A report released last month by the Subcommittee on Economic and Consumer Policy revealed dangerous levels of toxic heavy metals in baby food. It stirred up quite a bit of controversy and concern, and raised questions over whether baby food manufacturers were hiding dangerous levels of toxic heavy metals in food, and whether FDA was doing enough to ensure the safety of food.
In an effort to assure the public that FDA is taking the issue seriously, the agency published a constituent update about its actions to further prevent or reduce toxic elements in foods for babies and young children. It also issued a letter to manufacturers and processors of baby and toddler foods as a reminder of the “responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis,” which is part of the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food FSMA rule.
“FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air,” stated CFSAN Director Susan Mayne in the letter. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”
The agency also stated that it is finalizing a plan to reduce levels of toxic elements in baby foods, including:
“Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
Focused compliance and enforcement activities, including inspections.
Providing guidance to industry on how to meet their obligations under current regulations.”
The agency will also continue its surveillance sampling assignment that focuses on these products.
The most commonly cited observation during a Preventive Controls inspection is an incomplete or incorrect hazard analysis, according to FDA data. Food Safety Tech is hosting a special complimentary webinar series, instructed by Patricia Wester, founder of The Association for Food Safety Auditing Professionals, that will provide attendees with important tips on conducting and documenting a thorough hazard analysis. During the one-hour event, Wester will help participants understand how to recognize gaps in a hazard analysis as well as share best practices for closing those gaps. The content is geared toward food safety professionals and auditors who develop, manage or review food safety plans in a Preventive Controls landscape.
What: “Did You Know?” Tips on Improving Your Hazard Analysis
Date: Wednesday, September 18, 2019
Time: 12pm – 1pm ET
Register for the webinar
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!
- 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.
- CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
- TRUE. 91% got this right.
- Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
- FALSE. 87% answered correctly.
- You must document justification of records not required by a food safety plan in a food operation under FSMA.
- TRUE. Just 44% responded “true”.
- 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!
- 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”.
- Under FSMA supply chain requirements, you must document approved suppliers.
- TRUE. Once again, great job—100% answered correctly!
- 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.
- 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.
- Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
- TRUE. 74% answered correctly.
- Only the personnel of the carriers transporting food product require training and training records.
- FALSE. 96% got this one right.
- Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
- TRUE. 91% answered correctly.
Preparation is the key to success for any ongoing endeavor. In an industry where your enemies are fighting for survival at the expense of your business, you must be ready for anything. Your opponents are crafty, adaptable and more prevalent than you think.
No, I’m not describing your competitors. I’m talking about pests—a major threat to the integrity of food products and a threat to any facility’s bottom line. Whether it’s stored product pests contaminating inventory or rodents spreading pathogens as they skitter across equipment, pests are a risk that should be minimized.
With FSMA in full effect, preparation is more important than ever. FSMA mandates a proactive approach to food safety, and by extension, pest management. It’s important that the pest management program is exhaustive and integrates seamlessly into the overarching food safety plan.
Most, if not all, food processing facilities currently use an integrated pest management (IPM) program to help minimize the chance of pest problems, but FSMA puts more emphasis on being proactive to keep pests far from products at all times. Naturally, this doesn’t mean that a pest sighting in a facility is the end of the world, but it means that it should be resolved quickly, investigated and documented to help prevent such an occurrence from happening again.
Specifically, FSMA has numerous stipulations that trickle down to pest management.
- Hazard analysis. First, a comprehensive inspection should be done to identify the high-risk areas in your facility where pests may take residence. Entry points, potential food and water sources and harborage areas should all be noted.
- Preventive controls. Include regular facility maintenance reviews and a strict sanitation regimen in your food safety plan to help minimize the use of chemical pest management treatments.
- Monitoring. Use devices and employees to keep tabs on pest activity and conducive conditions to ensure preventive controls are working and executed across the facility.
- Corrective actions. Implement and enforce pest management solutions such as exclusion strategies (e.g., weather-stripping, door sweeps, vinyl strip doors), traps (e.g. pheromone traps, insect light traps, bait boxes), air curtains and repellants to help manage pest activity.
- Verification. Schedule regular service visits with your pest management professional to verify corrective actions are working to reduce pest problems over time. These visits should include an annual facility assessment and pest trend analysis, both of which help determine potential areas of improvement over time.
6. Record keeping and documentation. Document every action taken to prevent pests. That includes corrective actions and their results to prove that your written IPM and food safety plan has been implemented and is effective in helping to manage pests at the facility.
With these key components accounted for, it will be easier to be prepared for pests. But, even still, the real-world implementation of these tactics might not be abundantly clear. That being the case, let’s take a look at what food processing facility managers can start doing today to help protect their facilities and demonstrate a proactive approach to food safety.
So, what’s the best way to be more proactive in preventing pests?
Well, that question has a plethora of possible answers, but four of the most important are sanitation, exclusion, staff training and monitoring.
Perhaps the most important of all, sanitation helps to eliminate two key attractants—food and water—that draw pests inside a facility. Any spot where food particles or moisture is collecting, pests will be looking to find.
But sanitation shouldn’t seem daunting. Here are some actions you can start doing today to step up your sanitation program:
- Wipe down equipment regularly to break down the buildup of organic materials.
- Wipe off countertops and sweep floors in common areas where food is present, then sanitize with an organic cleaner afterwards to eliminate any remaining odors.
- Take out the garbage at least daily, and keep dumpsters at least 50 feet away from the building to avoid giving pests a harborage location nearby with an easy path to get indoors. Make sure to cleanse garbage bins and dumpsters regularly, or they’ll become attractive to pests, too!
A big part of preventing pests from getting inside a facility is simply blocking them out using exclusion.
During an inspection, a pest management provider will walk around the interior and exterior of the facility and look for any potential entry points for pests. They should recommend you seal any cracks and crevices they notice, as many pests can fit through extremely tiny gaps. For example, mice can fit through a hole the size of a dime. Gaps should be sealed with a water-resistant sealant to keep pests and moisture out.
In addition, make sure to keep windows and doors closed as much as possible or use screens to block pests. Automatic doors can help in this way, especially when paired with an air curtain to blow flying pests away from entrances. Pests can often come in through the biggest gap of all: The front door!
It’s always better to have a team behind you. Training employees on the basics of an IPM program and what they can do to help will take some of the weight off your shoulders.
Many pest management providers offer free staff training sessions, which can help employees understand what to look for around their work areas and what to do in the case of a pest sighting. Consider creating your own pest sighting protocol to make it clear what employees should do if and when a pest is spotted. They’ll need to record when, where, how many and what kind of pest(s) were seen at the time to give your pest management provider the best chance to create a customized solution to resolve the issue. If you can catch one of the pests in a container for future identification, that’s even better.
While employees can help by keeping an eye out for pests, it’s important to have ongoing monitoring techniques to measure pest activity around the facility.
Monitoring devices are a great way to do this, and your pest management professional can help you place them strategically around the hot spots in your facility. Fly lights, bait stations, pheromone traps and more can capture pests and serve a dual purpose. First, they’ll reduce pest populations around the facility, and, second, they’ll allow you and your pest management provider to see how many pests are present in certain areas.
Over time, this will give you a feel for which pest issues have been resolved and which continue to be a problem. That can determine the corrective actions taken and the long-term food safety plan, which will demonstrate a commitment to constant improvement. That’s a great thing to have on your side, especially when an auditor happens to stop by.
I know, I know—this wasn’t one of the four “answers” listed, but it’s still incredibly important! Documentation helps ensure you get credit for being so prepared.
It’s recommended that facility managers keep a few documents on hand to keep things simple. The food safety plan, annual assessments, sighting reports, a list of service changes over time, a list of monitoring devices and proof of your pest management professional’s certification are all important documents to keep updated and ready to go. That way, you can rest easy knowing you’re prepared at a moment’s notice.
It is never too early to start preparing. Pests aren’t going to stop searching for a food source anytime soon, so don’t stop your proactive efforts to keep them at bay. Your financial department will thank you.
Compliance to FSMA has presented a new and difficult challenge for industry, the public and the FDA since it passed on January 4, 2011. With compliance dates for the initial FSMA rule—Preventive Controls—coming in September 2016, food sites must establish plans now to meet the impending deadline.
Complying with the Preventive Controls Rule
The Preventive Controls Rule was published September 17, 2015, with the compliance date for registered companies (more than 500 employees) scheduled for September 19, 2016. The compliance date is one year later for companies with fewer than 500 employees, unless otherwise specified under FSMA.
Under the FSMA rules, registered food facilities must evaluate and implement preventive control provisions and meet the requirements and the approaching deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.
The following areas are all included under the FSMA Preventive Controls Rule:
- Hazard Analysis. Companies must identify and evaluate known and reasonably foreseeable hazards.
- Preventive Controls. Preventive controls must be implemented to significantly minimize or prevent the occurrence of hazards.
- Monitoring. Preventive controls must be monitored for effectiveness.
- Corrective Actions. Procedures for addressing failures of preventive controls and prevention of affected food from entering commerce are required.
- Verification. Facilities are required to verify that preventive controls, monitoring and corrective actions are adequate.
- Recordkeeping. Records must be kept for two years.
- Written Plan and Documentation. A written plan must document and describe procedures used to comply with requirements.
- Qualified Individual. A Qualified Individual who has been adequately trained must be present at the facility to manage the preventive controls for the site and the products processed and distributed at/from the site.
Failure to implement Preventive Controls (a.k.a., Hazard Analysis and Risk-based Preventive Controls (HARPC)) for qualified sites may result in fines and possible jail sentences.
Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning for FSMA compliance (see Table I). To complete your own planning assessment, review your progress compared to the questions below.
Companies must have their training, planning and development underway to comply, or face possible violations, fines, and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage the preventive controls program—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.
High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.
Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?
FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.
Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:
- Preventive controls
- Inspection and compliance
- Imported food safety
- Enhanced partnerships
I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.
Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.
Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.
Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.
Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.
Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.
The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.
Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.
As we review the general applications and requirements for the first two final rules of FSMA (Preventive Controls for Human Food and Preventive Controls for Animal Food), we’re not seeing a big departure from the proposed preventive controls. But with nearly 1,600 pages of reading, we may not have found all the changes yet. Areas of note include: For the first time in history, training is now a regulatory requirement; and a new definition for a “preventive controls qualified individual” that is separate and distinct from the “qualified individual” under the proposed rule. With further analysis of the rule to come, we fully anticipate the devil to be in the details.
In this first article on the final rules, we are pulling out the key points, providing a general perspective of the Preventive Controls for Human Food, and main elements and compliance dates for both Preventive Controls rules.
The Human Food Rule
FDA has emphasized that it has built more flexibility into key requirements of the Human Food rule, including giving facilities the flexibility to consider the nature of the preventive control, the facility, and the its food safety system when establishing the appropriate preventive control management strategies (e.g. monitoring, verification, validation, corrective action). In addition, the definition of farms, which are exempt from these regulations, has significantly changed to reflect modern farming practices.
The agency views the rule as better protecting public health by adopting a modern, preventive, and risk-based approach to food safety regulation for the future in three key ways:
- It creates new requirements for facilities to establish and implement hazard analysis and risk-based preventive controls for human food.
- It modernizes FDA’s long-standing CGMP regulations, updating, revising, and otherwise clarifying certain CGMP requirements, which were last updated in 1986.
- It clarifies the scope of the exemption for “farms” and makes corresponding revisions to regulations for the establishment, maintenance and availability of records.
The rules generally apply to establishments that are required to register with FDA. Key elements of the rule are as follows:
- Facilities must implement a food safety system that includes an analysis of hazards and risk-based preventive controls, including a written food safety plan that integrates hazard analysis of known or reasonably foreseeable biological, chemical, and physical hazards; preventive controls for processes, food allergens, and sanitation, supply-chain controls and a recall plan; and oversight and management of preventive controls to include monitoring, corrective actions/corrections, and verification.
- The definition of a “farm” is clarified to cover two types of farm operations not subject to the preventive controls rule (however, farms that conduct activities covered by the Produce Safety rule are subject to that rule):
- Primary Production Farm. An operation under one management in one general, but not necessarily contiguous, location devoted to the growing or harvesting of crops, the raising of animals (including seafood), or both. The final rule expands the definition to include facilities that pack or hold raw agricultural commodities grown on a farm under different ownership, and to those that solely harvest crops from farms.
- Secondary Activities Farm. The operation is majority owned by the primary production farm but located separately and is devoted to harvesting, packing and/or holding raw agricultural commodities.
- A flexible supply-chain program with separate compliance dates. In general, a manufacturing/processing facility must implement a risk-based supply chain program for raw materials/ingredients for which it has identified a hazard requiring a supply-chain applied control – unless it or its customer controls the hazard using preventive controls according to the preventive controls rules.
- Updated and clarified Current Good Manufacturing Practices (CGMPs). In addition, some previously nonbinding provisions have become binding rules.
- A new “Qualified Individual” aka the “preventive controls qualified Individual.” This is a more highly qualified position/level in the organization with responsibility to perform the hazard analysis and assign preventive controls, defined under the rule as “a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system.” The qualified individual is based on education/training as applied to the individual’s assigned job duties—with the assumption that each individual will be a “qualified individual” for his/her assigned role.
- Training is a requirement. Foremost is the training required for the preventive controls qualified individual and qualified individuals. Further training may be required under Proposed §117.135(c)(6)–Other Controls, which proposes that preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of §117.135(a).
The Animal Food Rule
In addition to key elements similar to #1–3 of Human Food (above), this rule:
- Establishes CGMPs for animal food production by which facilities that further process a by-product for use as animal food must do so in compliance with CGMPs, but can follow either the human food or animal food CGMPs.
- Does not apply to feed mills associated with fully vertically integrated farming operations that generally meet the definition of a farm. However, because FDA expressed concern that this leaves a food safety gap, it plans to publish a proposed rule in the future to require that some feed mill operations implement the CGMPs established by the Preventive Controls for Animal Food rule.