Tag Archives: hazards

USP Food Fraud Database

Why Include Food Fraud Records in Your Hazard Analysis?

By Karen Everstine
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USP Food Fraud Database

Food fraud is a recognized threat to the quality of food ingredients and finished food products. There are also instances where food fraud presents a safety risk to consumers, such as when perpetrators add hazardous substances to foods (e.g., melamine in milk, industrial dyes in spices, known allergens, etc.).

FSMA’s Preventive Controls Rules require food manufacturers to identify and evaluate all “known or reasonably foreseeable hazards” related to foods produced at their facilities to determine if any hazards require a preventive control. The rules apply both to adulterants that are unintentionally occurring and those that may be intentionally added for economically motivated or fraudulent purposes. The FDA HARPC Draft Guidance for Industry includes, in Appendix 1, tables of “Potential Hazards for Foods and Processes.” As noted during the recent GMA Science Forum, FDA investigators conducting Preventive Controls inspections are using Appendix 1 “extensively.”

The tables in Appendix 1 include 17 food categories and are presented in three series:

  • Information that you should consider for potential food-related biological hazards
  • Information that you should consider for potential food-related chemical hazards
  • Information that you should consider for potential process-related hazards

According to the FDA draft guidance, chemical hazards can include undeclared allergens, drug residues, heavy metals, industrial chemicals, mycotoxins/natural toxins, pesticides, unapproved colors and additives, and radiological hazards.

USP develops tools and resources that help ensure the quality and authenticity of food ingredients and, by extension, manufactured food products. More importantly, however, these same resources can help ensure the safety of food products by reducing the risk of fraudulent adulteration with hazardous substances.

Incidents for dairy ingredients, food fraud
Geographic Distribution of Incidents for Dairy Ingredients. Graphic courtesy of USP.

Data from food fraud records from sources such as USP’s Food Fraud Database (USP FFD) contain important information related to potential chemical hazards and should be incorporated into manufacturers’ hazard analyses. USP FFD currently has data directly related to the identification of six of the chemical hazards identified by FDA: Undeclared allergens, drug residues, heavy metals, industrial chemicals, pesticides, and unapproved colors and additives. The following are some examples of information found in food fraud records for these chemical hazards.

Undeclared allergens: In addition to the widely publicized incident of peanuts in cumin, peanut products can be fraudulently added to a variety of food ingredients, including ground hazelnuts, olive oils, ground almonds, and milk powder. There have also been reports of the presence of cow’s milk protein in coconut-based beverages.

Drug residues: Seafood and honey have repeatedly been fraudulently adulterated with antibiotics that are not permitted for use in foods. Recently, beef pet food adulterated with pentobarbital was recalled in the United States.

Heavy metals: Lead, often in the form of lead chromate or lead oxide which add color to spices, is a persistent problem in the industry, particularly with turmeric.

Industrial Chemicals: Industrial dyes have been associated with a variety of food products, including palm oil, chili powder, curry sauce, and soft drinks. Melamine was added to both milk and wheat gluten to fraudulently increase the apparent protein content and industrial grade soybean oil sold as food-grade oil caused the deaths of thousands of turkeys.

Pesticides: Fraud in organic labeling has been in the news recently. Also concerning is the detection of illegal pesticides in foods such as oregano due to fraudulent substitution with myrtle or olive leaves.

Unapproved colors/additives: Examples include undeclared sulfites in unrefined cane sugar and ginger, food dyes in wine, and tartrazine (Yellow No. 5) in tea powder.

Adulteration, chili powder, skim milk powder, olive oil
Time Series Plot of Records for Chili Powder (blue), Skim Milk Powder (green), and Olive Oil (orange)

Continue to page 2 below.

Minimizing Hazards and Fraud in Milk, IBM Research Partners with Cornell University

By Food Safety Tech Staff
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Americans consume an estimated 600 pounds of milk and milk-based products annually, according to the USDA. In an effort to minimize the hazards in the milk supply and prevent food fraud, IBM Research and Cornell University are joining forces. Combining next-generation sequencing with bioinformatics, the research project will collect genetic data from the microbiome of raw milk samples in a real-world situation at the Cornell University dairy plant and farm in Ithaca, New York.

Specifically, IBM and Cornell will sequence and analyze the DNA and RNA of food microbiomes, which will serve as a raw milk baseline, to develop tools that monitor raw milk and detect abnormalities that could indicate safety hazards and potential fraud. The data collected may also be used to expand existing bioinformatics analytical tools used by the Consortium for Sequencing the Food Supply Chain, a project that was launched by IBM Research and Mars, Inc. at the beginning of 2015.

“As nature’s most perfect food, milk is an excellent model for studying the genetics of food. As a leader in genomics research, the Department of Food Science expects this research collaboration with IBM will lead to exciting opportunities to apply findings to multiple food products in locations worldwide.” – Martin Wiedmann, Gellert Family Professor in Food Safety, Cornell University.

“Characterizing what is ‘normal’ for a food ingredient can better allow the observation of when something goes awry,” said Geraud Dubois, director of the Consortium for Sequencing the Food Supply Chain, IBM Research – Almaden, in a press release. “Detecting unknown anomalies is a challenge in food safety and serious repercussions may arise due to contaminants that may never have been seen in the food supply chain before.”

Cornell University is the first academic institution to join the Consortium for Sequencing the Food Supply Chain.

Emulate, FDA, organ chip

Are Organs-on-Chips the Next Pioneers in Food Safety?

By Food Safety Tech Staff
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Emulate, FDA, organ chip

FDA is evaluating the use of micro-engineered chips as a potential model for studying hazards in food. Last week the agency announced a multi-year cooperative R&D agreement (CRADA) with Emulate, Inc., a manufacturer of organ-on-chip technology that “emulates human biology. The company’s Human Emulation System, a platform that includes organ-chips, instrumentation and software, recreates the natural physiology of human tissues and organs with the intention of providing a “predictive model of human response to diseases, medicines, chemicals, and foods with greater precision and detail than other preclinical testing methods, such as cell culture or animal-based experimental testing,” according to the company’s press release.

“The flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just as in the human body. The chips are translucent, giving researchers a window into the inner workings of the organ being studied.” – Suzanne Fitzpatrick, Ph.D., senior advisor for toxicology, CFSAN

In the agency’s blog, FDA Voice, Fitzpatrick states that the chip technology could shed light on how the body processes an ingredient in a supplement or how a toxin(s) affects cells. It could also one day lead to much less animal testing, if at all. The goal of the research, which will begin with a liver-chip, is to be able to predict how organs will respond to exposure to chemical hazards in foods, cosmetics and dietary supplements more precisely than cell culture or animal-based tests. In the future, other organ-chips may be used, including kidney, lung and intestine models.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Microbiomes a Versatile Tool for FSMA Validation and Verification

By Douglas Marshall, Ph.D., Gregory Siragusa
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.

Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.

As a refresher of FSMA requirements, here is a brief overview. Validation activities include obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended, and to establish the validity of the food safety plan. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.

Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.

FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.

There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.

Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.

FSMA

FDA Addresses Hazards Requiring Control in New Draft Guidance

By Food Safety Tech Staff
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FSMA

Today FDA released a new draft guidance related to FSMA: Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA) details the agency’s current thinking related to “disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules”. These rules are the PC rules for human and animal food, the Produce rule and the Foreign Supplier Verification Program.

“This guidance provides our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of the statements accompanying the food,” according to an FDA release.

The draft is available on the Federal Register and is open for comment 180 days after publication (October 31).

Zia Siddiqi, Orkin
Bug Bytes

From HACCP to HARPC, and Integrating Pest Management

By Zia Siddiqi, Ph.D.
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Zia Siddiqi, Orkin

September 19, 2016 is a date that many of you probably had circled on your calendars. It marked the first date in which many food processing companies had to be in compliance with the FSMA preventive controls final rule.

It’s okay if you’re still revising your food safety plan. The regulations are so sweeping that some companies are still struggling to figure out if their plans are in compliance. At the heart of this law is a change in the philosophy of how we deal with contamination. Now, the focus is on preventing contamination rather than responding to it after it occurs.

This proactive approach to safety must be kept in mind when discussing how food safety plan requirements have changed. For many food manufacturing facilities, it means a change from HACCP to HARPC.

Hazard Analysis and Critical Control Points, or HACCP, should be more familiar to you. First developed in the late 1950s and early 1960s to provide safe food for astronauts in the U.S. space program, HACCP became the global standard for food safety in the 1980s, as large, multinational companies sought to ensure that their supply chains were safe.

HACCP evolved over the years into an effective, efficient and comprehensive food safety management approach. The system addresses food safety 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.

The seven principles of HACCP include:

  1. Conduct a hazard analysis
  2. Identify critical control points
  3. Set critical limits
  4. Establish monitoring actions
  5. Determine corrective actions
  6. Develop verification procedures
  7. Institute a record-keeping system

How are HACCP and HARPC different?

Following the passage of FSMA, the FDA instituted a new set of food safety standards, known as Hazard Analysis and Risk Based Preventive Controls (HARPC).

HARPC shouldn’t be seen as a replacement of HACCP standards. Rather, it’s an evolution of them. The following are some key changes.

You Must Anticipate Potential Hazards. One of the big changes in moving to HARPC standards is that your food safety plan must identify any and all reasonably foreseeable food safety hazards and include risk-based preventive controls for them. This moves beyond HACCP’s critical control points and asks that food processors look at how to minimize risk from the second food enters their facility to the second it ships out.

This includes naturally occurring hazards as well as hazards that can be intentionally or unintentionally introduced to the facility. The potential hazards that have expanded under HARPC include:

  • Biological, chemical, physical and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposition, parasites, allergens and unapproved food and color additives
  • Naturally occurring hazards or unintentionally introduced hazards
  • Intentionally introduced hazards (including acts of terrorism)

You should review the potential hazards—both seen and unseen—that could impact your facility to determine the risks that you should analyze for your plan.

HARPC Applies to Almost All Food Processing Facilities. The HACCP standards generally did not apply to all food processors. HARPC, however, covers many more U.S. processors. There are six major exceptions, however.

  • Food companies under the exclusive jurisdiction of the USDA
  • Companies subject to the FDA’s new Standards for Produce Safety authorities
  • Facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations
  • Low-acid and acidified canned food processors
  • Companies defined as “small” or “very small” businesses
  • Companies with a previous three-year average product value of less than $500,000

Do these changes mean that your existing food safety plan needs to be scrapped? Not at all. An existing HACCP plan can be modified with the help of a Preventive Control Qualified Individual (another new requirement) to comply with HARPC guidelines. This person needs to be intimately familiar with potential hazards and the risk-based preventive controls for them.

This may sound daunting at first, but moving to HARPC from HACCP will be an easier shift than starting from scratch. The key adjustments that you would need to focus on include identifying risk-based preventive controls for the hazards previously mentioned. Just remember, these hazards should be expanded to include both naturally occurring and unintentionally introduced hazards.

How Does Integrated Pest Management Fit into a Food Safety Plan?

Much like HARPC, Integrated Pest Management (IPM) focuses on being proactive. It emphasizes prevention, focusing on facility maintenance and sanitation, before considering chemical options for pest management.

An IPM plan is benchmarked with regular monitoring and analysis of effectiveness. This may seem cumbersome, but one shouldn’t overlook the value of documentation as a management tool. Collecting data and putting it in context with detailed analysis can be an effective way to prioritize your pest control efforts.

Detailed analysis accounts for things such as normal seasonal cycles, deficiencies in maintenance, exclusion, sanitation and harborages, just to name a few. This analysis can also help improve pest control efforts by prioritizing areas needing attention, especially when your staff is limited by time or resources.

Integrating IPM into your HARPC plan should include analyzing the risks of what could encourage pests to enter your facility, such as doors left open or incoming product shipments. Consider your pest control provider an expert source in how to assess all risks associated with pests and how to establish preventive controls for them.

Despite preventative efforts, unexpected pests will be inevitable. More emphasis will be placed on establishing action thresholds for different pests. This can be a problematic topic, because there are not scientific or broadly accepted threshold values for food processing pests.

Every facility, and often zones within facilities, will likely be different. Identify logical zones—ingredients, processing, packaging and warehousing—and sensible threshold values for each key pest in these zones. Furthermore, establish what the appropriate response should be at certain thresholds. The escalating responses to different levels of pest activity often include things such as automatic authority for certain limited types of pesticide application, more intensive monitoring and inspection, and, of course, higher management notifications, which might lead to more extensive measures.

IPM plans should be reviewed on an annual basis to ensure your program remains as effective as possible. Written food safety plans that follow the HARPC approach and comply with the FSMA rule should be reanalyzed whenever there is a significant change at the facility that might increase a known hazard or introduce a new one. Review the plan at least every three years, if no significant changes occur.

Even if your facility’s deadline for compliance with HARPC standards is a year or two away, now is the time to take a look at your plan and make sure you’re in compliance.

FST Soapbox

Intelligent Algorithms Shape Food Safety

By Steven Burton
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The North American food safety testing market is projected to reach $16 billion by 2020, according to a recent study by Markets and Markets. In just a few short years, it’s safe to say that purchasing a software solution to create and manage food safety programs will become ubiquitous, equivalent to that of employing any other software tool such as Microsoft Excel.

However, there is a broad range of capabilities for food safety software, and some solutions are much more complex than others. Many types of HACCP software operate as part of an ERP system, merely managing documents online under IT administration. But the technological capabilities of a food safety management system are endless in terms of value-driven innovation. Any competitive software on the market should go further, and be flexible and agile enough to meet and contain the challenges of a changing regulatory landscape and aggressive market space.

One of the ways food safety management can take things further is through the use of intelligent algorithms that can help food safety professionals get the most out of their software—and their HACCP plan. For example, instead of manually searching for all the physical, chemical and biological hazards (as well as radiological hazards under HARPC), intelligent algorithms can use data from other HACCP plans to suggest hazards. By comparing facility types, process flows, ingredients and more, a sophisticated algorithm can make smart suggestions that give food safety professionals a significant leg up, cutting down research time and providing a context of learning since it’s much easier to learn by example than starting from scratch. As such, suggestions can equip food safety professionals with the right mindset to discover potential hazards.

There are core benefits to searching for software technologies that have intelligent algorithms in place to analyze and retrieve data for those food businesses looking to get the most long-term value out of their vendor purchase.

Facilities with High-Risk Products and Complex Process Steps

High-risk foods are defined by the FDA as foods that “may contain pathogenic microorganisms and will normally support formation of toxins or growth of pathogenic microorganisms.” High-risk foods include raw meat, poultry, fish, dairy, fresh fruit, and vegetables, and processors working with these products handle more hazards and process steps in general than processors making low-risk foods. Instead of sorting through hundreds of hazards, facilities with high-risk products and complex process steps are able to skip much of the manual grunt work and simply select automatically generated hazards and process steps suggested to them at their fingertips.

Small Business Owners or Basic Food Safety Professionals

It’s common for small food businesses to put the bulk of their food safety duties on the shoulders of the owner. For many who have no previous background in food safety, there can be an unexpected and frustrating learning curve to overcome before you can pay the sweat equity required to develop a HACCP plan, and not for lack of trying. Similarly, junior food safety employees in new facilities can find established food safety practices challenging to navigate. Through intelligent algorithms, a software system can reinforce food safety hazards and process steps that might have been missed or forgotten by making them instantly available for retrieval and selection.

Giving Back Time

Recordkeeping is an essential component to an excellent food safety culture. In the grand scheme of things, managing resources to allocate time to high-level tasks that require human expertise on the production floor is a critical activity that most food safety professionals prioritize. Having more time to correct potential risk actions is crucial to ensuring the lowest possible likelihood of a recall. Smart software systems facilitate better employee time management practices so they can maximize their hours for meaningful, rather than menial, work. By taking back the time that would have been spent researching hazards, smart suggestions provide food safety professionals with a starting point that allows them to choose from a curated selection without delay.

Experimental Facilities with Changing Product Portfolio

Facilities that have a tendency to experiment with product development (i.e., food startups) are prone to using a significant amount of ingredients and formulas. When it comes time to present the right information for inspections and audits, this translates into a substantial amount of additional work in maintaining a HACCP plan. Intelligent algorithms enable a clear and organized focus, eliminating the minutiae surrounding information management of experimental product development.

New Regulations and International Compliance

Around the world new regulations surrounding acceptable food safety documentation are coming into effect; notably, FSMA even adds to the traditional hazards included under HACCP. For foreign exporters as well as American businesses, regulatory expectations for a more comprehensive approach to hazards and critical control points are higher than in the past. In the face of new regulatory demands, smart algorithms help food businesses lay out a common framework so that they can build internationally compliant programs

Extra Safeguard Check

Human error is inevitable. The beauty of technology is that it acts as a safeguard to ensure there are no glaring omissions that may have an impact on food safety duties. As a final once-over before sending in the HACCP plan, it makes good sense to have smart suggestions to cover all the bases.

Intelligent algorithms allow food safety professionals to do more with their time. By selecting from suggestions related to ingredients, materials, packing and process steps, a considerable amount of time is restored to the work day compared to the time-consuming exercise of manually assembling lists. The main benefit to a food safety software solution with intelligent algorithms is to reinforce the right mindset for listing physical, chemical and biological hazards for ingredients, material, processes and beyond. While smart suggestions should always be verified by a food safety professional familiar with the internal operations of a facility, for companies that aim to work smarter but not harder, smart algorithms are a key feature to keep in mind when researching software vendors.

Imports

FSMA’s FSVP: Clearing the Confusion of Importing Rules

By Charles Breen
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Imports

On November 27, 2015, the Foreign Supplier Verification Programs for Food Importers (FSVP Rule) published in the Federal Register. The most significant new element is that importers are now responsible for assuring that the food they import complies with FDA requirements. Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

“Importer” is defined as: “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.” This differs from the importer of record as defined by Customs and Border Protection (CBP) as the person primarily responsible for paying any duties or an authorized agent acting on his behalf.

Under FSVP, an importer’s basic responsibilities are to:

  • Determine hazards reasonably likely to cause illness or injury
  • Evaluate the risk, using hazard analysis
  • Evaluate the foreign supplier’s performance
  • Perform supplier verification activities

Determining hazards and evaluating risk parallel the preventive control rules for human food (PCHF) and animal food (PCAF). Evaluation of a foreign supplier’s food safety performance and conducting verification activities are substantially aligned with supply-chain verification in 21 CFR 117 Subpart F (PCHF) and 21 CFR 507 Subpart E (PCAF). The importer is responsible for assuring compliance with FDA standards and requirements.

Deciding what parts of FSVP are applicable to each importer’s operation requires a comparison between what the importer does, and the exemptions, exceptions and modified requirements offered in the rule. These depend on what is imported, the food safety system in country of origin, the size of the importer, and the size of the foreign supplier. FDA delivered on its promise of flexibility, but deciding what applies requires some analysis.

If a food importer meets the definition of importer and does not fall into an exempted category or qualify for exceptions or modifications, then some or all of the FSVP rule applies to them. FDA estimates that about 55,000 importers will be covered by FSVP or some portion of it.

Who Is an Importer?

The U.S. owner or consignee of an article of food that is being offered for import into the United States is the importer. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the U.S. agent or representative of the foreign owner or consignee at the time of entry is the importer.

All importers must provide an identification number for each entry line of food that the importer brings into the country. FDA will be issuing more guidance on what it considers “an acceptable identification number.”  The agency is not mandating that each facility use a DUNS number, but is has ruled out other suggestions for the unique identification number that is required.

Exemptions to FSVP

FSVP does not apply to the following foods:

  • Fish and fishery products (in compliance seafood HACCP in 21 CRF 123)
  • Juice (in compliance with juice HACCP in 21 CFR 120)
  • Food for research or evaluation
  • Alcoholic beverages
  • Meat, poultry, and egg products regulated by USDA
  • Food imported for personal consumption,
  • Food that is transshipped through the United States
  • Food that is imported for processing and later export
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country (U.S. foods returned)

Partial exemption for import of low-acid canned foods (LACF). LACF are exempt from FSVP with respect to microbiological hazards for that food. To be exempt, the importer must verify and document that the food was produced in accordance with LACF requirements (21 CFR part 113). Other hazards not controlled by the LACF rule, if any, must be documented as controlled under FSVP.

Modified Requirements

Modified requirements for a receiving facility in compliance with the PCHF or PCAF rules that imports food:

  • If the process used controls the hazards of the imported food, the facility is considered in compliance with most of the FSVP rule.
  • If the food does not have any identified hazards requiring control, then the facility is considered in compliance with most of the FSVP rule.
  • If the facility has implemented a supply-chain program for the food in compliance with either PCHF or PCAF requirements, the facility is considered to be in compliance with most of the FSVP rule.

Receiving facilities must also accurately identify themselves to FDA for each entry line of food being imported.

Modified requirements for imported dietary supplements manufactured in compliance with CGMP requirements in 21 CFR part 111:

The importer must accurately identify itself to FDA for each entry line of dietary supplement or dietary ingredient being imported.

Modified requirements for very small importers:

Defined as less than $1 million in sales of human food a year, or less than $2.5 million in sales of animal food per year, very small importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance from those facilities.

Modified requirements for imports from small suppliers (i.e., qualified facilities under PCHF or PCAF, and some small farms not covered farms under the produce safety standards, and some small egg producers):

The importer must obtain written assurance before importing the food, and at least every two years after, that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations or the laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.

Modified requirements for food imported from a country with an officially recognized or equivalent food safety system:

Importers must determine that the supplier is in compliance with FDA requirements, or that the supplier is in compliance with food safety regulations or relevant laws in the country that FDA recognizes as equivalent.

At present, only New Zealand is officially recognized as comparable to the United States. FDA is in the process of auditing and evaluating audit results for mutual recognition with additional countries. The next countries to be recognized will most likely be Australia and Canada.

One final note: FSVP requires coverage of food contact surfaces, such as packaging. Manufacturers of food contact surfaces are not required to register with FDA. PCHF and PCAF rules are limited to those facilities required to register. The language requiring FSVP makes no exception for food contact surfaces.

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

Get Ready to Align Your Supplier Program with New FSMA Rules

By Dr. David Acheson
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Dr. David Acheson is the Founder and CEO of The Acheson Group

FSMA’s preventive controls rule mandates a supply-chain program to “provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.” The rule defines a supply-chain-applied control as “a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt.”

FDA made a few general updates in the final rule, including changing “supplier program” to “supply-chain program”, and it designated a subpart G with eight sections of regulatory text. Intended to improve clarity and readability, the language reflects its applicability to non-suppliers in a new requirement – that is, a supply-chain control can be applied and/or verified by a non-supplier (e.g., distributor, broker, aggregator). However, the receiving facility must verify the supply-chain-applied control itself or obtain documentation of the verification activity, review and assess the documentation, and document that review and assessment.

There are different compliance dates for the supply-chain program versus the entire rule, aligning  compliance with the dates of FSVP rule and providing greater consistency. This also addresses comment concerns that a receiving facility would be required to comply with the supply-chain program provisions before its supplier must comply with applicable new FSMA food safety regulations.

Does your current program comply with the new rules? If not, how can you bring it in line?

The Supply Chain Program

The rule requires a supply chain program when the receiving facility has identified, through its hazard analysis, that there is a hazard requiring a supply-chain-applied control. The program should address hazards requiring a preventive control that may be intentionally introduced for purposes of economic gain, as well as those unintentionally introduced.

FDA specifies the basic content of a supply-chain program, but allows for some flexibility. The rule mandates that the supply-chain program include:

  • Written procedures for receiving raw materials and other ingredients
  • Preventive control management components that include corrective actions and corrections, review of records and reanalysis
  • Supplier approval and use of only approved suppliers, but FDA is considering the issuance of guidance for temporary use of unapproved suppliers
  • Determining appropriate supplier verification activities
  • Conducting supplier verification activities
  • Documenting supplier verification activities:
    • Onsite audits
    • Sampling and testing of the raw material or ingredient (by the supplier or receiving facility)
    • Receiving facility review of the supplier’s relevant food safety records
    • Other appropriate supplier verification activities based on the risk associated with supplier performance and the raw material or other ingredient

In supplier approval and determination of supplier verification activities, the receiving facility must consider:

  • The hazard analysis, including the nature of the hazard, applicable to the raw material and ingredients
  • Where the preventive controls for hazards are applied
  • The supplier’s procedures, processes and practices related to the safety of the raw material and ingredients
  • Applicable FDA food safety regulations and the supplier’s compliance with them
  • The supplier’s food safety performance history relevant to the applicable raw materials, including results from testing for hazards, food-safety audit results and corrective action.
  • Any other relevant factors, such as storage and transportation practices

Other key points of the rule:

  • There must not be any financial conflicts of interests that influence the results of the verification activities. Payment must not be related to results
  • Domestic inspection by representatives of other federal agencies or by representatives of state, local, tribal, or territorial agencies may substitute for an audit
  • The definition of “supplier” has been revised so that the grower remains the supplier when the harvester is under separate management. The “supplier” is the establishment that “grows” food rather than that which “harvests” food.
  • Foreign suppliers may provide documentation, when applicable, of a written assurance that the supplier is producing the raw material or other ingredient in compliance with relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States
  • The provisions for supplier verification in the FSVP rule have been aligned with the provisions for a supply-chain program, so importers and receiving facilities can consider compliance with both the supplier-chain-program rule and the forthcoming FSVP regulations, as to avoid  duplication of verification activities
  • If the receiving facility is an importer in compliance with the FSVP requirements and has documentation of verification activities under FSVP, a supply-chain program is not required even if the receiving facility’s hazard analysis determines that a supply-chain-applied control is required
FST Soapbox

HACCP, HARPC, and How Using Software Helps

By Steven Burton
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With nearly one in every six Americans falling prey to foodborne illnesses each year, food safety is a major public health issue. For several decades, current Good Manufacturing Practices (cGMPs) provided the basic food safety framework for manufacturers. However, these guidelines were not sufficient to cover all potential food safety hazards. In the 1960s, NASA asked Pillsbury to manufacture the first foods for space flights, and so the Hazard Analysis & Critical Control Point (HACCP) system was born. HACCP was later endorsed by the Codex Alimentarius Commission, which was formed by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1963.

HACCP is a global standard and its principles are the defining elements of ISO 22000, BRC and SQF, all premiere global food safety standards. In 1996, an E. coli outbreak in Scotland claimed 10 lives. The Pennington report in the aftermath of this tragedy recommended use of HACCP by all food manufacturers to ensure food safety. While HACCP is mandatorily used for seafood, juice and USDA-regulated meat processing, it could not win universal acceptance across the food industry; most of the food industry sectors rely on cGMP for providing a food safety framework.

The number of people affected by foodborne illnesses can be attributed to a flawed food safety system. Thinking caps were put on and President Obama’s administration rigorously pursued what it hoped would be an effective food safety paradigm. On July 4, 2012 Hazard Analysis and Risk Based Prevention Control (HARPC) was introduced under FSMA section 103. Although the system is still a work in progress and FDA has yet not disclosed the regulations that will determine the functionality of HARPC, the agency is bound to issue the regulations by August 30, 2015. HARPC will become effective 60 days following this date, and companies will be required to enforce HARPC within a period of 12 to 36 months, depending on the size of a facility.

HARPC is designed along the lines of HACCP but is meant to be more comprehensive. For a “Simple Simon” it would be tough to differentiate between the two, but HARPC provides an all-encompassing food safety structure by focusing on preventive controls to make food safety more iron clad. With the exception of exempted facilities, HARPC will apply to all facilities subjected to FDA’s Bioterrorism Facility Establishment registration. All such facilities will be expected to enforce a functioning and adequate HARPC plan. Failure to do so and FDA would be authorized to take legal actions such as issuing a public warning letter or an import alert (in case of a foreign supplier), initiating criminal proceedings against a non-compliant facility, or suspending food facility registration of a facility until requirements are met. By doing so, FDA has put the onus squarely on the shoulders of respective facilities. Companies will be required to do a lot more and should expect deeper FDA involvement. Expert help to enforce a rather complex HARPC protocol seems unavoidable; there is a fair chance that users could find themselves lost in the translation and may end up facing FDA’s wrath if their plan is inadequate. Let me break it down a bit more and distinguish the main differences between HARPC and HACCP.

Qualified Food Safety Experience. HARPC requires one member of a company to be the qualified individual to complete an entire food safety plan. This means that said individual has undertaken education from a credible institution and gained experience by completing it. HACCP requires at least one person to be HACCP certified, but the plan must be constructed by a team of people.

Process Flow Diagram. Under the HACCP standard, food safety plans must include a clear flow diagram outlining the process, from start to finish, that the ingredients will take throughout your facility. HARPC has no regulations regarding this.

Hazard Variables. Traditionally, hazards were limited to biological, chemical and physical hazards under the HACCP paradigm. Yet, under HARPC, you must also outline Radiological and Terrorism hazards.

Controlling Hazards. Here is largely where the main difference lies: How to control a hazard. HACCP requires companies to mention their critical control points as well as outline a prerequisite program (PRP), although this has no set requirements. HARPC requires you to apply a sanitation preventive control to the hazards, which looks at monitoring, confirmation, corrective action, reviewing records and re-analyzing.

Reviewing the Plan. HACCP requires the individual in charge to review all HACCP documentation every year. This is in comparison to HARPC, which requires a facility to reanalyze its plan every three years.

Recall Plans. Recalls, as required under HARPC, are a special type of incident, with all of the attributes necessary to create and manage a recall plan. HACCP does not have such a requirement.

Use Software to Implement HARPC Plan

Using software can make life easier when it becomes time to implement a HARPC plan. Documentation is an important part of the HARPC system, and software can help generate most of the documents used to establish the plan. Such a system can link regulatory requirements with procedures and customize several aspects of the system during run time.

A risk analysis component of software helps a user identify the likelihood and severity of a particular hazard (a HARPC requirement). HARPC also requires sanitation control procedures at food surface contact points; software features can support cross contamination points to which hazards are assigned and controlled. Software also allows users to define equipment, with a facility to schedule and record calibration, maintenance, and verification activities, including management task assignment to satisfy HARPCs provisions regarding sanitation of utensils and equipment. In addition, it has the provision to document procedures as required by HARPC and can also flag employees for refresher training if they are involved in a violation.

Software also enables users to electronically record inspections, which satisfies the obligation under HARPC to carry out an environmental monitoring program (for pathogen controls). Interestingly, sensors could also be integrated with logging facilities to automatically collect sensor data, which could then be used to send out alerts if there is an abnormality. Software systems can also accommodate coverage of allergen hazards and run a food allergen control plan, including documentation of the process.

An incident management plan can assign and track corrective actions, root causes, employee retraining tasks, and preventive measures to individuals, and recall plans can be created and managed using the system. As many inspectors prefer remote review of documentation, software can provide such remote access, allowing inspectors to conduct off-site document reviews. This process can reduce on-site inspection times from five to three days. A list of approved suppliers can be maintained as well, and these suppliers can be linked to receiving functions, enabling users to receive and maintain a detailed and comprehensive record of ingredients.

HARPC is a reality that will have to be embraced very soon. Using software is a simple solution for the tough times that lay ahead for the food industry. It can serve as an all-encompassing and one-stop-shop for businesses that need help enforcing HARPC plans.