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Good Manufacturing Practices, HACCP, SSOPs, and CARVER

Introduction to Food Law
Overview of US Food Law
Government "Players" Involved in US Food Law
Requirements for Food Businesses

Producer/Processor/Preparer Liability
Looking Forward/Future Issues

Processing procedures (GMP and HACCP)

As stated previously, federal law prohibits adulterated food from entering interstate commerce.  Food is considered adulterated

  • (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health;...
  • (2) (A) if it bears or contains any added poisonous or added deleterious substance ... that is unsafe within the meaning of section 346 of this title;...
  • (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or
  • (4) if it 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; or
  • (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or
  • (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”

In general terms, this statute mandates that food companies follow good manufacturing practices (GMP) to assure the processing, storage and transporting environments are clean and that no unacceptable substances enter the food product. This page addresses GMP; it also addresses a more recent concept of HACCP.

  • Good manufacturing practice
    • The details for GMP are contained in regulations; for example see 21 CFR part 110;
    • The regulations address personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution.
      • Topics addressed as part of GMP include disease control; cleaniness; training; supervision; grounds; plant construction and design; general maintenance; cleaning and sanitizing substances; storage of toxic materials; pest control; sanitation of food-contact surfaces; storage and handling of cleaned portable equipment and utensils; water supply; plumbing; sewage disposal; toilet facilities; handwashing facilities; rubbish and offal disposal; equipment, utensil, systems, and instruments design, construction, maintenance and use; food operations; raw materials and ingredients; food manufacturing operations; and storage and transportation.
        • Most of these topics appear to primarily relate to paragraph (4), supra.
      • Also, "[r]egulations known as Good Manufacturing Practices (GMP) limit the amount of food and color additives used in foods. Manufacturers use only the amount of an additive necessary to achieve the desired effect." Excerpt from http://www.cfsan.fda.gov/~dms/qa-adf16.html. Also see the previous section of these materials.
    • See "Good Manufacturing Practices (GMPs) for the 21st Century - Food Processing;" consider the Executive Summary as required reading, but also familiarize yourself with the full document.
      • Note the suggestions/recommendations of this study.
    • Although GMP may directly deal primarily with 21 USC §342(a)(4), supra, GMPs can also be implemented to minimize the risk of food being adulterated as the result of any of the other conditions, such as paragraphs 1, 2, 3, 5, or 6 of 21 USC §342(a), supra.
    • Also see " Sanitary Food Transportation Act of 1990" -- Chapter 57 of USC Title 49.
      • Guidance on Bulk Transport of Juice Concentrates

        "The purpose of this guidance is to provide industry with recommendations for appropriate control measures to use in the bulk transport of:

        1. high degree Brix juice concentrate that is transported to a separate facility for final packaging or for dilution to a consumer strength concentrate and final packaging, and
        2. shelf stable single strength juice that is transported in aseptic packaging to a separate facility for final packaging."


        "This guidance is designed as an aid to operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities. It identifies the kinds of preventive measures operators of these establishments may take to minimize the risk that fluid milk under their control will be subject to tampering or other malicious, criminal, or terrorist actions."


    Enforcing GMP

    • FDA -- rely on state inspections? FDA's mandate is for occasional inspections; FDA does not have the staff to conduct more inspections; most food businesses are subject to state license requirements and thus occasional state inspections (see previous section). Accordingly, FDA inspections generally are conducted after a problem has been identified.
    • USDA -- required to conduct ongoing inspections of meat and poultry processing facilities. The ongoing inspections should be an opportunity for USDA inspectors to continuously monitor whether the firm is following GMP.
  • Hazard Analysis and Critical Control Point (HACCP)
    • An alternative or the "next generation" of GMP?
    • Overview of HACCP (by FDA)
    • A Focus on Hazard Analysis and Critical Control Point (HACCP) (by USDA)
    • HACCP is described as "a food safety program developed ... for astronauts...; [it] focuses on preventing hazards that could cause food-borne illnesses by applying science-based controls, from raw material to finished products... Traditionally, industry and regulators have depended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food. This approach, however, tends to be reactive, rather than preventive, and can be less efficient than the new system...

      HACCP offers a number of advantages over the current system. Most importantly, HACCP:

      • focuses on identifying and preventing hazards from contaminating food
      • is based on sound science
      • permits more efficient and effective government oversight, primarily because the recordkeeping allows investigators to see how well a firm is complying with food safety laws over a period rather than how well it is doing on any given day
      • places responsibility for ensuring food safety appropriately on the food manufacturer or distributor
      • helps food companies compete more effectively in the world market
      • reduces barriers to international trade.

