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Detailed Description

This law requires food processing firms to prepare and implement a Food Safety Plan.

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Hazard Analysis and Risk-based Preventive Controls:  Good Manufacturing Practices and Food Safety Plan

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The statute is codified at 21 USC 350g

The Congressional mandate states

"The owner, operator, or agent in charge of a facility shall ... evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated ... or misbranded ..., monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice." (21 USC 350g(a)).

It may be helpful to re-read the statute to identify the numerous Congressional concepts food businesses need to consider:

  • The owner, operator, or agent in charge of
  • a facility
  • shall evaluate
  • the hazards that
  • could affect food
  • manufactured, processed, packed, or held by such facility,
  • identify preventive controls and
  • implement preventive controls to
  • significantly minimize or prevent the occurrence of such hazards,
  • provide assurances that such food is not adulterated or
  • misbranded,
  • monitor the performance of those controls, and
  • maintain records of this monitoring as a matter of routine practice.

The remainder of this section will review many of these terms, both as defined in the statute and in the proposed regulation (Jan. 16, 2013), recognize and define numerous other concepts introduced by those statute and regulatory definitions, and attempt to summarize the business practices and recordkeeping/documentation mandated by this "simple" Congressional edict.

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Acronym/Short-hand Terms Defined

The statute is titled "Hazard analysis and risk-based preventive controls" (21 USC 350g); the proposed regulation has a different title:  "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (Federal Register; Vol. 78, No. 11; Wednesday, January 16, 2013; p. 3646 et seq). The FDA, in its informational comments, appears to be using "Preventive Controls" when referring to either the statute or regulation.  This web page may occasionally use the acronym GMP/HARPC as referring to the statute and regulation.  More frequently, hazard analysis will be used to reference this statute and regulation.

Another term used by FDA in its proposed regulation is "food safety plan".  The food industry is familiar with the term "HACCP plan" as it has been applied to meat & poultry, seafood and juice sectors of the food industry for nearly 20 years by both USDA FSIS and FDA.  The proposed regulation is NOT using the term HACCP.  It may be easier to refer to the planning requirement of FSMA as a "food safety plan" and thus align "food safety plan" with the acronym "GMP/HAPRC" or "hazard analysis" as defined above. 

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Food Safety Plan v. HACCP Plan

As the details of the proposed regulation are reviewed on this page, a brief comparison will occasionally be made to the well-established HACCP standards for meat & poultry, seafood and juice.  The purpose of these comparisons is to illustrate that many of the requirements of the FSMA and the FDA regulations are not new to U.S. food law, but instead have been refined based on several decades of experience and are being applied to food processors who in the past were not subject to HACCP requirements.

Links to U.S. food processing HACCP regulations:

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Refreshed cGMPs

The proposed Hazard Analysis regulation also "refreshes" FDA's long-standing Good Manufacturing Practices (GMP) regulation; more precisely, FDA is proposing to replace 21 CFR part 110 with new regulations:  proposed 21 CFR 117.10 to 117.110.  The refreshed GMPs will continue many of the past GMPs; some commentators might suggest that food handling practices will not dramatically change with the implementation of these new laws.  These commentators  might suggest that the most significant change will be the recordkeeping/documentation that the firm must now provide.  This observation is consistent with the statutory language summarized above, that is,

  • provide assurances that such food is not adulterated or misbranded (assuming that the assurances will take the form of documentation),
  • maintain records of this monitoring as a matter of routine practice.

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Owner, operator, or agent in charge of a facility

The first concepts in the statute are "owner, operator, or agent in charge" and "facility".  These two concepts also were fundamental components of the BioTerrorism Act of 2002 (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) enacted by Congress following September 11, 2001.  The 2002 law requires that all food facilities be registered (21 USC 350d).  The 2011 legislation uses those same concepts to define who is subject to the expanded hazard analysis.

  • "any [domestic or foreign] facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States"
  • "facility" includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.
    • Facility does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing)"
    • Farms generally are NOT subject to the hazard analysis/food safety plan described in this regulation.  However, farms that grow and harvest produce are subject to the produce safety regulation (also proposed by FDA in January 2013).  Furthermore, farms that process produce raised on OTHER farms are subject to this hazard analysis/food safety plan regulation.
  • See FDA Registration of Food Facilities
  • See 21 CFR 1.225 et seq
  • Proposed regulation:  Facility means a domestic facility or a foreign facility that is required to register
  • Proposed regulation:  Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.
    • Transport vehicles are NOT facilities and are not required to prepare a food safety plan if the vehicles hold food only in the usual course of business as carriers.
    • A facility may consist of one or more contiguous structures.
    • A single building may house more than one facility if the facilities are under separate ownership.
    • The private residence of an individual is not a facility.
    • Nonbottled drinking water collection and distribution establishments and their structures are not facilities.

