What is the primary concern for haccp team members conducting a hazard analysis

Since its inception in the 1960s as part of space travel, the application of HACCP principles has expanded throughout the food industry. The Food Safety Modernization Act (December 2010) is expected to lead to further adoption of the concept. This page briefly introduces the concept of HACCP and its evolution into a Food Safety Plan.

Hazard Analysis and Critical Control Point (HACCP)

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 [past] 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 past system. Most importantly, HACCP:

• focuses on identifying and preventing hazards that may render food unsafe
• 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 and following practices that reduce the risk of unsafe food 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 (and Food Safety Plans), as a concept, causes food businesses to implement practices that reduce the risk of unsafe food -- which is the stated goal.

Also see NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS. Hazard Analysis and Critical Control Point Principles and Application Guidelines, Introduction, August 14, 1997

"HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.

"HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world."

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.
  • USDA FSIS pre-approves HACCP plans; FDA does not. 
• 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 and each food product. The focus of HACCP 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.
• Seven principles of HACCP; see HACCP Principles  (as discussed subsequently, these seven principles from the 1980s have been refined in 2011)
• 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.
• Review the concepts of risk assessment and risk management to identify similarities with the seven HACCP principles listed above.

Need More than One HACCP Plan?

A different HACCP plan will be needed for each food product, each processing method and each facility if the processing raises unique or individualized risks.  If Plant A is used to process Product M and Product N, and the risks associated with the products are different, the firm will need individualized risk assessments and HACCP plans for each product.  If Business D manufactures Product F in two different facilities and uses different manufacturing processes that give rise to different risks, the business will need more than one HACCP plan.  One HACCP plan will not "fit all" if the product or process poses different risks or needs different strategies to address the risks.

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HACCP is required for processing MOST foods (January 2011)

• Meat and poultry (USDA) (9 CFR part 417) 
• Juice (FDA) (21 CFR part 120) 
• Seafood (FDA) (21 CFR part 123) 
• Food Safety Modernization Act 2010 (FDA) requires a Food Safety Plan for all other food processing businesses at 21 U.S.C. 350g; regulation is codified at 21 CFR part 117.

But also

• FDA is urging that HACCP principles be applied to retail and food service sectors of the food industry -- discussed in section that addresses the retail sector and Food Code
• HACCP is being suggested for the ag production sector (until HACCP is incorporated into the production sector, Good Agricultural Practices (GAP) will likely be adopted; we can expect that GAP will evolve into HACCP).
• 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).
• WHO HACCP
• EU Risk Analysis
• EUFIC:  Food industry standards – focus on HACCP
• ISO 22000

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HACCP for Processing Seafood

• See 21 CFR 123.6(c) for an example of the seven HACCP principles having been incorporated into regulations; these particular regulations address HACCP requirements for fish and fishery products.
  • Also see 21 CFR Part 123 Fish and Fishery Products; especially 21 CFR §123.6 (HACCP) and 21 CFR 123.11 (sanitation control procedures (SSOP))
  • See Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, November 2011

HACCP for Processing 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 //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.

HACCP for Processing Meat and Poultry

• FSIS HACCP ActivitiesMeat & Poultry
  • Hazard Analysis and Critical Control Point (HACCP) Systems for meat 9 CFR part 417
  • 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)

Implementing HACCP

• 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 reduce the risk of unsafe food products, but it also can lead to improved product quality.

Example:  FSIS. Guidebook for the Preparation of HACCP Plans. USDA, September 1999 at //www.fsis.usda.gov/OPPDE/nis/outreach/models/HACCP-1.pdf.

Preliminary Steps

• 1. Assemble the HACCP team, including one person who is HACCP-trained
• 2. Describe the food and its method of production and distribution
• 3. Develop and verify process flow diagram(s)
• 4. Decide whether products can be grouped using the process categories

PRINCIPLE I: CONDUCT A HAZARD ANALYSIS

• Biological Hazards
• Chemical Hazards
• Physical Hazards
• This list is expanding.

PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL POINTS

PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT

PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES

PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS

PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES

PRINCIPLE VII: ESTABLISH VERIFICATION PROCEDURES

• Validation
• Ongoing verification
• Reassessment

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HACCP also 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?
• Is the product refrigerated, frozen or shelf-stable?
• What safety hazard or quality issue are associated with this food product?

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?
• What are the ingredients?  Do any ingredient pose a food safety risk?
• Does the food offer specific characteristics, such as, a low fat products

Step #4 Develop a Flow Diagram

• The diagram or flow chart must cover all steps of the manufacturing process.
• It is 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 (again, this list is expanding)?
• 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.
• GMPs can and should control many hazards.
• A CCP for one product many not be a CCP for another product.

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, kind and count of bacteria.

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.

HACCP and the Food Safety Modernization Act

Following enactment of the Food Safety Modernization Act, a Food Safety Plan (HACCP by another name?) is required for all firms in the processing sector of the food industry that were not previously subject to HACCP.  The following points are drawn from that legislation.

• 21 U.S.C. 350g
• 21 CFR 117

Food Safety Plans must address the following points:

• Identify, evaluate and prepare a written analysis of known or reasonably foreseeable hazards that may be associated with the facility, including (A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; (B) hazards that occur naturally, or may be unintentionally introduced; and (C) hazards that may be intentionally introduced, including by acts of terrorism.

Comment:  note the explicit mention of intentional attacks on the food business.

• Identify and implement preventive controls, including at critical control points, to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented; and the food manufactured, processed, packed, or held by such facility will not be adulterated or misbranded.
• Monitor the effectiveness of the implemented preventive controls to assure that the identified hazards are significantly minimized or prevented.
• Establish procedures to ensure that if the implemented preventive controls are not properly implemented or are found to be ineffective (1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; (2) all affected food is evaluated for safety; and (3) all affected food is prevented from entering into commerce if the business cannot ensure that the affected food is not adulterated or misbranded.
• Verify that (1) the preventive controls implemented are adequate to control the hazards identified; (2) the business is monitoring as required by law; (3) the business is making appropriate decisions about corrective actions taken; (4) the implemented preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and (5) there is documented, periodic re-analysis of the plan to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.
• Maintain, for not less than two years, records documenting the monitoring of the implemented 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.
• Prepare a written plan that documents and describes the procedures used by the business to comply with these requirements, including analyzing the hazards and identifying the adopted preventive controls to address those hazards. Such written plan, together with the documentation, shall be made promptly available to a duly authorized representative of the FDA upon oral or written request.
• Conduct a re-analysis whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or not less frequently than once every three years, whichever is earlier. Such re-analysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. The business will revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The FDA may require a re-analysis in response to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.

Summary

HACCP and a Food Safety Plan are processes that food businesses can follow to minimize the risk of unsafe food.  It has evolved into the fundamental guiding principle for assessing risk associated with food processing and handling. The understanding and implementation of HACCP has been refined based on experience.

The food business is responsible for developing and implementing a Food Safety/HACCP plan for the food its processes or manufactures.  A specific Food Safety/HACCP plan is needed for each food and for each processing system employed by a food business because every food and every processing system/procedure poses different risks and requires different risk management practices. 

• HACCP places the responsibility and authority for devising an appropriate, individualized safety plan for each food on the business, rather than on a "broad-brush" government program.  HACCP is a planning, implementing and verifying procedure the food business must follow; it is not the numeric standards the business must comply with.  Those numeric standards are set by the individual food business based on scientific insight.

Food that is handled without a Food Safety/HACPP plan or handling the does not comply with the business' Food Safety/HACCP plan is considered adulterated and prohibited from being sold.

In the past, USDA required a HACCP plan for all meat and poultry processing.  Also in the past, FDA required a HACCP plan for seafood processors and juice processors.  The 2010 FDA Food Safety Modernization Act, as enacted by Congress, now mandates FDA to require Food Safety plans for all other food processing.  Several points:

1. The pre-existing HACCP requirements were not replaced by the latest Congressional mandate, so there are four HACCP requirements -- although similar, there are some differences among these legal mandates. 
2. Congress has not mandated that farms prepare and follow HACCP plans, but the line between farms (ag production) and food processing continues to shift towards production ag, thus requiring more types of food businesses to adopt HACCP plans.  For examples, farms that not only produce fruits and vegetables, but also prepare them for the fresh produce market, are within the regulatory scope of FDA with respect to the firm's processing practices and even some of the farms' in-field production practices.  On-farm regulation is not entirely new to production ag; for example, dairy farms have been subject to federal, state and local requirements for decades.  A later discussion will refine what is required of farms that produce and process produce for the fresh/raw fruit and vegetable market.
3. FDA's authority is broad, for example, a grain elevator storing wheat for processing into human food is within FDA's regulatory jurisdiction.
4. But, the food industry is imposing as many requirements on food ingredient and ag commodity suppliers as the government is imposing on those suppliers.

What is the primary focus of HACCP?

Which hazard is HACCP mostly concerned with?

What are the initial responsibilities of the HACCP team?

What is the most important part of the HACCP implementation?