FOOD SAFETY MODERNIZATION ACT

Good Manufacturing
Practices
for Making Low-Risk Foods
A Guide for Small-Scale Farms and Food Businesses

By Eduardo Gutierrez, Ph.D, NC State University Dept. of Food, Bioprocessing and Nutrition Sciences, Patricia Tripp, MS, Roland McReynolds, Esq.,
and Ravi Jadeja, Ph.D, Oklahoma State University Dept. of Animal and Food Sciences and Robert M. Kerr Food & Ag Products Center.

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Table of Contents
CHAPTER 1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 GMP Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 Definitions & Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

CHAPTER 2 Hazards in Food Processing . . . . . . . . . . . . . . . . 8

2.1 Microbiological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.3 Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

CHAPTER 3 Basic Concepts for Proper Food Preservation . . . . 19

3.1 Basic Food Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.2 pH (Acidity & Alkalinity) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.3 Water Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.4 Temperature Controls in Food Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5 Oxygen & Air Management During Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

CHAPTER 4 Good Manufacturing Practices . . . . . . . . . . . . . 26

4.1 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.2 Plant Grounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.3 Sanitary Operations (General maintenance) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.4 Sanitary Facilities & Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.5 Equipment & Utensils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.6 Processes & Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.7 Warehousing & Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.8 Human Food Byproducts for Use as Animal Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.9 Defect Action Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

This material is based upon work that is supported by the National Institute of Food and Agriculture, U.S. Department of
Agriculture, under award number 2016-70020-25789. Any opinions, findings, conclusions, or recommendations expressed in this
publication are those of the authors and do not necessarily reflect the view of the U.S. Department of Agriculture.

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CHAPTER 1
INTRODUCTION
Proper food preservation begins by knowing how food is grown, packed and/or manufactured
and by identifying and understanding which microbiological, chemical and physical hazards are
associated with different foods and food handling activities during food preparation. Spoilage of
foods can lead to different conditions conducive to food safety hazards and potentially foodborne
illnesses. Other lapses in the manufacture and packaging of foods can create risks for injury
and poisoning. Current Good Manufacturing Practices (cGMPs) are the foundation for a food
manufacturer to successfully minimize these risks to consumers.

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This manual was developed to be a resource for small and medium-scale processors Appendix 1). While these businesses are not exempt from HARPC and SC, they can
of certain types of foods that are regulated by the US Food and Drug Administration take advantage of the fact that FDA has determined the foods they produce are
(FDA) under the Food, Drug and Cosmetic Act (FDCA). FDA requires entities making low-risk to dramatically reduce the paperwork and effort they invest in HARPC and
food for human consumption to register with the agency as food ‘facilities’ SC programs. That’s because by complying with cGMPs they are addressing the most
and to properly apply cGMPs in producing their foods. In 2011 the Food Safety significant food safety risks that a HARPC and SC program would need to address in
Modernization Act (FSMA) became law, and FDA made significant changes to its food the case of low-risk foods; a business making low-risk foods that is in compliance
processing regulations as a result, including some important revisions to the cGMP with cGMPs therefore achieves the purpose of the HARPC and SC regulations, and
requirements, which now apply to virtually all processed foods only requires a little extra documentation to meet rule requirements.
under FDA jurisdiction.1
Any business that is making low-risk foods can benefit from this manual, including
Additionally, FDA’s FSMA regulations create requirements for many food businesses to Qualified Facilities. In the following pages we will explain the essentials of GMPs and
implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Supply allow you to understand the FDA food safety regulations that are relevant to your
Chain (SC) programs. These are complex rules that add further layers of food safety operation. We will also help you understand and identify the hazards that your food
management on top of the cGMPs. However, there are exemptions to the HARPC and safety program should address, and provide basic information about necessary steps
SC requirements that are important for small businesses to understand. for successful food manufacturing and preservation. And we will explain FDA’s rules
on labeling foods that may contain allergens, and help you ensure you don’t cause
Exemptions from HARPC and SC illness or injury to people with food allergies.
• Qualified Facilities This applies to establishments with less than $1 million in This manual does not address FSMA’s rules for farms growing produce, nor for
average annual sales2 of human food. Qualified facilities must give notice to FDA businesses packing, holding and processing animal food. We will not cover state or
that they fall under this sales threshold and annually verify whether their sales local rules that may govern food safety practices in addition to the FDCA. We will not
remain below that level. They also must warrant to FDA at least every two years cover state or county ‘cottage food laws’ that may cover food safety at home-based
that they have identified potential hazards in their production processes and are businesses as an alternative to the FDCA. (We do include a resource guide that will
taking all necessary steps to control those hazards. help you find answers to those questions elsewhere.) But if your farm or business
is making any of the low-risk foods included in Appendix 1, this guide will help you
• Low-Risk Food/Activity Combination Exemption This applies to establish-
understand how to ensure you follow the cGMPs that apply to those foods, and meet
ments with fewer than 500 full-time equivalent employees that are located on
FDA’s food safety regulations for food manufacturing of low-risk foods.
farms and that only pack, hold or manufacture foods that the FDA has determined
to be ‘low-risk’. For the full FDA list of these low-risk foods, see Appendix 1. Taking every reasonable step to minimize foreseeable food safety risks in the foods
you make is more than just a legal requirement. It’s a responsibility to, and covenant
Producers that fall under these two exemptions are not required to implement
with, your customers and the people who will eat your products. And it’s just plain
HARPC and SC programs; however, they must comply with cGMPs
good business. You want the public to trust that your food will not cause them physi-
beginning in September, 2018.
cal injury or illness. The collaborators behind this manual, Carolina Farm Stewardship
Importantly, food businesses with less than 500 employees that are not located on Association, North Carolina State University and Oklahoma State University, con-
farms still need to know about the Low Risk Activity/Food Combination (LRAFC) gratulate you for taking on the challenge of making good food, and for making the
exemption if they only pack, hold or manufacture foods on FDA’s low-risk list (see commitment to protect your customers through good food safety practices.

1 Businesses that pack, hold or manufacture food that make the majority of their sales directly to consumers are not covered by the Food, Drug and Cosmetic Act or FSMA, and are not required to register with FDA.
Making foods at these businesses – such as restaurants, grocery stores, CSAs, farm stands, and caterers – is usually subject to regulation by local public health agencies. Some states may also have ‘cottage food
laws’ that cover these establishments.
2 A business determines its average annual sales using the three previous years’ sales. The dollar threshold for the Qualified Exemption is to be adjusted for inflation, with 2011 as the base year for calculating that
adjustment. For 2018 the threshold is actually $1,079,963.

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 1 STEP ONE 2 STEP TWO

ENROLL & COMPLETE ENROLL & COMPLETE

Distance Education 1b STEP ONE PART B In-Person Workshop
Good Manufacturing Good Manufacturing
Done!
TRAINING
Practices Module ENROLL & COMPLETE Practices Module COMPLETED
Distance Education
Food Specific Modules
・ Preserves ・ Blanching
・ Dehydration ・ Frozen Foods

1.1 GMP Training

STEP ONE STEP TWO
Program participants must first complete the online Distance Education (DE) Once participants have completed the DE cGMP module and any relevant food
module specific to Good Manufacturing Practices (cGMPs). Then if any of the several specific DE module(s), they are eligible to participate in the final step of the training
additional DE modules specific to manufacturing certain types of food apply to your program consisting of an in-person workshop that covers the fundamentals of the
business, you should complete those courses too. Participants are only required to FDA’s cGMP regulations
complete the DE food specific module(s) that align best with the type of food they
are manufacturing. All DE courses include quizzes that must be passed with a score of
80 percent or higher.

Additional DE Food-Specific Modules

• Jellies, Jams and Preserves
• Food Dehydration
• Blanching
• Frozen Foods

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1.2 Definitions & Acronyms
The following terms and acronyms will be used throughout this manual.
Allergen A food ingredient that contains protein derived from a classified allergen Cosmetic Act that outline the conditions and practices that facilities must follow for
to include the top eight as identified by the FDA (milk, eggs, fish, crustacean shellfish, sanitary food processing. The details of the GMPs and what they require in terms of
tree nuts, peanuts, wheat and soy). personnel, sanitation, facility maintenance, equipment and utensils, warehousing
and distribution, and responses to contamination incidents are covered in Chapter 3
Acid food Food that has a natural equilibrium pH of 4.6 or below.
of this manual.
Allergen cross-contact The unintentional incorporation of a food allergen into food.
Hazard Any biological, chemical, or physical agent that has the potential to cause
Cross-contamination The unintentional transfer of a foodborne pathogen from a illness or injury. See Chapter 2 for a detailed discussion.
food or insanitary object to another food.
Hazard Requiring a Preventive Control A known or reasonably foreseeable
Facility Any establishment, structure or structures under one ownership at one hazard for which a person knowledgeable about the safe manufacturing, process-
general physical location or, in the case of a mobile facility, traveling to multiple ing, packing, or holding of food would establish one or more preventive controls to
locations, that manufactures / processes, packs or holds food for consumption in significantly minimize or prevent the hazard (biological, chemical or physical) in food.
the United States. It may consist of one or more contiguous structures, and a single Conducting an assessment evaluating the severity and probability of the illness or
building may house more than one distinct facility if the facilities are under separate injury if the hazards were to occur in absence of the preventive control may be neces-
ownership. The private residence of an individual is not a facility, and Retail Food sary. Management of the preventive controls must be addressed in the Food Safety
Establishments (see below) are not facilities. Facilities are required Plan after determining the control’s role in the food safety system as appropriate to
to register with FDA. the food, facility and the nature of the preventive control. This may include monitor-
ing, corrections or corrective actions, verification and recordkeeping.
Food Spoilage A process mediated by microorganisms (bacteria, molds, yeast and
fungi), enzymes (substances naturally present in food or introduced into a food Hazard Analysis and Risk-based Preventive Controls (HARPC) A system of food
by microorganisms that accelerate degradation) and chemicals present or formed processing, packing and handling controls that food manufacturers, processors,
inside the food. They all lead to food deterioration to a point at which it is not edible packers, and storage facilities are required to follow under FSMA, unless covered by
to humans. Spoilage is controlled by maintaining proper storage temperatures, an exemption. Facilities that are not exempt from HARPC must:
managing oxygen or carbon dioxide levels in the storage atmosphere, controlling
• Identify food safety and adulteration hazards associated with their foods
relative humidity, as well as by ensuring the cleanliness of the raw agricultural
and processes
commodities used to make the food. Spoilage occurs over time, gradually making the
food less desirable, and can lead to a foodborne illness if pathogens have been able • Implement controls to minimize the hazards
to grow or if existing microorganisms have produced toxins that cause human illness.
• Verify that the controls are working
Spoilage results in changes in the appearance, smell, flavor and texture of a food.
These parameters could also indicate that favorable conditions could have occurred • Design and implement corrective actions to address any deviations from the
for foodborne illness microorganisms to grow and/or produce toxins, although some controls that might arise in a food safety plan
of these toxins can be produced without detectable spoilage.
Harvesting Harvesting means activities that are traditionally performed on farms
Foodborne Illness A process that occurs when we consume foods that are contam- for the purpose of removing raw agricultural commodities from the place they
inated with a microorganism (pathogenic bacteria, viruses, parasites) or a chemical were grown or raised, and preparing them for use as food. Harvesting is limited to
(toxin) produced by microorganisms (mainly bacterial pathogens or fungi) that is activities performed on raw agricultural commodities, or on processed foods created
capable of producing illness. Foodborne illnesses can range in intensity from mild by drying/dehydrating a raw agricultural commodity without additional manufactur-
intestinal disorders to death. ing/processing, on a farm. Harvesting does not include activities that transform a raw
agricultural commodity into a processed food (see definition for manufacturing/pro-
Foodborne Infection Pathogenic microorganisms located in food that invade the
cessing). Examples of harvesting include cutting (or otherwise separating) the edible
human body after consumption of contaminated food. Growth of the microorgan-
portion of the raw agricultural commodity from the crop plant and removing or
isms in the food will not be necessary to cause illness. Examples: pathogenic E. coli,
trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems).
Salmonella, Listeria monocytogenes and all parasites and viruses.
Examples of harvesting also include cooling, field coring, filtering, gathering, hulling,
Foodborne Intoxication Pathogenic microorganisms that grow in the food and removing stems and husks from, shelling, sifting, threshing, trimming of outer leaves
produce a toxin that causes illness when the food is consumed cooked or raw. Growth of, and washing raw agricultural commodities grown on a farm.
of the microorganism in the food is necessary to produce the toxin. If the pathogen
Holding The storage of food, including activities performed incidental to storage
doesn’t grow in the food, it will not produce toxin and so will not produce intoxica-
of a food (e.g., activities performed for the safe or effective storage of that food,
tion. Examples: Staphylococcus aureous, Bacillus cereus and Clostridium botullinum.
such as fumigating food during storage), and drying/dehydrating raw agricultural
Food-contact surface Any surface that will come into contact with human food, commodities when the drying/dehydrating does not create a distinct commodity
including utensils and food-contact surfaces of equipment. (such as drying/dehydrating grapes into raisins). Holding also includes activities
performed as a practical necessity for the distribution of that food (such as blending
GMPs (Good Manufacturing Practices) Also referred to as Current Good
of the same raw agricultural commodity and breaking down pallets), but does not
Manufacturing Practices (cGMPs), the FDA regulations under the Food, Drug and

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include activities that transform a raw agricultural commodity into a processed food Prerequisite program Procedures, including Good Manufacturing Practices (GMPs),
(see definition for manufacturing/processing). Holding facilities could include ware- that provide the basic environmental and operating conditions necessary to address
houses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. risks in food processing activities.
Manufacturing/Processing Making food from one or more ingredients, or synthe- Process controls Procedures, practices and processes to ensure the control of
sizing, preparing, treating, modifying or manipulating food, including food crops parameters during operations such as heat processing and refrigerating foods.
or ingredients. For farms and farm mixed-type facilities, manufacturing/processing
Qualified Individual A person who has the education, training, or experience (or a
does not include activities that are part of harvesting, packing or holding.
combination thereof) necessary to manufacture, process, pack, or hold clean and safe
Microorganisms Yeast, molds, bacteria, viruses, protozoa, and microscopic para- food as appropriate to the individual’s assigned duties. A qualified individual may be,
sites, including species that are pathogens. but is not required to be, an employee of the establishment.
Packing Placing food into a container other than packaging the food, including Raw agricultural commodity Any food in its raw or natural state, including but not
activities performed incidental to packing a food (examples: activities performed limited to all fruits and vegetables that are washed, colored or otherwise treated in
for the safe or effective packing or re-packing of that food including sorting, culling, their intact natural form prior to marketing.
grading, and weighing or conveying incidental to packing or re-packing). Packing
Retail Food Establishment A business that manufactures foods and sells more than
does not include activities that transform a raw agricultural commodity into a pro-
half those products directly to consumers, including through on-premises sales, farm-
cessed food. Note: Packaging means placing food into a container that directly contacts
ers markets, community-supported agriculture, roadside stands, online, mail-order
the food and that the consumer receives.
and other direct marketing platforms. Depending on state law and the kind of foods
Preventive Controls Risk-based, reasonably appropriate procedures, practices, and made, a retail food establishment may be regulated by the local health department.
processes consistent with the current scientific understanding of the safe manufac-
SAHCOD Hazard A hazard that has a high risk of causing Serious Adverse Health
turing, processing, packing, or holding of food employed to significantly minimize
Consequences or Death.
or prevent the hazards identified under a hazard analysis. A hazard analysis refers
to the process of collecting and evaluating information on hazards (microbiological, Supply Chain (SC) Program A system for assessing the risks for hazards in food
chemical or physical) and the conditions leading to their presence to determine ingredients and materials provided by upstream suppliers that FSMA requires food
whether they must be addressed in the Food Safety Plan. The Food Safety Plan for manufacturers, processors, packers, and storage facilities to implement unless
operations manufacturing low-risk foods is based on the establishment and imple- they are covered by an exemption. A facility subject to HARPC must implement
mentation of Good Manufacturing Practices (GMPs) and any other process controls a risk-based SC program if its hazard analysis identifies a hazard that requires a
that minimize potential food safety risks. preventive control that should be applied by an upstream supplier. A facility does not
need to have a supply-chain program if it takes action to control the hazard, or if a
Preventive Controls Qualified Individual (PCQI) A qualified individual who has
subsequent entity (such as another processor) will control the hazard, and the facility
successfully completed training in the development and application of risk‐based
follows applicable cGMP requirements.
preventive controls at least equivalent to that received under a standardized curricu-
lum recognized as adequate by FDA, or is otherwise qualified through job experience Water activity (aw) A measure of the free moisture (available water) in a food.
to develop and apply a food safety system.
Pathogen A microorganism of public health concern because it is likely to cause
foodborne illness, intoxication or injury.
pH A measure of acidity or alkalinity of water soluble substances (pH stands for
‘potential of Hydrogen’). A pH value is a number from 1 to 14, with 7 as the middle
(neutral) point. Values below 7 indicate acidity, which increases as the number
decreases, 1 being the most acidic.