    HACCP has been endorsed by the National Academy of Sciences, the Codex Alimentarius Commission ..., and the National Advisory Committee on Microbiological Criteria for Foods. A number of U.S. food companies already use the system in their manufacturing processes, and it is in use in other countries, including Canada."

    • HACCP is required for some foods; e.g., meat (9 CFR 417), poultry (also 9 CFR 417), juice (21 CFR 120), and seafood (21 CFR 123.6).
    • HACCP is emerging as an industry-driven concept that the firm should take a proactive role in assuring the food processing procedure will lead to a safe product.
    • HACCP is considered an alternative to traditional government inspections; but the government retains a role in the overall process by using its regulatory authority to assure that businesses have adequate HACCP plans and that the plan is being appropriately implemented.
      • Are these plans pre-approved or are they reviewed only when the facility and records are inspected? For example, see 9 CFR 417.4 for regulations about validating the initial plan -- "the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended." The responsibility is primarily on the firm; not on the government regulator.
    • HACCP allows (requires) each business to focus on their operation and its unique characteristics rather than having a standardized inspection process that may not offer the flexibility to consider the uniqueness of each business. The focus is not on having a standardized production process but on having a monitoring process that is adequate to assure each business (regardless of its manufacturing process) is producing a safe product by minimizing the risk of a food safety problem.
    • 7 principles of HACCP; see HACCP Principles

      Principle 1: Conduct a hazard analysis.
      Principle 2: Determine the critical control points (CCPs).
      Principle 3: Establish critical limits (CL).
      Principle 4: Establish monitoring procedures.
      Principle 5: Establish corrective actions.
      Principle 6: Establish verification procedures.
      Principle 7: Establish record-keeping and documentation procedures.

    • See 21 CFR 123.6(c) for an example of these 7 principles having been incorporated into regulations; these particular regulations address HACCP requirements for fish and fishery products.


    • HACCP for juice 21 CFR Part 120
      • HACCP for juices (FDA) -- "The Food and Drug Administration today [January 18, 2001] announced a final rule designed to improve the safety of fruit and vegetable juice and juice products. Under the rule, juice processors must use Hazard Analysis and Critical Control Point (HACCP) principles for juice processing. Implementation of a HACCP system will increase the protection of consumers from illness-causing microbes and other hazards in juices." Excerpt from http://www.cfsan.fda.gov/~lrd/hhsjuic4.html
      • See 21 CFR 120.8 (HACCP plan for juice)
      • Also see 21 CFR 120.6 for SSOPs within HACCP for juice; major topics are sanitation controls, monitoring, and records.


      • Mandatory HACCP for seafood and juice
      • Voluntary HACCP for dairy (Grade A) and other land foods
      • Also, FDA is urging that HACCP principles be applied to retail and food service sectors of the food industry -- discussed again in next section of these materials
      • Recall that HACCP also is being suggested for the production sector.


      • The expanding acceptance of HACCP suggests that it may someday extend across the entire food industry (production, processing, and preparation) and around the world (for example, see Codex and ISO).

