Tag Archives: FSMA

How is HARPC Different From HACCP?

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and their similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

HACCP HARPC
(1) Is the preventative approach based on a standard, guideline or a set of laws?
Based on a guideline recommended by CODEX and NACMCF Based on FSMA act and principally, the Final Rule for Preventive Controls for Human Food
(2) What food safety risks are considered using the preventative approach?
Conventional – Biological, Chemical, and Physical Beyond the conventional risks for actual and potential food safety hazards
(3) What is the goal of the preventative approach?
To prevent, eliminate (or) reduce hazards to a safe level (in that priority) Preventive controls that prevent or significantly minimize “known or reasonably foreseeable” risks
(4) Who is primarily responsible for the development and maintenance of the preventive plan?
Primarily, a competent HACCP coordinator with assistance from multidisciplinary team Trained Preventive Controls Qualified Individual (PCQI) as described in the FSMA Act
(5) At what frequency is the preventive plan being reviewed by the facility?
At least once a year, or when required At least once in 3 years, or when required
(6) The plan is mandatory for what type of establishments?
For FDA and USDA mandated establishments, or when required for certification purposes For all establishments along the food supply chain that serve U.S. consumers, unless exempted
(7) The plan is excluded or exempted for what type of establishments?
Unless mandated or required for certification, HACCP is voluntary, and GMPs are mandatory Exemption list is provided by FDA, but this does not exempt facilities from following at least CGMPs
(8) Who is the interested party here? For whom is the plan for?
Stakeholders: auditors, inspectors, and customers The FDA
(9) What is the documented approach for making the preventive plan?
12 Steps of HACCP (includes 7 Principles) 7 Steps of Developing a HARPC Plan

HARPC as an Upgrade to HACCP

HACCP, or Hazard Analysis Critical Control Points, is already widely used due to requirements from retailers, auditing standards, and inspectors, though the USDA and the FDA only mandate it for meat, seafood, and juice products. As a global standard conceptualized the 1960s, HACCP has been continually developed and updated. HACCP requires a multi-disciplinary team for implementation and follows prescriptive steps.

HARPC covers food safety concerns beyond Critical Control Points and is mandated by the FDA for most facilities, with some exemptions. Instead of only looking at process steps where controls can be applied (as in HACCP plans), HARPC relies on the applicable FDA regulations, standards, and guidance documents to develop a Preventive Controls Plan.

How HACCP Works

HACCP is a globally recognized risk-based preventative approach recommended by the Codex Alimentarius Commission (or the ‘Food Code’) and the National Advisory Committee on Microbiological Criteria for Foods. It commonly focuses on controlling the three main food safety hazards: biological, chemical, and physical. The primary goals (in order of priority) are to prevent occurrences of the hazard, or eliminate, or reduce the food safety hazard to acceptable or safe levels.

 The HACCP plans are developed, implemented, and maintained by a multi-disciplinary team and the entire process is facilitated by a HACCP Coordinator, a person who is sufficiently knowledgeable and skilled in food safety concepts and principles and has undertaken a training program that has preferably been accredited by the International HACCP Alliance. The responsible person must review the HACCP plan at least annually, or whenever there are significant changes in food safety design layout, processes, product composition, or technology.

 The HACCP program is legally mandated for meat and poultry establishments (under USDA jurisdiction) and juice and seafood processing establishments (under FDA’s jurisdiction). Even though the HACCP program for several food establishments may be voluntary (unless specified by regulations, industrial standards, or by customers), it does not absolve a facility from implementing Current Good Manufacturing Practices (as provided in the 21 CFR 110 legal document) and other relevant pre-requisite program requirements necessary to maintain the safety and legality of the food products. In the Food Code, prior to HACCP recommendation, there are General Principles of Food Hygiene (provided in 10 sections) that have to be followed. Auditors, inspectors, customers, and other stakeholders may inspect the HACCP or food safety plan.

12 Steps of HACCP:

  • Assemble the multidisciplinary HACCP team
  • Describe the product
  • Identify its intended use
  • Construct a flow diagram
  • Conduct on-site confirmation of the flow diagram, and draw up the plant schematic
  • List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)
  • Determine Critical Control Limits (Principle 2)
  • Establish Critical Limits for each CCP (Principle 3)
  • Establish a monitoring system for each CCP (Principle 4)
  • Establish corrective actions (Principle 5)
  • Establish verification procedures (Principle 6)
  • Establish documentation and record-keeping (Principle 7)

How HARPC Works

In brief, this preventive control system mandated by FDA’s FSMA Act is to be implemented by all food establishments unless specifically exempted. Thus, it applies to food facilities in the U.S. that manufacture, process, pack, distribute, receive, hold, or import food, and for those firms exporting foodstuff to the US. The FDA has issued implementation deadlines for each of the different facility types (kindly refer to updated guidelines on the FDA site, www.fda.gov). Within a HARPC plan, the food safety hazards assessment is broader; generally, the following risks are considered:

  • Biological, physical, chemical, and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposed material, parasites, allergens, and unapproved food and color additives
  • Naturally occurring hazards
  • Unintentionally introduced hazards
  • Intentionally introduced hazards, including acts of terrorism

Preventive controls are science-based and shall be adequate to significantly minimize or prevent identified hazards “known or reasonably foreseeable” for each type of food subject to the relevant FDA regulation. The HARPC plan is developed, implemented, and maintained by a team of “preventive controls qualified individuals” as defined in the FSMA act, who have been trained or are sufficiently conversant with the FDA FSMA Final Rule for Preventive Controls for Human Food, and any other relevant rulemakings, such as the Final Rules on Animal Food, Produce Safety or Foreign Supplier Verification Program etc. (for more information, refer to the FDA site, www.fda.gov).  The responsible person must review the HARPC plan at least once every 3 years (if no significant changes occur in the plan) or whenever there is a significant change at the facility that might increase a known hazard or introduce a new one.

7 Steps of HARPC

  1. Assess the hazards—This includes the normal product-specific hazards, along with a broad range of other hazards (listed above) and facility-specific concerns such as food defense and emergency management issues.
  2. Institute Preventive Controls—These include sanitation procedures for food contact points, staff hygiene training, environment monitoring, supplier verification, and more.
  3. Monitor effectiveness of the controls—Not all controls are measurable by critical limit numbers, but these Preventive Controls can be evaluated on a routine basis.
  4. Establish corrective action measures—Recall plans may not seem preventive, but the critical steps between knowing something is wrong with a product and keeping it away from consumers’ hands should involve identifying and correcting the weak spots within the controls. The objective is to prevent occurrences of unsafe and non-conforming food product.
  5. Establish verification measures—The process of verification ensures that the facility is effectively meeting its food safety standards on a consistent basis.
  6. Follow proper and required recordkeeping—As with any FDA ruling, nothing is properly done until it’s recorded.
  7. Reanalyze the plan once every 3 years, or when needed—When changes in process or product happen, HARPC plans should be reevaluated.

Recap of Some Key Differences:

Hazard Analysis Method

The three conventional types of hazards that are addressed in the HACCP plans—physical, chemical, and biological—are accompanied by many more concerns in HARPC plans.

Radiation, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food or color additives, naturally occurring hazards, and intentionally and unintentionally introduced hazards round out the list of HARPC-related hazards.

Critical Control Points Versus Preventive Controls

Critical Control Points during process steps are central to HACCP. Each control point must include measurable critical limits—the temperature and length of time a sauce must be held at, for example, as a kill step. The objective of each control step is either to prevent, eliminate, or reduce food safety hazards to a safe and acceptable level. Food safety measures that aren’t specific to the process, such as personnel hygiene, are covered under Standard Operating Procedures (SOPs).

HARPC focuses on Preventive Controls that are science- or risk-based, and should be adequate to “significantly minimize or prevent” known or foreseeable hazards for each type of food subject to the federal regulations.

 

To learn more about HACCP, download our whitepaper, “HACCP Planning for Food Safety,” or contact our knowledgeable customer service representatives at cs@remcoproducts.com or at 317.876.9856. Contact us today to schedule a complementary on-site consultation regarding HACCP and HARPC plans.

To view more information about this and other sanitation topics, visit http://www.remcoproducts.com/knowledge-center.

 

SELECTED REFERENCES:

Food and Drug Administration. (2015). FSMA final rule for preventive controls for human food.

Joint FAO/WHO Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, & World Health Organization. (2003). Codex Alimentarius: Food hygiene, basic texts. Food & Agriculture Org.

US Food and Drug Administration. (2011). Food safety modernization act (FSMA). Public Law, 2011, 111-353.

Website: www.fda.gov

 

What you need to know about FSMA: Part 1

If you are in the food industry and have had your eyes and ears open, then most likely you have heard the word FSMA being thrown around… a lot. However, some people might find themselves unfamiliar with the term or have limited knowledge of it, so in this entry we are going to cover some general information regarding FSMA and in upcoming blogs we will go into further detail about each proposed rule issued by the FDA that supports this legislation.

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The people, pathogens and food of today are not those of the past. Our population is living longer and with problems that make them more susceptible to foodborne illness complications. Pathogens are evolving and becoming more adaptable and harder to kill. Our food is traveling more than it ever has. For example, the FDA states that 15% of food we eat is imported. A total 75% of our seafood, 20% of our vegetables, and 50% of our fruit is imported. However, one thing has not changed and that is the threat that foodborne illness presents to the food industry and its consumers. Continue reading What you need to know about FSMA: Part 1

The Birth of Food Safety, the FDA and CGMPs

Lately, we’ve been talking about Current food Good Manufacturing Practices—CGMPs for short—because they are the set of regulations that apply to just about every food processor not regulated by the USDA. CGMPs have also been getting quite a bit of press lately since we may see an update as a result of FSMA. We released an earlier blog article and a white paper on the topic for those who want to learn more.

But did you know that many of the regulations that guide the production of today’s food were largely spawned by the works of investigative journalists? These journalists were referred to as “muckrakers,” and they exposed government and business corruption.

food safety and 1900s meatpackingOne of the most well-known of these journalists was Upton Sinclair, who spent seven weeks working undercover in the Chicago meatpacking district on a research mission to expose the injustices and hazardous working conditions faced by meat industry workers. In Sinclair’s novel, The Jungle, his vivid descriptions of the unsanitary practices of the meatpacking industry captured the attention of the American public and President Theodore Roosevelt.

After reading The Jungle, Roosevelt sent a pair of advisors to assess the truthfulness of the novel’s depictions—and their report swayed the President to believe that Sinclair had provided an accurate representation. Shortly after Sinclair’s works became widespread, the Pure Food and Drugs Act and the Meat Inspection Act were passed in 1906. The passage of these regulations marked a turning point in federal food safety and was the beginning of what we know today as the FDA.

Although Sinclair had hoped that his accounts would improve working conditions for America’s poor laborers, he ended up making a huge and lasting impact on food safety. He was later quoted as saying, “I aimed for the public’s heart, and by accident hit it in the stomach.”

The early regulations were more specific about the standards for pharmaceuticals and accurate product labeling, and policies regarding food were much more ambiguous. Over the next 30 years, gaps in the protections provided to consumers by these regulations were exposed by a new generation of investigative journalists. In 1938, President Franklin D. Roosevelt signed the Food, Drug, and Cosmetic Act, received enthusiastically by an American public that had witnessed one too many food and drug safety disasters. This was the first law that mandated legally enforceable food standards, and CGMPs for food were officially established later on in 1969.

No one can deny that we have come a long, long way for food safety since the days written about by Upton Sinclair. But we may soon see another era of modernization of our food safety regulations. Do you think that the updates proposed by FSMA go far enough in preventing the production of unsafe foods? Are there holes in today’s laws you think should be considered? Tell us your thoughts.

Five Things You Maybe Didn’t Know About HACCP

If you work in food processing, chances are you’re probably familiar with the concept of a Hazard Analysis Critical Control Point or HACCP. Here’s a little about what we’ve learned about HACCP.

HACCP food safety sample verificationAs part of a HACCP Plan, a Hazard Analysis identifies “Critical Control Points” or CCPs — those points, steps or procedures in food manufacturing 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. With CCPs identified, a HACCP Plan provides a series of procedures to control the process and sensitive points in the food chain, with the ultimate goal of producing foods that are safe for consumers’ health.

HACCP is a part of the Food Safety and Modernization Act (FSMA) proposed by the Federal Drug Administration (FDA) in 2011. While FSMA is fairly new, did you know the concept of HACCP has actually been around for some time? Here is the answer to that question along with some other interesting things about HACCP that many people may not be aware of.

1. HACCP is not a new system.

HACCP is a concept that’s been around since the 1960s. It was developed by the Pillsbury Company, the US Army Laboratories and NASA to help produce safe food for space missions. Today, HACCP is a recognized international standard for safe food production. It is endorsed by the Food and Agricultural Organization (FAO), the World Health Organization (WHO), and in the United States by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF).

2. Not every hazard is a CCP.

As part of putting together a HACCP Plan, there’s a thought-process or Decision Matrix one can use to review each step in a food workflow process and determine the likelihood of hazards that could occur. Once a hazard is identified, then it is evaluated whether or not it is a CCP. Going through this evaluation, one will soon discover that not every hazard is a CCP. If a control measure is already in place to address the hazard, then chances are the hazard is not a CCP.

3. It takes a team to put together a HACCP Plan.

Through our experiences working with food processors, we’ve seen that some of the best HACCP Plans are the result of a team effort by the key individuals responsible for food safety within a food processing operation. The team may include managers from quality assurance, plant operations, engineering, maintenance, sanitation, and shipping & receiving. In addition, it’s often advised that someone who works on the line, such as a Line Supervisor and/or Machine Operator, provide input to the HACCP Plan to help assure alignment with day-to-day operations.

4. One person should be responsible for the HACCP Plan.

While it often takes a team to put together a well-structured HACCP Plan, we’ve also observed that maintaining the plan should ideally be the responsibility of just one person within a food processing organization. That person is usually the HACCP Coordinator. However, if there is no HACCP Coordinator, then the responsibility often falls to the Quality Manager, or even the company’s CEO.

5. Review the HACCP Plan regularly.

In a perfect world, anytime something changes within a food process, then the HACCP Coordinator should review the HACCP Plan and update it accordingly. At the very least, it’s suggested that a HACCP Plan be reviewed every 3 to 6 months.

How does your food processing facility deal with HACCP? If you have any additional tips or observations about putting together and maintaining a successful HACCP Plan, we’d love to hear them.