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CHAPTER 2
Hazards in Food Processing
The starting place for a small business’s food safety program is understanding the food safety
hazards that are relevant to its products. A hazard is any biological, chemical (including
radiological), or physical condition that can cause illness or physical injury and is known to be,
or has the potential to be, associated with a food or with the facility where a food is made.
This chapter discusses these terms and other important factors impacting food spoilage
and food safety.

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 Table 1. Biological, chemical and physical hazard sources.
SOURCE BIOLOGICAL HAZARD CHEMICAL HAZARD PHYSICAL HAZARD
Workers Disease, skin, hair, nails, and clothing Soaps, greases, pest control substances, Jewelry, clothing, pens, gum, paper
or other chemicals used inside or outside
the manufacturing area
Ingredients or Materials Microorganisms associated with each Allergens, lubricants or other chemicals Foreign materials
ingredient or cross-contamination used in manufacturing
within processing areas
Equipment Poor sanitation practices and procedures Lubricants, cleaning agents and exhaust Metal fittings/shavings and parts
and problems with airflow contamination on food contact surfaces
Processes Cross contamination, poor heat Boiler chemicals in steam generation or Foreign materials
treatments and storage conditions from residues
including inappropriate temperature
Building Structures Floors, condensation of water, pests, Ventilation effluents from different Metal, wood, glass, plastic, and paper
traffic or product flow and walls/ceilings rooms and chemicals during in storage

Any particular hazard may be introduced into a food at any time during the Fortunately for manufacturers of low-risk foods, FDA has already analyzed
journey from field to fork, including during harvesting, processing/manufacturing, of the relevant reasonably foreseeable hazards in these foods and determined the
transportation, or storage. There are five key sources of contamination to address controls necessary to prevent them. In its FSMA regulations, FDA specifically identi-
in your food safety plan. fies these types of low-risk foods, and comes to the conclusion that establishments
that only make the foods on this list will adequately address all hazards requiring
Key Potential Sources of Contamination to Address preventive controls if they implement GMPs. FDA’s list of low-risks foods can be found
in Appendix 1.
• Workers
For Qualified Facilities making only low-risk foods, this means that having
• Ingredients or materials
a compliant GMP program satisfies FDA’s requirement that you identify potential
• Equipment hazards in your production processes and take all necessary steps to control those
hazards. Beginning in 2020, FDA’s documentation requirements for this exemption
• Manufacturing processes themselves
require you to file a written statement with the agency every two years that you have
• Building structures conducted this review of your hazards and your controls, which must be submitted
during the period Oct. 1 and Dec. 31. You can confidently make that assurance by
Table 1 above correlates these potential contamination routes to the relevant likely
verifying that you are still only making foods on the low-risk list and that you are
biological, chemical and physical hazards.
compliant with GMPs.
FSMA further defines a hazard requiring a preventive control as known or
Farm-based LRAFC producers that are not Qualified Exempt, but that have fewer
reasonably foreseeable biological, chemical or physical hazards for which a person
than 500 employees, don’t have to file such a written statement at any interval.
knowledgeable about the safe manufacturing, processing, packing, or holding of
Implementing GMPs will control all hazards requiring preventive controls.
food would establish one or more preventive controls to significantly minimize or
prevent the hazards in food. Producers of LRAFCs only that aren’t based on a farm, that aren’t Qualified Exempt,
and that have fewer than 500 employees also benefit from FSMA’s low-risk determi-
To determine if there are such reasonably foreseeable hazards in packing, holding
nations. You are required by FSMA to have a written food safety plan and a written
or manufacturing a food, a food maker would conduct an assessment of the risk
hazard analysis, and to implement preventive controls as part of a HARPC program.
of such hazards and the severity and probability of any illness or injury if those
But because FDA has already done the hazard analysis with respect to these low-risk
hazards were to occur. This hazard analysis would involve collecting and evaluating
foods, your written food safety plan will simply discuss your GMP program, and your
information on microbiological, chemical or physical hazards and the conditions
hazard analysis simply needs to state that you are producing only foods that are
leading to their presence to determine their significance for food safety. Management
deemed low-risk by FDA and that therefore your GMP program is sufficient to address
would then need to identify the actions necessary to prevent those hazards, i.e.
all hazards. And because adhering to GMPs in low-risk foods inherently controls any
preventive controls.
hazards that might be present in raw materials that you bring in from other suppliers,
FSMA defines preventive controls as risk-based, reasonably appropriate procedures, you can also cite your GMP program as your basis for a decision not to implement a
practices, and processes consistent with the current scientific understanding of the Supply Chain Program.
safe manufacturing, processing, packing, or holding of food employed to significantly
The following sections discuss the key biological, chemical and physical hazards that
minimize or prevent the hazards identified under a hazard analysis.
are of concern in food production and that GMPs are designed to address.

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2.1 Microbiological Hazards
The CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in
the United States. Foodborne microbial pathogens linked to produce, meat and poultry contamination at field, packing or
processing environments include bacterial, fungal, viral, and protozoa organisms. These pathogens may become problematic
under certain conditions including inadequate cleaning and sanitation, inappropriate equipment or facilities, temperature
abuse, poor storage conditions (overcrowding), excessive moisture exposure, inadequate heat treatments and lack of training.
These aspects form part of the basic establishment of a GMP program to manufacture food.
To control microbiological hazards we need to think like including soil, water, plants, air and the skin of humans
a microbe and understand where they come from, what where constant fluctuations in moisture, temperature and
Favorable Conditions Influencing Bacteria,
they need to grow and survive, and where they live within food sources occur. Those fluctuations in resources are
Mold and Yeast Growth
our food growing and manufacturing environments. In considered detrimental to Gram-negative bacteria because
general, when we think of bacterial pathogens we first Remember the acronym FATTOM+ they are accustomed to living in very favorable conditions.
need to consider their growing conditions and how they Gram-positive microorganisms in contrast tend to adapt,
Food (nutrient source)
are built. It is also important to note that only bacteria, survive and grow under many different environments,
Acidity (pH factors)
molds and yeast grow in foods, while viruses and para- resist different environmental stresses and utilize and
Time
sites only grown within their host, not in food, and would source a wide range of environmental nutrients. Examples
Temperature
only cause an illness through cross-contamination. include: Staphylococcus aureus, Clostridium botulinum
Oxidation Reduction Potential (reduced/no oxygen)
(proteolitic and non-proteolitic), Streptococcus, Listeria
Because of the large number and diversity of low-risk Moisture (water activity)
monocytogenes, Bacillus cereus.
foods, it is not possible to cover all processes and GMPs + Microbial Competition
relevant for controlling microbiological hazards for every Irrespective of whether a bacteria are Gram-negative
low-risk food category, but the following information or Gram-positive, one of the most important factors
will provide the basic concepts needed to guide you in impacting microbial loads (concentrations) in food and
successful food manufacturing. food environments is the generation time of these microorganisms. In simple terms,
Generation time is the amount of time it takes for bacteria to double in numbers
BACTERIA (Figure 2), and can be manipulated by controlling and/or modifying the following
components of a food or food ingredients.
Understanding the origin, basic structural characteristics and potential routes of con-
tamination of microbiological hazards will allow any food manufacturer to address Factors that Affect Figure 2. Generation time of some
and control these hazards before they become a problem in food manufacturing Bacterial Growth bacteria under ideal temperature,
environments. In the case of bacteria, the structural characteristics of these organ- nutrient, oxygen, acidity and water
• Water Activity
isms impact the potential efficacy of sanitizers, including their ability to penetrate conditions.
(available free water in food)
bacterial membranes and inactivate or oxidize those membranes. TIME # OF BACTERIA
• Acidity
In general, bacteria are classified as either Gram-positive or Gram-negative (Figure 20 min 2
1). This is important because some sanitizers available in the food industry are less • Oxygen
effective on Gram-negative bacteria, and others are less effective on Gram-positive 40 min 4
• Nutrients
ones. Knowing whether the bacteria that are likely hazards in the specific foods you 1 hour 8
make are Gram-positive or Gram-negative helps you determine the correct sanitizer • Temperature
to use. In general, Gram-negative bacteria that are human pathogens live in the 80 min 16
Bacteria can multiply in environments
intestinal and respiratory tracts of many animals or insects and are accustomed
outside of a host organism as well as 100 min 32
to warm, moist conditions,
inside a host. Most can multiply very
favorable pH and a constant 2 hours 64
quickly, reaching high numbers in
Figure 1. Gram-negative (left); food supply. Examples include:
a short period of time if they are in 4 hours 4096
Gram-positive (right) Pathogenic E. coli, Salmonella
the right environment. It is unlikely
spp., Shigella, Campylobacter 6 hours 262,144
that only a single bacterial cell will
jenuni, Vibrio cholerae, Vibrio
be present on a food or food contact
parahaemolyticus, Yersinia
surface, or in an environment; Where
enterocolitica, Brucella spp.
there is one, there are usually many others and sometimes millions. Some pathogens,
Gram-positive bacteria that such as E. coli O157:H7, can cause illness with just 10 cells ingested. Other pathogens
are human pathogens tend to require a much higher dose: Listeria monocytogenes needs around
live in natural environments 1,000 cells to cause illness.

10 Good Manufacturing Practices Manual • [Link]

Under favorable conditions, some bacteria can multiply (double) once every 20
Figure 3. Generation time of some bacteria under ideal temperature, nutrient,
minutes and it is unlikely that in food or on food contact surfaces the initial microbial
oxygen, acidity and water conditions.
load is determined by only one bacterium. Consequently, higher initial microbial
loads will lead to rapid microbial accumulation under certain growing conditions
(see Figure 3). Under the ideal growing conditions, one bacteria could multiply into How Bacteria Grow
hundreds of thousands organisms within a matter of 6 hours. Such conditions can
occur in food or food environments. Making sure that adequate processes and that all
cGMPs are in place will reduce or eliminate these microorganisms and the likelihood Stationary

LOG NUMBER OF BACTERIA

of pathogen contamination that carries over into the finished product. Foods that are
th)

Deat
allowed to be processed as low-risk activity food/combinations under FSMA are those ow
that do not necessarily provide growth conditions that will favor pathogen growth g (Gr

h
due to being high in acidity, salt or sugar, or because producing them requires that Lo
they undergo manufacturing processes that eliminate microbiological hazards. Lag
Another important aspect in microbial growth is related to how microorganisms
grow under different environments. In general bacteria grow following an exponen-
tial growth curve with four distinct phases. TIME
Phases of Bacteria Growth
through toxin-producing spores resulting in food intoxication. The toxin is produced
1 Lag
after the spore has germinated into a new vegetative cell as part of the
2 Log or Growth reproduction process.
3 Stationary Vegetative cells are destroyed by heat in food processing, but spores are very
resistant to heat: it takes temperatures above 100° C to destroy them. Spore-forming
4 Death
bacteria become a concern under anaerobic conditions found on different foods even
Temperature, water activity, salt or sugar content, preservatives, acidity, fermen- if these foods use preservatives, dehydration or other hurdles to reduce the ability
tation, ethanol concentrations and oil content will impact each phase differently, of bacteria to grow. In many instances, thermal processes are designed to inactivate
delaying or accelerating each phase depending on the conditions needed by any spores that would otherwise germinate under storage conditions once the food has
particular microorganism. been prepared, packaged and shipped.
Lag phase At this stage bacteria adapt themselves to their surrounding conditions. Bacteria and spores are both inhibited from growing in high acid environments (pH
They are not yet able to divide and they are in the process of maturing. During this below 4.6). In foods with high acidity and low water activity, germination of spores
phase synthesis of RNA, enzymes and other molecules occurs. from Clostridium botulinum, Clostridium perfringens and Bacillus cereus is unlikely.
However, during the dehydration and blanching processes that might be applied in
Log (Growth) phase This period is characterized by cell doubling and the number of
preparing vegetables and spices for further low-risk processing, these pathogens
new bacteria appearing per unit time is proportional to the present population. The
could produce spores or existing spores may germinate, producing the toxin, if ger-
actual rate of this growth depends upon the growing conditions in the food or food
mination conditions are not controlled. And if this happens, the toxin will remain in
environment, which affect the frequency of cell division.
food even after thermal processing, potentially causing severe intoxication to those
Stationary phase During this period bacterial growth is stopped by factors such as consuming these products.
the depletion of an essential nutrient, or the formation of an inhibitory product such
The most common vegetative and spore forming human pathogens that could be
as an organic acid. Stationary phase results from a situation in which growth rate and
found in foods, food ingredients and food environments are illustrated in Table 2.
death rate are equal.
Because some of the ingredients can be used in making low risk foods, it’s important
Death phase In this period bacteria die due to lack of nutrients and environmental to consider potential microbial hazards relevant to those ingredients so you can
conditions, including stressful temperatures and toxic chemicals produced by the properly control those hazards during food manufacturing.
bacteria that injure cells and cause cell death.
Other strategies that could be used to control and potentially remove pathogens
The goal in manufacturing food is to provide the necessary hurdles within the manu- include the removal of available water from food through desiccation and the use of
facturing process that will prevent bacteria from entering food or from entering the preservatives followed by storing the food under aerobic conditions to prevent spore
Log growth phase if they are present, since under ideal conditions bacterial numbers germination. The most common vegetative and spore forming human pathogens
could reach millions of organisms in a matter of hours depending on the characteris- associated with food, food environments or sick humans are listed in Table 3, while
tics of the organism. Table 4 describes FDA’s current understanding of LRAFCs, their associated human
pathogens and key cGMPs. Understanding the origin of each microorganism within
Bacteria can exist as active vegetative cells or dormant spores. Vegetative cells form
the food chain is important in identifying hazards and th GMP practices needed to
spores under adverse conditions as a mean of survival. When conditions become
prevent contamination from these microorganisms.
favorable, the spores germinate, with each spore again becoming a vegetative cell
with the ability to reproduce. Some bacterial pathogens cause disease when humans
directly consume the vegetative cells in food, while others cause disease indirectly

Good Manufacturing Practices Manual • [Link] 11

Table 2. Food ingredients associated with different biological hazards Table 3. Common vegetative and spore forming bacteria
INGREDIENT SOURCE POTENTIAL BIOLOGICAL HAZARD VEGETATIVE BACTERIA SPORE FORMERS
Raw milk and raw Campylobacter, Salmonella, Brucella, Mycobacterium • Brucella spp. • Produce a spore that allows them to
milk products spp., Strep group A survive harsh conditions.
• Campylobacter
Soft cheese and refrigerated Listeria monocytogenes • Once harsh conditions pass, spore
• Pathogenic E. Coli
ready-to-eat foods opens and a new vegetative cell
• Listeria monocytogenes grows and is able to produce toxins.
Eggs Salmonella
• Mycobacterium bovis Examples
Meat and poultry Salmonella, EHEC, C. perfringens,
Campylobacter (poultry), L. monocytogenes, • Salmonella spp. • Bacillus cereus
Yersinia enterocolitica (pork) • Shigella spp. • Clostridium botulinum
Grains and cereal products Salmonella, EHEC, Bacillus cereus (rice) • Staphylococcus aureus (capable of • Clostridium perfringens
producing a heat stable toxin)
Fruits and vegetables(fresh) Salmonella, EHEC, L. monocytogenes, viruses,
Clostridium botulinum (vegetables), parasites • Streptoococcus group A
Tree nuts/peanuts Salmonella, EHEC • Vibrio spp.

Spices Salmonella, EHEC, C. perfringens • Yersinia enterocolitica

Non-potable water/ice Salmonella, EHEC, viruses, parasites

EHEC is Enterohemorrhagic E. coli, one of the most important E. coli groups within the genus Escherichia.

Table 4. LRAFC, associated pathogens and key cGMPs in food.

LOW-RISK ACTIVITY FOOD EXAMPLES OF FINISHED PRODUCT ASSOCIATED PATHOGEN KEY CGMPS
COMBINATION
Baked grain products Bread, Cookies Clostridium botulinum, Clostridium Control of water activity, prevention
perfringens, Bacillus cereus, of hydration during packaging, storage
Staphylococcus aureus and transport
Chopping, coring, cutting, peeling, Acid fruit and vegetable products that Bacillus cereus, Clostridium perfringens, Sanitation procedures, equipment
pitting, shredding, and slicing of foods. have a pH less than 4.2, Sliced baked Staphylococcus aureus, Pathogenic E. coli use, maintenance and design of
goods, Shredded dried cereals, equipment, sourcing of food (supply
Dried herbs or spices, Gums, resins, chain best practices), water quality,
Game meat jerky sanitizer concentrations
Boiling Gums, latexes and resins Salmonella, Mycotoxins, Sanitation of boiling equipment,
Staphylococcus aureus avoidance of cross contamination after
boiling, bottling conditions
Dried Foods Rice/pasta, Pulses/grains, Herbs/spices, Salmonella, Pathogenic E. coli, Control of water activity, prevention of
Dried game meat, Chips, Cereals Staphylococcus aureus, Bacillus cereus, hydration during packaging, storage and
C. Perfringens, Aflotoxins (nuts) transport, application of preservatives
including sulfites
Freezing Acid fruits and vegetables with Salmonella, Pathogenic E. coli, Listeria Sanitation of trays and freezing
a pH below 4.2 monocytogenes equipment, water quality, sourcing of
ingredients (supply chain best practices)
Extracting (through pressing, distilling, Oils, Herbal extracts Salmonella, Pathogenic E. coli, Sanitation of pressing unit,
or with solvents) dehydrated herbs, Staphylococcus aureus, C. Perfringens concentration of solvent (generally
fresh herbs, fruits and vegetables, ethanol concentrations), sanitation
grains and spices of distillation equipment
Coating Dried or dehydrated fruits and Salmonella, Pathogenic E. coli, Water quality, sanitation of utensils and
vegetables, nuts, grains, popcorn Staphylococcus aureus, C. Perfringens equipment including trays/other vessels

12 Good Manufacturing Practices Manual • [Link]

FUNGI YEASTS Yeast in a petri dish
This group of single cell or multicellular organisms can occur as yeasts, molds, and Yeasts are important
mushrooms. The cell is larger than a bacterial cell, and the organism reproduces by microorganisms in food
releasing spores, which can produce mycotoxins during germination that cause food preservation or spoilage.
intoxication. Fungi spores are able to survive the high temperatures and pH extremes This group of single cell
often used in food preservation. Freezing also does not kill fungi spores. Thus control microscopic organisms
of vegetative cells of fungi during food storage, dehydration, extraction, baking reproduces by budding.
and coating before they enter the spore-forming stage is essential to reduce the risk Some may form filaments
of human disease. This could be achieved through sanitation practices that reduce (pseudohyphae, or false
microbial loads, by sourcing ingredients that at least meet USDA grade standards, hyphae) similar to those
and by maintaining a pest and debris free environment. formed by molds. There
are over 1,500 species of
MOLDS Mold in a petri dish
yeast, many of them with
food manufacturing implications. In general they are capable of converting sugar
Molds are important in into alcohol and carbon dioxide, and they are normally found in fruits and berries
the food industry and rich both in sugars and organic acids that allow yeast to grow and reproduce. Heating
often used to add flavor foods to 77° C destroys most yeast forms, and therefore yeasts are unlikely to present
or color to cheese and a food safety risk in processed foods. Yeasts are found in soil, insects, the guts of
sauces. They are long mammals, deep-sea environments and in and on human bodies. Those associated
branching thread-like fil- with humans generally live on the skin and could potentially cause disease. Examples
aments, often referred to of yeast found in humans that are known to cause disease include Candida albicans
as hyphae. Some molds and Rhodotorula rubra, which can become a source of cross contamination.
and yeasts can cause
Control methods for yeast within cGMPs are mainly linked to good personal hygiene
disease or food spoilage.
and proper hand washing practices.
Others have an important
role in food production
Normal Uses for Yeast During Low Risk Food Production
including beverages, biodegradation or in the production of antibiotics and enzymes.
Molds are also used in the making of food additives such as lactic or citric acid. In • Baking
general molds require moisture to be able to develop, thus the water activity in food
• Extraction
tends to determine their ability to grow on certain foods. If they are not controlled
before they reach the reproductive stage, molds will release spores into the air which • Dehydration
can contaminate enclosed environments and the respiratory tracts of humans. Most
molds have little heat resistance and cannot survive thermal processes.
VIRUSES
General Characteristics of Molds Viruses are microscopic and the smallest of all the microbiological associated hazards.
They can survive outside their host for over 2–3 weeks. Viruses are unique because
• Tolerate a lower pH and water activity than bacteria
they can only grow and reproduce inside the cells of their host, meaning they cannot
• Produce mycotoxins (chemical hazard) reproduce in or on food products and the environment, but can be transmitted by
food that is contaminated with these organisms. There are millions of viruses in
• Raise the pH of food by metabolizing organic acids
the environment, but 219 virus species have been known to infect humans. Only a
few virus cells are needed to cause disease in humans, and they are easily spread
Control Methods for Mold in Food Manufacturing through the environment or from person to person. Enteric viruses are viruses that
• Thermal processing can be passed to humans through food via the gastrointestinal tract, and according
to the CDC are the number one cause of human foodborne disease; however, fatality
• Use of preservatives (mold inhibitors)
rates are low when compared to bacterial pathogens like Listeria monocytogens and
• Low water activity Salmonella enterica. In most cases, humans infected with enteric viruses shed those
viruses in feces, and this can happen when an individual is showing disease symp-
toms or if the virus remains present in the host after infection. Viruses are spread to
food through cross contamination from human feces by food handlers who have not
washed their hands properly before touching food or food contact surfaces. Examples
of viruses associated with food include Norovirus and Hepatitis A. Prevention is key
to reducing the spread of viruses, including basic handwashing, proper restroom use,
and immediate illness reporting prior to handling food.

Good Manufacturing Practices Manual • [Link] 13

Human Norovirus (NoV) Norovirus typically produces the following symptoms: human transmission through a fecal-oral route is possible. Protozoa that live in blood
nausea, vomiting, abdominal pain or cramps, watery or loose diarrhea, malaise, low- or tissue are transmitted to humans by an arthropod vector such as mosquito or sand
grade fever and muscle pain. It has a very low infectious dose (1–10 viral particles) fly bites.
with an incubation period between 24–48 hours, and symptoms may persist for up
Three specific parasites that are considered foodborne protozoan parasites are Giardia
to 3 days in individuals that are not immunocompromised. Infected individuals can
lamblia, Cryptosporidium parvum and Cyclospora cayetanensis; for all of them the
pass disease to others after symptoms have subsided and for up to 3 weeks after.
common mode of transmission is contaminated water, and all are highly tolerant to
Elderly and children and immunocompromised individuals tend to be the most
chlorine disinfection. They most commonly cause diarrhea and other gastrointestinal
affected by this virus.
symptoms, and they most often contaminate food due to food handlers not following
The use of sanitizers could help reduce or eliminate NoV contamination. However, not good hygiene practices.
all sanitizers are able to inactivate this microorganism, and some others need very
high concentrations to effectively inactive them: in the case of chlorine solutions, Classifications of Human-Infecting Protozoa, Based on their Mode
concentrations of up to 1000ppm may be needed to inactivate NoV. of Movement
Hepatitis A (HAV) HAV is associated with liver disease and gastrointestinal symp- • Sarcodina – the ameba, e.g., Entamoeba,
toms including nausea, fever, anorexia, diarrhea, and jaundice. Disease symptoms
• Mastigophora – the flagellates, e.g., Giardia, Leishmania,
last up to 2 weeks in humans that are not immunocompromised and greater than 5
years old. It can be controlled through vaccination, but in general is associated with • Ciliophora – the ciliates, e.g., Balantidium, and
poor hygiene practices, contamination by direct contact with infected individuals
• Sporozoa – organisms whose adult stage is not motile (moving spontaneously),
and by ingestion of contaminated food and water. It has a very low infectious dose
e.g., Plasmodium, Cryptosporidium
of 10 or fewer viral particles, and disease symptoms can occur up to 50 days post
contamination; Progressive disease has been reported in 1–1.5% of cases, lasting up Irrespective of the type and movement of protozoa, their importance in food
to 6 months. contamination can’t be under estimated. Many food ingredients including herbs,
spices, fruits and vegetables and game meats may carry large concentrations of
Control Methods for Viruses in Food Processing these microorganisms. Their presence is mainly impacted by growing, handling and
processing conditions. For example Giardia lamblia is an infective protozoan with
• Vaccination (for HAV)
reservoirs in infected humans and domesticated and companion animal species, and
• Good personal hygiene and proper hand washing its outer shell makes it tolerant to UV light and chlorine levels. It’s mainly associated
with water, soil and fecal contamination of foods prior to harvest and during other
• Thermal processing
food processing. Infected food handlers normally shed Giardia cysts in feces, leading
• Sanitizers (in some instances and under certain circumstances to reduce the to contamination of food or food contact surfaces if handlers do not wash
survival and persistence of viruses in food environments) their hands adequately.
Cryptosporidium parvum is another protozoa associated with consumption of con-
PARASITES taminated water and infected wild and domestic animals. Like Giardia, its outer shell
allows it to survive outside the host for prolonged periods of time and makes it very
Parasites are single or multicellular organisms that live in the environment and on
tolerant to chlorine disinfection and desiccation.
or within a host (human or animal). They tend to source or receive their energy and
food from the environment or their host, and parasites of public health concern are Cyclospora cayetanensis is another protozoa associated with consumption of con-
transmitted through water, soil or fecal/oral transmission. Parasites can remain taminated water, herbs, fresh fruits and vegetables due to contaminated feces or
viable in the environment for long periods of time and are often transmitted through irrigation water. It needs days to weeks after being passed in a bowel movement to
water contaminated with fecal matter. Infection from these organisms causes a tre- become infectious for other individuals. Berries and some species of leafy greens are
mendous burden of disease around the world, especially in tropical and subtropical among the produce items most commonly associated with this disease.
latitudes. Not all parasites can multiply in food, and some are not heat resistant.
Control Methods for Protozoa in Food Processing
Protozoa Protozoa are single-celled organisms that can live in nature and multiply
in humans, contributing to their survival and persistence under multiple natural and • Freezing
anthropogenic environments. Transmission from environmental sources to humans
• Thermal processing
is typically through ingestion of contaminated water or food, although human-to-

