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Rules and Standards for Food Processing

This page offers some details about provide some details about FDA’s GMPs, USDA & FDA's SSOPs, FDA & USDA's HACCP, FDA's Food Safety Plans, and FDA & USDA's Food Defense Plans.



Topics Addressed on this Page

  • FDA’s Good Manufacturing Practices (21 CFR Part 110 and 21 CFR Part 117 Subpart B)
  • USDA’s Operating Procedures for Egg Processing (9 CFR §§590.504 to 590.575)
  • FDA’s HACCP for Juice and Seafood Processing (21 CFR Parts 120 & 123)
  • USDA’s SSOP and HACCP for Meat and Poultry Processing (9 CFR Parts 416 & 417)
  • FDA’s Food Safety Plan for all other Food Processors (21 U.S.C. §305g; 21 CFR Part 117 Subpart C)



U.S. food processing firms have been subject to manufacturing/processing rules or standards for decades, but the standards continue to evolve.  The development and application of Hazard Analysis and Critical Control Point (HACCP) principles to seafood, juice, meat and poultry processing has been a significant event since the 1990s.  More recently, Congress expanded its perception of HACCP principles and directed that all other food processors adopt such practices by developing and implementing a Food Safety Plan.  This page provides a brief overview of past Good Manufacturing Practices (GMP), Sanitary Standard Operating Procedures (SSOPs), HACCP principles, and the components envisioned to be included in a Food Safety Plan.  



FDA has regulations specifying Good Manufacturing Practices (GMPs) for the food processors that FDA is responsible for regulating (see 21 CFR Part 110 and 21 CFR Part 117 Subpart B).  GMPs address a variety of topics.

USDA has some comparable regulations for egg processors; these Operating Procedures (9 CFR §§590.500 – 590.575) address topics similar to FDA’s GMPs, but are more specific because the egg operating procedures address a single food industry.

USDA also has Sanitary Standard Operating Procedures (SSOPs) for the meat and poultry industries (see 9 CFR Part 416).  Again, many of the topics addressed in the SSOPs are similar to topics addressed in FDA’s GMPs.

In addition, FDA has some detailed expectations for the juice and seafood industries to augment the GMPs (e.g., 21 CFR §120.6 and 21 CFR §123.11); FDA also refers to these additional requirements for juice and seafood as SSOPs – a source of possible confusion.

FDA refined its GMPs (in late 2015).  These revisions (codified at 21 CFR Part 117 Subpart B; but 21 CFR Part 110 remains), of course, do not apply to egg products, meat and poultry processing which are regulated by USDA.  Restated, USDA is not updating the operating procedures for egg processing or the SSOPs for meat and poultry processing at this time (early 2016).

FDA has required juice and seafood processors to develop and implement HACCP plans (21 CFR Part 120 and 21 CFR Part 123, respectively); these plans are underpinned by GMPs (see 21 CFR §120.5 and 21 CFR §123.5) and continue to be underpinned by the newest GMPs (21 CFR Part 117 Subpart B).

Similarly, USDA requires meat and poultry processors to have HACCP plans (9 CFR Part 417); although not explicitly stated in the USDA regulations, one would expect a relationship between the processor’s SSOPs and its HACCP plan. 

In late 2010/early 2011, Congress enacted the FDA Food Safety Modernization Act to require all FDA food processors (except seafood and juice processors) to develop and implement a Food Safety Plan (21 U.S.C. §350g), occasionally described as the “next generation of HACCP.” 

  • Prior to the Food Safety Modernization Act, food processors overseen by FDA (except seafood and juice processors) were not required to have a HACCP plan.
  • Congress allows seafood and juice processors to continue to apply existing HACCP regulations and plans, rather than require those businesses to revise their practices to align with the requirements of a Food Safety Plan.
  • The Food Safety Plan of the Food Modernization Act has no impact on USDA, or the HACCP requirements that USDA has in place for meat and poultry processors.

FDA regulations for the development and implementation of Food Safety Plans are codified at 21 CFR Part 117 Subpart C.

The primary components of 1) FDA HACCP plans for juice and seafood processors, 2) USDA HACCP plans for meat and poultry processors, and 3) the Food Safety Plans for other food processors subject to FDA oversight are similar.  There also are some significant differences that warrant mention.

The following sections provide some details about GMPs, SSOPs, HACCP and Food Safety Plans.


