What You Need to Know About the FDA 
Regulation: Current Good 
Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive 
Controls for Human Food (21 CFR Part 
117): Guidance for Industry 
 
Small Entity Compliance Guide 
 
Additional copies are available from: 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-1700 
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm or 
http://www.regulations.gov 
 
You may submit either electronic or written comments regarding 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-0920 listed in the notice of availability that publishes in the Federal Register.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
October 2016 
 
1 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I. INTRODUCTION ....................................................................................................................... 4 
II. WHO MUST COMPLY WITH THE RULE? ........................................................................... 6 
III. KEY TERMS USED IN PART 117 ......................................................................................... 6 
IV. WHO IS EXEMPT FROM THE REQUIREMENTS FOR HAZARD ANALYSIS AND 
RISK-BASED PREVENTIVE CONTROLS OR SUBJECT TO MODIFIED 
REQUIREMENTS? ........................................................................................................................ 7 
V. WHAT FOODS ARE COVERED BY THIS REGULATION? ................................................ 8 
VI. WHEN DO I HAVE TO COMPLY WITH THE RULE? ........................................................ 9 
VII. HAZARD ANALYSIS.......................................................................................................... 10 
A. What must Hazard Identification consider? .......................................................................... 10 
B. What must your Hazard Evaluation include? ........................................................................ 10 
VIII. PREVENTIVE CONTROLS ............................................................................................... 11 
A. Oversight And Management Of Preventive Controls ........................................................... 12 
B. When is a Preventive Control Not Required? ....................................................................... 14 
IX. RISK-BASED SUPPLY-CHAIN PROGRAM FOR MANUFACTURING/PROCESSING 
FACILITIES ................................................................................................................................. 15 
A. Requirements ........................................................................................................................ 15 
B. Compliance Dates For The Requirements Of The SupplyChain Program ......................... 16 
X. EDUCATION AND TRAINING ............................................................................................ 17 
XI. INFORMATION FOR QUALIFIED FACILITIES ............................................................... 18 
A. How Can I Tell If My Business is a Qualified Facility? ....................................................... 18 
B. How Do I Tell FDA That My Business Is A Qualified Facility? ......................................... 18 
C. What Other Information Must A Qualified Facility Provide FDA? ..................................... 19 
D. When Must I Tell FDA That My Business Is A Qualified Facility? .................................... 19 
E. Withdrawal of a Qualified Facility Exemption ..................................................................... 20 
XII. WHAT ON-FARM LOW-RISK ACTIVITIES BY SMALL OR VERY SMALL 
BUSINESSES ARE EXEMPT FROM HAZARD ANALYSIS AND PREVENTIVE 
CONTROLS? ................................................................................................................................ 20 
A. On-Farm Packing Or Holding Of Food ................................................................................ 22 
1. What Packing or Holding Activities On a Farm MixedType Facility are Within the 
Definition Of Farm and not Subject to the Requirements for Hazard Analysis and 
Preventive Controls? ............................................................................................................... 22 
2. What Low-Risk Packing or Holding Activity/Food Combinations are Exempt from Hazard 
Analysis and Preventive Controls if Performed On a Farm By a Small or Very Small 
2  Contains Nonbinding Recommendations 
Business and Are the Only Activities That Would Be Subject To the Requirements or Hazard 
Analysis and Preventive Controls? ......................................................................................... 23 
B. On-Farm Manufacturing/Processing Of Food....................................................................... 24 
1. What Food Manufacturing/Processing Activities on a Farm MixedType Facility Are 
Within the Definition Of Farm And are not subject to the requirements for Hazard Analysis 
and Preventive Controls? ........................................................................................................ 24 
2. What Low-Risk Food Manufacturing/Processing Activities Are Exempt From Hazard 
Analysis And Preventive Controls If Performed On A Farm By A Small Or Very Small 
Business And Are The Only Activities That Would Be Subject To The Requirements For 
Hazard Analysis And Preventive Controls? ........................................................................... 24 
XIII. UPDATED AND CLARIFIED CURRENT GOOD MANUFACTURING PRACTICE 
(CGMP)......................................................................................................................................... 27 
A. Personnel (21 CFR 117.10) ................................................................................................... 27 
B. Plant and Grounds (21 CFR 117.20) ..................................................................................... 29 
C. Sanitary Operations (21 CFR 117.35) ................................................................................... 30 
D. Sanitary Facilities and Controls (21 CFR 117.37) ................................................................ 32 
E. Equipment and Utensils (21 CFR 117.40) ............................................................................ 33 
F. Processes and Controls (21 CFR 117.80) .............................................................................. 34 
G. Warehousing and Distribution (21 CFR 117.93) .................................................................. 38 
H. Defect Action Levels (21 CFR 117.110) .............................................................................. 38 
XIV. HOLDING AND DISTRIBUTION OF HUMAN FOOD BY-PRODUCTS FOR USE AS 
ANIMAL FOOD ........................................................................................................................... 38 
XV. DEFINITIONS ...................................................................................................................... 39 
 
3  Contains Nonbinding Recommendations 
 
What You Need to Know About the FDA 
Regulation: Current Good 
Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive 
Controls for Human Food (21 CFR Part 
1
117): Guidance for Industry  
 
Small Entity Compliance Guide 
 
This guidance represents the Food and Drug Administrations (FDA or Agency) current thinking 
on this topic.  It does not establish any rights for any person and does not bind 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 using the contact information on the title page. 
I. INTRODUCTION 
The FDA 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 regulation.  On September 17, 2015, FDA 
published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food (PCHF rule) (80 FR 55907).   
This final rule became effective on November 16, 2015. It creates new requirements for the 
production of human food by registered food facilities, and revises previous requirements.  
Compliance dates are staggered  see When Do I Have to Comply with the Rule? 
                                                 
1 This guidance has been prepared by the Office of Food Safety and the Office of Analytics and Outreach in the 
Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
4  Contains Nonbinding Recommendations 
The PCHF rule also revised the definition of farm and expanded it to cover more operations. 
Operations defined as farms are not subject to the PCHF rule. See Definitions, page 40. 
We have 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 food facilities about the PCHF regulation and enable 
them to better understand the requirements of the rule.  The rule is binding and has the full force 
and effect of law.   
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendation, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.   
Purpose of this Compliance Guide  
This guide was developed to inform domestic and foreign food facilities about the PCHF 
regulation and how to comply with it. It contains important information that may affect your 
firm. 
Key Requirements 
1.  Covered facilities must establish and implement a food safety system that includes 
an analysis of hazards and implementation of risk-based preventive controls.   (21 
CFR, Part 117, subpart C) 
The rule requires a written food safety plan for all covered facilities unless an exemption 
applies.  The  written  plan  must  be  prepared  by  (or  its  preparation  overseen  by)  a 
preventive controls qualified individual (see Definitions, page 45) and must include (21 
CFR 117.126): 
  A hazard analysis  
  Preventive controls  
  A risk-based supply chain program, if appropriate  
  A recall plan, if there are any hazards associated with the food 
  Procedures for monitoring the implementation of the preventive controls 
  Procedures for verifying that the preventive controls are consistently implemented 
and are effectively minimizing or preventing the identified hazards  
2.  Manufacturing/processing facilities must have a risk-based supply chain program 
for those raw materials and other ingredients for which a hazard has been 
controlled before receipt (a supply-chain-applied control) (21 CFR Part 117, 
subpart G).   
5  Contains Nonbinding Recommendations 
The risk-based supply-chain program is flexible, with separate compliance dates. 
3.  Covered facilities must meet updated Current Good Manufacturing Practice 
(CGMP) requirements (21 CFR, Part 117, subpart B). 
 II. WHO MUST COMPLY WITH THE RULE?   
The requirements of this rule apply to businesses  either in the U.S. or any other country  that 
are required to register with FDA as food facilities because they manufacture/process, pack, or 
hold food for consumption in the U.S. 
III. KEY TERMS USED IN PART 117 
The PCHF rule uses a substantial number of terms in very specific ways. A full list of these 
terms appears in this guide on page 39. The terms defined here and below in Section IV. Who is 
Exempt from the Requirements for Hazard Analysis and Risk-Based Preventive Controls 
or Subject to Modified Requirements? will help you determine if your business is subject to 
the rule. 
 
