Tag Archives: HACCP

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The Results Are In: FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.

We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.

If you haven’t taken Part II yet, take the Supply Chain IQ Test now.

And now for the results!

  1. Control limits must be included within the hazard analysis and preventive controls for HACCP.
    • FALSE. More clarification is needed here, as 96% of respondents said this is true.
  2. CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
    • TRUE. 91% got this right.
  3. Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
    • FALSE. 87% answered correctly.
  4. You must document justification of records not required by a food safety plan in a food operation under FSMA.
    • TRUE. Just 44% responded “true”.
  5. You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
    • TRUE. Congratulations, 100% got this one right!
  6. Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
    • FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
  7. Under FSMA supply chain requirements, you must document approved suppliers.
    • TRUE. Once again, great job—100% answered correctly!
  8. A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
    • TRUE. 91% knew this one.
  9. A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
    • FALSE. 91% answered correctly.
  10. Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
    • TRUE. 74% answered correctly.
  11. Only the personnel of the carriers transporting food product require training and training records.
    • FALSE. 96% got this one right.
  12. Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
    • TRUE. 91% answered correctly.

How ERP Can Help Ensure Food Safety in the Cannabis Edibles Market

By Daniel Erickson
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The popularity of cannabis edibles and infused beverages as a socially accepted and convenient method of marijuana consumption has grown exponentially for consumers in states with a legalized market for both recreational and medicinal cannabis. The edibles industry’s success has been met with many challenges however, as the absence of federal regulation has provided little guidance regarding food safety practices. With consumers generally expecting these products to have the same safety expectations as they do with other food and beverages they consume, many manufacturers have elected to follow FSMA best practices to ensure cannabis edibles’ integrity in the marketplace. Proactive cannabis growers, processors and dispensaries are seeking out ERP software solutions in greater numbers to utilize the technological tools and vendor experience in the food and beverage market to establish greater accountability and plan for current and future compliance requirements.

Cannabis Edibles Defined

Cannabis-derived edibles are food or beverage products that are made with cannabis or infused with cannabis extract—either consumed recreationally or to manage or alleviate health concerns. Cannabis extractions used in edibles include tetrahydrocannabinol (THC), which is psychoactive, and cannabidiol (CBD), which is not, as well as many derivatives when speaking of “whole plant” benefits. While there are a variety of edibles including gummies, candies, cookies, energy drinks, teas and chocolates, the defining characteristic of these products is that they are meant for human consumption. Public perception is that these products are held to the same safety and quality considerations as mainstream food and beverage products available in the market. With these expectations and lack of oversight, the responsibility falls on the manufacturer to meet those expectations and ensure a safe, consistent, quality edible product.

Safety and Quality Concerns

An unregulated industry at the federal level has resulted in a lack of consistency, predictability and safety in the edibles market. Frequently, it has been found that edibles don’t always produce the same experience from one consumption to the next, resulting from inconsistent appearance, taste, texture and potency. These variances pose a problem from a marketing perspective, as it impacts brand recognition, loyalty and returning customers. Similar to the food and beverage industry, foodborne illnesses, outbreaks, undeclared ingredients and inaccurate labeling provide further concern in an unregulated manufacturing environment. Specific safety issues of the cannabis industry include extraction processes, mold and bacteria growth, chemical exposure, pest and pesticide contamination, employee handling of products and the unintentional ingestion of cannabis edibles. With the high risks associated with this market, it is necessary for proactive growers, processors and dispensaries to adequately address quality and safety concerns that mitigate risk until the eventuality of regulatory oversight.

How ERP Can Help

Implementing an industry-specific ERP software solution that provides security and standardizes and automates business functions helps support cannabis manufacturers by providing the proper tools to track operations from seed-to-sale. With support for best practices and streamlined and documented processes, companies can incorporate safety and quality initiatives from cultivation to the sale of edible products and beyond. Utilizing the expertise of ERP vendors in the area of food safety management, edible manufacturers are provided with the same benefits that food and beverage companies have experienced for decades with ERP solutions. Cannabis ERP software allows your company to track all aspects of growing, manufacturing, packaging, distribution and sales—providing functionality that manages inventory, traceability, recipes and labeling to support quality initiatives.