Topics Addressed in FDA’s existing GMPs

Food processing firms overseen by FDA are subject to Good Manufacturing Practices (GMP); see 21 CFR Part 110

GMPs provide some definitions for determining whether food is adulterated (and thus illegal to sell) because it has been manufactured, prepared, packed or held under insanitary conditions.  More precisely, GMPs help define whether 1) food has been manufactured under conditions that it are unfit for food; or 2) food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health (21 CFR 110.5).

The broad topics addressed in FDA's GMPs include:

  • Personnel:  disease control; cleanliness; education and training; supervision
  • Plant and grounds: grounds; plant construction and design
  • Sanitary operations:  general maintenance; substances used in cleaning and sanitizing; storage of toxic materials; pest control; sanitation of food-contact surfaces; storage and handling of cleaned portable equipment and utensils
  • Sanitary facilities and controls:  water supply; plumbing; sewage disposal; toilet facilities; hand-washing facilities; rubbish and offal disposal
  • Equipment and utensils
  • Processes and controls: raw materials and other ingredients; manufacturing operations
  • Warehousing and distribution

GMPs apply to all food processors subject to FDA’s oversight, including juice and seafood processors that are subject to HACCP, as well as all other food processors who are being mandated to develop Food Safety Plans.

FDA has finalized revised GMP regulation, see 21 CFR Part 117 Subpart B


Topics Addressed in USDA Egg Operating Procedures

USDA FSIS oversees facilities where shelled eggs are packed and where shell eggs are processed into egg products.  See 21 U.S.C. 1034(d).  USDA FSIS traditionally viewed shell egg safety as FDA's responsibility. However, "[i]n October 2011, OGC opined that FSIS, through the Egg Products Inspection Act (EPIA), does have inspection authority over shell eggs. This included the egg-laying barns..." see p. 7 of pdf at .

Despite the change in the understanding of FSIS' role in the egg industry, the following regulations continue to emphasize FSIS past, narrower perspective of overseeing egg processing.

These Operating Procedures are more detailed than FDA’s GMPs, but specificity is possible in this FSIS regulation because it applies only to egg processing. The regulation addresses the following topics:

  • Premises/facilities, water supply, drainage, construction, doors, floors, walls, ceilings, odors, air, drains, dressing rooms, toilet rooms, lavatory accommodations, hand washing facilities, facilities for cleaning and sanitizing utensils and equipment, storage of shells, trash, and other refuse
  • Processing equipment and utensils:  design, construction, material; able to examine, segregate, and process the product; permit easy access to all parts for cleaning and sanitizing
  • General operating procedures, such as processing, storing, and handling of shell eggs, ingredients, and egg products; pasteurization, heat treatment, stabilization, and other processes; operate to prevent deterioration of products
  • Candling and transfer-room facilities, equipment and operations
  • Classifications of shell eggs
  • Egg cleaning operations
  • Sanitizing and drying of shell eggs prior to breaking
  • Breaking room facilities & operations
  • Liquid egg cooling & holding
  • Freezing facilities & operations
  • Defrosting facilities & operations
  • Spray process drying facilities & operations
  • Spray process powder; definitions and requirements
  • Albumen flake process drying facilities & operations
  • Drying, blending, packaging, and heat treatment rooms and facilities
  • Dried egg storage
  • Washing and sanitizing room or area
  • Cleaning and sanitizing requirements
  • Health and hygiene of personnel
  • Pasteurization of liquid eggs
  • Heat treatment of dried whites

Again, these regulations are quite specific because they apply to one industry.


Topics Addressed in USDA SSOPs for Meat and Poultry Processing

USDA FSIS has regulations addressing the operation of meat and poultry facilities.  The regulations refer to the standards as Sanitation Standard Operating Procedures (SSOPs) even though the topics are similar to those addressed in GMPs and Egg Operating Procedures.

Each official establishment must be operated and maintained to prevent insanitary conditions and to ensure that the product is not adulterated.  Topics include

  • Grounds and facilities:  grounds and pest control; construction; light; ventilation; plumbing; sewage disposal; water supply and water, ice, and solution reuse; dressing rooms, lavatories, and toilets.
  • Equipment and utensils:  equipment and utensils used for processing or handling product or ingredient; equipment and utensils must be available for FSIS inspection; receptacles for storing inedible material
  • Sanitary operations:  food-contact surfaces; non-food-contact surfaces; cleaning compounds, sanitizing agents, processing aids, and other chemicals; product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation
  • Employee hygiene:  cleanliness; clothing; disease control.