Table 1--Key Terms Used in Part 117 
Term  Definition 
Facility  Any establishment, structure, or structures under one ownership at 
one general physical location, or a mobile facility traveling to 
multiple locations, that manufactures/processes, packs, or holds 
food for consumption in the U.S. 
Manufacturing/Processing  Making food from one or more ingredients, or creating, preparing, 
treating, modifying or manipulating food, including food crops or 
ingredients 
Packing  Placing food into a container other than a container that directly 
contacts the food and that the consumer receives, including 
incidental activities to ensure the safe or effective packing of that 
food such as sorting, culling, grading, and weighing or conveying.  
Holding  Storage of food, including activities ensuring the safe or effective 
storage of a food such as fumigating food during storage, and 
drying/dehydrating raw agricultural commodities (when the 
drying/dehydrating does not create a distinct commodity, e.g., 
drying/dehydrating hay or alfalfa).  Holding also includes activities 
necessary for the distribution of food such as blending of a raw 
agricultural commodity or breaking down pallets. 
6  Contains Nonbinding Recommendations 
IV. WHO IS EXEMPT FROM THE REQUIREMENTS FOR HAZARD 
ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS OR SUBJECT 
TO MODIFIED REQUIREMENTS? 
Table 2--Exemptions and Modified Requirements for Part 117 
Exemption or Modified Requirement  Conditions 
To be eligible for modified requirements, a qualified 
Qualified Facilities  businesses (when 
facility is required to notify FDA about its status; and 
including the sales by any subsidiaries, 
affiliates, and any entity of which the facility is  attest that it is either: 
a subsidiary or affiliate) with average annual   
sales of less than $500,000 with at least half  1.  Addressing identified hazards through preventive 
the sales to consumers or to local retailers or 
controls and monitoring the preventive controls; or 
restaurants or Indian reservation (within the 
2.  Complying with applicable non-Federal food 
same state or within 275 miles) or very small 
safety regulations, and notifying consumers of the 
businesses as defined below. 
name and complete business address of the facility 
 
where the food was manufactured or processed. 
Very small businesses (including any 
 
subsidiaries or affiliates) averaging less than 
A qualified facility must submit these notifications to 
$1,000,000 (adjusted for inflation) -- in both 
FDA during the same two year timeframe that the facility 
sales of human food plus the market value of 
is required to update its facility registration. 
human food that is manufactured, processed, 
 
packed, or held without sale (e.g. held for a 
An otherwise Qualified Facility that does NOT notify 
fee), per year during the 3-year period 
FDA is subject to the requirements for Hazard Analysis 
preceding the current calendar year. 
and Preventive Controls. 
 
(21 CFR 117.5(a)) 
Low-risk, on-farm activities performed by  For specific information on which activities are covered, 
small businesses (less than 500 full-time  see page 20. 
equivalent employees) or very small businesses 
as defined above. 
(21 CFR 117.5(g) and (h)) 
Activities covered by the seafood HACCP  The facility must be in compliance with part 123 
requirements of 21 CFR part 123. 
(21 CFR 117.5(b)) 
Activities that are subject to the juice HACCP  The facility must be in compliance with part 120 
requirements of 21 CFR part 120. 
(21 CFR 117.5(c)) 
Activities that are subject to the low-acid  The exemption applies only with respect to 
canned food requirements of 21 CFR part  microbiological hazards regulated under part 113, and the 
113.  facility must be in compliance with part 113. 
(21 CFR 117.5(d)) 
7  Contains Nonbinding Recommendations 
Exemption or Modified Requirement  Conditions 
Manufacturing, processing, packing, or holding  The facility must be in compliance with part 111, and 
of a dietary supplement covered by the Current  with requirements for serious adverse event reporting for 
Good Manufacturing Practices (CGMP)  dietary supplements 
requirements of 21 CFR part 111. (Note: this 
exemption does not apply to dietary 
ingredients) 
(21 CFR 117.5(e)) 
Activities of a facility that are subject to  See FDAs Produce Safety Rule at (21 CFR part 112) for 
Standards for Produce Safety, section 419 of  a description of these activities 
the Federal Food, Drug, & Cosmetic Act.  (https://www.federalregister.gov/articles/2015/11/27/2015
(21 CFR 117.5(f))  -28159/standards-for-the-growing-harvesting-packing-
and-holding-of-produce-for-human-consumption) 
Alcoholic beverages regulated by the Alcohol  Non-alcoholic beverage foods in prepackaged form and 
and Tobacco Tax and Trade Bureau (TTB) of  that constitute not more than 5 percent of the overall sales 
the U.S. Treasury Department.  of the facility are also exempt. 
(21 CFR 117.5(i)) 
Facilities that only store raw agricultural  Storage of raw agricultural commodities that are fruits and 
commodities -- other than fruits and  vegetables is not exempt. 
vegetables -- intended for further distribution 
or processing. 
(21 CFR 117.5(j)) 
Facilities that only store packaged food that is  Modified requirements apply for the storage of packaged 
not exposed to the environment  food that must be refrigerated for safety. 
(21 CFR 117.7) 
Note: A facility that manufactures/processes, packs, or holds only a food contact substance or pesticide is NOT 
required to register with FDA and is NOT required to comply with the Preventive Controls for Human Foods 
Regulation. 
V. WHAT FOODS ARE COVERED BY THIS REGULATION? 
Table 3--Foods covered by Part 117 
CGMP Requirements (subparts A, B and F)  Hazard Analysis and Risk-based 
Preventive Controls Requirements 
(subparts A, C, D, E, F, and G) 
Ingredients for dietary supplements and dietary  Ingredients for dietary supplements 
supplements 
Infant formula  Infant formula 
Beverages (including alcoholic beverages and  Beverages except for alcoholic beverages and 
bottled water)  juices covered under 21 CFR 120 
8  Contains Nonbinding Recommendations 
CGMP Requirements (subparts A, B and F)  Hazard Analysis and Risk-based 
Preventive Controls Requirements 
(subparts A, C, D, E, F, and G) 
Fruits and vegetables2  Fruits and vegetables3 
Fish and other seafood  Exempt; covered under 21 CFR 123 
Dairy products  Dairy products 
Baked goods  Baked goods 
Snack foods  Snack Foods 
Candy  Candy 
Acid, acidified, and low-acid canned foods  Acid, acidified, and low-acid canned foods 
except low-acid canned foods covered under 
21 CFR 113 that only have microbiological 
hazards 
Game meat  Game meat 
Note: A facility that manufactures/processes, packs, or holds only a food contact substance or pesticide is NOT 
required to register with FDA and is NOT required to comply with the Preventive Controls for Human Foods 
Regulation. 
VI. WHEN DO I HAVE TO COMPLY WITH THE RULE? 
Table 4--Compliance Dates for Part 117 
Size and Type of Business  Compliance Date 
Qualified facilities (including very small  September 17, 2018, except that the 
businesses) as defined  above  compliance date for a facility to retain 
records to support its status as a qualified 
facility is January 1, 2016 
Small businesses, i.e., a business with  September 18, 2017 
fewer than 500 full-time equivalent 
employees 
                                                 