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Food Safety Plan

Proposed regulation 117.126  The owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food safety plan.

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Food Safety Plan Exemptions

Food Safety Plan is not required of the following food processors:

  • Fish and fishery products at a facility in compliance with HACCP for fish (21 CFR 123).
  • Juice products at a facility in compliance with HACCP for juice (21 CFR 120)
  • Dietary supplements in compliance with a) 21 CFR 111 (Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements) and b) Serious Adverse Event Reporting for Dietary Supplements (FDCA sec. 761)
  • Alcoholic beverages at a facility that is required to obtain a permit from Secretary of the Treasury and to register as a facility engaged in manufacturing, processing, packing, or holding alcoholic beverages.
  • Food (other than alcoholic beverages) if the food is in prepackaged form that prevents any direct human contact with such food; and constitutes not more than 5 percent of the overall sales of the facility
  • Thermally processed low-acid foods packaged in hermetically sealed containers at a facility in compliance with 21 CFR 113, but this exemption applies only for  microbiological hazards
  • Facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing (i.e., grain elevators??)
  • A qualified facility (defined subsequently), as long as the exemption has not been withdrawn; qualified facilities are subject to modified requirements
  • Activities of a facility subject to FDCA sec. 419 (Standards for Produce Safety)
    • The implication of this exemption is that a farm which processes only fruits and vegetables that it is growing for the fresh/raw market does not need to develop and implement a food safety plan, but such a farm will be subject to the produce safety regulation.
  • On-farm low-risk packing or holding of food conducted by a small or very small business (this exception could encompass a farm handling another farm's commodities if the other conditions are met)
  • On-farm low-risk manufacturing/processing activities conducted by a small or very small business (this exception could encompass a farm processing another farm's commodities if the other conditions are met; this exception does NOT encompass farms that are NOT small or very small businesses, NOR does it encompass farms that engage in manufacturing or processing that is NOT low-risk)

The two regulations FDA proposed in January 2103 (Hazard Analysis and Produce Safety) abut one another; it is critical that the line distinguishing between the two regulations is clear.

    • Hazard Analysis rule focuses on food processing; Produce Safety rule focuses on "on-farm" activities of growing and harvesting fresh/raw produce. 
    • Drawing the line between the applications of the two regulations arises when fresh/raw produce is packaged on the farm where the produce is grown.  Such a farm is subject only to the Produce Safety regulation.  Produce packaged anywhere other than the farm where it is grown is subject to the Hazard Analysis regulation.
    • Therefore, a farm that grows and harvests BUT ALSO manufactures, processes, packs or holds foods for others will be regulated as a food processor.  The food processing component (i.e., manufacturing, processing, packing or holding) of activities on a farm are subject to "hazard analysis" and requires a food safety plan.
    • Growing and harvesting of food grain (on-farm activities), for example, is not subject to either of these regulations:  this activity is neither food processing nor the growing of produce.
    • Holding of food is subject to Hazard Analysis regulation, EXCEPT holding of fresh/raw produce on the farm where the produce was grown is subject to the Produce Safety regulation.
    • Congress authorized FDA to set forth an exemption for grain elevators, that is, even though a grain elevator holds food, grain elevators will be exempt from preparing and implementing a food safety plan. See 21 USC 350g(m)

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GMP rule does not apply to "farms" or the holding or transportation of "raw agricultural commodities"

  • Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both
  • The term "farm” includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership
  • Farm includes facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
  • 21 USC 321(r):  The term “raw agricultural commodity” means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

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Food Safety Plan Components

A food processor must prepare and implement a food safety plan. 

Regulatory Definitions

  • Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The term "farm” includes:
    • (1) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm...; and
    • (2) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm ...
  • Examples of food include: Fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods.
  • Harvesting applies to farms ... and means activities that are traditionally performed by farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities on the farm on which they were grown or raised ... Harvesting does not include activities that transform a raw agricultural commodity ... into a processed food ... Gathering, washing, trimming of outer leaves of, removing stems and husks from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities grown on a farm ... are examples of harvesting.
  • Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. For farms ... holding also
    includes activities traditionally performed by farms for the safe or effective storage of raw agricultural commodities grown or raised on the ... farm ..., but does not include activities that transform a raw agricultural commodity ... into a processed food...
  • Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are: Cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. For farms ..., manufacturing/processing does not include activities that are part of harvesting, packing, or holding.
  • Packaging (when used as a verb) means placing food into a container that directly contacts the food and that the consumer receives.
  • Packing means placing food into a container other than packaging the food. For farms..., packing also includes activities (which may include packaging) traditionally performed by
    farms to prepare raw agricultural commodities grown or raised on the ... farm ... for storage and transport, but does not include activities that transform a raw agricultural commodity ... into a processed food...
  • Raw agricultural commodity means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.
  • Processed food means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.