Each official establishment shall develop, implement, and maintain written standard operating procedures for sanitation (Sanitation SOP's):

  • Development of Sanitation SOP's
  • Implementation of SOP's
  • Maintenance of Sanitation SOP's
  • Corrective Actions
  • Recordkeeping requirements
  • Agency verification


Humane Slaughter

Although not defined by USDA FSIS as an SOP, a humane slaughter process must be implemented by official establishments, see 9 CFR part 313.  The standards address the maintenance of the livestock holding and handling facilities, such as pens, driveways and ramps, the handling or moving of livestock, and the stunning of livestock at the beginning of the slaughter process.  Carbon dioxide, captive bolt, gun shot and electric current are considered acceptable methods to stun the animal as long as the process meets USDA regulations.  Similarly, the FSIS anticipates  that most poultry slaughter facilities render the animal insensible to pain before the slaughter process is initiated.


Additional Topics addressed in FDA SSOPs for Juice and Seafood Processing

In addition to complying with GMPs, the FDA has addressed some specific issues for juice and seafood processors as SSOPs.


Juice SSOP

  • Each juice processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing. The SSOP shall address:
  • Safety of the water that contacts food or food contact surfaces or that is used in the manufacture of ice
  • Condition and cleanliness of food contact surfaces
  • Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces
  • Maintenance of hand washing, hand sanitizing, and toilet facilities
  • Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants
  • Proper labeling, storage, and use of toxic compounds
  • Control of employee health conditions
  • Exclusion of pests from the food plant


Seafood SSOP

  • The processor shall monitor the conditions and practices during processing to ensure conformance with GMPs
  • Each processor shall maintain records that document monitoring and corrections.
  • Sanitation standard operating procedure controls may be included in the HACCP plan
  • Each seafood processor should have and implement a written sanitation standard operating procedure
  • Each processor shall monitor the conditions and practices during processing to ensure conformance GMPs
  • Each processor shall maintain records that document monitoring and corrective actions
  • Processors of smoked and smoke-flavored fishery products shall include in their HACCP plans how they are controlling the food safety hazard associated with the formation of toxin by Clostridium botulinum
  • Processors shall include in their HACCP plans how they are controlling the origin of the molluscan shellfish they process to ensure 1) they only process molluscan shellfish harvested from growing waters approved for harvesting 2) they accept only shellstock from a harvester that is in compliance with licensure requirements or is certified, and 3) they accept only containers of shucked molluscan shellfish that bear the required label


Topics addressed in FDA GMP revisions

As stated previously, FDA proposed a regulation in early 2013 that would update its GMPs by replacing the current regulation.

The list of topics and much of the language in the proposed 21 CFR Part 117 Subpart B is identical to the current language of 21 CFR Part 110.  There are some changes but they are best described as clarifying past statements or reflecting current practices and concerns; for example:

  • Preventing cross contact is emphasized in the updated regulation
  • Suggestions on how to comply with some regulatory standards are NOT included in the updated regulation.


Review of HACCP Principles

GMPs, Operating Procedures and SSOPs are only part of the standards or expectations that food processors must comply with.  In the past several decades, the concept of HACCP emerged, was applied to some sectors of the food processing industry, and is evolving into Food Safety Plans.  A brief review of the HACCP principles may help in understanding the application of HACCP and Food Safety Plans.

HACCP has often been described as founded on seven principles.  The following list is copied from USDA Food Safety and Inspection Service, Key Facts: The Seven HACCP Principles, revised January 1998 at

Principle 1: Conduct a hazard analysis.

  • Plants determine the food safety hazards identify the preventive measures the plant can apply to control these hazards.

Principle 2: Identify critical control points.

  • A critical control point (CCP) is a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

Principle 3: Establish critical limits for each critical control point.

  • A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

Principle 4: Establish critical control point monitoring requirements.

  • Monitoring activities are necessary to ensure that the process is under control at each critical control point. FSIS is requiring that each monitoring procedure and its frequency be listed in the HACCP plan.

Principle 5: Establish corrective actions.

  • These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce.

Principle 6: Establish record keeping procedures.

  • The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.

Principle 7: Establish procedures for verifying the HACCP system is working as intended.