Implementing HACCP

  • Introduction
    • Is HACCP voluntary or mandatory? Mandatory for seafood, juice, meat and poultry.
    • Regulatory agencies involved with HACCP include FDA, USDA, and various state agencies. International organizations also are promoting HACCP, see Codex and ISO.
    • HACCP is intended to assure product safety, but it can also lead to improved product quality.
    • HACCP can generally be implemented with a 12-step process
      • Step #1 Assemble a HACCP Team
        • A commitment from management.
        • Multidisciplinary membership.
        • Know the manufacturing process and the products
        • Know how to take corrective action.
        • Understand the HACCP principles.
      • Step #2 Processing and Distribution of Foods
        • A separate HACCP is needed for each product.
        • What method will be used for distributing the product?
        • Refrigerated or frozen or shelf-stable?
        • Safety hazard or quality issue?
      • Step #3 Intended Use and Consumers
        • What impact will the product have on the general public?
        • Are you targeting a specific segment of the market? Particular consumers? Are you targeting a wholesale or retail market.
        • Ingredients
        • Lower fat products
      • Step #4 Develop a Flow Diagram
        • Must cover all steps of the manufacturing process.
        • Not an engineering drawing.
        • Verify the accuracy and completeness of the flow diagram.
        • Take the diagram to the production floor to assure/verify its accuracy.
      • Step #5 Conduct a Hazard Analysis
        • Are you concerned about microbiological, chemical or physical hazards?
        • Identify steps in the manufacturing process where a hazard can happen.
        • Consider risk (probability) of the hazard and severity if the hazard occurs.
        • Remember -- hazard is limited to safety; it does not focus on quality issues (even though they may be related).
        • Identify preventative measures that can be applied.
      • Step #6 Critical Control Points (CCP)
        • CCP -- any place in the manufacturing and distribution process where control can be applied to prevent a hazard.
        • GMP’s can and should control many hazards.
        • What is a CCP for one product many not be for another.
      • Step #7 Critical Limits (CL)
        • Limit that must be met to insure safety of the product.
        • Exceeding the CL means a health hazard exists.
        • CLs can be derived from regulatory standards (e.g., dairy), guidelines, studies, experts, etc.
        • Examples of CLs: temperatures (for some products it may be what is too high and for other products it may be what is too low), time, pH, residues, bacteria counts and kinds.
      • Step #8 Monitoring/Inspection
        • Planned sequence of observations or measurements.
        • Must control CCP’s
        • Must be effective.
        • Monitoring intervals must be reliable.
        • Must be rapid, no lengthy analysis.
        • Adequate plan to see that the monitoring is carried out.
      • Step #9 Corrective Actions
        • Specify procedures to be taken when deviations occur.
        • Corrective actions must be documented.
        • Eliminate actual or potential hazards.
        • Be prepared to put products on hold if a problem is identified.
        • Make changes to prevent future occurrence.
      • Step #10 Records
        • Must include every part of the HACCP program, from team membership through all actions -- steps #1 - 12
      • Step #11 Verification
        • Consists of methods, procedures or tests used in monitoring compliance.
        • CCP’s are under control
        • Necessary changes have been made.
        • All records are complete.
        • Sample analysis to verify.
        • Training and knowledge.
      • Step #12 Evaluation and Revision
        • At least an annual review.
        • Anytime manufacturing process is changed or products are changed.
        • Anytime new raw materials or sources are used.
        • Anytime formulation is changed.
        • Anytime new equipment is installed; in some cases, even adjusting the performance of the equipment may necessitate are review of the HACCP..
        • Anytime there is a change in personnel or shifts.
        • Anytime there is a changes in storage or distribution.
    • See 9 CFR 417.2 (HACCP plan for animals and animal products)
    • HACCP for meat (FSIS) -- "Every official [meat] establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. 9 CFR 417.2
    • Official establishment: "Any slaughtering, cutting, boning, meat canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this subchapter." 9 CFR 301.2
    • List of plants under federal inspection (FSIS)

Court Case Addressing the Relationhip Between HACCP and USDA's Inspection Mandate

The following excerpts from two court case address expectations of USDA inspections following the adoption of HACCP.

  • This case finds that HACCP is consistent with USDA inspection laws.

American Federation of Government Employees v. Veneman, US Court of Appeals for the District of Columbia, No. 01-5035, March 29, 2002

... [T]he Federal Meat Inspection Act ("FMIA") and the Poultry Products Inspection Act ("PPIA") ... seek to ensure that all meat and poultry products processed for human consumption are wholesome and unadulterated. See 21 U.S.C. §602; 21 U.S.C. §451. The FMIA requires USDA inspectors to conduct a post-mortem "examination and inspection of the carcasses and parts thereof of all cattle, sheep, swine, goats, horses, mules and other equines" ... The PPIA requires USDA inspectors to conduct a "post mortem inspection of the carcass of each bird processed" .

The USDA's Food Safety and Inspection Service ("FSIS") traditionally assigned federal inspectors to processing lines where they conducted "organoleptic" inspections of carcasses, relying on sight, touch and smell in examining the head, viscera, and exterior of the carcasses to detect signs of adulteration, such as tumors, parasites and other diseases . In "the mid-1990s, FSIS embarked on a comprehensive food safety initiative targeting the agency's resources at what it perceived as a serious health risk-foodborne pathogens, such as salmonella and E. coli , which cannot be detected by organoleptic inspection. At the same time it determined to make changes in the current inspection process to combat these microbial causes of foodborne illness, FSIS addressed what it considered to be another failure of the present regulatory system-that it provides processing plants with little incentive to detect and eliminate unacceptable carcasses before presenting them for inspection."