The following areas supported by ERP can lead cannabis edible manufacturers to succeed in the realm of food safety:

Inventory Control. ERP’s automatic recording and tracking of inventory attributes, including balances, expiration dates, plant tag ID’s, serial and lot numbers and end-to-end traceability, allows cannabis edible manufacturers to maintain appropriate raw material and product levels, reduce waste, evaluate inventory flow, facilitate rotation methods and avoid overproduction. It provides accurate ingredient and cost tracking throughout the greenhouse operations and supply chain by use of barcode scanning that links product information to batch tickets, shipping documents and labels. Maintaining real-time and integrated information facilitates the ability to locate items in the event of contamination or recall. This detailed level of continuous monitoring mitigates the risk of unsafe consumables entering the market.

Labeling. Accurate product labeling is essential for food safety in the cannabis edibles industry, and its importance cannot be understated. Proper labeling and transparency ensure that consumers are provided a consistent experience and also help to mitigate unintentional consumption of cannabis-infused products. Certain states have enacted labeling requirements to increase accountability and mitigate the misrepresentation of cannabis edibles on the label with unverified, misleading or inaccurate information. Employing an automated ERP system assists with label creation that includes nutrient analysis, ingredient and allergen statements, testing notification for bio-contaminants and pathogens and expiration dates to ensure quality—providing a faster and more efficient method for labeling. Accurate labeling is also an imperative component of product recall planning, as traceability and labeling history documented in ERP software helps to identify and locate items quickly in the event of a recall.

Recipe and Formulation Management. To achieve consistency of products in taste, texture, appearance, potency and intended results, complex recipe and formula management are maintained with a real-time ERP solution that delivers tightly managed control. Raw material data, version and revision information and production notes are documented for each batch. The monitoring of key quality specifications such as THC and CBD percentage, containment and impurities testing, etc. are readily handled within the system and allows for the scalability of recipes as needed. Direct access to the calculation of specific nutritional values, which includes ingredient and allergen information, provides accurate labeling and consumer information for product packaging—a valuable asset in the cannabis edibles market. R&D functionality supports the creation of new and innovative edibles and marijuana-infused beverages in a sandbox environment to meet the demands of this consumer-driven market.

Approved Supplier Relationships. Assurance of cannabis edible safety is enhanced through the acquisition of quality raw materials from trusted vendors. An ERP solution plays an essential role in the process as it maintains a supplier list by documenting detailed supplier information and test results to assure in-house qualifications and potency standards are met. A fully-integrated ERP system regulates quality control testing to ensure consistent and approved materials are being used and undeclared substances, harmful chemicals and impure ingredients are unable to infiltrate the supply chain. Failure to meet quality control standards results in ingredients being quarantined, removed from production and disposed of safely, and indicates that a search for alternate vendors is needed. This detailed level of documentation is a best practice for maintaining current and accurate supplier information in the event of a product recall.

Current Good Manufacturing Practices (cGMPs). As the bedrock for the food and beverage industries, following cGMPs establishes an important foundation for the edibles market. An ERP efficiently documents processes to ensure safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes monitoring equipment status, establishing cleaning and hygienic procedures, training employees, reporting illnesses, maintaining food and cannabis handling certifications and eliminating allergen cross-contact risks. Validating procedures within an ERP solution automates documentation of an audit trail and addresses food safety concerns more efficiently than manual methods.