  • Validation ensures that the plans do what they were designed to do; that is, they are successful in ensuring the production of safe product. Plants will be required to validate their own HACCP plans. FSIS will not approve HACCP plans in advance, but will review them for conformance with the final rule.
  • Verification ensures the HACCP plan is adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP records, critical limits and microbial sampling and analysis. FSIS is requiring that the HACCP plan include verification tasks to be performed by plant personnel. Verification tasks would also be performed by FSIS inspectors. Both FSIS and industry will undertake microbial testing as one of several verification activities. the occurrence of the identified food safety hazard.


Subsequently, these principles were expanded into “implementation steps”:

  1. Assemble HACCP team
  2. Describe product
  3. Identify intended use
  4. Construct flow diagram
  5. On-site confirmation of flow diagram
  6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)
  7. Determine Critical Control Points (Principles 2)
  8. Establish critical limits for each CCP (Principle 3)
  9. Establish a monitoring system for each CCP (Principle 4)
  10. Establish corrective actions (Principle 5)
  11. Establish verification procedures (Principle 6)
  12. Establish Documentation and Record Keeping (Principle 7)

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Some Common Elements of Juice, Seafood, and Meat & Poultry HACCP

HACCP regulations are available at the following citations; consider reviewing these regulations as the following materials are studied.

The following materials are a compilation of concepts embedded in the HACCP regulations for juice, seafood, and meat & poultry processors.  Each of these three HACCP regulations pose some unique requirements but they also have a core of similarities.  The purpose of this compilation is to introduce HACCP by focusing on the commonalities.

As one reviews the HACCP regulations for juice, seafood, and meat & poultry processors, the following concepts are common among the regulations.


Written hazard analysis

  • Identify food safety hazards likely to occur
    • List of 9 or 10 categories of hazards to consider
    • List of factors that could impact the safety of a final food product, e.g., ingredient, processing procedures, packaging, storage, facility, equipment, plant sanitation, employee hygiene
      • Develop a detailed flow chart to identify risks the product may be exposed to
    • Reasonable probability that a hazard will occur is based on experience (has occurred in the past), data, scientific reports, etc
  • Identify control/preventive measures to control these hazards
  • Review current process to determine if modifications are needed
  • Identify Critical Control Points (CCPs)


  • Consider hazards arising from within and outside the plant
  • Analysis is conducted by a trained individual


Written HACCP plan

  • HACCP plan developed and implemented
  • Developed by a trained individual
  • A plan for each plant and for each type of product – can group products into a HACCP plan as long as hazards, CCPs, critical limits and procedures are identical/essentially the same

A plan for each processing procedure/final product (FSIS)

  • List food hazards likely to occur
  • List CCPs
  • List Critical Limits (CLs) for each CCP
  • List procedure (and frequency) to monitor that operations are within CL at each CCP
  • Include corrective plan should operation be outside the range of CL at a CCP; this assumes the cause of the deviation has been correctly anticipated
    • Stop food from entering commerce
    • Cause of deviation is (identified &) corrected/eliminated (CCP will be under control after corrective action has been taken)
      • Measures to prevent recurrence have been taken
    • Predetermined corrective action is taken as described in HACCP plan – this assumes that cause of deviation is identified and the cause aligns with cause anticipated when HACCP plan was developed


      • If cause of current deviation does not align with presumed cause, then be certain food is not distributed, determine this unanticipated cause, and remedy the situation; determine whether  HACCP plan needs to be modified to accommodate this new/unanticipated  cause for deviation
      • Review affected food and take corrective action to assure adulterated food does not enter commerce


      • Validation procedures
        • Test the HACCP plan during first year to make sure it is adequate (CCPs, CLs, monitoring, recordkeeping, corrective actions &review of recrods)
        • Test/reassess the HACCP plan annually thereafter
        • Test/reassess the HACCP plan when a change in process, raw materials, product formulation, packaging, distribution, or intended use of product has been made
          • Reassess HACCP plan when changes occur
        • Reassess whether the hazard analysis needs to be revised or updated whenever there has been a change in process, raw materials, product formulation, packaging, distribution, or intended use of product has been made (is this reassessment of the hazard analysis considered part of the validation procedure?)
          • The reassessment/validation of hazard analysis is to be performed by a trained individual
      • Verification procedure
        • Verify the HACCP plan is adequate to control food safety hazards
        • Review customer complaints
        • Determine whether there are additional CCPs to monitor; also determine if the CLs were correct??
        • Calibrate monitoring equipment – assumes CL can be mechanical measured at CCPs
        • Test a sample of the product to assure it is acceptable (FDA)
        • Observe monitoring and corrective actions taken (FSIS)
        • Review the records to assure 1) monitoring of CLs at CCPs has been conducted, 2) that appropriate corrective actions have been taken when operations were outside the CL range for CCPs, 3) that monitoring equipment was tested and recalibrated according to the HACCP plan.
      • Recordkeeping system
        • Document ongoing monitoring of CL at CCP; record actual/observed values at CCPs
        • Review that CL at CCPs are being document and that the CLs are within the acceptable range
        • Document corrective actions for deviations resulting from both anticipated causes (and thus the corrective action was already in HACCP plan) and unanticipated causes (and thus there was no appropriate corrective action already in the HACCP plan)
        • Verify that appropriate corrective actions have been taken
        • Document the testing and calibration of monitoring equipment that was performed to assure the monitoring equipment was working
        • Record the result of any product testing
        • Verify that records of product tests are complete and tests were conducted according to facilities written procedures
        • Document SSOPs and their implementation (see juice HACCP)
        • Written hazard analysis
        • Written HACCP plan (with CCPs, CLs, monitoring and verification procedures)
        • Document that HACCP system has been verified, that HACCP plan has been validated, and that hazard analysis has been validated
        • Review records for completeness prior to shipping product and that CLs were met (FSIS)
      • Person with HACCP training or job experience may 1) develop hazard analysis and control measures, 2) develop HACCP plan, 3) verify and monitor HACCP plan, 4) review records
      • Person with HACCP training 1) develops HACCP plan, 2) reassess and modifies HACCP plan, 3) reassess and modifies the HACCP analysis, and 4) reviews the records.
      • Person with HACCP training to develop, reassess and modify HACCP plan

      Form of records, signing & dating, record retention are not detailed in this summary.



      Some Additional Elements of Juice, Seafood and Meat & Poultry HACCP

      Lack of HACCP plan RENDERS the product adulterated (seafood) compared to Lack of HACCP plan MIGHT render the product adulterated (FSIS)

      Agency verification (FSIS):  review HACCP plan, review CCP records, review adequacy of corrective actions, review CLs; review records of HACCP system, observe & measure CCPs, collect & analyze samples, and on-site observations and record review.

      HACCP is inadequate if it does not meet regulatory requirements, personnel are not performing tasks, business fails to take corrective actions, HACCP records are not maintained, and adulterated product is produced or shipped (FSIS).

      GMPs will determine whether sanitary conditions are met (seafood)


      Food Safety Plan – Statute

      21 U.S.C. 350g

      The Food Safety Plan, as enacted by Congress as part of the FDA Food Safety Modernization Act, has been described as the “next generation of HACCP.”   This overview of the food safety plan statute illustrates several HACCP concepts that also will underpin food safety plans; in addition, the overview reveals how the concept of a "food safety plan" extends the overall purpose and idea of HACCP.


      Under a Food Safety Plan, the operator of a facility shall

      • evaluate hazards that could affect food processed or held by at the facility
      • identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards
      • provide assurances that such food is not adulterated
      • provide assurances that such food is properly labelled for major food allergens
      • monitor the performance of the preventive controls, and
      • maintain records of monitoring as a matter of routine practice.


      The operator shall develop a written hazard analysis that

      • identifies and evaluates known or reasonably foreseeable hazards, including
        • biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and
        • hazards that occur naturally, or may be unintentionally introduced
        • identifies and evaluates hazards that may be intentionally introduced, including by acts of terrorism.


      The operator shall identify and implement preventive controls, including at critical control points, to assure that

      • known or reasonably foreseeable hazards will be significantly minimized or prevented
      • any hazard that may be intentionally introduced will be significantly minimized or prevented and addressed
      • the food processed or held will not be adulterated or misbranded relative to major food allergens


      The operator of a facility shall monitor the effectiveness of the preventive controls.