2 The CGMPs do not apply to farms; activities of farm mixed-type facilities that fall within the farm definition; 
establishments solely engaged in the holding and/or transportation of raw agricultural commodities; and 
establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional 
manufacturing/processing, such as roasting nuts).  They do apply when a farm or farm mixed-type facility 
dries/dehydrates raw agricultural commodities that are covered produce to create a distinct commodity (compliance 
can also be achieved by following applicable requirements for packing and holding in the produce safety standards). 
3 Hazard Analysis and Preventive Control requirements do not apply to farms conducting activities on produce 
covered by the Produce Safety Rule.  Farms conducting activities on produce covered by the Produce Safety Rule 
will be required to comply with that rule. (https://www.federalregister.gov/articles/2015/11/27/2015-
28159/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption). 
9  Contains Nonbinding Recommendations 
Businesses producing  grade A milk  September 17, 2018 
and milk products under the  Pasteurized 
Milk Ordinance (for those products only) 
All other businesses  September 19, 2016 
Note:  Separate compliance dates have been established for the supply-chain program provisions.  Refer to the 
Compliance Dates For The Requirements Of The SupplyChain Program section on page 16.  
VII. HAZARD ANALYSIS  
You must identify and evaluate, based on experience, illness data, scientific reports, and other 
information, known or reasonably foreseeable hazards (hazards that are known to be, or have the 
potential to be, associated with the facility or the food) for each type of food manufactured, 
processed, packed, or held at your facility to determine whether there are any hazards requiring a 
preventive control. These hazards may occur naturally, may happen unintentionally, or may be 
intentionally introduced for economic gain, and must be identified if they affect the safety of the 
food.  This analysis must be written and included in your food safety plan (21 CFR 117.130). 
A. What must Hazard Identification consider? 
Table 5--Hazards that must be considered (21 CFR 117.130(b)) 
Type of Hazard  Description 
Biological hazards  Microbiological hazards such as parasites, environmental 
pathogens, and other pathogens 
Chemical hazards  Radiological hazards, substances such as pesticide and drug 
residues, natural toxins (such as mycotoxins), 
decomposition, unapproved food or color additives, and 
food allergens 
Physical hazards  Stones, glass, and metal fragments 
B. What must your Hazard Evaluation include?  
The hazard evaluation must include consideration of the severity of the illness or injury caused, 
if the identified hazards were to occur and the probability that the hazards will occur without 
preventive controls. The evaluation must consider the effect on the safety of the finished food for 
the intended consumer (21 CFR 117.130(c)). 
Table 6--Factors the Hazard Evaluation Must Consider 
Factors to Consider  Description 
Formulation of the food  Certain ingredients such as acids and 
preservatives inhibit growth of, or even kill, 
microorganisms of public health significance. 
Some ingredients may contain allergens.  
10  Contains Nonbinding Recommendations 
Condition, function, and design of the facility  Equipment with close-fitting parts may be 
and equipment  difficult to clean and allow pathogens to become 
established. Equipment with metal-to-metal 
contact may generate metal fragments. 
Sanitation, including employee hygiene  Ready-to-eat foods may be subject to 
contamination from the environment or from 
food handlers. 
Raw materials and other ingredients  Contaminated ingredients can introduce hazards 
such as pathogens or toxins. 
Transportation practices  Failure to adequately control temperature during 
transportation could make a food unsafe if the 
product requires time and temperature controls 
to ensure safety. 
Manufacturing/processing procedures  Improper cooling or holding of certain foods can 
result in germination of pathogenic sporeforming 
bacteria or production of toxins by certain 
pathogenic bacteria. 
Packaging and labeling activities  Packaging in glass can result in glass fragments 
in food. Labeling of food allergens is critical for 
allergic consumers. 
Storage and distribution  Some foods require refrigerated storage to 
maintain safety. 
Intended or reasonably foreseeable use  It is reasonably foreseeable that some foods 
intended to be cooked will be eaten without 
cooking (e.g., cookie dough, soup mixes used to 
prepare dips). 
Environmental pathogens  Environmental pathogens may contaminate a 
ready-to-eat food exposed to the environment 
prior to packaging  
VIII. PREVENTIVE CONTROLS 
Your written plan must specify controls to ensure that identified hazards will be minimized or 
prevented (21 CFR 117.135).  Preventive controls may include controls for processes, food 
allergens, and sanitation, as well as supply-chain safety, and a recall plan. Included are: 
  Controls at critical control points (CCPs), if there are any CCPs; and 
  Controls, other than those at CCPs, which are also necessary for food safety. 
The types of preventive controls you use will depend on the facility and the food: 
11  Contains Nonbinding Recommendations 
1.  Process controls are the procedures, practices, and processes to ensure the control of 
operations such as heat processing, acidifying, irradiating, and refrigerating foods.  When 
applicable to a process control, you must specify the parameter that is monitored (e.g., the 
temperature, the pH of the food) and the minimum or maximum value that ensures 
control (e.g., a minimum of 165F (for a heat treatment), a maximum of 41F (for 
refrigerated storage)).  (21 CFR 117.135(c)(1)) 
2.  Food allergen controls are the procedures for ensuring protection of food from allergen 
cross-contact (preventing the unintentional incorporation of an allergen in a food)  
including during storage, handling, and use  and correctly labeling the finished food if 
it contains any of the eight major food allergens (milk, eggs, fish, crustacean shellfish, 
tree nuts, peanuts, wheat, soybeans).  (21 CFR 117.135(c)(2)) 
3.  Sanitation controls are the procedures to ensure the facilitys sanitation practices are 
adequate to significantly minimize or prevent hazards such as environmental pathogens, 
biological hazards due to employee handling, and food allergen hazards.  Sanitation 
controls must address the cleanliness of food-contact surfaces, including food-contact 
surfaces of utensils and equipment, and prevention of allergen cross-contact and cross-
contamination from insanitary objects and from personnel to food, food packaging 
material, and other food-contact surfaces; and from raw product to processed product. 
Note that sanitation controls do not include all sanitation procedures used in the facility, 
only those that are used to control hazards.  (21 CFR 117.135(c)(3)) 
4.  Supply-chain controls are activities taken to verify that suppliers that are controlling 
hazards are doing so effectively.  This will be covered in section IX. Risk-based Supply 
Chain Safety Program for Manufacturing/Processing Facilities.  (21 CFR 117.135(c)(4)) 
5.  A recall plan is necessary for any food with a hazard requiring a preventive control. It 
must be written and must include steps to take (and who is responsible for taking them) to 
(21 CFR 117.139):  
  Notify your direct customers,  
  Notify the public, if necessary,  
  Check the effectiveness of the recall, and 
  Dispose of the food appropriately. 
A. Oversight And Management Of Preventive Controls 
The rule provides flexibility in the steps needed to ensure that preventive controls are effective 
and to correct problems that may arise. These procedures are designed to provide assurance that 
preventive controls are consistently performed. 
12  Contains Nonbinding Recommendations 
Table 7--Preventive Control Management Components 
Function  Explanation 
Monitoring  You must have written procedures for monitoring each 
(21 CFR 117.145)  preventive control, including how often these procedures are to 
be performed.  
Corrective actions and  Steps taken to identify and correct a problem that occurs during 
corrections  food production. Corrective actions include steps to identify a 
(21 CFR 117.150)  problem with preventive control functioning, reduce the 
likelihood the problem will recur, evaluate the affected food for 
safety, and 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 food. 
Verification & Validation  These are activities to ensure that preventive controls are 
(21 CFR 117.155 and 21  consistently applied and effective in controlling the hazards. Its 
CFR 117.160)  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).  
Product testing and  These are verification activities, but are only required when 
environmental monitoring  appropriate to the food, the facility, the nature of the preventive 
(21 CFR 117.165 (a)(2) and  control, and the role of that control in the facilitys food safety 
(a)(3))  system. Environmental monitoring generally would be required 
if contamination of a ready-to-eat food with an environmental 
pathogen is a hazard requiring a preventive control. 
Records   Records may be originals, true copies  i.e., reproductions of 
(21 CFR 117.126 and 21  originals  or electronic 
CFR 117.190)   
Two types of records are required 
  Records of your food safety plan itself, i.e., hazard analysis 
and preventive controls development; recall plan; and 
monitoring, corrective action and verification procedures 
  Implementation records, i.e., monitoring data, corrective 
actions taken, validation documentation, verification activity 
records, supply-chain program execution, and personnel 
training 
13  Contains Nonbinding Recommendations 
 
B. When is a Preventive Control Not Required?  
You are not required to implement a preventive control for an identified hazard if any of the 
following circumstances apply (21 CFR 117.136): 
(1) You determine and document that the type of food (e.g., raw agricultural commodities 
such as cocoa beans, coffee beans, and grains) could not be consumed without application of 
an appropriate control. (For example, cocoa beans must be roasted to make cocoa products, 
and to achieve the desired characteristics of the beans the roasting process will achieve an 
adequate time and temperature that controls the hazard of Salmonella associated with the raw 
cocoa beans). 
(2) 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 food, in accordance with trade practice, that 
o
the 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. 
 (3) 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, a foodservice establishment, or some other business not subject to the 
requirements) to provide assurance the customer is manufacturing, processing, or preparing 
the food in accordance with applicable food safety requirements and you: 
  Disclose in documents accompanying the food, in accordance with trade practice, that 
o
the 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 food in accordance with applicable food 
safety requirements. 
 (4) You rely on your customer to provide assurance that the 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 food, in accordance with trade practice, that 
o
the food is not processed to control [identified hazard]; and 
14  Contains Nonbinding Recommendations 
  Annually obtain from your customer written assurance that your customer: 
o
  Will disclose in documents accompanying the food, in accordance with trade 
practice, that the 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 food in accordance with applicable food 
safety requirements, or 
  Obtain a similar written assurance from the entity's customer. 
 (5) You have established, documented, and implemented a system that ensures control, at a 
subsequent distribution step, of the hazards in the food product you distribute and you 
document the implementation of that system.  
IX. RISK-BASED SUPPLY-CHAIN PROGRAM FOR 
MANUFACTURING/PROCESSING FACILITIES 
If a manufacturing/processing facility has identified in its raw materials and ingredients a hazard 
that requires a control and that control is applied in the supply chain before receipt, the facility 
must have a supply-chain program (21 CFR 117.405).  Manufacturing/processing facilities that 
control all identified 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 foods. 
 
Food facilities covered by the regulation 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.  
A. Requirements 
The supply-chain program must be written (21 CFR 117.405(b)) and must include: 
  Using approved suppliers (21 CFR 117.410(a)(2), 117.415(a)(1), and 117.420);  
  Determining appropriate supplier verification activities (including determining the 
frequency of conducting the activity) (21 CFR 117.410(a)(2) and 117.425); 
  Conducting supplier verification activities (21 CFR 117.410(a)(3), 117.430 and 117.435);  
15  Contains Nonbinding Recommendations 
  Documenting supplier verification activities (21 CFR 117.410(a)(4) and 117.475); 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 
117.410(a)(5) and 117.475).  
When a supply-chain-applied control is applied by an entity other than the receiving facility's 
supplier (e.g., when a non-supplier applies controls to certain produce, because growing, 
harvesting, and packing activities are under different management), the receiving facility must 
(21 CFR 117.405(c)): 
  Verify the supply-chain-applied control; or 
  Obtain documentation of an appropriate verification activity from another entity, review 
and assess the entity's applicable documentation, and document that review and 
assessment. 
Other entities in the supply chain, such as a broker or distributor, can conduct supplier 
verification activities, but the receiving facility (the manufacturer/processor) must review and 
assess the entitys documentation verifying control of the hazard and document this review (21 
CFR 117.415(a)). 
Supplier verification activities may be (21 CFR 117.410(b):  
  onsite audits;  
  sampling and testing of raw materials and other ingredients; 
  review of the suppliers relevant food safety records; and 
  other appropriate supplier verification activities.  
Approving suppliers and determining the appropriate supplier verification activities (and their 
frequency) are based on the risk associated with the raw material or other ingredient and supplier 
performance (21 CFR 117.410(d)). 
B. Compliance Dates For The Requirements Of The SupplyChain Program  
Separate compliance dates have been established for the supply-chain program provisions so that 
a food facility will not be required to comply with the supply-chain program provisions before its 
supplier is required to comply with the PCHF rule or the produce safety rule (if applicable). 
 