"In July 1996, FSIS took the first step in implementing its new initiative by promulgating the Pathogen Reduction/ Hazard Analysis and Critical Control Points ('HACCP') final rule . The rule required meat and poultry plants to develop and install a system of preventive controls to ensure the safety of their products ... Because the HACCP rule gave processing plants greater control over production decisions, FSIS determined that changes in its traditional organoleptic inspection methods would be necessary to realign the roles of federal inspectors with the new HACCP philosophy ... Accordingly, in 1997 FSIS published a notice in the Federal Register explaining that as a result of the HACCP final rule, "[e]very aspect of traditional FSIS methods of inspection for slaughter and processing needs to be reconsidered" ... The notice said the agency was launching the Inspection Models Development Project (the "Models Project"), through which it would design and test various new inspection models in a series of trials in volunteer meat and poultry slaughter establishments . If - after gathering data on the various test models and preparing a final report analyzing the different models - the FSIS decided that its traditional inspection methods needed to be changed, then it pledged to initiate rulemaking to alter existing inspection procedures.

The first new inspection approach, tested at several volunteer processing plants under the Models Project, gave industry personnel the task of separating normal from abnormal carcasses and parts. Federal inspectors had two limited roles: oversight and verification. Oversight inspectors observed establishment personnel as they processed carcasses and removed unacceptable products from the food supply; verification inspectors randomly sampled carcasses to determine if the plant was complying with relevant performance standards.

In 1998, the plaintiffs in this action sought to enjoin implementation of the new inspection model, arguing that it violated the FMIA and PPIA because federal inspectors were not personally inspecting each carcass ... We [found that]. [b]ecause the model program had federal employees "inspecting people not carcasses," the USDA was not fulfilling its statutory duty to conduct post-mortem inspections of carcasses.

On remand ... [t]he government ... [argued] that it had modified its Models Project. [calling] for federal inspectors to play two roles:

(1) "carcass inspectors" stationed at the end of slaughter lines would examine each poultry carcass for adulteration after the carcasses were eviscerated, sorted, washed and trimmed by establishment employees but before the carcasses were put into the chiller; and (2) "verification inspectors" would oversee the poultry establishment's inspection efforts ...

In the three participating hog plants, the modified program called for federal carcass inspectors located at up to three fixed locations along the slaughter lines: in the area where the carcass and head were separated; where the carcass and viscera were separated; and at the pre-wash verification location. These inspectors would be responsible for examining the carcass, head, and viscera of all hogs . Other inspectors would also be assigned to hog plants to verify the effectiveness of the plant's process control systems.

The USDA determined that its modified inspection program, which calls for one carcass and one verification inspector per slaughter line at poultry plants, and one verification inspector and up to three carcass inspectors at hog plants, would be sufficient to allow its employees to detect adulterated meat and poultry .

We therefore hold that the USDA's current modified inspection model ... does not violate the FMIA or the PPIA. Because the modified program calls for federal inspectors in participating poultry plants to personally examine each poultry carcass leaving the slaughter line, the USDA is complying with the PPIA's requirement that "the carcass of each bird processed" be inspected for adulteration ... The modified program also satisfies the FMIA because the program calls for federal inspectors in participating hog plants to inspect all hog carcasses, heads and viscera, as the statute demands.

  • This excerpt from this case provides a brief summary of some events surrounding USDA's implemenation of HACCP; the excerpt is provided as background for understanding USDA's adoption of HACCP as part of its mandatory inspection of meat and poultry processing plants.

See Supreme Beef Processors, Inc., v. USDA, US Court of Appeals for the 5th Circuit, No. 00-11008, December 6, 2001

The Federal Meat Inspection Act (FMIA) authorizes the Secretary of Agriculture to "prescribe the rules and regulations of sanitation" covering slaughtering, meat canning, salting, packing, rendering, or similar establishments in which cattle, sheep, swine, goats, horses, mules and other equines are slaughtered and the meat and meat food products thereof are prepared for commerce... Further, the Secretary is commanded to, where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, ... refuse to allow said meat or meat food products to be labeled, marked, stamped, or tagged as "inspected and passed." In sum, the FMIA instructs the Secretary to ensure that no adulterated meat products pass USDA inspection, which they must in order to be legally sold to consumers.

The FMIA contains several definitions of "adulterated," including 21 U.S.C. § 601(m)(4), which classifies a meat product as adulterated if "it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health." Thus, the FMIA gives the Secretary the power to create sanitation regulations and commands him to withhold meat approval where the meat is processed under unsanitary conditions. The Secretary has delegated the authority under the FMIA to the Food Safety and Inspection Service (FSIS).