Hazard Analysis Critical Control Points (HACCP) Requirements. Establishing a food safety team that develops a HACCP plan to enact procedures that protect consumers from the biological, chemical and physical dangers of edibles is a recommended best practice for quality assurance, despite the current lack of federal regulations. Critical control points recorded within an ERP solution prevent and control hazards before food safety is compromised. Parameters within the ERP system can be utilized to identify potential hazards before further contamination can occur. Applying these best practices historically used by food and beverage manufacturers can provide an enhanced level of food safety protocols to ensure quality, consistent and safe consumables.

Food Safety Plan. As a requirement of FSMA, a food safety plan provides a systematic approach of identifying and addressing food safety hazards by implementing preventative food safety procedures throughout the manufacturing, processing, packing and storage of products. With a trained Preventative Control Qualified Individual (PCQI) at the helm to coordinate the company-specific plan, an ERP solution automates and records preventative controls, full forward and backward lot traceability, recall plans and employee training records within an integrated system to ensure that food safety policies and procedures are being followed.

With the growth of the edibles and infused beverage market expected to skyrocket over the next four years, the success of growers, processors and manufacturers will continue to thrive off of technological tools and established best practices. Employing the industry experience of ERP software providers that have implemented food safety and quality control procedures will follow suit of the market and be a sought-after resource when federal regulations are imposed. Proactive cannabis businesses are already experiencing a return on investment in their ability to provide quality, consistent products that meet cannabis enthusiasts’ high expectations and keep them ahead of this trending market.

Shawna Wagner, DNV GL
FST Soapbox

How to Strengthen Your Audit Score

By Shawna Wagner
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Shawna Wagner, DNV GL

It is one week before your scheduled audit. Are you running around from department to department crossing the T’s and dotting the I’s, or are you cool, calm and collected, as it is just another audit? More than likely you have been in both cases, but how does one finally get to the collected stage? It is not about being nervous—even as a lead auditor I get nervous (I am human, too)— it is about being ready!

Believe it or not, I can generally gage if the audit is going to flow well within the first hour of arrival. My questions from audit to audit of course change, but overall, I am asking for the same materials and results. If the team is getting baffled by questions in the beginning stages of the audit, I know I am in for a long ride. Why does this happen? If the situation has gone down hill rather quickly, I find that whomever at the plant is responsible for the implementation of the audit standard, has never taken the time to read or review it. That, my friends, is one of the most critical mistakes you can make. I know these standards are not world-class bestselling books that you are dying to binge read by the fireplace with a glass of wine—if this was your view, you would be an auditor already. HA! The standards are not always black and white as far as requirements, but just taking the time to read the standard will enhance your understanding of where the auditor is coming from.

Now you have read the standard, you understand it and are comfortable. You have a 200,000 square-foot facility, 200 employees and four different HACCP plans to watch over. How could you possibly score an excellent, “A”, pass, whatever the top score may be defined as? I am sure you have heard the expression, it is not all about you, and that holds true for audits. So many times I have witnessed that the quality manager (or equivalent) try to undertake the entire audit from start to finish and answer all the questions. This is not a best-practice approach. A good example here would be that many audits now talk about annual objectives and key performance indicators. As an auditor, I expect that your plant manager (or equivalent key person responsible) come talk about these with their senior management. Too often I see the quality department commit to answering these questions, but as an auditor, I am interested in your system and how it works throughout your entire facility. I do not just want to know about the quality department. Get all departments involved. They, too, then get firsthand experience of understanding what the audit requirements are, instead of just reading endless emails of what needs to be accomplished.