      The operator of a facility shall establish procedures to ensure that, if the preventive controls are not properly implemented or are found to be ineffective

      • appropriate action is taken to reduce the likelihood of recurrence of the implementation failure;
      • all affected food is evaluated for safety; and
      • all affected food is prevented from entering into commerce if the operator cannot ensure that the affected food is not adulterated or misbranded relative to major food allergens


      The operator of a facility shall verify that

      • the preventive controls are adequate to control the identified hazards;
      • the operator is monitoring the effectiveness of preventive controls;
      • the operator is making appropriate decisions about corrective actions;
      • the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards (verification can include the use of environmental and product testing programs and other appropriate means); and
      • there is documented, periodic reanalysis of the plan to ensure that the food safety plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.


      The operator of a facility shall maintain records documenting the monitoring of the preventive controls, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

      The operator of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of a food safety plan, including analyzing the hazards and identifying the preventive controls adopted to address those hazards. Such written plan and associated records shall be made promptly available to FDA upon oral or written request.

      The operator in charge of a facility shall conduct a reanalysis

      • whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard,
      • whenever a significant change is made in the activities conducted at a facility if the change creates a significant increase in a previously identified hazard, or
      • not less frequently than once every 3 years, whichever is earlier.

      Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified shall be implemented before the change in activities at the facility is operative.  The operator shall revise the written food safety plan if such a significant change is made, or document the basis for concluding that no additional or revised preventive controls are needed.

      The FDA may require a reanalysis to respond to new hazards and developments in scientific understanding, including results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.


      Some Differences between General Components of HACCP and Food Safety Plan Statute

      • The Food Safety Plan statute slightly extends the list of hazards
      • The statute includes intentional attacks as a hazard
      • The statute identifies the labeling of major food allergens as a concern
      • The statute mandates a reanalysis of the food safety plan no less often than every three years
      • The statute empowers FDA to mandate a reanalysis of a food safety plan



      Overview of Food Safety Regulation

      21 CFR Part 117 Subpart C

      • Adds a recall plan as part of the food safety plan
      • The hazard evaluation includes an assessment of the severity of illness or injury should the hazard occur
      • The proposed regulation does NOT address intentional attacks
      • Preventive controls address process controls, food allergen controls, sanitation controls, and recall plan (as already mentioned)
      • Corrective actions continue to distinguish between anticipated problems and unanticipated problems.
      • Expanded list of events that trigger reanalysis of the food safety plan
      • Refined the responsibilities of the “trained individual”:  prepare food safety plan, validate preventive controls, review records for implementation and effectiveness of preventive controls, review records for appropriateness of  corrective actions, and reanalysis of food safety plan
      • Refined the required records:  written food safety plans (and its six required components), monitoring preventive controls, document corrective actions,


      Food Defense:  Assessing vulnerabilities to an intentional attack within a food system or infrastructure

      Since September 2001, there has been increased focus on the risk of an intentional attack on the U.S. food system.  The industry recognized that the military assesses the risk of an intentional attack on a continuous basis.  The process used by the military is known as CARVER.  Throughout the 2000s, the U.S. food industry studied the application of CARVER.  The Food Safety Modernization Act incorporates intentional attack into the development and implementation of a Food Safety Plan.  This section reviews CARVER and begins to suggest how it might be incorporated into HACCP.  The discussion also introduces the Food Defense regulation proposed by FDA in December 2013.


      How does a food business begin to address the risk of an intentional attack on its product? One idea is to implement the military's concept of CARVER.

      See FDA web page on CARVER + Shock Primer; additional excerpts drawn from USDA/FDA "An Overview of the CARVER Plus SHOCK Method for Food Sector Vulnerability Assessments" at

      "The CARVER plus Shock method is an offensive targeting prioritization tool that has been adapted for use in the food sector. This tool can be used to assess the vulnerabilities within a system or infrastructure to an attack. It allows you to think like an attacker by identifying the most attractive targets for attack. By conducting such a vulnerability assessment and determining the most vulnerable points in your infrastructure, you can then focus your resources on protecting your most vulnerable points.

      "CARVER is an acronym for the following six attributes (discussed in further detail later) used to evaluate the attractiveness of a target for attack:

      • Criticality - measure of public health and economic impacts of an attack
        • A target is critical when introduction of threat agents into food at this location would have significant health or economic impact.
      • Accessibility – ability to physically access and egress from target
        • A target is accessible when an attacker can reach the target to conduct the attack and egress the target
          undetected. Accessibility is the openness of the target to the threat. This measure is independent of the
          probability of successful introduction of threat agents.
      • Recuperability – ability of system to recover from an attack
        • A target’s recuperability is measured in the time it will take for the specific system to recover productivity. The effect of a possible decrease in demand is considered in this criterion.
      • Vulnerability – ease of accomplishing attack
        • A measure of the ease with which threat agents can be introduced in quantities sufficient to achieve the attacker’s purpose once the target has been reached. Vulnerability is determined both by the characteristics of the target (e.g., ease of introducing agents, ability to uniformly mix agents into target) and the characteristics of the surrounding environment (ability to work unobserved, time available for introduction of agents). It is also important to consider what interventions are already in place that might thwart an attack.
      • Effect – amount of direct loss from an attack as measured by loss in production
        • Effect is a measure of the percentage of system productivity damaged by an attack at a single facility. Thus, effect is inversely related to the total number of facilities producing the same product.
      • Recognizability – ease of identifying target
        • A target’s recognizability is the degree to which it can be identified by an attacker without confusion with other targets or components.

      "In addition, the modified CARVER tool evaluates a seventh attribute, the combined health, economic, and psychological impacts of an attack, or the SHOCK attributes of a target.

      • Shock is the combined measure of the health, psychological, and collateral national economic impacts of a successful attack on the target system. Shock is considered on a national level. The psychological impact will be increased if there are a large number of deaths or the target has historical, cultural, religious or other symbolic significance. Mass casualties are not required to achieve widespread economic loss or psychological damage. Collateral economic damage includes such items as decreased national economic activity, increased unemployment in collateral industries, etc. Psychological impact will be increased if victims are members of sensitive subpopulations such as children or the elderly.

      "The attractiveness of a target can then be ranked on a scale from one to ten on the basis of scales that have been developed for each of the seven attributes. Conditions that are associated with lower attractiveness (or lower vulnerability) are assigned lower values (e.g., 1 or 2), whereas, conditions associated with higher attractiveness as a target (or higher vulnerability) are assigned higher values (e.g., 9 or 10). Evaluating or scoring the various elements of the food sector infrastructure of interest for each of the CARVER-Shock attributes can help identify where within that infrastructure an attack is most likely to occur."

      FDA has not abandoned the concepts that underpin CARVER + Shock, but has refined its explanation of the concepts and their application.  See FDA resources on Food Defense:

      • FDA Food Defense -- web-based information describing several approaches to addressing the concern of intentional attacks on the food industry
      • The Food Safety Modernization Act adds intentional attacks as a risk or hazard to be analyzed as part of a Food Safety Plan; see 21 U.S.C. 350i and 21 U.S.C. 350g(b)(2).
        • The FDA shall a) conduct a vulnerability assessment of the food system; b) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food; c) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food; and d) determine the time, manner, and form in which these determinations are made publicly available.
        • The FDA shall promulgate regulations a) specifying how a person shall assess whether the person is required to implement mitigation strategies to protect against intentional adulteration of food; and b) specify appropriate science-based mitigation strategies to protect the food supply chain at specific vulnerable points.  These regulations shall apply only to food for which there is a high risk of intentional contamination.
        • This section does not apply to farms, except for those that produce milk.
      • FDA regulation: Mitigation Strategies to Protect Food Against Intentional Adulteration 21 CFR 121

      Instructor's Opinion: From a food firm's perspective, I am drawn to the concepts of accessibility (ability of an attacker to physically access and egress from a target), vulnerability (ease with which the attacker could accomplish the deed), and recognizability (likelihood that an attacker could identify the firm as a target).  Do not forget the class discussion about the Minnesota dairy farm that was attacked by a disgruntled farm neighbor.  I would also consider who may be motivated to attack the firm:  a competitor, a disgruntled employee, a ???.  These are four points that I would urge managers of ALL food businesses to consider.



      Like FDA, USDA bases its vision for food defense on the concept of "CARVER + shock"; many of USDA web resources link to FDA's food defense materials.  The two agencies are pursuing similar procedures in assisting the food industry identify and minimize its exposure to intentional attacks.



      Good Manufacturing Practices and Sanitary Standard Operating Procedures guide food processors in the construction and operation of their facilities to reduce the risk of adulterated food.

      Hazard Analysis & Critical Control Points and Food Safety Plans are founded on the seven principles of HACCP but the Food Safety Plan expands the scope of issues a food processor is expected to consider and address, such as major allergens, preparing a recall plan, and the risk of an intentional attack against the food product.




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