14 Good Manufacturing Practices Manual • [Link]

2.2 Chemical Hazards
Chemical hazards found in food and food environments are substances that can cause a health problem when ingested or
inhaled, including toxins, chemicals and chemical residues. Chemical hazards may either be naturally occurring (mycotoxins),
intentionally added (nitrates, sulfites, preservatives, color additives, and synthetic substances approved for use in food), or
unintentionally added (chemical residues from sanitizers, pesticides or environmental pollutants) in foods. Food allergens are
also classified as a chemical hazard.
Chemical hazards can produce acute foodborne In food processing, it is possible for heavy metals to
illness, or chemical poisoning through consumption leach from unsuitable materials being used as food
Sources of Chemical Hazards in Food Processing
of abnormally high doses of chemicals. The risk level contact equipment, including acidic food being fed
• Ingredients, including color additives
depends on the duration of exposure and toxicity of the through copper and lead pipes. The implementation
• Allergens
substance. The most effective control of contamination of GMPs, requiring that food contact surfaces be
• Food contact surfaces
from these hazards is prevention through the estab- made of suitable, nonporous, nontoxic material, will
• Employees
lishment of food safety controls, including making sure reduce the risk of heavy metal contamination in a food
• Non-food grade chemicals, such as pesticides
chemicals are applied solely for their intended use, and production process.
following all instructions on chemical labels.
All chemicals used in making food or used in a food facility should have a letter of INDUSTRIAL CHEMICALS
guarantee from the manufacturer, which specifies in writing the controls, treatments
Contamination of food with these toxic chemicals may occur unintentionally during
and analyses that have been performed to reduce or eliminate these hazards from
food manufacturing activities. It is important to consider these potential hazards in
the use of those substances.
your cGMP program since in many instances they are overlooked. These chemicals are
associated with high risk and low risk food combinations, and the examples provided
PESTICIDES below highlight situations where they may be present in low risk foods.
Pesticides are substances that are designed to control pests, weeds and diseases, Acrylamide Acrylamide is a known carcinogen that is formed in food through
and eliminate or reduce pathogens, particularly in the production of food. They high-temperature cooking methods such as baking, frying and roasting, and is a
include insecticides, fungicides, herbicides, rodenticides, sanitizers and molluscicides. particular concern with starchy foods. Examples of foods most at risk are potato prod-
Pesticides must be registered with the US Environmental Protection Agency (EPA) ucts such as crisps and chips; coffee; crackers; bread; and other cereal products. The
and be used according to label instructions. Use and application of these chemical European Union funded the first to study issues with acrylamide formation, which
substances is regulated, and applicator licenses are needed to apply certain resulted in the development of industry guidelines for minimizing contamination
types of pesticides. risks, which are summarized below.
The U.S. Department of Agriculture (USDA) and EPA regulate and monitor the use
Industrial Guidelines for Minimizing Acrylamide Risk
and residues of these substances to ensure any contamination is within safe limits.
The limits apply both to food produced in the USA and imported from elsewhere. • Avoiding sources of asparagine;
Monitoring of pesticide residues on foods and food-contact surfaces may be a
• Avoiding long cooking times and high cooking temperatures where possible; and
requirement for certain ingredients, and pesticide analysis in finished food products
could be an appropriate verification activity that demonstrates that pesticides have • Replacing ammonium bicarbonate as a processing aid in bread.
been used in according to their labels and relevant federal regulations.
Chloropropanols Chloropropanols are a group of chemical contaminants, the most
notable of which is 3-monochloropropane-1,2-diol (3-MCPD), that can occur in foods
HEAVY METALS and food ingredients at low levels as a result of processing, migration from packaging
materials during storage, or cooking by the end-user of the food. It has been found
Heavy metals are metals with high atomic mass including mercury, cadmium, arsenic
in a variety of foods including malt extracts, baked products, dehydrated leaves
and lead. Toxic in low amounts, heavy metals are recognized as a health hazard for
including teabags, and fried foods. Control of processing conditions and selection of
humans linked to contamination of food from the environment. Once in the food,
ingredients and packaging materials is the main strategy to control
these metals cannot be removed. In fresh produce, lead and cadmium are the most
levels of Chloropropanols.
common heavy metals of concern for consumers, while lead and mercury are the
most common metal contamination sources in fish. In order for contamination to Furans Furans are colorless and volatile liquids used in some chemical manufacturing
occur, the growing environment must have high concentrations of these chemicals. industries and found in foods. It is believed that Furans form in food during heat
Federal regulations establish maximum acceptable levels for each heavy metal con- treatment techniques such as cooking, bottling, and canning. Furan has been found
taminant, which tend to be specific to metal-food type combinations. Control of raw in bottled foods, beans, pasta meals, herb extracts, and oils.
materials is the only mechanism for ensuring that levels do not become unsafe.
Dioxins/Polychlorinated biphenyls (PCBs) These are persistent manmade toxic
chemicals used in multiple industries, and they have been found in soil, water,

Good Manufacturing Practices Manual • [Link] 15

sediment, plants and animal tissue in all parts of the world. Their release to the Polycyclic aromatic hydrocarbons (PAHs) PAHs are a group of compounds that
environment generally occurs as a byproduct of fires and by certain manufacturing are considered to be carcinogenic and to be genotoxic. They are mainly found in
processes. Their widespread environmental occurrence means that they may be pres- petroleum and coal, and can be formed by the incomplete combustion of these fuels
ent in any foods, and food is the most common route of human exposure. The highest or other organic materials. PAHs have been detected in air, water, soil and foods.
concentrations are found in fatty foods, oil infusions, and dehydrated fruits. The only Foods may become contaminated through direct environmental exposure, migration
control to ensure safe levels of these chemicals in processed food is to prohibit their from packaging material, or during high-temperature processing such as baking and
use in the production of foods and food ingredients. frying. The occurrence of PAHs in fruit, vegetables and cereals is primarily due to soil
and air exposure. Other foods of concern are fish, fats and oils including cocoa butter,
and smoked foods.

Figure 4. Top 8 Food Allergies in the US

MILK SOY FISH PEANUTS

WHEAT CRUSTACEAN SHELLFISH TREE NUTS EGGS

FOOD ALLERGENS (naturally occurring chemicals)

Food allergens are chemical contaminants that can result in serious health conse- One of the most common mistakes in food manufacturing is improper labeling
quences in humans. A food allergy refers to an immune system reaction that occurs of foods, especially the failure to disclose potential allergens in a food product.
from consuming certain foods. This reaction can occur almost immediately after con- Undeclared allergens are a leading cause of food recalls, accounting for 47 percent of
suming food or just by being exposed to small quantities of the allergen. Symptoms all recalls of FDA regulated foods in 2014. The National Institutes of Health estimates
associated with allergen exposure can range from digestive problems, hives or that 4 percent of adults and 5 percent of children have food allergies.
swollen airways, to anaphylaxis in severe cases. In general the best approach to
Those situations can be significantly reduced by the implementation of an allergen
eliminate any issues associated with allergens is through avoidance of the allergens.
control plan that includes labeling guidelines and controls coupled with prevention
In the United States there are 8 main sources of allergens responsible for over 90% of
of cross-contact by scheduling, using different equipment and utensils to handle
food allergic reactions (Figure 4).
allergens, and implementing a sanitation program that eliminates allergen residues
When allergens are present in a food handling area, it is important to be sure proper from food contact surfaces. Because of the significant health hazards that food aller-
controls are in place to reduce the risk of cross-contamination of non-allergenic foods gens cause in susceptible individuals, it is important to understand and follow FDA’s
with allergen-containing foods. This is especially important when using a shared- allergen labeling rules for the good of your customers and your business. See Chapter
use kitchen where others may be processing foods containing allergens. A robust 4.3 for a detailed discussion of federal allergen labeling requirements.
cleaning routine can assist in the removal of allergens, but the use of sanitizers alone
is not 100% effective for removing allergens.

16 Good Manufacturing Practices Manual • [Link]

FUNGAL TOXINS (chemical toxins)
We mentioned previously that molds, a biological hazard, are capable of producing levels of mycotoxin contamination. Some examples of the most relevant mycotox-
a chemical hazard called mycotoxins. There are several foodborne mycotoxins found ins found in food are the following: Aflatoxins, Ochratoxins, Fumonisins, Patulin,
in a wide variety of agricultural products worldwide. Food processing techniques Trichothecenes, and Zearalenone (Table 5 and Table 6).
such as milling and heat treatments at specific time/temperature controls can reduce

Table 5. Most common mycotoxins found in foods, their health impacts and production conditions.
FUNGAL TOXIN COMMON FOOD CROPS AFFECTED HEALTH EFFECTS OPTIMAL GROWING CONDITIONS
Aflatoxins Peanuts, corn, milk and cheese, meat Carcinogenic effects, immuno- 10-48 °C, water activity (aw) as low as
Aspergillus flavus, Aspergillus parasiticus (contamination from livestock feed), suppression, jaundice, liver failure and 0.82 and pH in the range of 2.0-11.0
nuts, grains, soybeans, figs dried spices other symptoms
and cocoa beans
Ochratoxin A (OTA) Cereal grains, coffee, pork products, Carcinogenic effects, kidney damage Temperatures ranging from 5-40
Aspergillus ochraceus, Aspergillus wine, beer and dried grapes °C, optimal growth at temperatures
carbonarius, Penicillium verrucosum 25-30°C
Fumonisins Corn, sorghum and other cereal grains Carcinogenic effects (humans), brain Moisture content at or above 14%
Fusarium verticillioides, Fusarium disease (livestock)
proliferatum, Fusarium spp.; Aspergillus
niger
Patulin Damaged and rotting fruits, fruit juices Carcinogenic effects 10-48 °C, water activity (aw) as low as
Aspergillus, Penicillium patulinum and vegetables (Apples most common) 0.82 and pH in the range of 2.0-11.0

Table 6. Common chemical hazards associated with different food and food environments.
CATEGORY CHEMICAL HAZARD POTENTIAL SOURCES
Plant toxins Toxins, Curcubitacins, Cyanogenic glycosides, Naturally occurring in different plant cultivars
Glycoalkaloids, Lectins
Biogenic amines No histamine sources By products of bacterial growth produced during food
spoilage before or after packaging of game meats,
dehydrated foods
Contaminants from Food Contact Materials Bisphenol A, Phthalates, Semicarbazide Can be found in packaging, water,
food contact surfaces
Radiological Strontium-96, iodine-131 and cesium-137 Sources include water, produce, soil, air, packaging
materials and ingredients with radionucleotides

Good Manufacturing Practices Manual • [Link] 17

2.3 Physical Hazards
Physical hazards are either foreign materials unintentionally introduced to food products or naturally occurring objects that
are hazardous to the consumers and that can contaminate food at any stage of production. In Table 1, we mentioned several
sources of physical hazards often found in food.
Potential risks associated with physical hazards are determined by the physical Physical Hazard Detection Methods
characteristics of the object (shape, size, sharpness), the type of product,
• Magnets to attract or remove metals
and the individual consuming the product. All of them pose risks to consumers
including cuts to the mouth or throat, damage to the intestines, damage to teeth • Metal detectors to detect metal
or gums, and choking.
• X-Ray machines to identify hazards
Items that are 7 to 25mm are considered choking hazards for adults. For children,
• Visual Inspection
physical hazards smaller that 7mm could pose a significant choking risk. The severity
of the choking risk of any particular physical hazard is dependent on the physical Visual inspection is the most common method used in small-scale food processing.
characteristics (shape, hardness, sharpness) and material of the object. Table 7
Economically motivated hazards These are hazards that result from the addition of
highlights common materials risks.
any substance to food that could cause injury or illness to consumers and provide an
Several methods are available to detect foreign materials in food processing lines. economic advantage to the company. Examples include adding soy or almond oil to
another oil not containing any allergens, or adding melamine to milk products.

Table 7. Materials of concern as physical hazards and their common sources

CATEGORY INJURY POTENTIAL SOURCES
Glass Cuts, bleeding; may require surgery to remove Bottles, jars, light fixtures, utensils, gauge covers
Wood Cuts, infection, choking; may require surgery to remove Fields, pallets, boxes, buildings
Stones Choking, broken teeth Fields, buildings
Bullet/BB Shot/Needles Cuts, infection; may require surgery to remove Animals shot in fields, hypodermic needles used for
infections
Personal effects Choking, cuts, broken teeth; may require surgery Employee
to remove
Jewelry Cuts, infection; may require surgery to remove Pens/pencils, buttons, careless employee practices
Metal Cuts, infection; may require surgery to remove Machinery, fields, wire, employees
Insects and other filth Illness, trauma, choking Fields, plant post-process entry
Insulation Choking; long-term if asbestos Building materials
Plastic Choking, cuts, infection; may require surgery to remove Sources include water, produce, soil, air, packaging
materials and ingredients with radionucleotides.

18 Good Manufacturing Practices Manual • [Link]

CHAPTER 3
Basic Concepts
for Proper Food Preservation
The goal of food preservations is to minimize or eliminate the presence of microorganisms in food
and to inhibit or inactivate enzymes and chemical reactions that will accelerate food spoilage
during storage. This can be achieved by multiple approaches including the control of temperature,
oxygen, acidity, and water activity, and the addition of food preservatives to prevent the growth
of bacteria, fungi and other microorganisms. Food preservation ensures that food remains in a
state where it is not contaminated by pathogenic organisms or chemicals and maintains its optimal
qualities of color, texture and flavor.

Good Manufacturing Practices Manual • [Link] 19

3.1 Basic Food Characteristics
The internal or external characteristics of food can serve as a hurdle to delay or prevent microbial growth. In general, Internal
(Intrinsic Factors) are specific to the commodity. Examples include the following: available nutrients, available water, pH
(acidity or alkalinity) and physical structure. External (Extrinsic) refers to parameters that humans normally manipulate in
foods via formulation, processing, packaging or storage to modify the characteristics of foods. These modifications could also
serve to extend shelf life and reduce or control microbial growth. Some examples of external factors include the modification
of temperature, atmosphere (presence or absence of oxygen), packaging, water activity, and the use of preservatives like Nisin,
Potassium sorbate, Sulfur dioxide, Nitrate, Nitrite, Sodium propionate and Benzoic acid.

FOOD PROTECTION VS. FOOD SAFETY

Food protection refers to having controls within growing and processing environ- as Preventive Controls For Human Food). Food Safety refers to the implementation
ments where it is necessary to prevent contamination of food by a potential health of food growing, handling, preparation, and storage practices in ways that prevent
hazard. Control can be achieved through planning and implementation of GMPs foodborne illness. It can only be achieved by careful handling of foods at all points
and other food safety programs including HACCP (Hazard Analysis of Critical Control within the food chain and by establishing a food safety program based on successful
Points) or HARPC (Hazard Analysis and Risk-Based Preventive Controls, also known implementation of GMPs.

Table 8. Food preservation methods impacting microbial growth and safety of low risk foods
PRESERVATION METHOD LIMITING FACTOR IN FOODS IMPACT ON FOOD SAFETY AND MICROBIAL GROWTH
Use of Preservatives pH of the food limits type of preservative. They can be synthetic, Inhibition of specific groups of micro-organisms
or of bacterial origin like Nisin
Drying (Dehydration and Final moisture content, case hardening, and length of the process and Controls water activity in food. Low water availability prevents or
salt curing) salt concentration. The type of food, fat content, time of exposure, controls microbial growth. In general salt binds with water molecules
piece size and temperature impact curing and drying time and thus acts as a dehydrating agent in foods
Pasteurization of honey • Final moisture content and time/temperature of the technique • Heat inactivation of microorganisms (yeast, molds and some
to inactivate some vegetative cells vegetative bacteria including Clostridium spp)
• Time/temperature combinations vary with pasteurization • Reduces water activity to retard the fermentation, oxidation and
technique (avoiding crystallization) other spoilage reactions
• Will not inactivate environmental chemical contaminants
Refrigeration Won’t eliminate human pathogens and it reduces metabolic activities Low refrigeration temperatures will delay microbial growth before
from foods and microorganisms. May introduce or reduce moisture foods or food ingredients are processed.
content depending on the type of food
Freezing Composition and size of the food. Bulkier foods require longer This method slows or inactivates enzymatic reactions and oxidation
freezing times that could impact the size of ice crystals in food. Larger processes, it also reduces water activity and inactivates some
crystal will rupture food tissue and when thawing will increase water pathogens. It won’t inactivate toxins or other chemical contaminants
leakage due to ruptured tissues (quality issue)
Vacuum/low oxygen Anaerobic conditions may lead to off flavors and growth of Clostridium Low oxygen tension inhibits strict aerobes and delays growth of
packaging (No time/ and Bacillus pathogenic species facultative anaerobes
temperature controls)
Sugar preservation No all foods are suited for high sugar concentrations A high sugar concentration creates high osmotic pressure, which
impacts survival and growth of most microorganisms
Preserves pH, brix and packaging temperature Acidity at a pH of 3 to 3.5 used for the pectin to produce a gel, coupled
with brix vales of 63 to 68% (high solutes) and cooking times, control,
prevent or inactivate microbial growth.

20 Good Manufacturing Practices Manual • [Link]

Depending on the type of food and manufacturing conditions, different preservation as defined by FDA are foods that will present little to no risk to consumers when
methods can be used to extend the shelf life of food. This cGMP manual explains consumed because of their intrinsic characteristics and preservation and packaging
those manufacturing conditions that are of importance in manufacturing low methods. Table 8 illustrates some of the most common food preservation methods
risk activity/food combinations as described by FDA (Appendix 1). Low risk foods impacting the safety of food.

3.2 pH (Acidity & Alkalinity)

A pH of 6.0–7.5 is considered optimal for bacterial growth (Figure 5). Most food products fall within the slightly acidic
to neutral range. In general, having sufficiently high acidity/low pH controls/reduces microbial growth in foods. Every
microorganism has an optimum, maximum and minimum pH for growth, and by altering this acidity in foods we can alter the
growth rate (generation time), lag period, survival rates, and spore germination of a microorganism.
Foods with an intrinsic pH of 4.6 or less are classified as acid foods. An equilibrium will stop spore germination from Clostridium botulinum. Food makers can use milder
pH of 4.6 or below reduces the capacity of bacteria, fungi and yeast to grow, and thermal treatments for products with a pH of 4.6 or below, since the acidity coupled
with formulation and environmental conditions will combine to inactivate vegetative
cells and spores.
Figure 5. pH range of different chemicals and foods.
There are some other microorganisms that are capable of growing or surviving at low
pH, including many pathogenic E. coli strains, Salmonella and other microorganisms
(Table 9). For this reason it is imperative to reduce the potential for any foodborne

Basic illness by preventing cross contamination of

foods with these pathogens since high acidity
14 alone may not prevent growth or survival in
Illustration of pH meter
Sodium Hydroxide different high acid foods.
13 Household Bleach
Acidity is measured by using a pH meter.
12 This instrument measures the hydrogen-ion
Ammonia Solution activity in water-based solutions, indicating
11 Soap its acidity or alkalinity expressed as pH. It
measures the difference in electrical potential
10 Detergent between an instrument and a reference elec-
trode. The difference in electrical potential
9 Milk of Magnesia is linked to the acidity or pH of the solution.
In foods it is imperative to measure the
8 Eggs equilibrium pH. This is normally achieved over
Blood
Neutral 7 Pure Water
Milk
time and may require several measurements
before the pH has finally stabilized.
6 Table 9. Acidity (pH) limits for microbial growth of certain microorganisms
5 Coffee
of concern
Tomato Juice Salmonella spp 4.2-5.0
4
Orange Juice Staphylococcus (toxin) 4.0 (4.5)
3 Soda Pop Vibrio parahaemolyticus 4.8
Vinegar
2 Lemon Juice
C. botulinum (toxin) 4.6-5.0 (4.6)
1 Hydrochloric Acid Enterohemorrhagic [Link] 4.4
0 Aspergillus niger 1.2
Acidic

Good Manufacturing Practices Manual • [Link] 21

3.3 Water Activity Figure 6. Impact of water activity on microbial growth. Lower water
availability will slow down or even prevent microbial growth depending on
Water activity (aw) is a measure of the free moisture, water activity
or available water, in a product. It represents the quotient
of the water vapor pressure of the substance divided by
the vapor pressure of pure water at the same temperature.

BACTERIA CONCENTRATION
When all of the water is available, aw = 1, and when none is
aw = 0.97
available, aw = 0. Water activity values below 0.83 prevent
aw = 0.94
bacterial growth and germination of bacterial spores. Low
aw = 0.90
aw values aid in thermal processing: low water activity foods
may require milder heat treatments to inactivate human TIME

pathogens (see Figure 6).

Figure 7. Range in water activity of foods and some of the most important human
pathogens of concern.
INSTRUMENTS FOR MEASURING WATER ACTIVITY (aw) LIMITS
WATER ACTIVITY FOR MICROBIAL GROWTH
Electric Hygrometer Water activity is easily and accurately determined from the 0.98 Campylobacter
equilibrium relative humidity, a measure of the relative humidity of air in equilibrium
0.97 Clostridium botulinum type E (non-proteolytic)
with the sample food that is referred to as equilibrium relative humidity (ERH).
An electric hygrometer is used to measure ERH. This instrument uses resistance or 0.94 Salmonella
capacitance sensors to measure relative humidity. Any alteration in relative humidity
triggers a very rapid proportional change in capacitance. A single measurement takes 0.94 Clostridium perfringens
approximately 30 to 90 minutes. 0.93 Clostridium botulinum types A & B (proteolytic)
Dew Point Instrument This instrument Dew Point Instrument 0.92 Listeria monocytogenes
measures the temperature at which
condensation occurs on a cooled mirror in 0.83 Staphylococcus aureus (an aw of 0.86 for toxin production)
the headspace of its sample chamber. The
0.88 Many yeasts
aw is computed by converting temperatures
of the food sample and the mirror to vapor 0.75 Many molds
pressures and calculating the ratio between
them. It’s usually much faster than a WATER ACTIVITY (aw) OF SOME FOODS
hygrometer, generally taking only 5 minutes 0.97–1.00 Fresh Fruits
for a single measurement. However, this
instrument should not be used to measure 0.95–1.00 Cheese
products that are below 0.20 or 0.30 aw. And 0.95–1.00 Fresh Meat
although a dew point instrument costs less
than a hygrometer, it is also more delicate, 0.87–0.95 Cured Meat
and the condensation of water on the mirror
0.75–0.80 Jam
may trap airborne contaminants, hindering
the instrument’s accuracy. 0.70 Peanut Butter
Figure 7 summarizes a range of water activity, food and pathogen combinations. 0.54–0.75 Honey
This list is not exhaustive and will change based on the characteristics of the product.
Many low risk foods may fall at different water activity levels and manufacturers of 0.55–0.75 Dried Fruit
these foods should determine the water activity of the product to help them in the 0.55–0.80 Chocolate
establishment of controls to reduce microbial hazards.
0.10–0.20 Cereal
0.10 Crackers

22 Good Manufacturing Practices Manual • [Link]

3.4 Temperature Controls in Food Processing
There are two basic forms of thermal treatments to preserve food: a) subjecting the food to very low temperatures,
or b) subjecting the food to very high temperatures. In either case, the food must be held at the desired temperature for
a predetermined period of time in order to assure microbial inactivation of spoilage and pathogenic organisms.
Factors that Affect Thermal Processing HIGH TEMPERATURE TREATMENTS
• The container (heat penetration properties)
There are two main temperature categories in thermal processing: pasteurization
• Type of food and sterilization. The basic purpose for thermal processing is to reduce or eliminate
microbial activity, to reduce or eliminate enzyme activity, and to produce physical or
• Target microorganism
chemical changes to make the food meet a certain quality standard. This will provide
• pH of the food the necessary level of quality and food safety under the desired storage conditions of
the food receiving the thermal process.
• Fill weight vs. drained weight distribution
Pasteurization This technique is a relatively mild heat treatment, in which food is
LOW TEMPERATURE TREATMENTS heated to less than 100°C. It is mainly used for destroying enzymes, yeast, vegetative
pathogens and other microorganisms that are relatively heat-sensitive. The severity
Low temperature food preservation is based on the principle that less energy is avail- of treatment that is needed in a low risk food like honey, jam, jelly, and herbal
able at lower temperatures for microorganisms and chemical reactions to carry out extracts, and the impact of the treatment on the shelf life of the processed food, is
their normal function and any chemical reactions. This reduction in metabolic power determined mostly by the pH of the food and its water activity. In low acid foods (pH
reduces enzyme activity and metabolic activities of microorganisms. greater than 4.6), the main purpose is to eliminate pathogenic bacteria, while in acid
foods with a pH below 4.6 pasteurization is intended to destroy spoilage microorgan-
Refrigeration (< 4°C) Refrigeration slows down the chemical and biological
isms and enzymes.
processes in foods and the accompanying deterioration and the loss of quality. The
storage life of fresh perishable foods such as meats, fish, fruits, and vegetables can
Three Pasteurization Methods
be extended by several days following this process. This process involves cooling
only without any phase change. Fresh fruits and vegetables are alive and thus they 1 Batch Method The food is held in a container, heated to at least 63°C, and held
continue giving off heat that adds to the refrigeration load of the cold storage room. for at least 30 minutes before being packaged.
Removing the field heat and cooling as soon after harvesting can extend the storage
2 High Temperature Short Time (HTST) or Flash Pasteurization The food is
life of produce. The optimum storage temperature of most fruits and vegetables is
passed through a system of heat exchangers and tubes that heat the food to at
about 0.5 to 1 °C above their freezing point.
least 72°C and hold it at that temperature for at least 15 seconds.
Freezing (< -20°C) This process involves three stages: (1) cooling to the freezing
3 Package Pasteurization This method is used in some liquid foods. The thermal
point, (2) freezing, and (3) further cooling to the desired subfreezing temperature.
treatment occurs after filling the containers with the liquid and immersing these
Considerations in freezing foods include the type of food to be frozen and the freez-
containers in hot water. This process is normally used when packaging into glass.
ing method. Typically there are four methods used for frozen foods, and all of them
look to create small ice crystal as fast as possible to prevent quality issues during Two groups of microorganisms survive pasteurization temperatures. Thermoduric
long-term storage and during thawing. organisms can survive exposure to relatively high temperatures. Thermophilic organ-
isms not only survive relatively high temperatures, but require high temperatures for
Four Freezing Methods their growth
1 Air-blast Freezing High-velocity air at about -30°C is blown over Sterilization The aim of this process is to eliminate all bacteria, including their
the food products. spores. Heat treatment of such products must be severe enough to inactivate/ kill the
most heat resistant bacterial microorganisms, which are the spores of Bacillus and
2 Contact Freezing Packaged or unpackaged food is placed on or between cold
Clostridium. Foods are placed in sealed containers and they are heated to tempera-
metal plates.
tures above 100°C and normally range between 110 and 121°C, depending on the
3 Immersion Freezing Food is immersed in low temperature brine. type of product, and for a specific time that will allow the food to reach commercial
sterilization (CS). CS is defined a decrease in the amount of the microorganisms to 1
4 Cryogenic Freezing Food is placed in a medium cooled by a cryogenic fluid such
trillionth of the amount that was present before the thermal treatment, also referred
as liquid nitrogen or liquid/solid carbon dioxide.
to as a 12 Logarithm (12D) reduction of microorganisms. CS implies less than absolute

Good Manufacturing Practices Manual • [Link] 23

destruction of all microorganisms and spores, but any that remain would be incapa-
ble of growth in the food under existing conditions. These sterilization temperatures
THERMAL TREATMENTS & LOW RISK FOODS
are needed for short periods of time (within a few seconds) to inactivate spores from Although some low-risk foods require the application of time/temperature controls,
Bacillus or Clostridium. These spores can also be killed at lower temperatures, but low-risk foods generally do not need to be refrigerated (until opened) and tend to
longer heat treatment periods must be applied. be high in sugar, salt or acid and, in most cases, low in water content. A combination
of these food characteristics are needed to classify foods as low-risk. The thermal
Sterilization methods processes (sterilization) of canning, for example, are designated to destroy the spores
of the bacterium C. botulinum. Sterilization requires heating to temperatures greater
• Ultra-Heat Treatment (UHT) This is generally performed at high temperatures
than 100°C, which would be necessary in the sterilization of low-acid foods (pH
with a short treatment duration (1s at 135°C).
greater than 4.6), but this is not the case for acidic foods that have a pH less than 4.6
• Canning The product is stored in containers that are hermetically sealed and then where C. botulinum cannot survive. When canning in glass jars, sterilization of the jars
sterilized through heating at temperatures over 100°C; treatment duration will is needed, not of the product, and this is accomplished by filling the jars with the hot
depend on the food. liquid, for example in making jams and jellies.
• Aseptic Processing The product and the package are sterilized separately For similar reasons, the pasteurization of honey is considered low-risk. Honey is low
and then the package is filled with the sterile product and sealed under in water content and high in acidity, which means bacteria cannot survive in it. Unlike
specific conditions. juice and milk that are pasteurized for food safety purposes, honey is pasteurized
for quality purposes, reducing the chance of fermentation and delaying granulation.
Honey is pasteurized by heating it to 71°C and quickly cooling it.

3.5 Oxygen & Air Management During Packaging

Removal of oxygen from packaging is an important factor for preserving low risk foods including chips, nuts, crackers,
dehydrated foods, spices, cocoa beans, and coffee. Several methods are available and include: pressure canning; boiling
water canning for jams, jellies and preserves; and vacuum or modified atmosphere packing for foods that do not require
time/temperature controls for safety. Removal of oxygen from foods tends to inhibit growth and persistence of most
microorganisms; however, spore formers including Clostridium botulinum, Bacillus cereus and Clostridium perfringens can survive
in anaerobic conditions and so can become a food safety problem for food manufacturers and consumers. Therefore GMPs and
the manipulation of other factors (temperature, acidity or water activity) must be employed to reduce hazards associated with
spore formers.

MODIFIED ATMOSPHERE PACKING (MAP) Films Used for MAP

• LDPE (low-density polyethylene)
MAP is a packaging practice that changes the composition of the internal atmosphere
of a package, with the goal of improving the shelf life of the product. The modifi- • PVC (polyvinyl chloride)
cation process lowers the amount of oxygen in the package from 20.9% to 0.5%,
• EVA (ethylene-vinyl acetate)
to slow down the growth of aerobic organisms and prevent oxidation reactions, by
replacing oxygen with nitrogen or carbon dioxide, both of which can lower the pH or • OPP (oriented polypropylene)
inhibit the growth of bacteria. This technique is used in packaging of baked goods,
The choice of which film to use will depend on the level of respiration from the food
dehydrated foods, pasta, and other dried foods.
product. Films designed to allow gases to escape the package are called permeable
films. Other films, called barrier films, used in vacuum packing, are designed to
PACKAGING MATERIALS prevent the exchange of gases and are mainly used with non-respiring products like
snacks and game meat products.
When selecting packaging films the main characteristics to consider are gas perme-
ability, water vapor transmission rate, mechanical properties, transparency, type of
package and sealing reliability.

24 Good Manufacturing Practices Manual • [Link]

3.6 Other Factors process vaporizes the plant material’s volatile compounds, which then go through
a condensation and collection process into a large container or finished package.
Essential oils from mint, herbs, spices, avocado, olives, seeds, and ethanol extractions
SALTING OF LOW RISK FOODS are typical products that fall under this category of low risk foods where sanitation
practices within the condenser and packaging materials tend to influence the safety
In the case of low risk foods, salting is not used as a preservation technique and
and quality of each product. During the separation stage where extracts are sepa-
instead is mainly used for flavoring purposes. For these foods, all chemical, physical
rated from the water vapor, cross contamination may occur if sanitation, employee
and microbiological hazards have to be controlled using other methods; the addition
hygienic practices and pest controls are not in place.
of salt will not introduce hazards in low risk grain products (e.g., soy nuts), peanut
and tree nut products, and processed seeds for direct consumption. When processing In some instances these products may be further infused with other herbs and
these types of products, cleaning and sanitation of equipment before mixing with aromatics, but in order to be considered low risk these infusion processes must
salt, and the storage conditions and source of the salt, are the factors that will impact occur with food ingredients that have undergone a treatment to eliminate chemical,
quality and safety of these products. physical and microbiological hazards. Some high priced food ingredients like edible
flowers and fruit blossoms tend to be processed though water distillation, and
EXTRACTION THROUGH PRESSING, so using only potable water for the process, along with good sanitation practices
and maintaining the cleanliness of equipment, tend to be the determining factors
DISTILLING & SOLVENTS impacting quality and safety of these essential oils.
Low risk foods produced through extraction rely on a thermal process to evaporate Solvent extraction This method employs food grade solvents, such as hexane
the desired substance from within foods, such as essential oils. Steam distillation is or ethanol, to isolate essential oils from plant material. It is best suited for plant
the most popular method used to extract and isolate essential oils from plants. This materials that yield low amounts of essential oil, that are largely resinous, or that are
delicate aromatics unable to withstand the pressure and distress of steam distillation.
Through this process, the non-volatile plant materials such as waxes and pigment
Steam Distillation
are also extracted and in some instances removed through filtration, refrigeration
or other processes. After the plant material has been exposed to the solvent, a waxy
compound is formed that is later mixed with alcohol to release the oils. Under these
processing conditions the most critical factors within your cGMP program include
the sourcing of solvents and the sanitation and hygienic practices followed during
extraction and packaging.
Maceration extraction Maceration processes are normally used for the extraction
of oils from seeds, and is generally used because the food manufacturer is looking to
extract essential oils with the strong flavors or aromas of the seed or grain being used
in for extraction. However, these oils also tend to oxidize faster due to the presence
of enzymes found in seeds. Under these processing conditions, any macerated plant
materials first needs to be dried as much as possible to reduce any microbial hazards
and to reduce excessive quantities of the enzymes that may expedite rancidity of
the essential oils. Solvents used in the extraction process to reduce rancidity include
vitamin E oil and wheat germ oil.

Good Manufacturing Practices Manual • [Link] 25

CHAPTER 4
Good Manufacturing Practices
The federal current GMP regulation (21 CFR 117 Subpart B) applies to all food products regulated
by the FDA, and requires food makers to ensure that ingredients, products and packaging materials
are handled safely and that food products are processed in a suitable environment. Designed
to provide flexibility, the GMP regulation is very general in nature to assist each operation in
developing and implementing appropriate practices. GMPs are the basis of a food safety system
meeting minimal food safety requirements. In the case of low risk activity/food combinations
produced at facilities with fewer than 500 employees, no further preventive controls are necessary
in addition to cGMPs for compliance with FDA’s food manufacturing regulations.

26 Good Manufacturing Practices Manual • [Link]

The current Good Manufacturing Practices address the nine aspects of food making Nine Aspects of Food Making
identified to the right (with references to the specific section of the cGMP regulation
1 Personnel (§117.10)
that covers each).
2 Plant Grounds (§117.20)
It is management’s responsibility to take all reasonable measures and precautions
to maintain the basic operational and environmental conditions required to produce 3 Sanitary Operations (§117.35)
safe foods. Communicating the GMP rules with employees through training can
4 Sanitary Facilities and Controls (§117.37)
minimize food safety risks significantly. Table 12 illustrates the most common
documentation and procedures used by the industry to demonstrate compliance 5 Equipment and Utensils (§117.40)
with cGMPs. This table should be used as a tool instead of an absolute and final list of
6 Processes and Controls (§117.80)
documents needed to develop and implement cGMPs.
7 Warehousing and Distribution (§117.93)
8 Holding and distribution of Human Food Byproducts
for use as Animal Food (§117.95)
9 Defect Action Levels (§117.110)

4.1 Personnel
DISEASE CONTROL Additionally, the effective use of hair restraints and/or beard covers is necessary to
avoid potential sources of cross-contamination of food. Operators must not store
Any person who has an illness, open lesions, infected wounds, or any other abnormal clothing or other personal belongings in food processing areas. Personnel are not
source of microbial contamination that could result in contamination of the food, allowed to eat, drink beverages, or use gum or use tobacco in any form in food
food-contact surfaces, or food packaging materials must not work in a food process- processing areas, and they may not have or bring cosmetics, chemicals or medications
ing area. With small wounds to the hand, the best practice is to cover the lesion first in to food processing areas.
with a bandage and then double glove.
EDUCATION & TRAINING
CLEANLINESS Personnel must be trained in food safety, food hygiene, and in the operation they are
People who work in direct contact with food, food ingredients or food contact performing at the facility. They should also receive training in the identification of
surfaces of equipment or utensils must wear clean outer garments, maintain a high hazards that could lead to food contamination, including poor personal hygiene and
degree of personal cleanliness and conform to hygienic practices while at work. They unsanitary work habits.
must wash their hands thoroughly and, if necessary (job specific), they must also
At least one supervisor must receive training in preventive controls for human food or
sanitize their hands before starting work, after each absence from the workstation,
participate in a PCQI course, and this individual is responsible for personnel supervi-
and at any other time when the hands have become soiled or contaminated. Jewelry
sion and compliance with all the GMP requirements and Preventive Controls.
must be covered or removed, and if personnel are handling food, they should remove
any jewelry that cannot be properly sanitized and covered from their hands.

Good Manufacturing Practices Manual • [Link] 27

4.2 Plant Grounds
Grounds around a food processing facility must be free from improperly stored equipment, litter, waste, and uncut weeds and
grass around the building; and management must take steps to reduce or eliminate dust in roads, yards or parking lots that
are in close proximity to food processing areas. All drains and areas that can harbor food borne pathogens and pests must be
adequately drained and free of any waste.

PLANT CONSTRUCTION & DESIGN • Provide shatter resistant light bulbs/fixtures/skylights/glass if such objects are
suspended over exposed food.
Plant construction and design should provide enough space for sanitary arrange-
• Allow proper separation of operations to prevent cross-contamination and
ment of equipment and storage of materials. All floors, walls and ceilings must be
allergen cross-contact.
constructed so that they are cleanable and must be kept clean and in good repair.
Any activities that may cross contaminate food need to be separated by partition, • Prevent drip or condensate from contaminating food products.
location, time or other means to prevent undesirable microorganisms, chemicals,
• Facilitate removal of debris and unused equipment without contaminating
filth or other material from entering the processing environment.
food products.
Construction of the food facility should prevent birds, animals, vermin and rodents
• Provide adequate ventilation and minimize allergen cross contact or food contami-
from entering or sheltering in the facility. Conditions within the facility should
nation potential from the operation of fans.
prevent contamination of foods with odors; noxious fumes or vapors; and glass from
light bulbs, skylights or any other glass source. • Permit employees to perform their duties without contaminating food/surfacing/
packaging, aisles and workspaces.
Properly Designed Facilities • Provide adequate lighting in hand-washing areas, dressing and locker
• Provide adequate space for equipment and storage of materials needed for rooms, and toilet rooms in areas where food is examined, manufactured,
maintenance and sanitation. processed or packaged.
• Allow access to areas over and around food processing vessels as necessary to
eliminate harborages for pests.

4.3 Sanitary Operations (General maintenance)

The plant and all fixtures must be kept in good repair and be maintained in a sanitary condition. Cleaning operations must be
conducted in a manner that will minimize the possibility of contaminating foods or equipment surfaces that contact food.

PEST CONTROL Single-service articles such as disposable utensils, paper cups, paper towels must
be stored in appropriate containers and handled in a manner that will prevent cross
No animals or birds are allowed anywhere in the plant, and programs must be contamination, and dispensing, use and disposal of these articles must be performed
in effect to prevent contamination by animals, birds and pests. Insecticides and in a manner that prevents contamination of food or equipment.
rodenticides may be used as part of a pest control program if they are used according
Any machine or device may be used for cleaning and sanitizing, as long as it has been
to label instructions and handled by trained personnel, and so long as the facility has
established that it will effectively serve for cleaning and sanitation purposes.
precautions and restrictions in place that will protect food against contamination
from these chemicals. Clean and sanitized portable equipment and utensils that will contact foods must be
stored in a manner that will protect the food contact surfaces from splash, dust and
SANITATION OF FOOD CONTACT SURFACES other contamination.

Utensils and equipment surfaces that are in contact with food must be cleaned
before and after use and as often as necessary to prevent food contamination.
Equipment surfaces that are not in contact with food should be cleaned as necessary
to minimize accumulation of dust, dirt, food particles and other debris. When utensils
or equipment are used in a continuous production operation, they must be cleaned
and sanitized on a predetermined schedule.

28 Good Manufacturing Practices Manual • [Link]

CHEMICAL CONTROL PROGRAMS shellfish, wheat, peanuts, soybeans, and tree nuts. (For FDA’s list of what counts as a
tree nut, see Table 10). Although more than 160 foods have been identified to cause
Addressing chemical hazards is another important element of general food allergies in sensitive individuals, these 8 “major food allergens” account for 90
maintenance cGMPs. percent of all food allergies in the U.S. Allergens other than the major food allergens
are not subject to FALCPA labeling requirements.
Key Chemical Hazard Controls
The law requires specific label declarations for those major food allergens in all
• Training employees on how to handle and apply chemicals used in sanitation, packaged foods under FDA’s jurisdiction, except for raw agricultural commodities
maintenance, or pest control. such as fruits and vegetables, and highly refined oils made from the 8 major allergens
and food ingredients made from such oils.
• Only using chemicals approved for food contact surfaces, or that have been
deemed ”Generally Recognized as Safe” (GRAS) by FDA. (See Appendix 2 for Products with labels that do not comply with FALCPA requirements may not be
further information on FDA’s GRAS list.) legally introduced into interstate commerce in the U.S. because such products would
be considered misbranded under the Food, Drug and Cosmetic Act.
• Storing chemicals in designated areas away from food, food ingredients, packag-
ing, and food contact surfaces.
Table 10. Food ingredients associated with different biological hazards
• Training maintenance personnel to properly clean and remove all chemical COMMON OR USUAL NAME SCIENTIFIC NAME
residues from food contact surfaces.
Almond Prunus dulcis (Rosaceae)
• Avoiding excessive application of food grade grease or lubricants on equipment.
Beech nut Fagus spp. (Fagaceae)
• Ensuring chemical containers and measuring tools are clearly labeled and that
they are used only for chemicals. Brazil nut Bertholletia excelsa (Lecythidaceae)

• Sourcing ingredients from reputable suppliers that effectively control Butternut Juglans cinerea (Juglandaceae)
chemical hazards.
Cashew Anacardium occidentale (Anacardiaceae)
• Vetting new suppliers of ingredients to ensure they have chemical hazard controls.
Chestnut (Chinese, American, Castanea spp. (Fagaceae)
European, Seguin)
ALLERGEN CONTROLS Chinquapin Castanea pumila (Fagaceae)
Implementing controls for allergen cross-contact is an important component
of general maintenance operations. Coconut Cocos nucifera L. (Arecaceae (alt. Palmae)
Filbert/hazelnut Corylus spp. (Betulaceae)
Programs Facilities Must Implement
Gingko nut Ginkgo biloba L. (Ginkgoaceae)
• Develop a master list of allergenic ingredients used in the facility.
• Prevent allergen cross-contact, such as physical barriers to separate processing Hickory nut Carya spp. (Juglandaceae)
lines, monitoring and reducing dust levels, and minimizing use of air compressors. Lichee nut Litchi chinensis Sonn. (Sapindaceae)
• Clean shared equipment that may come into contact with allergens prior to Macadamia nut/Bush nut Macadamia spp. (Proteaceae)
processing non-allergen materials.
Pecan Carya illinoensis (Juglandaceae)
• Avoid in-process or post-process allergen cross-contact, including scheduling pro-
cessing of allergen-containing materials after non-allergen containing materials. Pine nut/Pinon nut Pinus spp. (Pineaceae)
• Train employees in understanding allergens and recognizing allergen risks Pistachio Pistacia vera L. (Anacardiaceae)
in food manufacturing.
Sheanut Vitellaria paradoxa C.F. Gaertn. (Sapotaceae)
The minimum requirement when inspecting surfaces and food manufacturing
areas as part of an allergen control program is a visual inspection that there are no Walnut (English, Persian, Black, Juglans spp. (Juglandaceae)
cross-contact issues associated with allergens. Japanese, California)

In addition, the allergen control program must ensure all products containing aller-
gens are accurately labeled, and including monitoring to verify that any labels used
on finished products are correct and prepared and applied as intended.
Allergen Labeling Requirements The Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA) was enacted in 2004. FALCPA amended the Food and
Drug Cosmetic Act to establish labeling requirements for all FDA regulated packaged
foods that contain, or are made with ingredients that contain protein derived from
one or more of the 8 major classes of food allergens: milk, egg, fish, crustacean

Good Manufacturing Practices Manual • [Link] 29

When Do FALCPA Labeling Requirements Apply? Ingredients Subject to Specific FALCPA Labeling Requirements FALCPA labeling
requirements apply to foods that are made with any ingredient, including flavor-
1 When the common or usual name of an ingredient that is a major food allergen
ings, colorings, or incidental additives (e.g., processing aids), that is or contains
does not already identify its food source name.
a major food allergen. Spices are not mentioned in the legislative language for
2 When that major food allergen’s food source name is not already identified else- FALCPA because no spice is derived from one of the food sources of a major allergen.
where in the list of ingredients for another “allergenic” ingredient. However, if a seasoning mix or blend of spices contains a major food allergen as
an ingredient or processing aid (such a wheat flour used as a flow agent), then its
FALCPA requires that the presence of each major food allergen used as an ingredient
presence would have to be declared on both:
be disclosed at least once on the label in plain English terms.
1 The label for the seasoning mix or blend if sold as such
Some manufacturers are voluntarily labeling their products with statement such as
“may contain (insert name of allergenic ingredient)”, but this precautionary labeling 2 The label of any other food that includes the seasoning mix or blend
should NOT be used in lieu of adherence to FALCPA requirements. While FDA allows as an ingredient
such “may contain” statements, but such statements do not satisfy FALCPA’s require-
ment to have a “contains” listing on the label. Additional food labeling requirements are specific to each allergen that are
discussed below.
Labeling Options of Major Food Allergens TREE NUTS
The law provides a choice of two ways to label a food that contains a major food FALCPA requires that in the case of tree nuts (Table 10), the specific type of nut
allergen as an ingredient. must be declared (e.g., almonds, pecans, or walnuts).
1 Ingredient List The FISH AND CRUSTACEAN SHELLFISH
label must identify
A declaration of the “species” of fish or crustacean shellfish should be made using
the presence of major
the acceptable market name provided in FDA’s Seafood List. For example, any food
food allergens within
made with salmon should either include “fish (salmon)” in the ingredient list, or
the ingredient list. If
state “Contains salmon” in any “Contains” statement.
an ingredient that is
made from a major WHEAT (GLUTEN)
food allergen has a FALCPA labeling requirements apply to all grains that belong to the plant genus
name that does not called Triticum, the crossbred hybrid of wheat and rye called “triticale,” and
identify its source, that ingredients that contain proteins of any of these grains. Thus, wheat would
ingredient name must be immediately followed in parentheses by that name of include grains such as common wheat (Triticum aestivum L.), durum wheat
the source food. For example, if “whey”, which is derived from milk and contains (Triticum durum Desf.), club wheat (Triticum compactum Host.), spelt (Triticum
milk protein, is listed on a food label, it would have to be accompanied by the term spelta L.), semolina (Triticum durum Desf.), Einkorn (Triticum monococcum L.
“milk” in parentheses immediately after the term “whey”, unless milk is disclosed subsp. Monococcum), emmer (Triticum turgidumL. subsp. dicoccon (Schrank)
as an ingredient elsewhere in the ingredient list. Thell.), kamut (Triticum polonicum L.), and triticale (x Triticosecale ssp. Wittm.).
2 “Contains” Statement Alternatively, manufacturers can use a summary The term “flour” alone (unqualified) should only be used as a synonym for
“Contains” statement, placed on the label immediately following or adjacent to “wheat flour.” If “flour” is stated in an ingredient list without the parenthetical
the list of ingredients in a print size no smaller than that used for the ingredient declaration of wheat afterwards, either the term “wheat” must appear elsewhere
list. The word “Contains” must be followed by a complete list of the food source within the ingredient list for another allergenic ingredient or in a separate
names for all major food allergens used as ingredients in the packaged food, “Contains” statement.
whether or not some of those food source names were already disclosed within
PEANUTS AND SOYBEANS
the ingredient list
(e.g., “Contains milk, FDA believes that the singular terms “peanut,” and “soybean,” as well as the
egg, peanuts”). singular terms (e.g., almond, pecan, or walnut) for the different types of tree nuts
(Table 10) are acceptable substitutes for the plural terms for these major food
allergens for the purpose of satisfying the FALCPA labeling requirements. Also, the
terms “soybean,” “soy,” and “soya” are reasonable synonyms for the common or
usual name “soybeans,” and any one of these terms may be used to identify the
food source of the major food allergen “soybeans.”
However, packaged foods that are made using “soybeans” as an ingredient or as
a component of a multi-component ingredient (e.g., soy sauce or tofu) should use
the word “soybeans” as the appropriate common or usual name for this ingredient
(e.g., “soy sauce (water, wheat, soybeans, salt)”).

30 Good Manufacturing Practices Manual • [Link]

Single Ingredient Labeling Single ingredient foods must comply with the FALPCA Consequences of Non-Compliance with Allergen Labeling In the event that
allergen declaration. A single ingredient food that is or contains protein derived from a packaged food does not comply with the FALPCA labeling requirements, the
milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, or soybeans may company and its management may be subject to civil sanctions, criminal penalties,
identify the food source in the name of the food (e.g., “all-purpose wheat flour”) or or both. The FDA may also request seizure of the food products where the label of
use the “Contains” statement format. FDA recommends that if a “Contains” state- the product does not conform to FALPCA’s requirements. In addition, FDA is likely
ment format is used, the statement be placed immediately above the manufacturer, to request that a food product containing an undeclared allergen be recalled by the
packer, or distributor statement. For single ingredient foods intended for further manufacturer or distributor.
manufacturing where the “Contains” statement format is used, the statement should
be placed on the principal display panel (PDP) of the food package.

4.4 Sanitary Facilities & Controls

In general, any water that comes into contact with food, food contact surfaces, or processing equipment must be safe
and of adequate sanitary quality: using only water that meets drinking water standards for these types of activities is
considered a best practice.

PLUMBING & WASTE WATER DISPOSAL self-closing doors, and toilet rooms must not open directly into areas where food
is exposed. Single use toilet tissue must be provided, and signs in the employees’
The plumbing system must be of adequate size and design to be able to supply language must be posted that direct employees to wash and disinfect their hands
enough water to all areas in the facility and properly convey sewage or disposable with soap and sanitizer after using the toilet; and instructing employees directly
liquid waste away from the facility. Plumbing systems must be maintained in a handling unprotected food to wash and sanitize hands before work, after each
manner that will not create a source of contamination or unsanitary conditions, and absence from the workstation, and at any other time when the hands have become
sewage must flow into an adequate sewage system or be disposed of through other soiled or contaminated.
adequate means.
Hand-washing stations must be provided anywhere in the facility where the nature
Provide adequate floor drainage in areas where water or liquid waste is discharged of employees’ jobs requires them to wash, sanitize and dry their hands, and must
onto the floor, including water from cleaning and sanitizing operations. Backflow provide running potable water and cleaning and sanitizing liquids and conditions
and cross-connection between piping systems that discharge waste water or sewage that permit proper hand washing and disinfection. Water control valves should be
must be prevented, and waste water separated from those systems that provide manufactured in a way that protects against recontamination of hands in shutting
water for food manufacturing. off the flow of water.
Facilities must provide single use clean towels or suitable drying devices at
TOILET & HAND-WASHING FACILITIES hand-washing stations, as well as an easily cleanable waste receptacle. Rubbish and
offal disposal must be handled in such a manner that they won’t attract or harbor
Toilets and hand-washing facilities must be provided inside all food processing
pests or create sources of contamination.
facilities. Toilets must be kept cleaned, sanitized and in good condition and have

Good Manufacturing Practices Manual • [Link] 31

4.5 Equipment & Utensils
In general, equipment and utensils should be designed and constructed so that they are adequately cleanable, and do not
adulterate food with lubricants, fuel, metal fragments, contaminated water, or other debris. They should be installed so
that both the equipment and the areas around them can be cleaned easily. Food contact surfaces should be manufactured
from nontoxic materials and must be corrosion-resistant, and seams on food contact surfaces must be smoothly bonded and
maintained to minimize the accumulation of debris or food residues. See Table 11 for a list of recommended materials for
equipment and utensils.
Table 11. Recommended materials for food production
MATERIALS USED IN FOOD PLASTICS USED IN EQUIPMENT RUBBER ELASTOMERS USED IN EQUIPMENT
PROCESSING ENVIRONMENTS
• Stainless Steel (ANSI: 304, 303, 316, 316L, Plastics should be assessed for chemical compatibility Elastomers are normally found on pumps and valves,
321, 316TI) with the foods they will contact, taking into account and each material has unique elastic, swelling and
the acidity of the food and potential exposure of the shrinkage properties.
• Aluminum (poor corrosion properties, avoid in food
plastic to UV radiation.
contact surfaces) • Nitrile rubber
• Polypropylene
• Titanium • Nitrile/butyl rubber (NBR)
• Polyvinyl chloride (unplasticized)
• Copper (avoid in food contact surfaces) • Ethylene propylene diene monomer (EPDM)
• Acetal copolymer
• Galvanized iron (avoid in food contact surfaces) • Silicone rubber
• Polycarbonate
• High density polyethylene
• Polyethylene tetraphalate
• Polytetrafluroethylene (Teflon)

All equipment used in manufacturing, processing, packing, or holding food,

including conveying and manufacturing equipment such as gravimetric, pneumatic,
MEASUREMENT INSTRUMENTS
closed and automated systems, must be maintained in a sanitary condition. They Instruments used for measuring, regulating or recording temperatures, pH, acidity,
should be designed to be adequately cleanable, made of materials that are ade- water activity, and other critical aspects of food safety must be calibrated to ensure
quately cleanable, and must be adequately maintained to protect against allergen the accuracy of measurements, and maintained to provide the necessary mea-
cross-contact and cross contamination. Food-contact surfaces must be surement conditions needed for each operation. Calibration of equipment must be
corrosion-resistant and be made of nontoxic materials capable to withstand the performed according to manufacturer requirements and scheduled in a manner that
environment of their intended use. will ensure proper controls in food manufacturing. Each freezer and cold storage
compartment must have an indicating thermometer, temperature measuring or
Compressed air or other gases mechanically introduced into food or used to clean
recording device, and have an automatic control for regulating temperature, or an
food-contact surfaces or equipment must be treated in a way that food is not con-
automatic alarm system to indicate a significant temperature change.
taminated with unlawful indirect food additives.

Unacceptable Drainage Acceptable Drainage

DRAINAGE OF VESSELS
Unacceptable DrainageUnacceptable
Unacceptable
Drainage
DrainageUnacceptable Drainage Vessels used to hold food during storage or manufacturing processes should be
self-emptying, and built to prevent dead spaces that would allow proliferation of
microbial growth from accumulation of product in those locations. These vessels
should avoid having sharp corners and metal-to metal contact points and should be
easy to clean.

32 Good Manufacturing Practices Manual • [Link]

LUBRICANTS USDA H1 Lubricants
• Bearing greases
Much equipment and some utensils in food processing require lubrication to prevent
contact between moving and static surfaces, and so prevent excessive wear, potential • Chain lubricants
overheating and addition of physical hazards (fragments from equipment surfaces)
• Gearbox fluids (enclosed and open)
to food. Leakage from open lube points and bearings must be avoided to prevent
food contamination. When using these chemicals, personnel must avoid using excess • Assembly and anti-seize compounds
lubrication and mixing non food grade lubricants with food grade lubricants.
• Hydraulic and compressor fluids
Facilities may only use lubricants approved by the U.S. Department of Agriculture for
• Penetrating fluids
incidental contact with foods if there is a possibility that the substance will come into
contact with food. USDA classifies the acceptable substances as H1 lubricants, and • Can seamer lubricants
has registered H1 lubricants for all of the activities below; if you use lubricants for
• Sugar dissolving solutions
any of these purposes in your food processing equipment, confirm that you are using
products from the USDA’s H1 list. • Release agents
• General purpose sprays and lubricants

4.6 Processes & Controls

There must be a qualified individual who is responsible for supervising the overall sanitation of the plant.

RAW MATERIALS & INGREDIENTS Work-in-process–i.e. food when it is undergoing a manufacturing process– must
be protected against contamination, and so must finished food, food containers and
Raw materials must be inspected and sorted to insure they are clean, wholesome food packaging materials. Food or materials that are adulterated must be disposed to
and fit for processing into human food, and must be stored under conditions that will prevent other food from being contaminated. Measures such as sieves, traps, or metal
protect against cross-contamination, cross-contact with food allergens and product detectors must be used to protect against the inclusion of metal or other foreign
deterioration. They must be washed or cleaned to remove soil and other contamina- materials in food. Steps such as washing, peeling, trimming, etc. must be performed
tion using water of adequate sanitary quality; Water must not be reused for washing, in a way that protects food against contamination and allergen cross-contact, includ-
rinsing or conveying if such use could cause the food to be contaminated. ing protection contaminants that may drip, drain, or be drawn into the food. If ice
is used in the facility and comes in contact with food, it must be made from potable
Containers and carriers that convey raw materials and ingredients should be
water and be maintained in a sanitary condition.
inspected to assure that they are not a source of contamination for thaw raw ingredi-
ents, and raw materials must not contain levels of microorganisms that may produce Areas and equipment that are used to process human food should not be used to
food poisoning or other disease. If pathogen contamination is found in raw ingredi- process non-human-food-grade animal feed or inedible products unless there is no
ents, they must be pasteurized or treated during food manufacturing operations to possibility of contaminating the human food.
minimize or eliminate those microorganisms.
Blanching Heat-blanching must be effected by heating the food to the required
Frozen ingredients must be kept frozen until use, and if thawing is required prior to temperature, holding for a required time, then rapid cooling or passing the food to
use, thawing must be done in a manner that prevents contamination. subsequent manufacturing without delay. Growth and contamination by ther-
mophilic microorganisms in blanchers must be minimized by the use of adequate
MANUFACTURING OPERATIONS operating temperatures and by periodic cleaning and sanitizing.
Water Activity Foods that rely on control of available water for preventing growth
Food processing equipment must be kept in sanitary condition through
of undesirable microorganisms, such as dry mixes, nuts, intermediate moisture food,
frequent cleaning and sanitation, and equipment must be taken apart for thorough
and dehydrated food, must be processed and maintained at a safe moisture level.
cleaning when necessary. Food must be processed, packaged and stored under
conditions that will minimize the potential for undesirable microbiological
Controlling Water Activity
growth, toxin formation, deterioration, or contamination by other hazards,
and a facility must have instruments and procedures to monitor critical factors in • Monitor the aw of food
controlling those hazards. And food must be held under conditions that prevent
• Control the soluble solids/water ratio in finished food
growth of undesirable microorganisms.
• Protect finished food from moisture pickup, by use of a moisture barriers or other
means to avoid increases in the aw of the food

Good Manufacturing Practices Manual • [Link] 33

Acid Foods In manufacturing acid foods that rely principally the low intrinsic Records and Traceability Facilities must use a coding system that will allow
of pH of the ingredients for preventing growth of undesirable microorganisms, positive lot identification in the event of a recall, to identify and segregate lots of
the pH of the food must be monitored and maintained at 4.6 or below during the food that may be contaminated. Records of food processing activities should be kept
manufacturing process. for a period for two years after and be available for review by FDA personnel within
24 hours of a request.

4.7 Warehousing & Distribution

Storage and transportation of food must be under conditions that will protect against allergen cross-contact, prevent
deterioration of the food and the container, and protect against biological, chemical (including radiological), and physical
contamination of food.

4.8 Human Food Byproducts for Use as Animal Food

Human food byproducts held for distribution as animal food without additional manufacturing or processing by the human
food processor must be held and handled under conditions that will protect against contamination.
Handling requirements • Human food byproducts for use as animal food must have labeling that accurately
identifies the by-product by its common or usual name that is affixed to or accom-
• Containers and equipment used to convey or hold human food byproducts for use
panies the products when distributed.
as animal food before distribution must be constructed of appropriate material
and cleaned as necessary. • If your facility is responsible for transporting the human food byproducts, or if it
arranges a third party to transport them, you must ensure shipping containers and
• Human food byproducts for use as animal food must be held for distribution
bulk vehicles used to distribute the products are examined prior to use to protect
in a way that protects against contamination from sources such as waste, trash,
against contamination coming from the container or vehicle.
and debris.

34 Good Manufacturing Practices Manual • [Link]

4.9 Defect Action Levels
The manufacturer, processor, packer, and holder of food must at all times utilize quality control operations that reduce natural
or unavoidable defects to the lowest level currently feasible. The mixing of food containing defects at levels that render that
food adulterated with another lot of food is not permitted, and renders the mixed lot of food adulterated.
The Defect Levels Handbook provides information on what is considered adulterated food and can be found at [Link] and [Link]

Table 12. List of potential documentation needed to demonstrate proper implementation of Good Manufacturing Practices
GENERAL FOOD FACILITY ACTIVITIES FOOD MANUFACTURING OPERATIONS PERSONNEL RELATED ACTIVITIES RECORDS
• Ingredient specifications • Manufacturing procedures • Organizational chart including • General employee records
including scheduling when relevant responsibilities and main tasks
• Supplier Quality Assurance and • Employee training records
for food allergens
purchase contracts • Training programs including
• Process control records
• Sanitation procedures topics related to food safety, food
• Quality assurance and quality
hygiene and the specific activity • Sanitation records
control procedures • Health and Safety procedures
of the employee
• Allergen control records
• Laboratory protocols • Plant layout and traffic
and reporting systems zones including hygienic • Supply chain records
zoning requirements
• Specifications for finished product • Pest control records
• Plant maintenance procedures
• Pest control and • Personnel health records
housekeeping procedures • Storage procedures for materials,
• Use and management
ingredients and finished product
• Customer and official of raw materials
complaint records • Transportation procedures
• Control of rework when applicable
• Regulatory requirements for each • Allergen controls when applicable
• Labeling records
food product
• Management of chemicals and uses
• Laboratory analysis records for raw
• Second and third party audit within the facility
and finished products
evaluations and results
• Labeling control procedures
• Environmental monitoring records
• Recall procedures
• Test and hold records
of finished products
• Mock recall records

Good Manufacturing Practices Manual • [Link] 35

APPENDIX 1
FDA’s List of Low Risk Activity/
Food Combinations
Manufacturing/processing foods using the methods described below has been deemed
low-risk by the FDA in its FSMA regulations on Current Good Manufacturing Practices
and Risk-Based Preventive Controls.

• Boiling gums, latexes, and resins • 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
• Chopping, coring, cutting, peeling, pitting, shredding, and slicing acid fruits and
food allergens), coffee beans (roasted), game meat jerky, gums/ latexes/resins
vegetables that have a pH less than 4.2 (e.g., cutting lemons and limes), baked
that are processed foods, honey (pasteurized), jams/jellies/ preserves, milled
goods (e.g., slicing bread), dried/ dehydrated fruit and vegetable products (e.g.,
grain products that do not contain food allergens (e.g., corn meal) or that are
pitting dried plums), dried herbs and other spices (e.g., chopping intact, dried
single-ingredient foods (e.g., wheat flour, wheat bran), molasses and treacle, oils,
basil), game meat jerky, gums/ latexes/resins, other grain products (e.g., shred-
other fruit and vegetable products that do not contain food allergens (e.g., snack
ding dried cereal), peanuts and tree nuts, and peanut and tree nut products (e.g.,
chips made from potatoes or plantains), other grain products that do not contain
chopping roasted peanuts)
food allergens (e.g., popcorn), other herb and spice products (e.g., chopped or
• Coating dried/dehydrated fruit and vegetable products (e.g., coating raisins with ground dried herbs), peanut or tree nut products, (provided that they are single
chocolate), other fruit and vegetable products except for non-dried, non-intact ingredient, or are in forms in which the consumer can reasonably be expected to
fruits and vegetables (e.g., coating dried plum pieces, dried pitted cherries, and recognize the food allergen(s) without label declaration, or both (e.g., roasted
dried pitted apricots with chocolate are low-risk activity/food combinations but or seasoned whole nuts, single ingredient peanut or tree nut flours), processed
coating apples on a stick with caramel is not a low-risk activity/food combination), seeds for direct consumption, soft drinks and carbonated water, sugar, syrups,
other grain products (e.g., adding caramel to popcorn or adding seasonings to trail mix and granola (other than those containing milk chocolate and provided
popcorn provided that the seasonings have been treated to significantly minimize that peanuts and/or tree nuts are in forms in which the consumer can reasonably
pathogens, peanuts and tree nuts (e.g., adding seasonings provided that the be expected to recognize the food allergen(s) without label declaration), vinegar,
seasonings have been treated to significantly minimize pathogens), and peanut and any other processed food that does not require time/temperature control
and tree nut products (e.g., adding seasonings provided that the seasonings have for safety and that does not contain food allergens (e.g., vitamins, minerals, and
been treated to significantly minimize pathogens) dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form)
• Drying/dehydrating (that includes additional manufacturing or is performed on • Making baked goods from milled grain products (e.g., breads and cookies)
processed foods) other fruit and vegetable products with pH less than 4.2 (e.g.,
• Making candy from peanuts and tree nuts (e.g., nut brittles), sugar/syrups (e.g.,
drying cut fruit and vegetables with pH less than 4.2), and other herb and spice
taffy, toffee), and saps (e.g., maple candy, maple cream)
products (e.g., drying chopped fresh herbs, including tea)
• Making cocoa products from roasted cocoa beans
• 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 • Making dried pasta from grains
mint), fruits and vegetables (e.g., olives, avocados), grains (e.g., oilseeds), and
• Making jams, jellies, and preserves from acid fruits and vegetables with a pH of
other herb and spice products (e.g., chopped fresh min chopped dried mint)
4.6 or below
• Freezing acid fruits and vegetables with pH less than 4.2 and other fruit and
• Making molasses and treacle from sugar beets and sugarcane
vegetable products with pH less than 4.2 (e.g., cut fruits and vegetables)
• Making oat flakes from grains
• Grinding/cracking/crushing/ milling baked goods (e.g., crackers), cocoa beans
(roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products • Making popcorn from grains
(e.g., raisins and dried legumes), dried/dehydrated herb and spice products (e.g.,
• Making snack chips from fruits and vegetables (e.g., making plantain
intact dried basil), grains (e.g., oats, rice, rye, wheat), other fruit and vegetable
and potato chips)
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 • Making soft drinks and carbonated water from sugar, syrups, and water
peanut and tree nut products (e.g., roasted peanuts)
• Making sugars and syrups from fruits and vegetables (e.g., dates), grains (e.g., rice,

36 Good Manufacturing Practices Manual • [Link]

 sorghum), other grain products (e.g., malted grains such as barley), saps • Packaging baked goods (e.g., bread and cookies), candy, cocoa beans (roasted),
(e.g., agave, birch, maple, palm), sugar beets, and sugarcane cocoa products, coffee beans (roasted), game meat jerky, gums/ latexes/resins
that are processed foods, honey (pasteurized), jams/jellies/ preserves, milled grain
• Making trail mix and granola from cocoa products (e.g., chocolate), dried/
products (e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit and
dehydrated fruit and vegetable products (e.g., raisins), other fruit and vegetable
vegetable products (e.g., pitted, dried fruits; sliced, dried apples; snack chips),
products (e.g., chopped dried fruits), other grain products (e.g., oat flakes),
other grain products (e.g., popcorn), other herb and spice products (e.g., chopped
peanut and tree nut products, and processed seeds for direct consumption,
or ground dried herbs), peanut and tree nut products, processed seeds for direct
provided that peanuts, tree nuts, and processed seeds are treated to significantly
consumption, soft drinks and carbonated water, sugar, syrups, trail mix and
minimize pathogens
granola, vinegar, and any other processed food that does not require time/tem-
• Making vinegar from fruits and vegetables, other fruit and vegetable products perature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g.,
(e.g., fruit wines, apple cider), and other grain products (e.g., malt) bone meal) in powdered, granular, or other solid form)
• Mixing baked goods (e.g., types of cookies), candy (e.g., varieties of taffy), cocoa • Pasteurizing honey
beans (roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable
• Roasting and toasting baked goods (e.g., toasting bread for croutons)
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 • Salting other grain products (e.g., soy nuts), peanut and tree nut products,
(pasteurized), milled grain products (e.g., flour, bran, and corn meal), other fruit and processed seeds for direct consumption
and vegetable products (e.g., dried, sliced apples and dried, sliced peaches), other
• Sifting milled grain products (e.g., flour, bran, corn meal), other fruit and vegeta-
grain products (e.g., different types of dried pasta), other herb and spice products
ble products (e.g., chickpea flour), and peanut and tree nut products (e.g., peanut
(e.g., chopped or ground dried herbs, dried herb- or spice-infused honey, and
flour, almond flour)
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)

APPENDIX 2
Additional Resources
Food safety is just one aspect of the federal regulatory system for manufacturing food.
In this appendix you will find web links to key additional documents that explain other
aspects of FSMA that may be relevant to your business, as well as resources covering
other important food regulations.

Food Safety Modernization Act [Link]

[Link]
Carolina Farm Stewardship Association (CFSA) has a series of “Frequently Asked
Questions” explainers regarding who is covered by FSMA, and the basic requirements NSAC has a detailed explainer on FDA’s Current Good Manufacturing and Preventive
for those who are covered. Controls for Human Food Rule, including discussions of who is covered, and an over-
view of the requirements of the regulation.
[Link]
download-the-fsma-frequently-asked-questions/ [Link]
[Link]
The National Sustainable Agriculture Coalition (NSAC) worked with the FDA to
develop a flow chart to help farms and businesses determine if they are subject to the NSAC also has a short discussion of how to calculate the sales volume thresholds
FSMA Produce Rule, which establishes requirements for farms growing fruits, vege- for farms and food facilities to meet the qualified exemptions from the Produce
tables and other produce, and the FSMA Current Good Manufacturing and Preventive Safety Rule and the Current Good Manufacturing and Preventive Controls for Human
Controls for Human Food Rule. Food Rule.

Good Manufacturing Practices Manual • [Link] 37

[Link] Food Labeling
And NSAC has an explainer on the types of food-making businesses that are exempt The FDA’s official Food Labeling Guide is a non-binding guidance document explain-
from the requirement to register as food facilities with FDA, such as restaurants ing FDA’s interpretation of the rules on labeling foods, including nutrition labeling,
and other retail food establishments, Community Supported Agriculture enterprises, allergen labeling, ingredient lists, and health claims.
and others.
[Link]
[Link] GuidanceDocumentsRegulatoryInformation/LabelingNutrition/[Link]
The Northeast Center to Advance Food Safety at the University of Vermont maintains FDA maintains a Question and Answer document on the Food Allergen Labeling and
an extensive searchable clearinghouse of FSMA training materials and information. Consumer Protection Act (FALCPA).
[Link] [Link]
GuidanceDocumentsRegulatoryInformation/Allergens/[Link]
The text of FDA’s FSMA Produce Safety Rule and Current Good Manufacturing and
Preventive Controls for Human Food Rule are available from the Federal Register. FDA provides a model form for small businesses to use in claiming an exemption from
nutrition labeling requirements.
Produce Safety Rule [Link]
documents/2015/11/27/2015-28159/standards-for-the-growing-harvesting-packing- [Link]
and-holding-of-produce-for-human-consumption GuidanceDocumentsRegulatoryInformation/LabelingNutrition/[Link]
Current Good Manufacturing and Preventive Controls for Human Food For businesses that are not exempt from nutrition labeling requirements,
Rule [Link] FDA has published guidance on how to calculate serving sizes for purposes
current-good-manufacturing-practice-hazard-analysis-and-risk-based-preven- of nutrition labeling.
tive-controls-for-human
[Link]
FDA has a general resource page for the Produce Rule, with links to guidance docu- GuidanceDocumentsRegulatoryInformation/[Link]
ments and other interpretations from the agency.
FDA publishes a list of acceptable market names to use in labeling of foods containing
[Link] fish and crustacean shellfish.
FDA also has a general resource page for Current Good Manufacturing and Preventive [Link]
Controls for Human Food Rule, with links to guidance documents and other interpre- GuidanceDocumentsRegulatoryInformation/Seafood/[Link]
tations from the agency.
To determine if a chemical for use as a food ingredient has been deemed ‘Generally
[Link] Recognized as Safe’ (GRAS), visit the FDA’s GRAS resource center.
The Food Safety Preventive Controls Alliance is an industry-and-academic collabo- [Link]
ration that develops nationwide core curriculum, training and outreach programs to
assist companies producing human and animal food in complying FSMA.
[Link]

General Food Regulations

For farms and food businesses in North and South Carolina, CFSA has published
a manual overviewing the relevant state and federal regulations.
North Carolina [Link]
South Carolina [Link]

All links are current as of July 18, 2018.

38 Good Manufacturing Practices Manual • [Link]

1 “1.2 Definitions & Acronyms” on page 6
2 “1.1 GMP Training” on page 5
3 “INTRODUCTION” on page 3
4 “CHAPTER 1” on page 3
5 “2.2 Chemical Hazards” on page 15
6 “2.1 Microbiological Hazards” on page 10
7 “Hazards in Food Processing” on page 8
8 “Chapter 2” on page 8
9 “3.5 Oxygen & Air Management During Packaging” on page 24
9.1 - “3.6 Other Factors” on page 25
10 “3.4 Temperature Controls in Food Processing” on page 23
11 “3.3 Water Activity” on page 22
12 “3.2 pH (Acidity & Alkalinity)” on page 21
13 “3.1 Basic Food Characteristics” on page 20
14 “Basic Concepts
for Proper Food Preservation” on page 19
15 “Chapter 3” on page 19
16 “Additional Resources” on page 37
17 “Appendix 2” on page 37
18 “FDA’s List of Low Risk Activity/
Food Combinations” on page 36
19 “Appendix 1” on page 36
20 “4.9 Defect Action Levels” on page 35
21 “4.8 Human Food Byproducts for Use as Animal Food” on page 34
22 “4.7 Warehousing & distribution” on page 34
23 “4.6 Processes & Controls” on page 33
24 “4.5 Equipment & Utensils” on page 32
25 “4.4 Sanitary Facilities & Controls” on page 31
26 “4.3 Sanitary Operations (General maintenance)” on page 28
27 “4.2 Plant grounds” on page 28
28 “4.1 Personnel” on page 27
29 “Good Manufacturing Practices” on page 26
30 “Chapter 4” on page 26
31 “Food Safety Modernization Act” on page 1
32 “2.3 Physical Hazards” on page 18

Good Manufacturing Practices Manual • [Link] 39