Teamwork and understanding are now established—great! How strong are your programs? There are a few programs I want to touch on here, including your internal audit program and procedures. I can not write this article and tell you “X” is the solution, as there is not a one-size-fits-all approach. If you are spending two hours on an annual internal audit for a facility like the one mentioned above, it is possible that your program is lacking robustness. When conducting an internal audit and a requirement is in compliance, do you write what made it in compliance, what you reviewed, and with whom you spoke? This is a great way for you to compare what you see in your plant versus what an auditor sees in your plant, especially if you built your internal audit from an audit standard. How about your sanitation program? I came from a background of meat inspection, so maybe I am a bit biased, but your sanitation is encompassed with other pre-requisite programs in the facility. If your facility has untidy locker rooms, cafeterias and bathrooms, what motivates the employees to be tidy on the production floor? Sometimes it is the small things that go a very long way. In talking about sanitation, I have observed that many site managers never go in to watch your pre-operational inspections that may take place very early in the morning. Just because it is not on first shift, does not mean it is not important, and it also does not mean that it will not be audited. Likely, it will be audited!

Lastly, take all nonconformities that you have found either through internal or external audits, respond to them in a timely fashion, and get the root causes and preventative actions in place! Nothing pains me more then to see sites repeat a nonconformance, just to possibly get a major conformity. It’s like shooting yourself in the foot and your audit score takes an unnecessary plunge that could have been avoided.

Audits are not a fad and are not going away. It does take way more time to get to the cool, calm and collected stage for audits, but in the end, being audit ready all the time looks good on you and your site!

Shawna Wagner, DNV GL
FST Soapbox

Did You Write “NONE” for Biological, Chemical and Physical Hazards in Your HACCP Plan?

By Shawna Wagner
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Shawna Wagner, DNV GL

Ok, ok I know what you are thinking, another article about HACCP. You have been HACCP certified since 1999 and doing this for years—why read this article? That golden sticker on your certificate does not last forever. Industry has changed, approaches to food safety have changed, and your HACCP plan should have evolved. Did it?

Biological, chemical, physical, biological, chemical, and physical hazards. If you are any part of the quality assurance or HACCP team, you can recite this in your sleep. Do you recite economical and radiological hazards? These are one of the most commonly missed items in a plant’s HACCP plan that I have witnessed when auditing. This, of course, applies only to plants that must comply with FSMA, but does it truly hurt to think about including it in all plants? I mean, we are all in this for food safety, right?!

In speaking about radiological hazards, most of the time I will have site management tell me that I am not by a power plant so there are not hazards to my operations. If you are a producer of vegetables and fruits, or a plant receiving these kinds of ingredients, water and even soil can be a home to radioactive hazards! Radioactive minerals are naturally occurring and unless you know where to start, items such as Cadmium may sneak up on you in unacceptable levels. Economical hazards are, in my opinion, a bit easier to research. When looking at economical hazards, we are basically trying to prevent intentional contamination to gain or profit. In more common terms, this is often referred to as food fraud. Olive oil, fish, and even spices have been known to be the victims of food fraud. There are plenty of informational sites out there to help get you started on writing your hazard analysis for food fraud, however some I have found you do have to pay for.

Another common non-conformance that I see missing in HACCP audits is what I would call inputs and outputs to the HACCP flow chart. Inputs are: Water, compressed air, ice and even steam. Outputs are: Waste, animal feed or by-products. This is not an all-inclusive list, but certainly these examples could bring a new level of hazards to your facility, especially if you did not include them in your hazard analysis. Even worse, if you did include them but decided to write in your hazard analysis that word…dare I even say it… “NONE”: You wrote “none” for biological, chemical, and physical hazards. More than likely you have a pre-requisite program, letter of guarantee, or something that controls these hazards, and you absolutely want to include these in your HACCP plan. Give yourself credit! Auditors and customers alike truly want to see that you have documented and given thought to each of your processing steps. Make sure you take that HACCP flow chart and walk around your facility to ensure you have captured the needed information that will give you the best chance of catching items that can be missed. The plan is only as strong as the time you put into it, which leads me to my next point: Your HACCP or Food Safety Team.