In 1996, FSIS, after informal notice and comment rulemaking, adopted regulations requiring all meat and poultry establishments to adopt preventative controls to assure product safety. These are known as Pathogen Reduction, Hazard Analysis and Critical Control Point Systems or "HACCP." HACCP requires, inter alia, that meat and poultry establishments institute a hazard control plan for reducing and controlling harmful bacteria on raw meat and poultry products. In order to enforce HACCP, FSIS performs tests for the presence of Salmonella in a plant's finished meat products.

[The court goes on to invalidate "the Salmonella performance standards" because the presence of Salmonella may not have originated in the plant, for example, it may have been in the meat before it reached the plant. Therefore, this test was not an acceptable proxy for determining whether the HACCP plan was working.]


Assessing the vulnerabilities within a food system or infrastructure to an intentional attack

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

"CARVER is an acronym for the following six attributes ... used to evaluate the attractiveness of a target for attack:

    • Criticality - measure of public health and economic impacts of an attack
    • Accessibility – ability to physically access and egress from target
    • Recuperability – ability of system to recover from an attack
    • Vulnerability – ease of accomplishing attack
    • Effect – amount of direct loss from an attack as measured by loss in production
    • Recognizability – ease of identifying target

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."

FDA web page on CARVER + Shock

" [CARVER + Shock] allows the user to think like an attacker to identify the most attractive targets for an [intentional] attack. By conducting a CARVER + Shock assessment of a food production facility or process, the user can determine the most vulnerable points in their infrastructure, and focus resources on protecting the most susceptible points in their system."

A statement about CARVER from several years ago:

"As many of you know, FDA has developed both an operational risk management strategy and what we refer to as the CARVER process to assess the vulnerability of all segments of the food system. With CARVER, we break a particular food system into its smallest pieces (nodes) in the farm to table continuum. We then analyze each node and identify the “critical nodes” that are most likely targets for terrorist attack. Identification of the “critical nodes” then leads to development of countermeasures to reduce the risk at these nodes.

"The food Industry has demonstrated tremendous leadership in working with FDA to assess individual commodity production and delivery vulnerabilities. To date we have conducted CARVER analyses with the International Bottled Water Association (IBWA), the Food Processors Assoc. (NFPA), the Juice Products Association (JPA), and the Dairy Foods Association (IDFA). These industry groups have truly been leaders and examples of this partnership to improve the security of the nation’s food supply."

Another statement about CARVER from several years ago:

“Another area where we have made food security improvements is in assessing vulnerabilities from the farm to the table. FSIS has completed a vulnerability assessment for domestic products to determine the most vulnerable products, likely agents, and potential sites for deliberate contamination. A similar assessment is being conducted for imported products.

"Through this initial vulnerability assessment, we identified four commodities as being high-risk. Then, a working group created under the IFWG … conducted a detailed vulnerability assessment on these four products using a Department of Defense targeting method called CARVER + Shock. It is an offensive technique in that it identifies physical locations an enemy might find advantageous to introduce contaminants by evaluating the target through the enemy’s eyes.

“These assessments are powerful risk management tools that can be used to develop strategies and policies that reduce or eliminate the potential risk at vulnerable points along the farm-to-table continuum. Once you identify where a target may be, we can develop shields, or counter measures, to address the vulnerabilities identified.“

USDA Food Defense Plan -- guide sheet for food businesses


Employee Training

Implementing these procedures require that the business' employees are aware of their role in assuring the safety of the food product and that they follow the appropriate GMPs, SSOPs, and HACCP procedures. Employee training is invaluable in assuring the necessary steps are being taken to minimize the risk of an unsafe food product.

  • For example, training is address as part of mandatory HACCP for juice; see 21 CFR 120.13.
  • Training also is addressed as a component of GMP; see 21 CFR 110.10(c).
  • Likeiwse in the food processing sector, "Deficient employee training [means] Training that does not meet the following minimum requirements is considered deficient. Training, at a minimum, must include a written policy covering GMPs, personal hygiene, plant sanitation policies and procedures, food safety and quality control policies, and product tampering awareness and consequences. Training must be presented in a language that can be understood by all employees. Training programs should be updated annually and records should be kept of training sessions. All new employees must be provided with initial training that covers the minimum requirements and refresher courses should be provided quarterly. Operational deficiencies should result in additional training."
    • As this definition implies, businesses are expected to provide adequate employee training.
  • In the food preparation sector of the food industry, the Food Code requires that the "person in charge" have successfully completed an accredited program. see 2-102.11(B) of the 2005 Food Code.


Last updated March 19, 2010

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