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Food safety plan must be prepared by a qualified individual who has successfully completed training in the development and application of risk-based preventive controls, or be qualified through job experience. Job experience may qualify an individual if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.  All applicable training must be documented in records, including the date of the training, the type of training, and the person(s) trained.

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A food safety plan must include:

(1) a written hazard analysis [proposed Sec. 117.130(a)(2)]
(2) written preventive controls [proposed Sec. 117.135(b)]
(3) written procedures, and the frequency with which they are to be performed, for monitoring the implementation of the preventive controls [proposed Sec. 117.140(a)]
(4) written corrective action procedures [proposed Sec. 117.145(a)(1)]
(5) written verification procedures [proposed Sec. 117.150(e)]
(6) a written recall plan [proposed Sec. 117.137(a)]

A quick review of USDA FSIS HACCP requirements for meat & poultry processors reveals similarities to the FDA food safety plan (9 CFR 417.2(c))

(c) The HACCP plan shall, at a minimum:

  1. List the food safety hazards identified ... which must be controlled ...
  2. List the critical control points for each of the identified food safety hazards...
  3. List the critical limits that must be met at each of the critical control points...
  4. List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points...
  5. Include all corrective actions ... to be followed in response to any deviation from a critical limit...
  6. Provide for a recordkeeping system that documents the monitoring of the critical control points...
  7. List the verification procedures ... that the establishment will use...

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Link to FDA proposed Hazard Analysis regulation (about 2/3 of the way down the pdf) Review this link for details; the following items are only an overview.

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Hazard analysis:  hazard identification and hazard evaluation

The hazard identification must consider hazards that may occur naturally or may be unintentionally introduced, including:  (1) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other microorganisms of public health significance; (2) Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens; (3) Physical hazards; and (4) Radiological hazards.

Evaluation of the hazards must determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.

This regulatory language suggests that not all hazards need to be addressed in the food safety plan; only those hazards that are reasonably likely to occur.

Ultimately, food processors will need to address intentional attacks on food processing but that risk is NOT part of this proposed regulation.  Food processors can expect that regulation to be proposed sometime in the future, as required by Congress in the FSMA.

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Preventive controls

The term “preventive controls” means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following:
  • (A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment. 
  • (B) Supervisor, manager, and employee hygiene training. 
  • (C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment. 
  • (D) A food allergen control program. 
  • (E) A recall plan. (but is this not already part of the food safety plan?)
  • (F) Current Good Manufacturing Practices (cGMPs) 
  • (G) Supplier verification activities that relate to the safety of food.
Key points of this standard include
  • risk-based
  • reasonably appropriate procedures
  • person knowledgeable
  • significantly minimize hazards
  • consistent with the current scientific understanding
What do these points suggest?
  • The regulation is not going to require perfection; do your best to reduce the likely hazards/risks
  • There will be room for discretion/differences of opinion; this is both good and bad.
  • Focus on risk and reducing risk
  • Identify risk and identify appropriate practices based on science
  • Retain copies of the "science" that is relied on to identify the hazards/risks and to develop the procedures.
  • The food processor needs to understand the risks associated with the food and the processes; the food processor will need to understand science and how to apply science to food processing.
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Preventive controls must include

  1. process controls (i.e., procedures, practices, and processes performed on a food during manufacturing/processing to significantly minimize or prevent hazards that are reasonably likely to occur);
  2. food allergen controls (i.e., procedures, practices, and processes employed for (i) ensuring protection of food from cross-contact, including during storage and use; and (ii) labeling the finished food);
  3. sanitation controls (to significantly minimize or prevent hazards that are reasonably likely to occur due to employee handling; sanitation controls must include A) cleanliness of food-contact surfaces, B) prevention of cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product) and
  4. a recall plan.

Preventive controls are subject to (i) monitoring, (ii) corrective actions, and (iii) verification.

For more information about GMP within Preventive Controls, review a subsequent section.

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Back to components 3 through 6 of a Food Safety Plan

Monitor the preventive controls with sufficient frequency to provide assurance that they are consistently performed.

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Establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented.

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Verification

  • Validate the preventive controls by collecting and evaluating scientific and technical information to determine whether the preventive controls, when properly implemented, will effectively control the hazards
  • Verify that monitoring is being conducted
  • Verify that appropriate decisions about corrective actions are being made
  • Verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur.
  • Reanalysis the food safety plan at least once every 3 years; or whenever a significant change is made in the activities conducted at a facility creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard; or whenever there is new information about potential hazards associated with the food; or whenever a preventive control is not properly implemented and a specific corrective action procedure has not been established; or whenever a preventive control is found to be ineffective.

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Recall plan must describe steps to be taken, and assign responsibility to

  1. Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;
  2. Notify the public about any hazard presented by the food to protect public health;
  3. Conduct effectiveness checks to verify that the recall is carried out; and
  4. Appropriately dispose of recalled food; e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

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End of the components of a Food Safety Plan and onto documenting the Food Safety Plan and its implementation.

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Written Records

The food processor must have the following documents:

  1. The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan.
  2. Records that document the monitoring of preventive controls;
  3. Records that document corrective actions;
  4. Records that document verification, including those related to:
    1. (i) Validation,
    2. (ii) Monitoring,
    3. (iii) Corrective actions,
    4. (iv) Calibration of process monitoring and verification instruments,
    5. (v) Records review, and
    6. (vi) Reanalysis
  5. Records that document applicable training for the qualified individual.

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GMP within Preventive Controls

Link to FDA proposed Hazard Analysis regulation (about 45% of the way down the pdf) Review this link for details; the following items are only an overview.

GMPs have been part of FDA regulations for several decades.  However, the regulation proposed in January 2013 will replace existing GMP (21 CFR part 110) with a new GMP regulation (proposed as 21 CFR 117).  This section briefly reviews the recently proposed GMPs.  As mentioned in other paragraphs, this regulation and its underlying statute explicitly state the relationship between HARPC and GMP; a relationship that was not explicitly stated in the past.

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Personnel:   The plant management must take all reasonable measures and precautions to ensure (a) disease control, (b) cleanliness, (c) education and training, and (d) supervision.

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Plant and grounds:   The grounds about a food plant must be kept in a condition that will protect against the contamination of food.  Plant buildings and structures must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-production purposes.

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Sanitary operations:  Buildings, fixtures, and other physical facilities of the plant must be maintained in a sanitary condition and must be kept in repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against cross-contact and contamination of food, food-contact surfaces, or food-packaging materials.  Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures must be free from undesirable microorganisms and must be safe and adequate under the conditions of use.  Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.  Pests must not be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.  All food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against cross-contact and contamination of food.  Non-food-contact surfaces of equipment used in the operation of a food plant should be cleaned in a manner and as frequently as necessary to protect against cross-contact and contamination of food, food-contact surfaces, and food-packaging materials.  Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from cross-contact and contamination.

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Sanitary facilities and controls:   Each plant must be equipped with adequate sanitary facilities and accommodations: (a) water supply, (b) plumbing, (c) sewage disposal, (d) toilet facilities, (e) hand-washing facilities and (f) rubbish and offal disposal

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Equipment and utensils:  All plant equipment and utensils must be so designed and of such material and workmanship as to be adequately cleanable, and must be properly maintained.  Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives.

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Processes and controls:   All operations in the manufacturing, processing, packing and holding of food must be conducted in accordance with adequate sanitation principles.

Raw materials and ingredients:  Raw materials and ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and must be stored under conditions that will protect against cross-contact and contamination and minimize deterioration.

Manufacturing operations:  Equipment and utensils and finished food containers must be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary.

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Warehousing and distribution:  Storage and transportation of food must be under conditions that will protect against cross-contact and biological, chemical, physical, and radiological contamination of food, as well as against deterioration of the food and the container.

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Modified Requirements of "Qualified Facilities"

A qualified facility is not required to prepare and implement a food safety plan if the facility 1) documents that it has identified potential hazards associated with the food, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; or 2) documents that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law.


A qualified facility must provide notification to consumers as to the name and complete business address of the facility where the food was manufactured or processed:

  • (1) If a food packaging label is required, the notification must appear prominently and conspicuously on the label of the food.
  • (2) If a food packaging label is not required, the notification must appear prominently and conspicuously, at the point of purchase, on a label, poster,sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or in an electronic notice, in the case of Internet sales.

Qualified facility means a facility that is a very small business, or a facility to which both of the following apply:

1) During the preceding 3-year period, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and 2) the average annual monetary value of all food sold during the 3-year period was less than $500,000.

Qualified end-user means the consumer of the food, or a restaurant or retail food establishment that: 1) is located (i) In the same State as the qualified facility, or (ii) not more than 275 miles from such facility; and 2) Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.

FDA may withdraw the exemption in the event of an active investigation of a foodborne illness outbreak that is directly linked to the qualified facility; or b) If FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with the qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility.

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Closing Thought

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Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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