The notorious HACCP team. You have one, the head of the team is the QA manager, and you have team members to cover the multi-disciplinary basis. So, what’s the problem? Well, maybe none, but remember the comment about the golden sticker on your certificate? It’s the same thought process here. Your team must be continually updated and educated to keep up with the ever-changing world of food. That 1999 HACCP certificate is no longer valid in the eyes of some customers. I have seen many customers requiring that HACCP be retrained every five years. For the sites that must follow FSMA rules and regulations, have you completed your Preventative Controls Qualified Individual training? You should have, and who is their backup? It takes much planning and money to make this happen, but it is all a crucial step in maintaining food safety and your HACCP plan.

We all know that our programs and processes are not good for forever and that change is inevitable. There are always avenues for gathering information and accessing it. You must be willing to go out and get the resources that will place an upgrade on your food safety management system, as waiting for it can sometimes cause gaps and non-conformities. The big question is: Did you put in the hours?

HACCP, hazard analysis and critical control points

Food Safety Lessons for Cannabis

By Food Safety Tech Staff
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HACCP, hazard analysis and critical control points

A HACCP plan has historically been applied by the food manufacturing and food service industries to ensure the sale of  food that is safe for consumption. As the cannabis industry grows in the manufacture of cannabis-infused products, namely edibles, lessons can be learned from the progress and success of programs like Good Manufacturing Practices, HACCP, Juice HACCP and FSMA. One side of the coin is compliance with regulations; the other side of the coin is taking all necessary steps to ensure a safe product for the consumer.

A webinar next month, Lessons from Food Safety: Applications to the Cannabis Industry, organized as a partnership between Cannabis Industry Journal and the National Environmental Health Association (NEHA) will cover the above topics, along with the disparities in state-to-state cannabis safety and quality regulations, and implications for infused-product manufacturers. The webinar will be held at 1 pm ET on May 2. To learn more, follow this registration link.

Jordan Anderson, PAR Technology Corp.
FST Soapbox

Advocate for Change to Establish a Food Safety Culture

By Jordan Anderson
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Jordan Anderson, PAR Technology Corp.

Many times food companies will simply say, “We have to change our culture” or “We’ve always done things this way”, but this attitude will not remedy potential outbreaks or help develop food safety protocols.

As author and businessman Andy Grove once said, “Success breeds complacency. Complacency breeds failure. Only the paranoid survive.” This statement could not apply more to the food service and manufacturing industry.

The first step to change is convincing your organization from the top down to buy in; getting your executive team to accept the cultural change from manual paper-based approaches to digital food safety is paramount.

Common objections will be the investment and positive record of accomplishment. Taking a proactive and preventative approach to everyday food safety compliance will have a positive ROI over time while ensuring the utmost brand protection.

Presenting the potential damages of being linked to a foodborne outbreak is a great place to start. It typically will open the eyes and slightly intimidate each audience member. After all, executives and board members do not like to hear “profit loss”, “stock plunge”, and “tainted brand image”.

While this can all seem overwhelming, it does not have to be. Preparing a strategy and evaluating the processes needed to fulfill this goal will help alleviate the red tape to get this off the ground.

However, before we prepare a strategy, it is important to understand the basic premise behind food safety and how technology can enhance it.

In essence, food safety fundamentally revolves around individual human behavior. Human behavior in turn, is largely driven by culture. In order to successfully develop a food safety culture, an operation must possess impeccable leadership and incorporate the highest standards of food safety.

Most notably, the HACCP plan and individual processes created are a reflection of the human behavior that shapes and molds the culture of an organization. In large organizations, the challenges are often compounded by an increased number of locations and stakeholders (employees, suppliers, customers, etc.) Within these operations, food safety culture and human behavior can potentially become compromised due to the nature of the organization, or attitude and work ethic of the stakeholders.

Technology can assist in the development and maintenance of larger food safety cultures through the use of extensive and dynamic procedures. Human behavior can be shaped by the resources available in today’s food safety tool box. We can now overcome the arduous “pencil whipping” of safety checklists via handheld, wireless and cloud-based technologies. Such technologies are ubiquitous today in the form of apps downloaded from the internet, cell phones, reporting platforms and omnipresent communications.

