils .............................................................................................. 18 
F.  Plant OperationsManagement................................................................................. 19 
G.  Plant OperationsRaw Materials and Other Ingredients .......................................... 20 
H.  Plant OperationsGeneral ......................................................................................... 21 
I.  Holding and Distribution ................................................................................................ 21 
J.  Holding and Distribution of Human Food By-Products for Use as Animal Food ......... 22 
VI.  HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS ................... 23 
A.  Hazard Analysis .......................................................................................................... 23 
1.  What categories of hazards must you consider? ..................................................... 23 
2.  What must your hazard evaluation include? ........................................................... 23 
B.  Preventive Controls .................................................................................................... 24 
C.  Oversight and Management of Preventive Controls................................................... 26 
D.  Circumstances When a Preventive Control is Not Required ...................................... 27 
E.  Supply-Chain Program for Manufacturing/Processing Facilities ............................... 28 
1.  Requirements .......................................................................................................... 29 
2.  Exceptions ............................................................................................................... 30 
F.  Compliance Dates for the Requirements of the SupplyChain Program ................... 30 
2  Contains Nonbinding Recommendations 
G.  Education and Training .............................................................................................. 30 
H.  Reanalysis of Your Food Safety Plan ......................................................................... 31 
VII.  DEFINITIONS ............................................................................................................... 31 
 
 
3  Contains Nonbinding Recommendations 
Guidance for Industry 
 
Small Entity Compliance Guide 
 
What You Need to Know About the FDA Regulation: 
Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Food for Animals 
(21 CFR Part 507) 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
I.  INTRODUCTION 
 
The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration 
(FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to 
better protect public health by, among other things, adopting a modern, preventive, and risk-
based approach to food safety.  On September 17, 2015, FDA published the final rule Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals (PCAF or the rule) (80 FR 56173).  FDA has prepared this Small Entity Compliance 
Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness 
Act (Pub. Law 104-121).  The intent of this guide is to inform domestic and foreign animal food 
facilities about the PCAF regulations and enable them to better understand the requirements of 
the rule.  It contains important information that may affect your facility. 
 
The regulation creates new current good manufacturing practice (CGMP) requirements for 
animal food facilities.  In addition, it creates new requirements for certain animal food facilities 
to establish and implement risk-based preventive controls.  The regulations are found at Title 21 
of the Code of Federal Regulations part 507 (21 CFR part 507).  The rule became effective on 
November 16, 2015, but compliance dates are staggered  see section II. E When Do I Have to 
Comply with the Rule? 
 
In general, FDA guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.   
4  Contains Nonbinding Recommendations 
II.  OVERVIEW OF THE RULE 
 
A.  Key Requirements 
 
Current Good Manufacturing Practice requirements (21 CFR part 507 subpart B) apply to all 
facilities unless an exemption applies under 21 CFR 507.5. 
 
Unless an exemption applies (21 CFR 507.5), facilities must establish and implement a food 
safety system that includes a hazard analysis and implementation of risk-based preventive 
controls for those hazards the facility identifies as requiring a preventive control (21 CFR 507.33 
and 507.34). 
 
The rule requires a written food safety plan (21 CFR 507.31).  The written plan must be prepared 
by (or its preparation overseen by) one or more preventive controls qualified individuals (21 
CFR 507.31(b)) (see section VII. Definitions) and must include the following (21 CFR 
507.31(c)): 
 
  A hazard analysis 
 
  Preventive controls 
 
  A risk-based supply chain program, if appropriate 
 
  A recall plan, if there is a hazard requiring a preventive control identified for an animal 
food 
 
  Monitoring procedures 
 
  Corrective action procedures 
 
  Verification procedures 
 
Receiving facilities must have a risk-based supply chain program for those raw materials and 
other ingredients for which an identified hazard has been controlled before receipt (a supply-
chain-applied control) (21 CFR part 507, subpart E).  The risk-based supply-chain program is 
flexible and has separate compliance dates (see section II. E. of this guidance). 
 
B.  Who Must Comply With the Rule? 
 
The requirements of this rule apply to foreign and domestic establishments that are required to 
register with FDA as food facilities under section 415 of the Federal Food, Drug, and Cosmetic 
Act, (FD&C Act) because they manufacture, process, pack, or hold food for animal consumption 
in the U.S.  There are exemptions from the rule or modified requirements and these are listed in 
section II.D of this guidance in table 2. 
 
5  Contains Nonbinding Recommendations 
C.  Definitions 
 
The PCAF rule uses a number of terms in very specific ways.  A full list of these terms appears 
in this Guidance in section VII. Definitions.  Table 1 lists some of the key terms. 
 
Table 1Key Terms Used in Part 507 
 
Term  Definition 
Animal Food  Food for animals other than man and includes pet food, animal feed, 
and raw materials and ingredients 
Facility  A domestic facility or a foreign facility that is required to register 
under section 415 of the FD&C Act, in accordance with the 
requirements of 21 CFR part 1, subpart H 
Hazard  Any biological, chemical (including radiological), or physical agent 
that has the potential to cause illness or injury in humans or animals. 
Hazard requiring a preventive  A known or reasonably foreseeable hazard for which a person 
control  knowledgeable about the safe manufacturing, processing, packing, 
or holding of animal food would, based on the outcome of a hazard 
analysis (which includes an assessment of the severity of the illness 
or injury to humans or animals if the hazard were to occur and the 
probability that the hazard will occur in the absence of preventive 
controls), establish one or more preventive controls to significantly 
minimize or prevent the hazard in an animal food and components to 
manage those controls (such as monitoring, corrections or corrective 
actions, verification, and records) as appropriate to the animal food, 
the facility, and the nature of the preventive control and its role in 
the facilitys food safety system. 
Known or reasonably foreseeable  A biological, chemical (including radiological), or physical hazard 
hazard  that is known to be, or has the potential to be, associated with the 
facility or the animal food. 
Manufacturing/Processing  Making animal food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating animal food, 
including food crops or ingredients.  (See section VII. Definitions 
for examples). 
Preventive controls  Those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, 
processing, packing, or holding of animal food would employ to 
significantly minimize or prevent the hazards identified under the 
hazard analysis that are consistent with the current scientific 
understanding of safe food manufacturing, processing, packing, or 
holding at the time of the analysis. 
 
   
6  Contains Nonbinding Recommendations 
D.  Who Is Exempt From the Requirements for Hazard Analysis and Risk-Based 
Preventive Controls for Animal Food or Subject to Modified Requirements? 
 
Table 2 contains information for establishments on exemptions or modified requirements for part 
507. 
 
Table 2Exemptions and Modified Requirements for Part 507 
 
Exemption or Modified Requirement  Conditions 
Establishments that are not required to register with  Farms conducting activities on produce covered 
FDA under section 415 of the FD&C Act are exempt  by the Produce Safety Rule will be required to 
from 21 CFR part 507 (21 CFR 507.5(a))  comply with that rule (Title 21 Code of Federal 
Regulations part 117 (21 CFR part 117) 
Qualified Facilities are exempt from 21 CFR part  To be eligible for modified requirements, a 
507 subparts C and E (21 CFR 507.7(d)) and are:  qualified facility is required to notify FDA about 
  its qualified facility status; and that it is either: 
Very small businesses (including any subsidiaries or   
affiliates) averaging less than $2,500,000 (adjusted  1.  Addressing identified hazards through 
for inflation) -- in both sales of animal food plus the  preventive controls and monitoring the 
market value of animal food that is manufactured,  preventive controls; or 
processed, packed, or held without sale (e.g. held for   
a fee or supplied to a farm without sale), per year  2.  Complying with applicable non-Federal food 
during the 3-year period preceding the current  safety regulations and notifying consumers of 
calendar year.  the name and complete business address of 
  the facility where the animal food was 
OR  manufactured or processed. 
   
A facility to which both of the following apply:  3.  A qualified facility must submit these 
  notifications to FDA during the same two year 
  During the 3-year period preceding the applicable  time frame that the facility is required to 
calendar year, the average annual monetary value  update its facility registration (21 CFR 507.7) 
of the food manufactured, processed, packed, or   
held at the facility that was sold directly to  An otherwise Qualified Facility that does NOT 
consumers, retailers, or restaurants (within the  notify FDA is subject to the requirements for 21 
same state or Indian reservation or within 275  CFR part 507 
miles of the facility) was less than the monetary   
value of food sold by the facility (including sales  The qualified facility exemption can be withdrawn 
by any subsidiary or affiliate) to all other  in the event of a foodborne illness outbreak. See 
purchasers; and  21 CFR part 507 subpart D--Withdrawal of a 
  Qualified Facility Exemption 
  The average annual monetary value of all food 
sold during the 3-year period preceding the 
applicable calendar year was less than $500,000 
Low-risk, on-farm activities performed by small  For specific information on which activities are 
businesses (less than 500 full-time equivalent  covered, see section III of this guidance 
employees) or very small businesses (as defined in 
the rule) (21 CFR 507.5(e) and (f)) are exempt from 
21 CFR part 507 subparts C and E 
7  Contains Nonbinding Recommendations 
Exemption or Modified Requirement  Conditions 
Activities that are subject to the low-acid canned  The exemption applies only with respect to 
food requirements (21 CFR 500.23 and part 113) are  microbiological hazards regulated under 21 CFR 
exempt from 21 CFR part 507 subparts C and E (21  part 113 and the facility must be in compliance 
CFR 507.5(b))  with part 113 (21 CFR 507.5(b)(1) and (b)(2)) 
Activities of a facility that are subject to Standards  See FDAs Produce Safety Rule (21 CFR part 
for Produce Safety, section 419 of the FD&C Act (21  112) for a description of these activities  
CFR 507.5(c)) 
Establishments that only store raw agricultural  Storage of raw agricultural commodities that are 
commodities -- other than fruits and vegetables --  fruits and vegetables is not exempt 
intended for further distribution or processing (21 
CFR 507.5(g)) are exempt from 21 CFR part 507 
subparts C and E 
Current good manufacturing practice requirements  There can be no manufacturing or processing such 
(21 CFR part 507 subpart B) do not apply to  as grinding shells or roasting nuts or extracting oil 
establishments that are solely engaged in:  from cottonseed 
 
1.  The holding and/or transportation of one or more 
raw agricultural commodities; 
 
2.  Hulling, shelling, drying, packing, and/or holding 
nuts and hulls; or 
 
3.  Ginning of cotton 
 
(See 21 CFR 507.5(h)) 
Facilities solely engaged in the storage of unexposed  Subparts C and E of 21 CFR part 507 do not apply  
packaged animal food that does not require 
time/temperature control for pathogens (21 CFR 
507.10(a)) 
Facilities solely engaged in the storage of unexposed  Subparts C and E of 21 CFR part 507 do not apply 
packaged animal food that does require  except for modified requirements in 21 CFR 
time/temperature control for pathogens (21 CFR  507.51 to establish and implement temperature 
507.10(b))  controls, monitor the temperature controls, correct 
any problems, calibrate temperature monitoring 
equipment, and review and maintain records 
Holding and distribution of human food by-products  For the human food by-products for use as animal 
for use as animal food (21 CFR 507.12)  food, the by-product is subject only to the 
requirements of 21 CFR 507.28 as long as the by-
product does not undergo further manufacturing 
or processing at the human food facility, the 
human food facility is in compliance with 21 CFR 
part 117 subpart B; or, for the off-farm packing 
and holding of produce, in compliance with 21 
CFR 117.8; and the facility is in compliance with 
all applicable human food safety requirements of 
the FD&C Act and implementing regulations. 
 
8  Contains Nonbinding Recommendations 
E.  When Do I Have to Comply With the Rule? 
 
Facilities have different compliance dates based on business size.  Table 3 lists the compliance 
dates for the CGMP requirements in subpart B and the preventive controls requirements in 
subpart C of 21 CFR part 507.  Table 4 lists the compliance dates for the supply-chain program 
in subpart E of 21 CFR part 507. 
 
Table 3Compliance Dates for Part 507 
 
Business Size  Current Good Manufacturing  Preventive Controls 
Practice Compliance Date  Compliance Date 
Business other than small and very  September 19, 2016  September 18, 2017 
small 
Small businesses, i.e., a business  September 18, 2017  September 17, 2018 
with fewer than 500 full-time 
equivalent employees 
Qualified facilities (including very  September 17, 2018  September 17, 2019,  except for 
small businesses) as defined   records to support its status as a 
above  very small business is January 
1, 2017 
 
Table 4Compliance Dates for the Requirements of the Supply-Chain Program (Subpart E) 
 
Situation  Compliance Date 
A receiving facility is a small business and its  6 months after the receiving facilitys supplier of 
supplier will be subject to the CGMPs, but not the  that raw material or other ingredient is required 
preventive control requirements, of the animal food  to comply with the CGMP requirements of this 
preventive controls rule  rule 
A receiving facility is a small business and its  The later of: September 17, 2018 or 6 months 
supplier is subject to the animal food preventive  after the receiving facilitys supplier of that raw 
controls rule  material or other ingredient is required to comply 
with this rule 
A receiving facility is not a small business or a very  6 months after the receiving facilitys supplier of 
small business and its supplier will be subject to  that raw material or other ingredient is required 
CGMPs, but not the preventive control  to comply with the CGMP requirements of this 
requirements, of the animal food preventive controls  rule 
rule 
A receiving facility is not a small business or a very  The later of: September 18, 2017 or 6 months 
small business and its supplier will be subject to the  after the receiving facilitys supplier of that raw 
animal food preventive controls rule  material or other ingredient is required to comply 
with the applicable rule 
 
   
9  Contains Nonbinding Recommendations 
III. WHAT ON-FARM LOW-RISK ACTIVITIES BY SMALL OR VERY SMALL 
BUSINESSES ARE EXEMPT FROM HAZARD ANALYSIS AND PREVENTIVE 
CONTROLS? 
 
Certain manufacturing, processing, packing, and holding activities are not subject to the 
requirements for hazard analysis and risk-based preventive controls and supply-chain program 
when they are conducted on-farm by small or very small businesses, if these are the only 
activities they conduct that would be subject to the requirements for hazard analysis and risk-
based preventive controls.  The exemption only applies to the low-risk activity/animal food 
combinations listed in the regulation.  In addition, the requirements for a very small business also 
would not apply to very small on-farm businesses conducting only these low-risk, on-farm 
manufacturing, processing, packing, and holding activities.  Following are the exemptions for 
on-farm packing and holding of animal food and the exemptions for on-farm manufacturing/ 
processing of animal food. 
 
A.  On-Farm Packing or Holding of Animal Food 
 
The requirements for hazard analysis and risk-based preventive controls and supply-chain 
program do not apply to on-farm packing or holding of animal food by a small or very small 
business if the packing and holding activities are limited to packing (or re-packing) (including 
weighing or conveying incidental to packing or re-packing); sorting, culling, or grading 
incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of (21 
CFR 507.5(e)): 
 
  Roughage productse.g., alfalfa meal, entire plant meal, stem meal, pomace, and pulp 
 
  Plant protein mealse.g., algae, coconut (copra), guar, and peanut 
 
  Grain by-products and processed grain productse.g., bran, flour, germ meal, grits, 
groats, hominy feed, malt sprouts, middlings, pearled grain, polished grain, brewers 
grain, distillers grain, and gluten meal 
 
  Oilseed productse.g., oil and meal of safflower, soybean, or sunflower 
 
  Molassese.g., processed sugar cane, sugar beets, and citrus 
 
  Animal protein mealse.g., blood, feather, meat, meat and bone, and marine (e.g., crab, 
fish, and shrimp) 
 
  Milk productse.g., casein, cheese rind, and lactalbumin 
 
  Animal tissue-derived productse.g., fat 
 
  Vitamins, minerals, and concentrates 
 
  Processing aidse.g., enzymes, preservatives, and stabilizers 
10  Contains Nonbinding Recommendations 
 
  Any other processed animal food that does not require time/temperature control for safety 
 
B.  On-Farm Manufacturing/Processing 
 
The requirements for hazard analysis and risk-based preventive controls and supply-chain 
program do not apply to on-farm manufacturing/processing of animal food by a small or very 
small business if the only manufacturing/processing activities that the business conducts consist 
of the following low-risk manufacturing/processing activity/animal food combinations (21 CFR 
507.5(f)): 
 
  Chopping or shredding hay; 
 
  Cracking, crimping, flaking, pearling, peeling, shelling, or waferinggrain (e.g., barley, 
sorghum, corn, oats, rice, rye, and wheat), or oilseed (e.g., beans, canola, cottonseed, 
linseed, soybeans, and sunflowers); 
 
  Crushing, dry rolling, grinding, milling, pulverizinggrain, oilseed, grain by-products 
and processed grain products, oilseed products, hay, ensiled material, culled fruits and 
vegetables, roughage (e.g., cobs, hulls, husks, and straws, or roughage products); 
 
  Ensiling (including chopping, shredding, mixing, storing, or fermenting), i.e., making 
silage or haylage from forage ( e.g., sorghum (milo), corn (maize), alfalfa, and grass), 
grain, culled fruits and vegetables, or roughage; 
 
  Extracting (mechanical) or wet rolling grain, oilseed, brewers grain by-products, or 
distillers grain by-products; 
 
  Labeling roughage products, plant protein meals, grain by-products and processed grain 
products, oilseed products, molasses, animal protein meals, milk products, animal tissue-
derived products, vitamins, minerals, concentrates, processing aids, finished animal food, 
including animal food ready for consumption, or any other processed animal food that 
does not require time/temperature control for safety; and 
 
  Packaging roughage products, plant protein meals, grain by-products and processed grain 
products, oilseed products, molasses, animal protein meals, milk products, animal tissue-
derived products, vitamins, minerals, concentrates, processing aids, finished animal food, 
including animal food ready for consumption, or any other processed animal food that 
does not require time/temperature control for safety. 
   
11  Contains Nonbinding Recommendations 
IV. INFORMATION FOR QUALIFIED FACILITIES 
 
A.  How Can I Tell if My Business is a Qualified Facility? 
 
To be a qualified facility (see definitions in 21 CFR 507.3 and table 2 in section II.D of this 
guidance), a business must either be: 
 
  A very small business (a business, including any subsidiaries and affiliates, averaging 
less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding 
the applicable calendar year in sales of animal food plus the market value of animal food 
manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a 
farm without sale)), or 
 
  A facility to which both of the following apply: 
 
  During the 3-year period preceding the applicable calendar year, the average 
o
annual monetary value of the food manufactured, processed, packed or held at 
such facility that is sold directly to qualified end-users (consumers, or local 
restaurants and retail food establishments not more than 275 miles from the 
facility) during such period exceeded the average annual monetary value of the 
food sold by such facility (including sales by any subsidiary or affiliate) to all 
other purchasers; and 
 
  The average annual monetary value of all food sold during the 3-year period 
o
preceding the applicable calendar year was less than $500,000, adjusted for 
inflation. 
 
In determining whether a facility satisfies the definition of qualified facility, the baseline year for 
calculating the adjustment for inflation is 2011 (21 CFR 507.7(a)(1)). 
 
B.  How Do I Tell FDA That My Business is a Qualified Facility? 
 
  The attestation can be submitted to FDA in one of two ways: 
 
  Electronically  Go to http://www.fda.gov/furls and follow the instructions. FDA 
o
encourages electronic submission. 
 
  Mail  You must use Form FDA 3942b. Send the completed paper Form FDA 
o
3942b to the U.S. Food and Drug Administration (HFS-681), 5001 Campus 
Drive, College Park, MD 20740.  We recommend that you submit a paper copy 
only if your facility does not have reasonable access to the Internet. To obtain a 
copy of this form: 
 
  Download it from 
http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/Q
ualifiedFacilityAttestation/default.htm, or 
12  Contains Nonbinding Recommendations 
 
  Write to the U.S. Food and Drug Administration (HFS-681), 5001 
Campus Drive, College Park, MD 20740 or 
 
  Request a copy by phone at 1-800-216-7331 or 301-575-0156 
 
C.  What Other Information Must I Provide FDA? 
 
  In the attestation you provide FDA, you must include the following: 
 
  You have identified potential hazards associated with the animal food being 
o
produced, are implementing preventive controls to address the hazards, and are 
monitoring the performance of the preventive controls to ensure that such controls 
are effective (21 CFR 507.7(a)(2)(i)); or 
 
  You are in compliance with State, local, county, tribal, or other applicable non-
o
Federal food safety law, including relevant laws and regulations of foreign 
countries.  This attestation may be based on licenses, inspection reports, 
certificates, permits, credentials, certification by an appropriate agency (such as a 
State department of agriculture), or other evidence of oversight (21 CFR 
507.7(a)(2)(ii)). 
 
D.  When Must I Tell FDA That My Business is a Qualified Facility? 
 
The attestation verifying that your business is a qualified facility must be submitted to FDA 
initially (21 CFR 507.7(c)(2)(i))  
 
  By December 16, 2019, for a facility that begins manufacturing, processing, packing, or 
holding animal food before September 17, 2019 
 
  Before beginning operations, for a facility that begins manufacturing, processing, 
packing, or holding animal food after September 17, 2019; or 
 
Beginning in 2020, your attestation must be submitted to FDA every 2 years during the period 
beginning on October 1 and ending on December 31 (21 CFR 507.7(c)(2)(ii)). 
 
The determination of whether a facility satisfies the definition of qualified facility must be made 
annually no later than July 1 of each calendar year (21 CFR 507.7(c)(1)).  When the status of a 
facility changes from qualified facility to not a qualified facility based on the annual 
determination: 
 
  The facility must notify FDA of that change in status using Form FDA 3942b by July 31 
of the applicable calendar year (21 CFR 507.7(c)(3)), and 
 
13  Contains Nonbinding Recommendations 
  The facility must comply with the requirements for hazard analysis and preventive 
controls no later than December 31 of the applicable year, unless otherwise agreed to by 
FDA and the facility (21 CFR 507.7(d)). 
 
You must maintain the records you relied upon to support the attestations.  These records are 
subject to the record keeping requirements of the rule in 21 CFR part 507 subpart F (21 CFR 
507.7(f)). 
 
E.  Withdrawal of a Qualified Facility Exemption 
 
FDA may withdraw a qualified facility exemption  
 
  In the event of an active investigation of a foodborne illness outbreak that is directly 
linked to the qualified facility (21 CFR 507.60(a)(1)); or 
 
  If FDA determines that it is necessary to protect the public (human or animal) health and 
prevent or mitigate a foodborne illness outbreak based on conditions or conduct 
associated with the qualified facility that are material to the safety of the animal food 
manufactured, processed, packed, or held at such facility (21 CFR 507.60(a)(2)). 
 
Before FDA issues an order to withdraw a qualified facility exemption, FDA  
 
  May consider one or more other actions to protect the public (human or animal) health or 
mitigate a foodborne illness outbreak, including a warning letter, recall, administrative 
detention, suspension of registration, refusal of animal food offered for import, seizure, 
and injunction (21 CFR 507.60(b)(1)); 
 
  Must notify the owner, operator, or agent in charge of the facility, in writing, of 
circumstances that may lead FDA to withdraw the exemption, and provide an opportunity 
for the owner, operator, or agent in charge of the facility to respond in writing, within 15 
calendar days of the date of receipt of the notification, to FDA's notification (21 CFR 
507.60(b)(2)); and 
 
  Must consider the actions taken by the facility to address the circumstances that may lead 
FDA to withdraw the exemption (21 CFR 507.60(b)(3)). 
 
V.  CURRENT GOOD MANUFACTURING PRACTICE (CGMP) 
 
A.  Personnel 
 
The management of the establishment must take reasonable measures and precautions to ensure 
that all persons working in direct contact with animal food, animal food-contact surfaces, and 
animal food-packaging materials conform to hygienic practices necessary to protect against the 
contamination of animal food (21 CFR 507.14), including: 
 
   
14  Contains Nonbinding Recommendations 
  Maintaining adequate personal cleanliness; 
 
  Washing hands thoroughly in an adequate hand-washing facility as necessary and 
appropriate to protect against contamination; 
 
  Removing or securing jewelry and other objects that might fall into animal food, 
equipment, or containers; 
 
  Storing clothing or other personal belongings in areas other than where animal food is 
exposed or where equipment or utensils are cleaned; and 
 
  Taking any other necessary precautions to protect against the contamination of animal 
food, animal food-contact surfaces, or animal food-packaging materials 
 
B.  Plant and Grounds 
 
Grounds  The grounds around an animal food plant under the control of the management of 
the establishment must be kept in a condition that will protect against the contamination of 
animal food.  Maintenance of grounds must include (21 CFR 507.17(a)): 
 
  Properly storing equipment, removing litter and waste, and cutting weeds or grass within 
the immediate vicinity of the plant that may constitute an attractant, breeding place, or 
harborage for pests; 
 
  Maintaining driveways, yards, and parking lots so that they do not constitute a source of 
contamination in areas where animal food is exposed; 
 
  Adequately draining areas that may contribute contamination to animal food by seepage, 
foot-borne filth, or providing a breeding place for pests; and 
 
  Treating and disposing of waste so that it does not become a source of contamination in 
areas where animal food is exposed. 
 
Plant construction and design  The plant must be suitable in size, construction, and design to 
facilitate cleaning, maintenance, and pest control to reduce the potential for contamination of 
animal food, animal food-contact surfaces, and animal food-packaging materials, i.e., the plant 
must (21 CFR 507.17(b)): 
 
  Provide adequate space between equipment, walls, and stored materials to permit 
employees to perform their duties and to allow cleaning and maintenance of equipment; 
 
  Be constructed in a manner such that drip or condensate from fixtures, ducts, and pipes 
does not serve as a source of contamination; 
 
15  Contains Nonbinding Recommendations 
  Provide adequate ventilation (mechanical or natural) where necessary and appropriate to 
minimize vapors (e.g., steam) and fumes in areas where they may contaminate animal 
food, and in a manner that minimizes the potential for contaminating animal food; 
 
  Provide adequate lighting in hand-washing areas, toilet rooms, areas where animal food is 
received, manufactured, processed, packed, or held, and areas where equipment or 
utensils are cleaned; and 
 
  Provide shatter-resistant light bulbs, fixtures, and skylights, or other glass items 
suspended over exposed animal food in any step of preparation, to protect against the 
contamination of animal food in case of glass breakage. 
 
Animal food stored outdoors in bulk  The plant must protect animal food stored outdoors in 
bulk from contamination by any effective means, including (21 CFR 507.17(c)): 
 
  Using protective coverings where necessary and appropriate; 
 
  Controlling areas over and around the bulk animal food to eliminate harborage for pests; 
and 
 
  Checking on a regular basis for pests, pest infestation, and product condition related to 
safety of the animal food. 
 
C.  Sanitation 
 
  Buildings, structures, fixtures, and other physical facilities of the plant must be kept clean 
and in good repair to prevent animal food from becoming adulterated (21 CFR 
507.19(a)). 
 
  Animal food contact and non-contact surfaces of utensils and equipment must be cleaned 
and maintained and utensils and equipment stored as necessary to protect against the 
contamination of animal food, animal food-contact surfaces, or animal food-packaging 
materials.  When necessary, equipment must be disassembled for thorough cleaning. In 
addition (21 CFR 507.19(b)): 
 
  When animal food-contact surfaces used for manufacturing, processing, packing, 
o
or holding animal food are wet-cleaned, the surfaces must, when necessary, be 
thoroughly dried before subsequent use; and 
 
  In wet processing of animal food, when cleaning and sanitizing are necessary to 
o
protect against the introduction of undesirable microorganisms, all animal food-
contact surfaces must be cleaned and sanitized before use and after any 
interruption during which the animal food-contact surfaces may have become 
contaminated. 
 
16  Contains Nonbinding Recommendations 
  Cleaning compounds and sanitizing agents must be safe and adequate under the 
conditions of use (21 CFR 507.19(c)). 
 
  Only the following toxic materials may be used or stored in a plant where animal food is 
processed or exposed (21 CFR 507.19(d)(1))  
 
  Those required to maintain clean and sanitary conditions; 
o
 
  Those necessary for use in laboratory testing procedures; 
o
 
  Those necessary for plant and equipment maintenance and operation; and 
o
 
  Those necessary for use in the plant's operations. 
o
 
  Those toxic materials that are allowed to be used or stored in the plant area where animal 
food is manufactured, processed, or exposed must be identified, used, and stored in a 
manner that protects against contamination of animal food, animal food-contact surfaces, 
or animal food-packaging materials (21 CFR 507.19(d)(2)); 
 
  Other toxic materials, such as fertilizers and pesticides, must be stored in an area of the 
plant where animal food is not manufactured, processed, or exposed (21 CFR 
507.19(d)(3)); 
 
  Effective measures must be taken to exclude pests from the manufacturing, processing, 
packing, and holding areas of a plant and to protect against the contamination of animal 
food by pests.  The use of pesticides in the plant is permitted only under precautions and 
restrictions that will protect against the contamination of animal food, animal food-
contact surfaces, and animal food-packaging materials (21 CFR 507.19(e)); and 
 
  Trash must be conveyed, stored, and disposed of in a way that protects against the 
contamination of animal food, animal food-contact surfaces, animal food-packaging 
materials, water supplies, and ground surfaces, and minimizes the potential for the trash 
to become an attractant and harborage or breeding place for pests (21 CFR 507.19(f)). 
 
D.  Water Supply and Plumbing 
 
  Water must be adequate for the operations and must be derived from an adequate source 
(21 CFR 507.20(a)(1)). 
 
  Running water at a suitable temperature, and under suitable pressure as needed, must be 
provided in all areas where required for (21 CFR 507.20(a)(2)): 
 
  Manufacturing, processing, packing, or holding of animal food; 
o
 
  Cleaning of equipment, utensils, and animal food-packaging materials; and 
o
 
17  Contains Nonbinding Recommendations 
  Employee hand-washing facilities. 
o
 
  Water that contacts animal food, animal food-contact surfaces, or animal food-packaging 
materials must be safe for its intended use (21 CFR 507.20(a)(3)); 
 
  Water may be reused for washing, rinsing, or conveying animal food if it does not 
increase the level of contamination of the animal food (21 CFR 507.20(a)(4)); 
 
  Plumbing must be designed, installed, and maintained to (21 CFR 507.20(b)): 
 
  Carry adequate quantities of water to required locations throughout the plant; 
o
 
  Properly convey sewage and liquid disposable waste from the plant; 
o
 
  Avoid being a source of contamination to animal food, water supplies, equipment, or 
o
utensils, or creating an unsanitary condition; 
 
  Provide adequate floor drainage in all areas where floors are subject to flooding-type 
o
cleaning or where normal operations release or discharge water or other liquid waste 
on the floor; and 
 
  Ensure that there is no backflow from, or cross-connection between, piping systems 
o
that discharge waste water or sewage and piping systems that carry water for animal 
food or animal food manufacturing. 
 
  Sewage and liquid disposal waste must be disposed of through an adequate sewerage 
system or through other adequate means (21 CFR 507.20(c)); 
 
  Each plant must provide employees with adequate, readily accessible toilet facilities.  
Toilet facilities must be kept clean and must not be a potential source of contamination of 
animal food, animal food-contact surfaces, or animal food-packaging materials (21 CFR 
507.20(d)); and 
 
  Each plant must provide hand-washing facilities designed to ensure that an employee's 
hands are not a potential source of contamination of animal food, animal food-contact 
surfaces, or animal food-packaging materials (21 CFR 507.20(e)). 
 
E.  Equipment and Utensils 
 
  All plant equipment and utensils used in manufacturing, processing, packing, or holding 
animal food, including equipment and utensils that do not come in contact with animal 
food, must be designed and constructed of such material and workmanship to be 
adequately cleanable, and must be properly maintained (21 CFR 507.22(a)(1)); 
 
18  Contains Nonbinding Recommendations 
  Equipment and utensils must be designed, constructed, and used appropriately to avoid 
the adulteration of animal food with non-food grade lubricants, fuel, metal fragments, 
contaminated water, or any other contaminants (21 CFR 507.22(a)(2)); 
 
  Equipment must be installed so as to facilitate the cleaning and maintenance of the 
equipment and adjacent spaces (21 CFR 507.22(a)(3)); 
 
  Animal food-contact surfaces must be: 
 
  Made of materials that withstand the environment of their use and the action of 
o
animal food, and, if applicable, the action of cleaning compounds, cleaning 
procedures, and sanitizing agents (21 CFR 507.22(a)(4)); 
 
  Made of nontoxic materials; 
o
 
  Maintained to protect animal food from being contaminated. 
o
 
  Holding, conveying, manufacturing, and processing systems, including gravimetric, 
pneumatic, closed, and automated systems, must be designed, constructed, and 
maintained in a way to protect against the contamination of animal food (21 CFR 
507.22(b)); 
 
  Each freezer and cold storage compartment used to hold animal food must be fitted with 
an accurate temperature-measuring device (21 CFR 507.22(c)); 
 
  Instruments and controls used for measuring, regulating, or recording temperatures, pH, 
a , or other conditions that control or prevent the growth of undesirable microorganisms 
w
in animal food must be accurate, precise, adequately maintained, and adequate in number 
for their designated uses (21 CFR 507.22(d)); and 
 
  Compressed air or other gases mechanically introduced into animal food or used to clean 
animal food-contact surfaces or equipment must be used in such a way to protect against 
the contamination of animal food (21 CFR 507.22(e)). 
 
F.  Plant OperationsManagement 
 
  Management of the establishment must ensure that (21 CFR 507.25(a)): 
 
  All operations in the manufacturing, processing, packing, and holding of animal food 
o
(including operations directed to receiving, inspecting, transporting, and segregating) 
are conducted in accordance with the current good manufacturing practice 
requirements of this rule; 
 
  Animal food, including raw materials, other ingredients, or rework is accurately 
o
identified; 
 
19  Contains Nonbinding Recommendations 
  Animal food-packaging materials are safe and suitable; 
o
 
  The overall cleanliness of the plant is under the supervision of one or more competent 
o
individuals assigned responsibility for this function; 
 
  Adequate precautions are taken so that plant operations do not contribute to 
o
contamination of animal food, animal food-contact surfaces, and animal food-
packaging materials; 
 
  Chemical, microbial, or extraneous-material testing procedures are used where 
o
necessary to identify sanitation failures or possible animal food contamination; 
 
  Animal food that has become adulterated is rejected, disposed of, or if appropriate, 
o
treated or processed to eliminate the adulteration.  If disposed of, it must be done in a 
manner that protects against the contamination of other animal food; and 
 
  All animal food manufacturing, processing, packing, and holding is conducted under 
o
such conditions and controls as are necessary to minimize the potential for the growth 
of undesirable microorganisms to protect against the contamination of animal food. 
 
G. Plant OperationsRaw Materials and Other Ingredients 
 
  All raw materials and other ingredients must be examined to ensure that they are suitable 
for manufacturing and processing into animal food and must be handled under conditions 
that will protect against contamination and minimize deterioration (21 CFR 
507.25(b)(1)).  In addition: 
 
  Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles holding raw 
o
materials and other ingredients must be examined upon receipt to determine whether 
contamination or deterioration of animal food has occurred; 
 
  Raw materials must be cleaned as necessary to minimize contamination; 
o
 
  Raw materials and other ingredients, including rework, must be stored in containers 
o
designed and constructed in a way that protects against contamination and 
deterioration, and held under conditions, e.g., appropriate temperature and relative 
humidity, that will minimize the potential for growth of undesirable microorganisms 
and prevent the animal food from becoming adulterated. 
 
  Raw materials and other ingredients (21 CFR 507.25(b)(2))  
 
  Susceptible to contamination with mycotoxins or other natural toxins must be 
o
evaluated and used in a manner that does not result in animal food that can cause 
injury or illness to animals or humans; and 
 
20  Contains Nonbinding Recommendations 
  If frozen, must be kept frozen.  If thawing is required prior to use, it must be done in a 
o
manner that minimizes the potential for the growth of undesirable microorganisms. 
 
H. Plant OperationsGeneral 
 
  For the purposes of manufacturing, processing, packing, and holding operations, the 
following apply (21 CFR 507.25(c)(1)-(8)): 
 
  Animal food must be maintained under conditions, e.g., appropriate temperature and 
o
relative humidity, that will minimize the potential for growth of undesirable 
microorganisms and prevent the animal food from becoming adulterated during 
manufacturing, processing, packing, and holding; 
 
  Measures taken during manufacturing, processing, packing, and holding of animal 
o
food to significantly minimize or prevent the growth of undesirable microorganisms 
(e.g., heat treating, freezing, refrigerating, irradiating, controlling pH, or controlling 
water activity (a )) must be adequate to prevent adulteration of animal food; 
w
 
  Work-in-process and rework must be handled so that it is protected against 
o
contamination and the growth of undesirable microorganisms; 
 
  Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and 
o
cooling, must be performed in a way that protects against the contamination of animal 
food; 
 
  Filling, assembling, packaging, and other operations must be performed in a way that 
o
protects against the contamination of animal food and the growth of undesirable 
microorganisms; 
 
  Animal food that relies principally on the control of water activity (a ) for preventing 
o w
the growth of undesirable microorganisms must be processed to and maintained at a 
safe a  level; 
w
 
  Animal food that relies principally on the control of pH for preventing the growth of 
o
undesirable microorganisms must be monitored and maintained at the appropriate pH; 
and 
 
  When ice is used in contact with animal food, it must be made from water that is safe 
o
and must be used only if it has been manufactured in accordance with current good 
manufacturing practice as outlined in this rule. 
 
I.  Holding and Distribution 
 
  Animal food held for distribution must be held under conditions that will protect against 
contamination and minimize deterioration, including the following (21 CFR 507.27(a)): 
 
21  Contains Nonbinding Recommendations 
  Containers used to hold animal food before distribution must be designed, constructed 
o
of appropriate material, cleaned as necessary, and maintained to protect against the 
contamination of animal food; and 
 
  Animal food held for distribution must be held in a way that protects against 
o
contamination from sources such as trash. 
 
  The labeling for the animal food ready for distribution must contain, when applicable, 
information and instructions for safely using the animal food for the intended animal 
species (21 CFR 507.27(b)); 
 
  Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute 
animal food must be examined prior to use to protect against the contamination of animal 
food from the container or vehicle when the facility is responsible for transporting the 
animal food itself or arranges with a third party to transport the animal food (21 CFR 
507.27(c)); 
 
  Animal food returned from distribution must be assessed for animal food safety to 
determine the appropriate disposition. Returned animal food must be identified as such 
and segregated until assessed (21 CFR 507.27(d)); and 
 
  Unpackaged or bulk animal food must be held in a manner that does not result in unsafe 
cross contamination with other animal food (21 CFR 507.27(e)). 
 
J.  Holding and Distribution of Human Food By-Products for Use as Animal Food 
 
Human food by-products held for distribution as animal food without additional manufacturing 
or processing by the human food processor must be held under conditions that will protect 
against contamination, including the following (21 CFR 507.28(a)): 
 
  Containers and equipment used to convey or hold human food by-products for use as 
animal food before distribution must be designed, constructed of appropriate material, 
cleaned as necessary, and maintained to protect against the contamination of human food 
by-products for use as animal food; 
 
  Human food by-products for use as animal food held for distribution must be held in a 
way to protect against contamination from sources such as trash; and 
 
  During holding, human food by-products for use as animal food must be accurately 
identified. 
 
In addition: 
 
  Labeling that identifies the product by the common or usual name must be affixed to or 
accompany human food by-products for use as animal food when distributed (21 CFR 
507.28(b)); and 
22  Contains Nonbinding Recommendations 
 
  Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute 
human food by-products for use as animal food must be examined prior to use to protect 
against contamination of the human food by-products for use as animal food from the 
container or vehicle when the facility is responsible for transporting the human food by-
products for use as animal food itself or arranges with a third party to transport the human 
food by-products for use as animal food (21 CFR 507.28(c)). 
 
VI. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS 
 
A.  Hazard Analysis 
 
The first step in developing your food safety plan is to conduct a hazard analysis.  You must 
conduct the hazard analysis to identify and evaluate known or reasonably foreseeable hazards 
(hazards that are known to be, or have the potential to be, associated with the facility or the 
animal food) for each type of animal food manufactured, processed, packed, or held at your 
facility.  The identification and evaluation are based on experience, illness data, scientific 
reports, and other information.  The next step is to determine whether any of the identified 
known or reasonably foreseeable hazards require a preventive control (21 CFR 507.33(a)(1)).  
These hazards may occur naturally, may happen unintentionally, or may be intentionally 
introduced for economic gain. (See 21 CFR 507.33(b)(2).)  The hazard analysis must be written, 
regardless of its outcome, as part of the written food safety plan (21 CFR 507.33(a)(2)). 
 
1.  What categories of hazards must you consider? 
 
There are three categories of hazards--biological, chemical (including radiological), and physical 
that you must consider in your hazard analysis (21 CR 507.33(b)(1)).  Table 5 lists these 
categories with examples of each for animal food. 
 
Table 5Categories of hazards 
 
Category  Description 
Biological hazards  Microbiological hazards such as parasites, environmental pathogens, and other 
pathogens (e.g., Salmonella spp. or Listeria monocytogenes) 
Chemical (including  Hazards such as pesticide and drug residues, natural toxins (such as mycotoxins), 
radiological) hazards  decomposition, unapproved food or color additives, and  nutrient deficiencies or 
toxicities (such as inadequate thiamine in cat food or excessive copper in food 
for sheep) 
Physical hazards  Hazards such as stones, glass, and metal fragments 
 
2.  What must your hazard evaluation include? 
 
Your hazard evaluation must include consideration of the severity of the illness or injury caused 
to humans or animals if the identified hazards were to occur and the probability that the hazards 
will occur without preventive controls (21 CFR 507.33(c)).  The evaluation must consider the 
23  Contains Nonbinding Recommendations 
effect of various factors on the safety of the finished food for the intended animal (21 CFR 
507.33(d)).  Table 6 lists these factors. 
 
Table 6What Factors the Hazard Evaluation Must Consider 
 
Factors to Consider  Description 
Formulation of the animal food  Nutrient deficiencies and toxicities (such as lack of 
thiamine in cat food or too much copper in sheep food) can 
result in illness or injury to animals. Certain ingredients 
such as acids and preservatives inhibit growth of, or even 
kill, microorganisms of public health significance. 
Condition, function, and design of the  Equipment with close-fitting parts may be difficult to clean 
facility and equipment  and could allow pathogens to become established. 
Equipment with metal-to-metal contact may generate metal 
fragments. 
Raw materials and other ingredients  Contaminated ingredients can introduce hazards such as 
pathogens or chemical toxins (e.g., mycotoxins). 
Transportation practices  Failure to adequately clean animal-food contact surfaces of 
transportation equipment could result in contamination of 
an animal food. 
Manufacturing/processing procedures  Improper cooling or holding of certain animal food, such as 
pet food, can result in contamination of the animal food 
with environmental pathogens. 
Packaging and labeling activities  Failure to include on the labeling instructions for safe use 
for the intended species could result in unsafe use in a 
different species. 
Storage and distribution  Some animal food requires refrigerated storage or moisture 
controls to maintain safety. 
Intended or reasonably foreseeable use  Food for cattle containing copper could be a safety concern 
if fed to sheep. 
Sanitation, including employee  Animal food, such as raw pet food, may be subject to 
hygiene  contamination in an unclean facility, from unclean 
equipment, or from poor employee hygiene. 
Other relevant factors  Factors which may create hazards, e.g., weathers effect on 
levels of some natural toxins such as mycotoxins. 
 
B.  Preventive Controls 
 
Your written food safety plan must identify the preventive controls you have implemented to 
ensure that any hazards requiring a preventive control will be significantly minimized or 
prevented (21 CFR 507.34(a)). These controls include those at critical control points (CCPs) if 
there are any, or controls other than at CCPs as appropriate for animal food safety. Preventive 
controls may include any or all of the following (21 CFR 507.34(c)): 
 
  Process controls 
 
  Sanitation controls 
24  Contains Nonbinding Recommendations 
 
  Supply-chain controls 
 
  Recall plan. 
 
The types of preventive controls you must use will depend on the facility and the animal food: 
 
  Process controls are procedures, practices, and processes to ensure the control of 
operations such as heat processing, acidifying, irradiating, and refrigerating foods.  When 
applying a process control, you must specify the parameter that is monitored (e.g., the 
temperature, the pH of the animal food) and the minimum or maximum value that 
ensures control (e.g., a minimum of 375F (for a heat treatment), a maximum of 41F (for 
refrigerated storage). (See 21 CFR 507.34(c)(1).) 
 
  Sanitation controls are procedures, practices, and processes to ensure that the facilitys 
sanitation practices are adequate to significantly minimize or prevent hazards such as 
environmental pathogens and biological hazards due to employee handling (21 CFR 
507.34(c)(2)).  Sanitation controls must address: 
 
  The cleanliness of animal food-contact surfaces, including animal food-contact 
o
surfaces of utensils and equipment; 
 
  Prevention of cross-contamination from insanitary objects and from personnel to 
o
animal food, animal food packaging material, and other animal food-contact surfaces, 
and from raw product to processed product; and 
 
  The sanitation controls do not include all sanitation procedures used in the facility, 
o
only those that are used to control a hazard requiring a preventive control. 
 
  Supply-chain controls are activities taken to verify that suppliers that are controlling 
hazards are doing so effectively.  This will be covered in section VI.E on Supply Chain 
Program for Receiving Facilities (21 CFR 507.34(c)(3)). 
 
  A recall plan is required for any animal food with a hazard requiring a preventive control 
(21 CFR 507.38). It must be written and must include steps to take and the person 
responsible for taking the steps to: 
 
  Notify your direct customers; 
o
 
  Notify the public, if necessary; 
o
 
  Check the effectiveness of the recall; and 
o
 
  Appropriately dispose of the recalled animal food. 
o
 
25  Contains Nonbinding Recommendations 
C.  Oversight and Management of Preventive Controls 
 
The PCAF rule provides flexibility in the steps needed to ensure that preventive controls are 
effective and to correct problems that may arise.  These procedures or management components 
are designed to provide assurance that preventive controls are effective and consistently 
performed (21 CFR 507.39).  Table 7 provides information on these management components 
and recordkeeping. 
 
Table 7 Preventive Control Management Components 
 
Management  Explanation 
Components 
Monitoring  You must have written procedures for monitoring each preventive control, 
including how often these procedures are to be performed (21 CFR 507.40) 
Corrective actions  Procedures taken to identify and correct a problem that occurs during animal food 
and corrections  production.  Corrective actions include steps taken when a problem occurs with 
implementation of a preventive control, steps taken to reduce the likelihood the 
problem will recur, steps taken to evaluate the affected animal food for safety, and 
steps taken to prevent it from entering commerce.  Corrective actions must be 
documented in records.  Corrections that dont include all these steps may be taken 
in certain situations, such as for minor problems that dont affect the safety of the 
animal food (21 CFR 507.42) 
Verification &  These are activities to ensure that preventive controls are consistently applied and 
Validation  effective in controlling the hazards.  It is critical to verify that controls are carried 
out and, where necessary, to validate with scientific evidence that a control 
measure effectively controls an identified hazard.  Verification activities include 
calibration (or accuracy checks) of process monitoring and verification instruments 
(such as thermometers) and reviewing records to verify that monitoring is being 
conducted and appropriate corrective actions are taken (if necessary) (21 CFR 
507.45 and 507.47) 
Product testing and  These are verification activities for implementation and effectiveness of preventive 
environmental  controls. Environmental monitoring generally would be required if contamination 
monitoring  of a finished animal food with an environmental pathogen is a hazard requiring a 
preventive control (21 CFR 507.49) 
26  Contains Nonbinding Recommendations 
Management  Explanation 
Components 
Records  Records may be originals, true copies  i.e., reproductions of originals  or 
electronic (21 CFR 507.202(a)(1)) and must be made promptly available to an 
authorized representative of the Secretary of Health and Human Services (such as 
an FDA investigator or State inspector conducting inspections for FDA) (21 CFR 
507.200(c)).  The following apply to records: 
 
  Records include your food safety plan itself, i.e., hazard analysis and 
preventive controls development; recall plan; and monitoring, corrective action 
and verification procedures 
  Records include implementation records, i.e., monitoring data, corrective 
actions taken, validation documentation, verification activity records, supply-
chain program execution, and personnel training 
  Your records must include information to identify your plant or facility, the 
date when the activity was documented, and product or lot code if applicable 
(21 CFR 507.202(b)) 
  Records must be kept for at least 2 years after the date prepared, or as long as 
necessary for those records used to support your status as a qualified facility 
(21 CFR 507.208(a)) 
  Existing records you use to comply with other Federal, State, or local 
regulations do not need to be duplicated if they satisfy the record keeping 
requirement. Existing records may be supplemented where needed to satisfy 
the requirements for part 507 (21 CFR 507.212(a)) 
 
D.  Circumstances When a Preventive Control is Not Required 
 
If you are a manufacturer/processor, you are not required to implement a preventive control for 
an identified hazard if any of the following circumstances apply (21 CFR 507.36): 
 
  You determine and document that the animal food in question could not be consumed 
without application of an appropriate control. 
 
  You rely on your customer who is subject to the requirements for hazard analysis and 
risk-based preventive controls to ensure that the identified hazard will be significantly 
minimized or prevented, and you: 
 
  Disclose in documents accompanying the animal food, in accordance with trade 
o
practice, that the animal food is not processed to control [identified hazard]; and, 
 
  Annually obtain from your customer written assurance that the customer has 
o
established and is following procedures (identified in the written assurance) that will 
significantly minimize or prevent the identified hazard, unless your customer has 
determined that the identified hazard is not a hazard in the animal food intended for 
use for a specific animal species and your customer's written assurance provides this 
determination, specifying the animal species and why the identified hazard is not a 
hazard. 
 
27  Contains Nonbinding Recommendations 
  You rely on your customer who is not subject to the requirements for hazard analysis and 
risk-based preventive controls (e.g., because the customer is a qualified facility subject to 
modified requirements or some other business not subject to the requirements) to provide 
assurance the customer is manufacturing, processing, or preparing the animal food in 
accordance with applicable animal food safety requirements and you: 
 
  Disclose in documents accompanying the animal food, in accordance with trade 
o
practice, that the animal food is not processed to control [identified hazard], and 
 
  Annually obtain from your customer written assurance that your customer is 
o
manufacturing, processing, or preparing the animal food in accordance with 
applicable animal food safety requirements. 
 
  You rely on your customer to provide assurance that the animal food will be processed to 
control the identified hazard by an entity in the distribution chain subsequent to the 
customer and you: 
 
  Disclose in documents accompanying the animal food, in accordance with trade 
o
practice, that the animal food is not processed to control [identified hazard]; and 
 
  Annually obtain from your customer written assurance that your customer: 
o
 
  Will disclose in documents accompanying the animal food, in accordance with 
trade practice, that the animal food is not processed to control [identified 
hazard]; and 
 
  Will only sell to another entity that agrees, in writing, that it will: 
 
  Follow identified procedures that will significantly minimize or prevent the 
identified hazard  if the entity is covered by hazard analysis and risk-based 
preventive controls requirements  or, if it is not so covered, it will 
manufacture, process, or prepare the animal food in accordance with 
applicable animal food safety requirements; or 
 
  Obtain a similar written assurance from the entity's customer. 
 
  You have established, documented, and implemented a system that ensures control, at a 
subsequent distribution step, of the identified hazards in the animal food product you 
distribute and you document the implementation of that system. 
 
E.  Supply-Chain Program for Manufacturing/Processing Facilities 
 
If a manufacturing/processing facility (i.e., receiving facility) has identified in its raw materials 
and ingredients a hazard that requires a preventive control and the receiving facility relies on a 
control applied in the supply chain before receipt, the facility must have a supply-chain program 
(21 CFR part 507 subpart E).  Manufacturing/processing facilities that control all identified 
28  Contains Nonbinding Recommendations 
hazards with their own preventive controls, or who follow requirements applicable when relying 
on a commercial customer to control hazards, do not need to have a supply-chain program for 
such animal food. 
 
Animal food facilities subject to the supply-chain program requirements of this rule are 
responsible for ensuring that raw materials and other ingredients for their products are received 
only from approved suppliers, or  if received on a temporary basis from unapproved suppliers 
 ensuring those materials are subject to verification activities before being accepted for use (21 
CFR 507.110(d)(1), 507.115(a)(1) and 507.120). 
 
1.  Requirements 
 
a.  The supply-chain program must be written (21 CFR 507.105(b)) and must include: 
 
  Using suppliers approved by the receiving facility (21 CFR 507.110(a)(1), 507.115(a)(1), 
and 507.120); 
 
  Determining appropriate supplier verification activities (including determining the 
frequency of conducting the activity) (21 CFR 507.110(a)(2) and 507.125); 
 
  Conducting supplier verification activities (21 CFR 507.110(a)(3), 507.130 and 507.135); 
 
  Documenting supplier verification activities (21 CFR 507.110(a)(4) and 507.175); and 
 
  When applicable, verifying a supply-chain-applied control applied by an entity other than 
the receiving facility's supplier and documenting that verification, or obtaining 
documentation of an appropriate verification activity from another entity, reviewing and 
assessing that documentation, and documenting the review and assessment (21 CFR 
507.110(a)(5) and 507.175). 
 
  Other entities in the supply chain, such as a broker or distributor, can conduct supplier 
verification activities, but the receiving facility must review and assess the entitys 
documentation verifying control of the hazard and document this review (21 CFR 
507.110(a)(5)). 
 
b.  Supplier verification activities (21 CFR 507.110(b)(1)-(4)) include: 
 
  Onsite audits; 
 
  Sampling and testing of raw materials or other ingredients; 
 
  Review of the supplier's relevant food safety records; and 
 
  Other appropriate supplier verification activities based on the risk associated with the raw 
material or other ingredient and supplier performance. 
   
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2.  Exceptions 
 
  A receiving facility that is an importer, is in compliance with the foreign supplier 
verification requirements, and has documentation of verification activities which provide 
assurance that the hazards requiring a supply-chain-applied control for a raw material or 
other ingredient have been significantly minimized or prevented, does not need to 
conduct supplier verification activities for that raw material or other ingredient (21 CFR 
507.105(a)(2)). 
 
  The requirements in subpart E do not apply to animal food that is supplied for research or 
evaluation use (21 CFR 507.105(a)(3)). 
 
F.  Compliance Dates for the Requirements of the SupplyChain Program 
 
Separate compliance dates have been established for the supply-chain program provisions so that 
an animal food facility will not be required to comply with the supply-chain program provisions 
before its supplier is required to comply with the PCAF rule or the produce safety rule (if 
applicable).  See table 4 in section II.E for the compliance dates. 
 
G. Education and Training 
 
Establishments subject to subpart C of this rule must ensure that the individual (preventive 
controls qualified individual) who prepares or oversees preparation of their animal food safety 
system has completed training in the development and application of risk-based preventive 
controls at least equivalent to that received under a standardized curriculum recognized as 
adequate by FDA, or is otherwise qualified through job experience to develop and apply an 
animal food safety system (21 CFR 507.31 and 507.53(c)(1)). 
 
In addition, each individual (including temporary and seasonal personnel) engaged in (or 
supervising) manufacturing, processing, packing, or holding animal food covered by this rule 
must: 
 
  Be a qualified individual, i.e., have the education, training, or experience (or a 
combination of these) necessary to manufacture, process, pack, or hold safe animal food 
as appropriate to the individual's assigned duties (21 CFR 507.4(b)(1)); and 
 
  Receive training in the principles of animal food hygiene and animal food safety, 
including the importance of employee health and personal hygiene, as appropriate to the 
animal food, the facility and the individual's assigned duties (21 CFR 507.4(b)(2)). 
 
Additional qualifications for supervisory personnel:  responsibility for ensuring compliance 
with the requirements of this rule must be clearly assigned to supervisory personnel who have 
the education, training, or experience (or a combination of these) necessary to supervise 
subordinates in the production of safe animal food (21 CFR 507.4(c)). 
 
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Records documenting required training in the principles of animal food hygiene and animal food 
safety must be established and maintained (21 CFR 507.4(d)). 
 
H. Reanalysis of Your Food Safety Plan 
 
You must reanalyze your food safety plan at least once every 3 years (21 CFR 507.50(a)). You 
must also conduct a reanalysis whenever: 
 
  A significant change in the activities at your facility creates a potential for a new hazard 
or a significant increase in a previously identified hazard (21 CFR 507.50(b)(1)); 
 
  You become aware of new information about potential hazards associated with the 
animal food (21 CFR 507.50(b)(2)); 
 
  It is appropriate after an unanticipated animal food safety problem (21 CFR 
507.50(b)(3)); and 
 
  You find that a preventive control(s) or the food safety plan as a whole is ineffective (21 
CFR 507.50(b)(4)). 
 
VII. DEFINITIONS 
 
Adequate:  That which is needed to achieve the intended purpose in keeping with good public 
(human and animal) health practice. 
 
Affiliate:  Any facility that controls, is controlled by, or is under common control with another 
facility. 
 
Animal food:  Food for animals other than man, and includes pet food, animal feed, and raw 
materials and ingredients. 
 
Audit:  The systematic, independent, and documented examination (through observation, 
investigation, records review, discussions with employees of the audited entity, and, as 
appropriate, sampling and laboratory analysis) to assess an audited entity's food safety processes 
and procedures. 
 
Calendar day:  Every day shown on the calendar. 
 
Correction:  An action to identify and correct a problem that occurred during the production of 
animal food, without other actions associated with a corrective action procedure (such as actions 
to reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, 
and prevent affected animal food from entering commerce). 
 
Critical control point:  A point, step, or procedure in a food process at which control can be 
applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an 
acceptable level. 
31  Contains Nonbinding Recommendations 
 
Environmental pathogen: A pathogen capable of surviving and persisting within the 
manufacturing, processing, packing, or holding environment such that food for animals may be 
contaminated and may result in foodborne illness if that animal food is not treated to 
significantly minimize or prevent the environmental pathogen.  Examples of environmental 
pathogens for the purposes of this rule include Listeria monocytogenes and Salmonella spp. but 
do not include the spores of pathogenic sporeforming bacteria. 
 
Facility:  A domestic facility or a foreign facility that is required to register under section 415 of 
the FD&C Act, in accordance with the requirements of 21 CFR part 1, subpart H. 
 
Farm:  As modified by The Human Food Preventive Controls rule and found in 21 CFR 1.227: 
 
(1) Primary production farm. A primary production farm is an operation under one 
management in one general (but not necessarily contiguous) physical location devoted to 
the growing of crops, the harvesting of crops, the raising of animals (including seafood), 
or any combination of these activities.  The term farm includes operations that, in 
addition to these activities: 
 
(i)  Pack or hold raw agricultural commodities; 
 
(ii) Pack or hold processed food, provided that all processed food used in such activities 
is either consumed on that farm or another farm under the same management, or is 
processed food identified in paragraph (1)(iii)(B)(1) of this definition; and 
 
(iii)Manufacture/process food, provided that: 
 
(A) All food used in such activities is consumed on that farm or another farm under 
the same management; or 
 
(B) Any manufacturing/processing of food that is not consumed on that farm or 
another farm under the same management consists only of: 
 
(1) Drying/dehydrating raw agricultural commodities to create a distinct 
commodity (such as drying/dehydrating grapes to produce raisins), and 
packaging and labeling such commodities, without additional 
manufacturing/processing (an example of additional 
manufacturing/processing is slicing); 
 
(2) Treatment to manipulate the ripening of raw agricultural commodities (such as 
by treating produce with ethylene gas), and packaging and labeling treated 
raw agricultural commodities, without additional manufacturing/processing; 
and 
 
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(3) Packaging and labeling raw agricultural commodities, when these activities do 
not involve additional manufacturing/processing (an example of additional 
manufacturing/processing is irradiation); or 
 
(2) Secondary activities farm.  A secondary activities farm is an operation, not located on a 
primary production farm, devoted to harvesting (such as hulling or shelling), packing, 
and/or holding of raw agricultural commodities, provided that the primary production 
farm(s) that grows, harvests, and/or raises the majority of the raw agricultural 
commodities harvested, packed, and/or held by the secondary activities farm owns, or 
jointly owns, a majority interest in the secondary activities farm.  A secondary activities 
farm may also conduct those additional activities allowed on a primary production farm 
as described in paragraphs (1)(ii) and (iii) of this definition. 
 
FDA:  The Food and Drug Administration. 
 
Food:  As defined in section 201(f) of the FD&C Act (articles used for food or drink for man or 
other animals, chewing gum, and articles used for components of any such article), and includes 
raw materials and ingredients. 
 
Food-contact surfaces:  Surfaces that contact animal food, and surfaces from which drainage  
or other means of transfer  onto the animal food, or onto surfaces that contact the animal food  
ordinarily occurs during the normal course of operations.  Food-contact surfaces include utensils 
and animal food-contact surfaces of equipment. 
 
Full-time equivalent employee:  Represents the number of employees of a business entity for the 
purpose of determining whether the business qualifies for the small business exemption.  The 
number of full-time equivalent employees is determined by dividing the total number of hours of 
salary or wages paid directly to employees of the business entity and of all of its affiliates and 
subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours  52 weeks).  
If the result is not a whole number, round down to the next lowest whole number. 
 
Harvesting:  Activities on farms and farm mixed-type facilities that are traditionally performed 
on farms for the purpose of removing raw agricultural commodities from the place they were 
grown or raised and preparing them for use as animal food.  Harvesting is limited to activities 
performed on raw agricultural commodities, or on processed foods created by drying/dehydrating 
a raw agricultural commodity without additional manufacturing/processing, on a farm.  
Harvesting does not include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the FD&C Act.  Examples of harvesting include 
cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the 
crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots or stems).  Examples of harvesting also include cooling, field coring, filtering, gathering, 
hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural 
commodities grown on a farm. 
 
Hazard:  Any biological, chemical (including radiological), or physical agent that has the 
potential to cause illness or injury in humans or animals. 
33  Contains Nonbinding Recommendations 
 
Hazard requiring a preventive control :  A known or reasonably foreseeable hazard for which a 
person knowledgeable about the safe manufacturing, processing, packing, or holding of animal 
food would, based on the outcome of a hazard analysis (which includes an assessment of the 
severity of the illness or injury to humans or animals if the hazard were to occur and the 
probability that the hazard will occur in the absence of preventive controls), establish one or 
more preventive controls to significantly minimize or prevent the hazard in an animal food, and 
components and to manage those controls (such as monitoring, corrections or corrective actions, 
verification, and records) as appropriate to the animal food, the facility, and the nature of the 
preventive control and its role in the facility's food safety system. 
 
Holding:  Storage of animal food and includes activities performed incidental to storage of an 
animal food, e.g., activities performed for the safe or effective storage of that animal food, such 
as fumigating animal food during storage, and drying/dehydrating raw agricultural commodities 
when the drying/dehydrating does not create a distinct commodity  such as drying/dehydrating 
hay or alfalfa.  Holding also includes activities performed as a practical necessity for the 
distribution of that animal food  such as blending of the same raw agricultural commodity and 
breaking down pallets, but does not include activities that transform a raw agricultural 
commodity into a processed food as defined in section 201(gg) of the FD&C Act. Holding 
facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and 
liquid-storage tanks. 
 
Known or reasonably foreseeable hazard:  A biological, chemical (including radiological), or 
physical hazard that is known to be, or has the potential to be, associated with the facility or the 
animal food. 
 
Lot:  The animal food produced during a period of time and identified by an establishment's 
specific code. 
 
Manufacturing/processing:  Making animal food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating animal food, including food crops or ingredients. 
Examples of manufacturing/processing activities include:  Baking, boiling, bottling, canning, 
cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, extruding, formulating, freezing, grinding, homogenizing, 
irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), 
pasteurizing, peeling, pelleting, rendering, treating to manipulate ripening, trimming, washing, or 
waxing.  For farms and farm mixed-type facilities, manufacturing/processing does not include 
activities that are part of harvesting, packing, or holding. 
 
Microorganisms:  Yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites, 
including species that are pathogens.  The term undesirable microorganisms includes those 
microorganisms that are pathogens, that subject animal food to decomposition, that indicate that 
animal food is contaminated with filth, or that otherwise may cause animal food to be 
adulterated. 
 
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Mixed-type facility:  An establishment that engages in both activities that are exempt from 
registration under section 415 of the FD&C Act, and activities that require the establishment to 
be registered.  An example is a farm mixed-type facility, which is an establishment that is a 
farm, but also conducts activities outside the farm definition that require it to be registered. 
 
Monitor:  To conduct a planned sequence of observations or measurements to assess whether 
control measures are operating as intended. 
 
Packing:  Placing animal food into a container other than packaging the animal food and also 
includes re-packing and activities performed incidental to packing or re-packing an animal food, 
e.g., activities performed for the safe or effective packing or re-packing of that animal food (such 
as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing), but 
does not include activities that transform a raw agricultural commodity into a processed food as 
defined in section 201(gg) of the FD&C Act. 
 
Pathogen:  A microorganism of public (human or animal) health significance. 
 
Pest:  Any objectionable animals or insects including birds, rodents, flies, and larvae. 
 
Plant:  The building or structure or parts thereof, used for or in connection with the 
manufacturing, processing, packing, or holding of animal food. 
 
Preventive controls:  Those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, processing, packing, or 
holding of animal food would employ to significantly minimize or prevent the hazards identified 
under the hazard analysis that are consistent with the current scientific understanding of safe 
food manufacturing, processing, packing, or holding at the time of the analysis. 
 
Preventive controls qualified individual:  A qualified individual who has successfully completed 
training in the development and application of risk-based preventive controls at least equivalent 
to that received under a standardized curriculum recognized as adequate by FDA or is otherwise 
qualified through job experience to develop and apply a food safety system. 
 
Qualified auditor:  A person who is a qualified individual as defined in this part and has 
technical expertise obtained through education, training, or experience (or a combination thereof) 
necessary to perform the auditing function.  Examples of potential qualified auditors include: 
 
(1) A government employee including a foreign government employee; and 
(2) An audit agent of a certification body that is accredited in accordance with regulations in 
21 CFR part 1, subpart M Accreditation of Third-Party Certification Bodies to Conduct 
Food Safety Audits and to Issue Certifications. 
 
Qualified end-user:  With respect to a food, it means the consumer of the food (where the term 
consumer does not include a business); or a restaurant or retail food establishment (as those 
terms are defined in 21 CFR 1.227) that: 
 
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(1) Is located; 
 
(i)  In the same State or the same Indian reservation as the qualified facility that sold 
the food to such restaurant or establishment; or 
 
(ii)  Not more than 275 miles from such facility; and 
 
(2) Is purchasing the food for sale directly to consumers at such restaurant or retail food 
establishment. 
 
Qualified facility:  a facility that is a very small business: (when including the sales by all its 
subsidiaries or affiliates, if it has any; or of the entity of which the facility itself is a subsidiary or 
affiliate, if it is either); OR a facility to which both of the following conditions apply: 
 
(1) During the 3-year period preceding the applicable calendar year, the average annual 
monetary value of the food manufactured, processed, packed or held at the facility that is 
sold directly to qualified end-users (as defined above) exceeded the average annual 
monetary value of the food sold by the facility to all other purchasers; and 
 
(2) The average annual monetary value of all food sold during the 3-year period preceding 
the applicable calendar year was less than $500,000, adjusted for inflation. 
 
Qualified facility exemption:  An exemption applicable to a qualified facility. 
 
Qualified individual:  A person who has the education, training, or experience (or a combination 
of these) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the 
individual's assigned duties.  A qualified individual may be, but is not required to be, an 
employee of the establishment. 
 
Raw agricultural commodity:  Any food in its raw or natural state, including all fruits that are 
washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. 
 
Receiving facility:  A facility that is subject to Hazard Analysis and Risk-Based Preventive 
Controls and the Supply-Chain Program, and that manufactures/processes a raw material or other 
ingredient that it receives from a supplier. 
 
Rework:  Clean, unadulterated animal food that has been removed from processing for reasons 
other than insanitary conditions or that has been successfully reconditioned by reprocessing and 
that is suitable for use as animal food. 
 
Sanitize:  To adequately treat cleaned surfaces by a process that is effective in destroying 
vegetative cells of pathogens, and in substantially reducing numbers of other undesirable 
microorganisms, but without adversely affecting the product or its safety for animals and 
humans. 
 
Significantly minimize:  To reduce to an acceptable level, including to eliminate. 
36  Contains Nonbinding Recommendations 
 
Small business:  For purposes of this rule, a business (including any subsidiaries and affiliates) 
employing fewer than 500 full-time equivalent employees. 
 
Subsidiary:  A company which is owned or controlled directly or indirectly by another company. 
 
Supplier:  The establishment that manufactures/processes the animal food, raises the animal, or 
grows the food that is provided to a receiving facility without further manufacturing/processing 
by another establishment, except for further manufacturing/processing that consists solely of the 
addition of labeling or similar activity of a de minimis nature. 
 
Supply-chain-applied control:  A preventive control for a hazard in a raw material or other 
ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. 
 
Unexposed packaged animal food:  A packaged animal food that is not exposed to the 
environment. 
 
Validation:  Obtaining and evaluating scientific and technical evidence that a control measure, 
combination of control measures, or the food safety plan as a whole, when properly 
implemented, is capable of effectively controlling the identified hazards. 
 
Verification:  The application of methods, procedures, tests and other evaluations, in addition to 
monitoring, to determine whether a control measure or combination of control measures is or has 
been operating as intended and to establish the validity of the food safety plan. 
 
Very small business:  For purposes of this rule, a business (including any subsidiaries and 
affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year 
period preceding the applicable calendar year in sales of animal food plus the market value of 
animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or 
supplied to a farm without sale). 
 
Water activity (a ):  A measure of the free moisture in an animal food and is the quotient of the 
w
water vapor pressure of the substance divided by the vapor pressure of pure water at the same 
temperature. 
 
Written procedures for receiving raw materials and other ingredients:  Written procedures to 
ensure that raw materials and other ingredients are received only from suppliers approved by the 
receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved 
suppliers whose raw materials or other ingredients are subjected to adequate verification 
activities before acceptance for use). 
 
You:  For purposes of the rule, is the owner, operator, or agent in charge of a facility. 
37