Table 8--Compliance dates for the Requirements of the Supply-Chain Program (Subpart G) 
16  Contains Nonbinding Recommendations 
Type of Facility  Compliance Date 
Receiving facility is a small business and its  September 18, 2017 
supplier will not be subject to the human 
preventive controls rule or the produce safety 
rule 
Receiving facility is a small business and its  September 18, 2017 or 6 months after the 
supplier will be subject to the human  supplier is required to comply with the 
preventive controls rule or the produce safety  applicable rule, whichever is later 
rule 
Receiving facility is not a small or very small  March 17, 2017 
business and its supplier will not be subject to 
the human preventive controls rule or the 
produce safety rule 
Receiving facility is not a small or very small  6 months after the supplier is required to 
business and its supplier will be subject to the  comply with the applicable rule 
human preventive controls rule or the produce 
safety rule 
X. EDUCATION AND TRAINING 
Companies subject to this rule must ensure that their food safety system is developed and applied 
by an 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 (21 CFR 117.4). 
In addition, each individual (including temporary and seasonal personnel) engaged in (or 
supervising) manufacturing, processing, packing, or holding food covered by this rule must (21 
CFR 117.4(b)): 
  Be a qualified individual, i.e., have the education, training, or experience (or a 
combination of these) necessary to manufacture, process, pack, or hold clean and safe 
food as appropriate to the individual's assigned duties; and 
  Receive training in the principles of food hygiene and food safety, including the 
importance of employee health and personal hygiene, as appropriate to the food, the 
facility, and the individual's assigned duties. 
Additional qualifications for supervisory personnel: Responsibility for ensuring compliance by 
individuals 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 clean and safe food (21 CFR 117.4(c)). 
17  Contains Nonbinding Recommendations 
Records documenting the required training in the principles of food hygiene and food safety 
must be established and maintained (21 CFR 117.4(d)). 
XI. 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 117.3), a business must either be:  
  A very small business (a business, including any subsidiaries and affiliates, averaging 
less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding 
the applicable calendar year in sales of human food plus the market value of human food 
manufactured, processed, packed, or held without sale (e.g., held for a fee); or  
  A facility (when including the sales by any subsidiary; affiliate; or subsidiaries or 
affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) 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 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 117.201(a)(1)). 
B. How Do I Tell FDA That My Business Is A Qualified Facility? 
  The information can be submitted to FDA in one of two ways (21 CFR 117.201(b)): 
 Electronically  Go to http://www.fda.gov/furls and follow the instructions. FDA 
o
encourages electronic submission. 
 Mail  You must use Form FDA 3942a (21 CFR 117.201(b)(2)). Send the 
o
completed paper Form FDA 3942a 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: 
18  Contains Nonbinding Recommendations 
  Download it from 
http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/Q
ualifiedFacilityAttestation/default.htm, or 
  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 A Qualified Facility Provide FDA? 
  You must attest that you either: 
  Have identified potential hazards associated with the food being produced, are 
o
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 117.201(a)(2)(i)); or  
  Are in compliance with State, local, county, tribal, or other applicable non-
o
Federal food safety law, including relevant laws and regulation 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 
117.201(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 117.201(c)(2)(i)) 
  By December 17, 2018, for a facility that begins manufacturing, processing, packing, or 
holding food before September 17, 2018, or 
  Before beginning operations, for a facility that begins manufacturing, processing, 
packing, or holding food after September 17, 2018. 
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 117.201(c)(2)(ii)). 
The determination whether a facility satisfies the definition of qualified facility must be made 
annually no later than July 1 of each calendar year (21 CFR 117.201(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 3942a by July 31 
of the applicable calendar year (21 CFR 117.201(c)(3)), and  
19  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 117.201(d)). 
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 117.251(a)(1)); or 
  If FDA determines that it is necessary to protect the public 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 food manufactured, processed, packed, or 
held at such facility (21 CFR 117.251(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 health or mitigate a 
foodborne illness outbreak, including a warning letter, recall, administrative detention, 
suspension of registration, refusal of food offered for import, seizure, and injunction (21 
CFR 117.251(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 
117.251(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 117.251(b)(3)). 
XII. 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 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/food combinations listed in the 
regulation. In addition, the modified requirements for a very small business also would not apply 
to very small on-farm businesses conducting these low-risk, on-farm manufacturing, processing, 
20  Contains Nonbinding Recommendations 
packing and holding activities.  The terms that apply with respect to the foods associated with the 
activity/food combinations are listed below, followed by the exemptions for on-farm packing and 
holding of food and the exemptions for on-farm manufacturing/processing of food. Some foods 
that are considered fruits and vegetables (i.e., coffee bean, cocoa beans, fresh herbs, peanuts, 
sugar cane, sugar beets, tree nuts, seeds for direct consumption) were considered separately. 
 
Table 9--Activity/Food Combinations (21 CFR 117.5(g)(2)) 
Activity/Food Combination  Description and/or Examples 
Term 
Dried/dehydrated fruit and  Includes only products such as raisins and dried legumes made 
vegetable products   without additional manufacturing/processing beyond 
drying/dehydrating, packaging, and/or labeling. 
Other fruit and vegetable  Includes those products that have undergone one or more of the 
products   following processes: acidification, boiling, canning, coating 
with things other than wax/oil/resin, cooking, cutting, chopping, 
grinding, peeling, shredding, slicing, or trimming.  
Examples include flours made from legumes (such as chickpea 
flour), pickles, and snack chips made from potatoes or plantains. 
Examples also include dried fruit and vegetable products made 
with additional manufacturing/processing (such as dried apple 
slices; pitted, dried plums, cherries, and apricots; and sulfited 
raisins).  
 
This category does not include dried/dehydrated fruit and 
vegetable products made without additional 
manufacturing/processing such as raisins and dried legumes. 
This category also does not include products that require 
time/temperature control for safety, such as fresh-cut fruits and 
vegetables. 
Peanut and tree nut products   Includes such products as roasted peanuts and tree nuts, 
seasoned peanuts and tree nuts, and peanut and tree nut flours. 
Processed seeds for direct  Include such products as roasted pumpkin seeds, roasted 
consumption   sunflower seeds, and roasted flax seeds. 
Dried/dehydrated herb and  Includes only processed food products as dried intact herbs 
spice products   made without additional manufacturing/processing beyond 
drying/dehydrating, packaging, and/or labeling. 
21  Contains Nonbinding Recommendations 
Activity/Food Combination  Description and/or Examples 
Term 
Other herb and spice products   Includes those processed food products such as chopped fresh 
herbs, chipped or ground dried herbs (including tea), herbal 
extracts (e.g., essential oils, extracts containing more than 20 
percent ethanol, extracts containing more than 35 percent 
glycerin), dried herb- or spice infused honey, and dried herb- or 
spice-infused oils and/or vinegars.  
 
This category does not include dried/dehydrated herb and spice 
products made without additional manufacturing/processing 
beyond drying/dehydrating, packaging, and/or labeling.  This 
category also does not include products that require 
time/temperature control for safety, such as fresh herb-infused 
oils. 
Grains   Includes barley, dent- or flint-corn, sorghum, oats, rice, rye, 
wheat, amaranth, quinoa, buckwheat and oilseeds for oil 
extraction, such as cotton seed, flax seed, rapeseed, soybeans, 
and sunflower seed. 
Milled grain products   Includes such products as flour, bran, and corn meal. 
Baked goods   Includes such products as breads, brownies, cakes, cookies, and 
crackers.  
 
This category does not include products that require 
time/temperature control for safety, such as cream-filled 
pastries. 
Other grain products   Include such products as dried cereal, dried pasta, oat flakes, 
and popcorn. 
A. On-Farm Packing Or Holding Of Food  
1. What Packing or Holding Activities On a Farm MixedType Facility are Within the 
Definition Of Farm and not Subject to the Requirements for Hazard Analysis and 
Preventive Controls?  
There are packing and holding activities that are within the farm definition and so are not 
subject to the requirements for  hazard analysis and preventive controls when performed on a 
farm or a farm mixedtype facility (see Farm and Mixed-Type Facility in Definitions, Pages 
40 and 43) and therefore do not need to be specified in the exemption.  Drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to 
produce raisins, and drying/dehydrating fresh herbs to produce dried herbs) and packaging and 
22  Contains Nonbinding Recommendations 
labeling such commodities, without additional manufacturing/processing (such as chopping and 
slicing) are within the farm definition.  (See 21 CFR 117.5(g)(1).) 
2. What Low-Risk Packing or Holding Activity/Food Combinations are Exempt from 
Hazard Analysis and Preventive Controls if Performed On a Farm By a Small or Very 
Small Business and Are the Only Activities That Would Be Subject To the Requirements 
or Hazard Analysis and Preventive Controls?  
The requirements for hazard analysis and risk-based preventive controls do not apply to on-farm 
packing or holding of 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 these foods (21 CFR 117.5(g)(3)): 
  Baked goods   e.g., bread and cookies  
o
  Candy  e.g., hard candy, fudge, maple candy, maple cream, nut brittles, taffy, and 
o
toffee 
  Roasted cocoa beans and cocoa products 
o
  Roasted coffee beans  
o
  Game meat jerky 
o
  Gums, latexes, and resins that are processed foods 
o
  Pasteurized honey  
o
  Jams, jellies, and preserves 
o
  Milled grain products  e.g., flour, bran, and corn meal 
o
  Molasses and treacle 
o
  Oils  e.g., olive oil and sunflower seed oil 
o
  Other fruit and vegetable products  e.g., flours made from legumes; pitted, dried 
o
fruits; sliced, dried apples; snack chips 
  Other grain products  e.g., dried pasta, oat flakes, and popcorn 
o
  Other herb and spice products  e.g., chopped or ground dried herbs, herbal extracts 
o
  Peanut and tree nut products  e.g., roasted peanuts and tree nut flours 
o
  Processed seeds for direct consumption  e.g., roasted pumpkin seeds 
o
23  Contains Nonbinding Recommendations 
  Soft drinks and carbonated water 
o
  Sugar 
o
  Syrups  e.g., maple and agave syrups 
o
  Trail mix and granola 
o
  Vinegar 
o
  Any other processed food that does not require time/temperature control for safety  
o
e.g., vitamins, minerals, and dietary ingredients, such as bone meal, in powdered, 
granular, or other solid form. 
B. On-Farm Manufacturing/Processing Of Food 
1. What Food Manufacturing/Processing Activities on a Farm MixedType Facility Are 
Within the Definition Of Farm And are not subject to the requirements for Hazard 
Analysis and Preventive Controls?  
There are manufacturing/processing activities that are within the farm definition and so are not 
subject to the requirements for  hazard analysis and preventive controls when performed on a 
farm or a farm mixedtype facility (see Farm and Mixed-Type Facility in Definitions, Pages 
40 and 43) and therefore do not need to be specified in the exemption.  
These include (21 CFR 117.5(h)(1)): 
  Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to 
produce dried herbs) and packaging and labeling such commodities, without additional 
manufacturing/processing (such as chopping and slicing) 
  Treatment to manipulate ripening of raw agricultural commodities (such as by treating 
produce with ethylene gas), and packaging and labeling the treated raw agricultural 
commodities, without additional manufacturing/processing  
  Packaging and labeling raw agricultural commodities without additional 
manufacturing/processing. 
2. What Low-Risk Food Manufacturing/Processing Activities Are Exempt From Hazard 
Analysis And Preventive Controls If Performed On A Farm By A Small Or Very Small 
Business And Are The Only Activities That Would Be Subject To The Requirements For 
Hazard Analysis And Preventive Controls?  
The requirements for hazard analysis and risk-based preventive controls do not apply to on-farm 
manufacturing/processing of food by a small or very small business if the 
24  Contains Nonbinding Recommendations 
manufacturing/processing activities are limited to the following low-risk 
manufacturing/processing activity/food combinations (21 CFR 117.5(h)(3)): 
  Boiling gums, latexes, and resins 
  Chopping, coring, cutting, peeling, pitting, shredding, and slicing acid fruits and 
vegetables that have a pH less than 4.2 (e.g., cutting lemons and limes), baked goods 
(e.g., slicing bread), dried/dehydrated fruit and vegetable products (e.g., pitting dried 
plums), dried herbs and other spices (e.g., chopping intact, dried basil), game meat jerky, 
gums/latexes/resins, other grain products (e.g., shredding dried cereal), peanuts and tree 
nuts, and peanut and tree nut products (e.g., chopping roasted peanuts) 
  Coating dried/dehydrated fruit and vegetable products (e.g., coating raisins with 
chocolate), other fruit and vegetable products except for non-dried, non-intact fruits and 
vegetables (e.g., coating dried plum pieces, dried pitted cherries, and dried pitted apricots 
with chocolate are low-risk activity/food combinations but coating apples on a stick with 
caramel is not a low-risk activity/food combination), other grain products (e.g., adding 
caramel to popcorn or adding seasonings to popcorn provided that the seasonings have 
been treated to significantly minimize pathogens, peanuts and tree nuts (e.g., adding 
seasonings provided that the seasonings have been treated to significantly minimize 
pathogens), and peanut and tree nut products (e.g., adding seasonings provided that the 
seasonings have been treated to significantly minimize pathogens) 
  Drying/dehydrating (that includes additional manufacturing or is performed on processed 
foods) other fruit and vegetable products with pH less than 4.2 (e.g., drying cut fruit and 
vegetables with pH less than 4.2), and other herb and spice products (e.g., drying 
chopped fresh herbs, including tea) 
  Extracting (including by pressing, by distilling, and by solvent extraction) from 
dried/dehydrated herb and spice products (e.g., dried mint), fresh herbs (e.g., fresh mint), 
fruits and vegetables (e.g., olives, avocados), grains (e.g., oilseeds), and other herb and 
spice products (e.g., chopped fresh mint, chopped dried mint) 
  Freezing acid fruits and vegetables with pH less than 4.2 and other fruit and vegetable 
products with pH less than 4.2 (e.g., cut fruits and vegetables) 
  Grinding/cracking/crushing/milling baked goods (e.g., crackers), cocoa beans (roasted), 
coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., raisins and 
dried legumes), dried/dehydrated herb and spice products (e.g., intact dried basil), grains 
(e.g., oats, rice, rye, wheat), other fruit and vegetable products (e.g., dried, pitted dates), 
other grain products (e.g., dried cereal), other herb and spice products (e.g., chopped 
dried herbs), peanuts and tree nuts, and peanut and tree nut products (e.g., roasted 
peanuts) 
25  Contains Nonbinding Recommendations 
  Labeling baked goods that do not contain food allergens, candy that does not contain 
food allergens, cocoa beans (roasted), cocoa products that do not contain food allergens), 
coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, 
honey (pasteurized), jams/jellies/preserves, milled grain products that do not contain food 
allergens (e.g., corn meal) or that are single-ingredient foods (e.g., wheat flour, wheat 
bran), molasses and treacle, oils, other fruit and vegetable products that do not contain 
food allergens (e.g., snack chips made from potatoes or plantains), other grain products 
that do not contain food allergens (e.g., popcorn), other herb and spice products (e.g., 
chopped or ground dried herbs), peanut or tree nut products, (provided that they are 
single-ingredient, or are in forms in which the consumer can reasonably be expected to 
recognize the food allergen(s) without label declaration, or both (e.g., roasted or seasoned 
whole nuts, single-ingredient peanut or tree nut flours)), processed seeds for direct 
consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola (other 
than those containing milk chocolate and provided that peanuts and/or tree nuts are in 
forms in which the consumer can reasonably be expected to recognize the food 
allergen(s) without label declaration), vinegar, and any other processed food that does not 
require time/temperature control for safety and that does not contain food allergens (e.g., 
vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or 
other solid form) 
  Making baked goods from milled grain products (e.g., breads and cookies) 
  Making candy from peanuts and tree nuts (e.g., nut brittles), sugar/syrups (e.g., taffy, 
toffee), and saps (e.g., maple candy, maple cream) 
  Making cocoa products from roasted cocoa beans 
  Making dried pasta from grain 
  Making jams, jellies, and preserves from acid fruits and vegetables with a pH of 4.6 or 
below 
  Making molasses and treacle from sugar beets and sugarcane 
  Making oat flakes from grain 
  Making popcorn from grains 
  Making snack chips from fruits and vegetables (e.g., making plantain and potato chips) 
  Making soft drinks and carbonated water from sugar, syrups, and water 
26  Contains Nonbinding Recommendations 
  Making sugars and syrups from fruits and vegetables (e.g., dates), grains (e.g., rice, 
sorghum), other grain products (e.g., malted grains such as barley), saps (e.g., agave, 
birch, maple, palm), sugar beets, and sugarcane 
  Making trail mix and granola from cocoa products (e.g., chocolate), dried/dehydrated 
fruit and vegetable products (e.g., raisins), other fruit and vegetable products (e.g., 
chopped dried fruits), other grain products (e.g., oat flakes), peanut and tree nut products, 
and processed seeds for direct consumption, provided that peanuts, tree nuts, and 
processed seeds are treated to significantly minimize pathogens 
  Making vinegar from fruits and vegetables, other fruit and vegetable products (e.g., fruit 
wines, apple cider), and other grain products (e.g., malt) 
  Mixing baked goods (e.g., types of cookies), candy (e.g., varieties of taffy), cocoa beans 
(roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., 
dried blueberries, dried currants, and raisins), dried/dehydrated herb and spice products 
(e.g., dried, intact basil and dried, intact oregano), honey (pasteurized), milled grain 
products (e.g., flour, bran, and corn meal), other fruit and vegetable products (e.g., dried, 
sliced apples and dried, sliced peaches), other grain products (e.g., different types of dried 
pasta), other herb and spice products (e.g., chopped or ground dried herbs, dried herb- or 
spice-infused honey, and dried herb- or spice-infused oils and/or vinegars), peanut and 
tree nut products, sugar, syrups, vinegar, and any other processed food that does not 
require time/temperature control for safety (e.g., vitamins, minerals, and dietary 
ingredients (e.g., bone meal) in powdered, granular, or other solid form) 
  Packaging baked goods (e.g., bread and cookies), candy, cocoa beans (roasted), cocoa 
products, coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed 
foods, honey (pasteurized), jams/jellies/preserves, milled grain products (e.g., flour, bran, 
corn meal), molasses and treacle, oils, other fruit and vegetable products (e.g., pitted, 
dried fruits; sliced, dried apples; snack chips), other grain products (e.g., popcorn), other 
herb and spice products (e.g., chopped or ground dried herbs), peanut and tree nut 
products, processed seeds for direct consumption, soft drinks and carbonated water, 
sugar, syrups, trail mix and granola, vinegar, and any other processed food that does not 
require time/temperature control for safety (e.g., vitamins, minerals, and dietary 
ingredients (e.g., bone meal) in powdered, granular, or other solid form) 
XIII. UPDATED AND CLARIFIED CURRENT GOOD MANUFACTURING 
PRACTICE (CGMP) 
A. Personnel (21 CFR 117.10) 
The management of the establishment must take reasonable measures and precautions to ensure: 
27  Contains Nonbinding Recommendations 
  Disease control  Any person who has or appears to have any abnormal source of 
microbial contamination (e.g., illness, open lesions, including boils, sores, or infected 
wounds) that reasonably could contaminate food, food-contact surfaces, or food-
packaging materials must be excluded from any operations which could result in such 
contamination until the condition is corrected (unless conditions such as open lesions, 
boils and infected wounds are adequately covered).  
 Personnel must be instructed to report such health conditions to their supervisors. 
  Cleanliness  All persons working in direct contact with food, food-contact surfaces, 
and food-packaging materials must conform to hygienic practices while on duty as 
necessary to protect against allergen cross-contact and against contamination of food. 
Methods for cleanliness include: 
 (1) Wearing suitable outer garments, in a manner that protects against allergen 
cross-contact and against the contamination of food, food-contact surfaces, or food-
packaging materials. 
 (2) Maintaining adequate personal cleanliness. 
 (3) Washing hands thoroughly (and sanitizing when necessary to protect against 
undesirable microorganisms) in an adequate hand-washing facility before starting 
work, after any absence from the work station, and at any other time when the hands 
may have become soiled or contaminated. 
 (4) Removing unsecured jewelry or other objects that might fall into food, 
equipment, or containers, and removing hand jewelry that cannot be adequately 
sanitized if food is manipulated by hand. If hand jewelry cannot be removed, it may 
be covered by material which effectively protects against contamination of the food, 
food-contact surfaces, or food-packaging materials. 
 (5) Maintaining gloves in an intact, clean, and sanitary condition if used in food 
handling. 
 (6) Wearing effective hair restraints where needed, including hair nets, headbands, 
caps, beard covers, etc. 
 (7) Storing clothing or other personal belongings away from areas where food is 
exposed or where equipment or utensils are washed. 
 (8) Confining eating food, chewing gum, drinking beverages, or tobacco use to 
areas away from where food may be exposed or where equipment or utensils are 
washed. 
28  Contains Nonbinding Recommendations 
 (9) Taking any other necessary precautions to protect against allergen cross-
contact and contamination of food, food-contact surfaces, or food-packaging 
materials with microorganisms or foreign substances, including perspiration, hair, 
cosmetics, tobacco, chemicals, and medicines applied to the skin. 
B. Plant and Grounds (21 CFR 117.20) 
  Grounds  the grounds around a food plant under the control of the operator must be 
kept in a condition that will protect against the contamination of food. The methods for 
adequate maintenance of grounds must include: 
(1) 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.  
(2) Maintaining roads, yards, and parking lots so that they do not constitute a 
source of contamination in areas where food is exposed. 
(3) Adequately draining areas that may contribute contamination to food by 
seepage, foot-borne filth, or providing a breeding place for pests. 
(4) Operating systems for waste treatment and disposal so that they do not 
constitute a source of contamination in areas where food is exposed. 
(5) If the plant grounds are bordered by grounds not under the operator's 
control and not maintained in the manner described in paragraphs (1) through (4) of 
this section, care must be exercised in the plant by inspection, extermination, or other 
means to exclude pests, dirt, and filth that may be a source of food contamination. 
  Plant construction and design  the plant must be suitable in size, construction, and 
design to facilitate maintenance and sanitary operations for food-production purposes 
manufacturing, processing, packing, and holding food. The plant must: 
(1) Provide space for the placing of equipment and storage of materials adequate 
for maintenance, sanitary operations, and the production of safe food. 
(2) Allow for adequate precautions to reduce the potential for allergen cross-
contact and for contamination of food, food-contact surfaces, or food-packaging 
materials with microorganisms, chemicals, filth, and other extraneous material. The 
potential for allergen cross-contact and for contamination may be reduced by 
adequate food safety controls and operating practices or effective design, including 
the separation of operations in which allergen cross-contact and contamination are 
likely to occur, by one or more of the following means: location, time, partition, air 
flow systems, dust control systems, enclosed systems, or other effective means. 
29  Contains Nonbinding Recommendations 
(3) Allow for adequate precautions to protect food in installed outdoor bulk vessels 
by any effective means, including  
  Using protective coverings 
o
  Controlling areas over and around the vessels to eliminate harborage for pests 
o
  Checking on a regular basis for pests and pest infestation 
o
  Skimming fermentation vessels when necessary 
o
(4) Be constructed so that   
  Floors, walls, and ceilings may be adequately cleaned, kept clean, and kept in 
o
good repair, 
  Drip or condensate from fixtures, ducts and pipes does not contaminate food, 
o
food-contact surfaces, or food-packaging materials, and  
   Aisles or working spaces are provided between equipment and walls and are 
o
adequately clear and wide enough to allow employees to perform their duties 
and to protect against contaminating food, food-contact surfaces, or food-
packaging materials with clothing or personal contact. 
(5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and 
toilet rooms and in all areas where food is examined, manufactured, processed, 
packed, or held and where equipment or utensils are cleaned. Light bulbs, fixtures, 
skylights, or other glass suspended over exposed food in any step of preparation must 
be shatter-resistant or otherwise protect against food contamination in case of glass 
breakage. 
(6) Provide adequate ventilation or control equipment to minimize dust, odors 
and vapors (including steam and noxious fumes) in areas where they may cause 
allergen cross-contact or contaminate food; and locate and operate fans and other air-
blowing equipment in a manner that minimizes the potential for allergen cross-
contact and for contaminating food, food-packaging materials, and food-contact 
surfaces. 
(7) Provide, where necessary, adequate screening or other protection against 
pests. 
C. Sanitary Operations (21 CFR 117.35) 
  General maintenance  buildings, fixtures, and other physical facilities of the plant 
must be maintained in a clean and sanitary condition and must be kept in repair 
30  Contains Nonbinding Recommendations 
adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils 
and equipment must be conducted in a way that protects against allergen cross-contact 
and against contamination of food, food-contact surfaces, or food-packaging materials. 
  Substances used in cleaning and sanitizing, and storage of toxic materials   
Cleaning compounds and sanitizing agents must be free from undesirable 
microorganisms and must be safe and adequate under the conditions of use. Compliance 
with this requirement must be verified by any effective means, including purchase of 
these substances under a letter of guarantee or certification, or examination of these 
substances for contamination. Only the following toxic materials may be used or stored in 
a plant where food is processed or exposed  
  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
Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, 
held, and stored in a manner that protects against contamination of food, food-contact 
surfaces, or food-packaging materials. 
  Pest control  Pests must not be allowed in any area of a food plant.  
  Guard, guide, or pest-detecting dogs may be allowed in some areas of a plant if the 
o
presence of the dogs is unlikely to result in contamination of food, food-contact 
surfaces, or food-packaging materials. 
  Effective measures must be taken to exclude pests from the manufacturing, 
o
processing, packing, and holding areas and to protect against the contamination of 
food on the premises by pests. 
   The use of pesticides to control pests in the plant is permitted only under 
o
precautions and restrictions that will protect against the contamination of food, food-
contact surfaces, and food-packaging materials. 
  Sanitation of food-contact surfaces    All food-contact surfaces, including utensils 
and food-contact surfaces of equipment, must be cleaned as frequently as necessary to 
protect against allergen cross-contact and against contamination of food. 
(1) Food-contact surfaces used for manufacturing/processing, packing, or 
holding low-moisture food must be in a clean, dry, sanitary condition before use. 
31  Contains Nonbinding Recommendations 
When the surfaces are wet-cleaned, they must, when necessary, be sanitized and 
thoroughly dried before subsequent use. 
(2) In wet processing, when cleaning is necessary to protect against allergen cross-
contact or the introduction of microorganisms into food, all food-contact surfaces 
must be cleaned and sanitized before use and after any interruption during which the 
food-contact surfaces may have become contaminated. Where equipment and utensils 
are used in a continuous production operation, the utensils and food-contact surfaces 
of the equipment must be cleaned and sanitized as necessary. 
(3) Single-service articles (such as utensils intended for one-time use, paper cups, 
and paper towels) must be stored, handled, and disposed of in a way that protects 
against allergen cross-contact and against contamination of food, food-contact 
surfaces, or food-packaging materials. 
  Sanitation of non-food-contact surfaces  Non-food-contact surfaces of equipment used 
in the operation of a food plant must be cleaned as frequently as necessary to protect 
against allergen cross-contact and against contamination of food, food-contact surfaces, 
and food-packaging materials. 
  Storage and handling of cleaned portable equipment and utensils  Cleaned and 
sanitized portable equipment with food-contact surfaces and utensils must be stored in a 
location and manner that protects food-contact surfaces from allergen cross-contact and 
from contamination. 
D. Sanitary Facilities and Controls (21 CFR 117.37) 
Each plant must be equipped with adequate sanitary facilities and accommodations including: 
  Water supply  The water supply must be adequate for the intended operations and 
must be derived from an adequate source. Any water that contacts food, food-contact 
surfaces, or food-packaging materials must be safe and of adequate sanitary quality. 
Running water at a suitable temperature, and under pressure as needed, must be provided 
in all areas where required for the processing of food, for the cleaning of equipment, 
utensils, and food-packaging materials, or for employee sanitary facilities. 
  Plumbing  Plumbing must be of adequate size and design and adequately installed and 
maintained to: 
(1) Carry adequate quantities of water to required locations throughout the plant. 
(2) Properly carry sewage and liquid disposable waste from the plant. 
32  Contains Nonbinding Recommendations 
(3) Avoid contaminating food, water supplies, equipment or utensils, or creating 
an unsanitary condition. 
(4) Provide adequate floor drainage in all areas where floors are subject to flooding-
type cleaning or where normal operations cause water or other liquid waste on the 
floor. 
(5) Provide that there is not backflow from, or cross-connection between, piping 
systems that discharge waste water or sewage and piping systems that carry water for 
food or food manufacturing. 
  Sewage disposal  Dispose sewage into an adequate sewerage system or dispose it 
through other suitable means. 
  Toilet facilities  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 food, food-contact surfaces, or food-packaging materials. 
  Hand-washing facilities  Each plant must ensure that an employee's hands are not a 
source of contamination of food, food-contact surfaces, or food-packaging materials by 
providing hand-washing facilities that are adequate, convenient, and furnish running 
water at a suitable temperature. 
  Rubbish and offal disposal  Convey, store, and dispose of rubbish and any offal so as 
to minimize the development of odor, minimize the potential for the waste becoming an 
attractant and harborage or breeding place for pests, and protect against contamination of 
food, food-contact surfaces, food-packaging materials, water supplies, and ground 
surfaces. 
E. Equipment and Utensils (21 CFR 117.40) 
  All plant equipment and utensils used in manufacturing, processing, packing, or holding 
food must   
(1) Be designed and of such material and workmanship that they are adequately 
cleanable, and must be adequately maintained to protect against allergen cross-
contact and contamination. 
(2) Be designed, constructed, and used appropriately to avoid the adulteration of 
food with lubricants, fuel, metal fragments, contaminated water, or any other 
contaminants. 
(3) Be installed so as to facilitate cleaning and maintenance of the equipment and 
of adjacent spaces. 
(4) Have food-contact surfaces that are corrosion-resistant when in contact with 
food. 
33  Contains Nonbinding Recommendations 
(5) Have food-contact surfaces made of nontoxic materials and designed to 
withstand the environment of their intended use and the action of food, and, if 
applicable, cleaning compounds, sanitizing agents, and cleaning procedures, and  
(6) Be maintained so that food-contact surfaces are protected from allergen cross-
contact and from being contaminated by any source, including unlawful indirect 
food additives. 
  Seams on food-contact surfaces must be smoothly bonded or maintained so as to 
minimize accumulation of food particles, dirt, and organic matter and thus minimize the 
opportunity for growth of microorganisms and allergen cross-contact. 
  Equipment in areas where food is manufactured, processed, packed, or held that does not 
come into contact with food must be so constructed that it can be kept in a clean and 
sanitary condition. 
  Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, 
closed, and automated systems, must be of a design and construction that enables them 
to be maintained in an appropriately clean and sanitary condition. 
  Each freezer and cold storage compartment used to store and hold food capable of 
supporting growth of microorganisms must be fitted with an indicating thermometer, 
temperature-measuring device, or temperature-recording device so installed as to 
show the temperature accurately within the compartment. 
  Instruments and controls used for measuring, regulating, or recording temperatures, 
pH, acidity, water activity, or other conditions that control or prevent the growth of 
undesirable microorganisms in food must be accurate and precise and adequately 
maintained, and adequate in number for their designated uses. 
  Compressed air or other gases mechanically introduced into food or used to clean 
food-contact surfaces or equipment must be treated in such a way that food is not 
contaminated with unlawful indirect food additives. 
F. Processes and Controls (21 CFR 117.80) 
  General -  
(1) Conduct all operations in the manufacturing, processing, packing, and 
holding of food  including operations involved in receiving, inspecting, 
transporting, and segregating  consistent with adequate sanitation principles. 
(2) Use appropriate quality control operations to ensure that food is suitable for 
human consumption and that food-packaging materials are safe and suitable. 
34  Contains Nonbinding Recommendations 
(3) Place overall sanitation of the plant under the supervision of one or more 
competent individuals assigned responsibility for this function. 
(4) Take adequate precautions to ensure that production procedures do not 
contribute to allergen cross-contact or to contamination from any source. 
(5) Use chemical, microbial, or extraneous-material testing procedures where 
necessary to identify sanitation failures or possible allergen cross-contact and food 
contamination. 
(6) Reject all food that has become contaminated to the extent that it is adulterated, 
or if appropriate, treat or process the food to eliminate the contamination. 
  Raw Materials and Other Ingredients 
(1) Assure that raw materials and other ingredients are clean and suitable for 
processing into food by inspection, segregation, or other methods as necessary. 
Store them under conditions that protect against allergen cross-contact and against 
contamination and that will minimize deterioration. Wash or clean raw materials as 
necessary to remove soil or other contamination. For washing, rinsing, or conveying 
food, only use water that is safe and of adequate sanitary quality. Water may be 
reused for washing, rinsing, or conveying food if it does not cause allergen cross-
contact or increase the level of contamination of the food. 
(2) Either make certain that raw materials and other ingredients do not contain 
levels of microorganisms that may make the food injurious to the health of 
humans, or pasteurize or otherwise treat them during manufacturing operations so that 
they no longer contain levels that would cause the product to be adulterated. 
(3) Ensure that raw materials and other ingredients susceptible to contamination 
with aflatoxin or other natural toxins comply with FDA regulations for poisonous 
or deleterious substances before these raw materials or other ingredients are 
incorporated into finished food. 
(4) Ensure that raw materials, other ingredients, and rework that is susceptible to 
contamination with pests, undesirable microorganisms, or extraneous material 
comply with applicable FDA regulations for natural or unavoidable defects if they are 
to be used in manufacturing food. 
(5) Hold raw materials, other ingredients, and rework in bulk, or in containers 
designed and constructed so as to protect against allergen cross-contact and 
against contamination.  Hold them at the temperature and relative humidity and in a 
manner necessary to prevent the food from becoming adulterated. Material scheduled 
for rework must be identified as such. 
35  Contains Nonbinding Recommendations 
(6) Keep frozen raw materials and other ingredients frozen. If thawing is required 
prior to use, it must be done in a manner that prevents the raw materials and other 
ingredients from becoming adulterated. 
(7) Hold liquid or dry raw materials and other ingredients received and stored in 
bulk form so that they are protected against allergen cross-contact and against 
contamination. 
(8) Identify raw materials and other ingredients that are food allergens, as well 
as rework that contains food allergens, and hold them in a manner that prevents 
allergen cross-contact. 
  Manufacturing Operations  
(1) Maintain equipment and utensils and food containers in an adequate condition 
through appropriate cleaning and sanitizing, as necessary. When necessary, take 
equipment apart for thorough cleaning. 
(2) Conduct all food manufacturing, processing, packing, and holding under the 
conditions and controls necessary to minimize the potential for the growth of 
microorganisms, allergen cross-contact, contamination of food, and 
deterioration of food. 
(3) Hold food that can support the rapid growth of undesirable microorganisms at 
temperatures that will prevent the food from becoming adulterated during 
manufacturing, processing, packing, and holding. 
(4) Ensure that measures such as sterilizing, irradiating, pasteurizing, cooking, 
freezing, refrigerating, controlling pH, or controlling a  that are taken to destroy 
w
or prevent the growth of undesirable microorganisms are adequate under the 
conditions of manufacture, handling, and distribution to prevent food from being 
adulterated. 
(5) Handle work-in-process and rework in a manner that protects against allergen 
cross-contact, contamination, and growth of undesirable microorganisms. 
(6) Take effective measures to protect finished food from allergen cross-contact 
and from contamination by raw materials, other ingredients, or refuse. When 
raw materials, other ingredients, or refuse are unprotected, they must not be handled 
simultaneously in a receiving, loading, or shipping area if that handling could result 
in allergen cross-contact or contaminated food. Protect food transported by conveyor 
against allergen cross-contact and against contamination as necessary. 
36  Contains Nonbinding Recommendations 
(7) Equipment, containers, and utensils used to convey, hold, or store raw 
materials and other ingredients, work-in-process, rework, or other food must be 
constructed, handled, and maintained during manufacturing, processing, packing, and 
holding in a manner that protects against allergen cross-contact and against 
contamination. 
(8) Take adequate measures to protect against the inclusion of metal or other 
hazardous material in food. 
(9) Food, raw materials, and other ingredients that are adulterated: 
  Must be disposed of in a manner that protects against the contamination of 
o
other food; or 
  If the adulterated food is capable of being reconditioned, it must be: 
o
  Reconditioned using a method that has been proven effective; or 
  Reconditioned and reexamined and found no longer to be 
adulterated before being incorporated into other food. 
(10) Perform steps such as washing, peeling, trimming, cutting, sorting and 
inspecting, mashing, dewatering, cooling, shredding, extruding, drying, 
whipping, defatting, and forming so as to protect food against allergen cross-
contact and against contamination. Protect food from contaminants that may drip, 
drain, or be drawn into the food. 
(11) When heat blanching is required in the preparation of food capable of 
supporting microbial growth, heat the food to the required temperature, hold it at this 
temperature for the required time, and then either rapidly cool the food or pass it to 
subsequent manufacturing without delay. Growth and contamination in blanchers by 
microorganisms that grow at high temperatures must be minimized by the use of 
adequate operating temperatures and by periodic cleaning and sanitizing as necessary. 
(12) Treat or maintain batters, breading, sauces, gravies, dressings, dipping 
solutions, and other similar preparations that are held and used repeatedly over 
time so that they are protected against allergen cross-contact and against 
contamination, and minimizing the potential for the growth of undesirable 
microorganisms.  
(13) Perform filling, assembling, packaging, and other operations so that the food 
is protected against allergen cross-contact, contamination and growth of undesirable 
microorganisms. 
37  Contains Nonbinding Recommendations 
(14) Food, such as dry mixes, nuts, intermediate moisture food, and dehydrated 
food that relies principally on the control of a  for preventing the growth of 
w
undesirable microorganisms must be processed to and maintained at a safe moisture 
level. 
(15) Monitor and maintain food, such as acid and acidified food, that relies 
principally on the control of pH for preventing the growth of undesirable 
microorganisms at a pH of 4.6 or below. 
(16) When ice is used in contact with food, make it from water that is safe and of 
adequate sanitary quality. Ice must be used only if it has been manufactured in 
accordance with current good manufacturing practice. 
G. Warehousing and Distribution (21 CFR 117.93) 
Store and transport food under conditions that will protect against allergen cross-contact and 
against biological, chemical (including radiological), and physical contamination of food, as well 
as against deterioration of the food and the container. 
H. Defect Action Levels (21 CFR 117.110) 
  The manufacturer, processor, packer, and holder of food must utilize quality control 
operations at all times that reduce natural or unavoidable defects to the lowest level 
currently feasible. 
  The mixing of a food containing defects at levels that render the food adulterated with 
another lot of food is not permitted and renders the final food adulterated, regardless of 
the defect level of the final food. For examples of defect action levels that may render 
food adulterated, see the Defect Levels Handbook, which is accessible at 
http://www.fda.gov. 
XIV. 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 117.95(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 
38  Contains Nonbinding Recommendations 
  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 
  During holding, human food by-products for use as animal food must be accurately 
identified 
 In addition: 
  Labeling that identifies the by-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 
117.95(b)). 
  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 117.95(c)). 
XV. DEFINITIONS 
Acid foods or acidified foods: Foods that have an equilibrium pH of 4.6 or below. 
Adequate: That which is needed to achieve the intended purpose in keeping with good public 
health practice. 
Affiliate: Any facility that controls, is controlled by, or is under common control with another 
facility. 
Allergen cross-contact: The unintentional incorporation of a food allergen into a food. 
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 a supplier's food safety processes and 
procedures. 
Batter: A semifluid substance, usually composed of flour and other ingredients, into which 
principal components of food are dipped or with which they are coated, or which may be used 
directly to form bakery foods. 
Blanching, except for tree nuts and peanuts: A prepackaging heat treatment of foodstuffs for an 
adequate time and at an adequate temperature to partially or completely inactivate the naturally 
occurring enzymes and to effect other physical or biochemical changes in the food. 
39  Contains Nonbinding Recommendations 
Correction: An action to identify and correct a problem that occurred during the production of 
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 food for safety, and 
prevent affected 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. 
Defect action level: A level of a non-hazardous, naturally occurring, unavoidable defect at which 
FDA may regard a food product adulterated and subject to enforcement action under section 
402(a)(3) of the Federal Food, Drug, and Cosmetic Act. 
Environmental pathogen: A pathogen capable of surviving and persisting within the 
manufacturing, processing, packing, or holding environment so that food may be contaminated 
and may cause foodborne illness if that food is consumed without treatment to significantly 
minimize the environmental pathogen. Examples of environmental pathogens for the purposes of 
this part 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 Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of part 1, 
subpart H of this chapter. 
Farm:  
(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: 
40  Contains Nonbinding Recommendations 
(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 
(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:  (1) Articles used for food or drink for man or other animals, (2) chewing gum, and (3) 
articles used for components of any such article, and includes raw materials and ingredients.  
Food allergen: Major food allergens defined in section 201(qq) of the FFDCA, i.e., milk, eggs, 
fish (e.g., bass, flounder, cod), crustacean shellfish (e.g. crab, lobster, shrimp), tree nuts (e.g., 
almonds, walnuts, pecans), peanuts, wheat, soybeans, and any ingredient that contains protein 
derived from one or more of them. 
Food-contact surfaces: Surfaces that contact human food, and surfaces from which drainage  or 
other means of transfer  onto the food, or onto surfaces where food contact ordinarily occurs 
during the normal course of operations. Food-contact surfaces include utensils and 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. 
41  Contains Nonbinding Recommendations 
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 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 FFDCA. 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, 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. 
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 food 
would, based on the outcome of a hazard analysis (which includes an assessment of the severity 
of the illness or injury 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 a food and components, and to manage those controls (such as 
monitoring, corrections or corrective actions, verification, and records) as appropriate to the 
food, the facility, and the nature of the preventive control and its role in the facility's food safety 
system. 
Holding: Storage of food, and activities performed incidental to storage of a food, e.g., activities 
performed for the safe or effective storage of that food, such as fumigating 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 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 FFDCA. 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 
food. 
Lot: The food produced during a period of time and identified by an establishment's specific 
code. 
42  Contains Nonbinding Recommendations 
Manufacturing/processing: Making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating 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, formulating, freezing, grinding, homogenizing, irradiating, 
labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, 
peeling, 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 food to decomposition, that indicate that food is 
contaminated with filth, or that otherwise may cause food to be adulterated. 
Mixed-type facility: An establishment that engages in activities that are exempt from registration 
under section 415 of the FFDCA as well as activities that require the establishment to be 
registered. An example is a farm mixed-type facility, 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 food into a container other than packaging4 the food and also includes re-
packing and activities performed incidental to packing or re-packing a food (e.g., activities 
performed for the safe or effective packing or re-packing of that 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 Federal Food, Drug, and Cosmetic Act.  
Pathogen: A microorganism of public health significance. 
PCHF:  The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food Regulation (21 CFR Part 117) 
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 human food. 
                                                 
4 Packaging means placing food into a container that directly contacts the food and that the 
consumer    receives 
43  Contains Nonbinding Recommendations 
Preventive controls: Those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, processing, packing, or 
holding of 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 as required by  117.180(c)(2). Examples of potential 
qualified auditors include: 
(1) A government employee including a foreign government employee5,; and 
 (2) An audit agent of a certification body that is accredited in accordance with regulations in 
part 1, subpart M of this chapter6. 
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  1.227 of this chapter) that: 
 (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: 
                                                 
5 For example, a government inspector 
6 See 21 CFR part 1, subpart M, Accreditation of Third-Party Certification Bodies to conduct Food Safety Audits 
and to Issue Certifications 
44  Contains Nonbinding Recommendations 
(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 individual: A person who has the education, training, or experience (or a combination 
of these) necessary to manufacture, process, pack, or hold clean and safe 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. 
Quality control operation: A planned and systematic procedure for taking all actions necessary 
to prevent food from being adulterated. 
Raw agricultural commodity: means 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. 
Ready-to-eat food (RTE food): Any food that is normally eaten in its raw state or any other food, 
including a processed food, for which it is reasonably foreseeable that the food will be eaten 
without further processing that would significantly minimize biological hazards. 
Receiving facility: A facility that is subject to subpart C, Hazard Analysis and Risk-Based 
Preventive Controls,  and subpart G, Supply-Chain Program, and that manufactures/processes a 
raw material or other ingredient that it receives from a supplier. 
Restaurant: A facility that prepares and sells food directly to consumers for immediate 
consumption. Restaurant does not include facilities that provide food to interstate 
conveyances, central kitchens, and other similar facilities that do not prepare and serve food 
directly to consumers. Entities in which food is provided to humans, such as cafeterias, 
lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, 
catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants 
Retail food establishment: An establishment that sells food products directly to consumers as its 
primary function. A retail food establishment may manufacture/process, pack, or hold food if the 
establishment's primary function is to sell food, including food that it manufactures/processes, 
packs, or holds, from that establishment directly to consumers. A retail food establishment's 
primary function is to sell food directly to consumers if the annual monetary value of sales of 
food products directly to consumers exceeds the annual monetary value of sales of food products 
to all other buyers. The term consumers does not include businesses. A retail food 
establishment includes grocery stores, convenience stores, and vending machine locations. 
45  Contains Nonbinding Recommendations 
Rework: Clean, unadulterated 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 food. 
Safe-moisture level: A level of moisture low enough to prevent the growth of undesirable 
microorganisms in the finished product under the intended conditions of manufacturing, 
processing, packing, and holding. The safe moisture level for a food is related to its water 
activity (a ). An a  will be considered safe for a food if adequate data are available that 
w w
demonstrate that the food at or below the given a w will not support the growth of undesirable 
microorganisms. 
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 the consumer. 
Significantly minimize: To reduce to an acceptable level, including to eliminate.  
Small business: For purposes of this rule, a business (including any subsidiaries and affiliates) 
employing fewer than 500 full-time equivalent employees. 
Subsidiary: Any company which is owned or controlled directly or indirectly by another 
company. 
Supplier: The establishment that manufactures/processes the 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 food: Packaged 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 $1,000,000, adjusted for inflation, per year, during the 3-year 
period preceding the applicable calendar year in sales of human food plus the market value of 
human food manufactured, processed, packed, or held without sale (e.g., held for a fee). 
46  Contains Nonbinding Recommendations 
Water activity (a  ): A measure of the free moisture in a food and is the quotient of the water 
w
vapor pressure of the substance divided by the vapor pressure of pure water at the same 
temperature. 
You: For purposes of this rule, the owner, operator, or agent in charge of a facility. 
 
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