History has shown that in challenged cultures, individuals often behave as though they are not a part of the whole, and operate as one, rather than as a team that is linked together under one vision and shared effort. However, during the processing, handling and storage of food, we need all stakeholders to act as a collective operation and function as one. The growing adoption of technology is the fundamental turning point that can help drive human behavior and food safety culture in a positive direction.

The introduction of FSMA has brought both challenges and opportunities to the food safety industry—the requirement to document and record actions of a larger food safety plan is one of them. Conceptually speaking, you are only as good as your records say you are. In this context, we are faced with both the challenge of maintaining a positive and efficient food safety culture, in addition to the burden of increased regulatory compliance.

However, FSMA and the innovative technological era have guided the industry to a crossroads of sorts. I suggest embracing the FSMA mentality and implementing food safety technology into your operations. This will not only protect and preserve your organization, but perhaps more importantly, it will define your food safety culture, and implement a positive change into your brand.

HACCP, hazard analysis and critical control points

A Guide to HACCP

By Food Safety Tech Staff
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HACCP, hazard analysis and critical control points

HACCP is discussed often by food safety professionals. While the industry is well aware of the program and its necessity, the cannabis industry is far greener in this area. Food safety consultant Kathy Knutson, Ph.D. developed a series on HACCP for the cannabis industry for our sister publication, Cannabis Industry Journal. It also serves as a great primer for the novice in the food industry. You can read the article, “Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 1”, by following the link below.

Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 1

Eggs

USDA Proposes Rule to Make Egg Products Safer

By Food Safety Tech Staff
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Eggs

Earlier this week the USDA’s FSIS proposed to amend inspection regulations, modernizing food safety inspection systems, in an effort to make egg products safer. It would require official plants that process egg products to develop HACCP systems, sanitation standard operating procedures and meet sanitation requirements consistent with meat and poultry regulations.

“FSIS is proposing that official plants will be required to produce egg products in such a way that the finished product is free of detectable pathogens,” according to a USDA news release. “The regulatory amendment also uses agency’s resources more efficiently and removes unnecessary regulatory obstacles to innovation.”

FSIS will also be taking over jurisdiction of egg substitutes.

According to the agency, the financial impact of the proposed rule could be minimal, as it states 93% of egg products plants already have a written HACCP plan that deals with at least one production step in the process.

Once published in the Federal Register, a 120-comment period will go into effect.

Alert

FDA Inspections: Top Five Violations for FY2017

By Food Safety Tech Staff
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Alert

FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Among the items on the spreadsheet are food safety hazards, failure to clean, sanitation records, corrective action plan, and lack of sanitation.

“These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.” – FDA

The following are the top five (most frequent) observations.

  • 5. Contamination: Cleaning and sanitizing operations for utensils and equipment not conducted in a manner that protects against contamination of food, food contact surfaces and food packaging materials.
  • 4. Failure to implement HACCP plan procedures.
  • 3. Facility not constructed in a way that enables floors, walls and ceilings to be adequately cleaned; buildings, fixtures and other physical facilities not kept in sanitary condition.
  • 2. Sanitation monitoring: Sanitation conditions and practices not monitored with enough frequency to be in conformance with CGMP.
  • 1. Pests: Lack of effective pest exclusion from processing areas and contamination of foods, and failure to provide adequate screen against pests.
FSMA

FSMA Exempt? FDA Guidances Explain

By Food Safety Tech Staff
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FSMA

This week FDA released three guidances to help food producers understand how the FSMA rules apply to their commodities. The regulations covered in the guidances pertain to low-acid canned foods (LACF), juice HACCP and seafood HACCP. Since FDA’s regulations for HACCP and LACF were in place before the FSMA final rules were established, the agency is clarifying the FSMA requirements as well as exemptions for these products.

The following guidances are available on FDA’s website: