Tag Archives: compliance
Top Five Questions When Building a Comprehensive Food Safety Plan
Over the last 20 years, I have helped thousands of companies prepare for food safety audits. You can only imagine the plethora of questions that my team and I are asked by the food companies as they build their food safety programs. Many revolve around the basics of building an initial food safety plan. Here are the top five food safety plan questions I am asked regularly that I will address within this article:
- What are the foundations of a good food safety plan?
- Who should be involved in the process of building the food safety plan?
- Can I convert my HACCP Plan into a food safety plan?
- Are there resources and tools available to help build my food safety plan?
- Should I add food safety culture to my food safety plan?
What Are the Foundations of a Good Food Safety Plan?
FDA dictates that a food safety plan is a set of written documents that are based on food safety principles and incorporates:
- Hazard analysis
- Preventive controls
- Supply-chain programs
- Recall plan
- Written procedures to be followed for:
- Corrective actions
- Verification and validation
A food safety plan is developed for every individual facility based on the unique issues at each facility. For example, if a company has multiple processing plants processing the exact same product in multiple areas throughout the country, each facility will need their own unique plan. The reason for that is each facility may have different risks based on process flow layout, equipment used, suppliers and even employee and management cultures.
Each facility will have a separate HACCP plan detailing each chemical, biological and physical risk for the layout of the operation and equipment used. Recall plans will need to be created for each facility’s unique customers. Supplier monitoring will need to be developed for each facility’s unique suppliers.
Who Should be Involved in the Process of Building the Food Safety Plan?
Creating the team to build your food safety plan is one of the most important steps in the process and probably the most overlooked. Most teams I have seen include the QA and/or food safety person, the operations manager and the maintenance manager. This is too limited and often leads to risks being missed and processes that are either too simple or over complicated. A food safety team should have a member from each of the following departments:
- Food Safety/QA
- Crew or shift lead
- Executive management (preferably the CEO)
- A line worker or two
Why the CEO, a shift supervisor and line worker(s)? The CEO creates the company culture and should be funneling information down from the top. If the CEO is part of the team, the whole organization will see the importance of the food safety plan.
Line workers and crew leads are on the floor working the processes day in and out. They will be key to implementation of the plan. As processes are created, the line workers and crew chiefs can provide amazing insight on the processes and reporting tools that will be most effective on the floor. Having this information before implementation will save hours of time and minimize the risk of having to alter processes that don’t work in reality.
Can I Convert my HACCP Plan into a Food Safety Plan?
Many companies have a basic HACCP plan for their facilities. Often the question is, “Isn’t my HACCP plan a food safety plan?” The answer is yes and no. Basically, you can have an HACCP plan and not have a food safety plan, but you cannot have a food safety plan without an HACCP plan.
A food safety plan is more encompassing than an HACCP Plan. Looking at your facility floor plan and analyzing chemical, biological and physical risks is a key part of a food safety plan. The food safety plan adds another layer of monitoring for all risks and provides added processes for preventative controls, recalls and supplier monitoring.
Also, companies that have only an HACCP plan often have not been keeping that plan up to date with an all encompassing team described above. Once the new, more robust teams are created and they start building the food safety plan, many find they need to significantly alter their HACCP plans.
Are There Resources and Tools Available To Help Build My Food Safety Plan?
Luckily, we live in a technical world full of inexpensive or free tools. There are many very smart people that have services available to assist in creating a food safety plan as well. Here is a list of some free and low cost solutions:
- The FDA created a free solution, the “FDA Food Safety Plan Builder.” This solution walks you through the process of creating a food safety plan step-by-step.
- If you need a food safety plan for a specific GFSI Standard, walking through the individual check lists provided by the standards you choose will lead you to the creation of a food safety plan, albeit a very robust one.
- If you do not need full certification, building a food safety plan based on GFSI Global Markets is a great stepping stone and they have a free toolkit.
- There are many software tools that you can purchase. The pricing and features will vary based on the company. Google “Food Safety Plan Software” and you will see the many options available.
- Working with a consultant is a great option if you don’t have the time to learn the process of creating, building and implementing a food safety plan. There are many great and not so great consultants in the industry. If you decide to go this route make sure you interview at least three consultants and ask the following questions:
- “Are you going to coach us on how to own and maintain our food safety program or do you do everything on your own?” Many consultants think they “own” the programs they develop, as if they are proprietary systems. Some will charge you year after year to use their program. Avoid these consultants.
- “How long have you been consulting?”
- “May I talk with a couple of your past clients?” If they are unwilling to provide testimonials that may be a red flag.
Should I Add Food Safety Culture to My Food Safety Plan?
Recently, I wrote an article for FoodSafetyTech.com titled “The Costs Of Food Safety: Correction vs. Prevention,” and the opening sentence is “Every company that grows, produces, packs, processes, distributes and serves food has a food safety culture. In the food industry, when looking at food safety culture there are essentially two groups: The correction and the prevention groups.”
By starting the process of creating a food safety plan, you are already crossing the chasm into the “prevention group.” Adding elements of food safety employee training, recognition and food safety behavior management into your food safety plan and implementing those elements will alter your organization in some of the most positive ways.
Every food company has a food safety culture, some are toxic and others are refreshingly positive. If you have read this article to the end I assume you either have a positive food safety culture or would like to create one. Incorporating key teams members in your planning and taking advantage of the resources available will place you on the path to developing an effective food safety plan and a company culture that embraces food safety.
FDA To Host Industry Webinar on Draft Guidance on Action Levels for Lead in Juice
The U.S. Food & Drug Administration will be hosting a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to discuss the recent draft guidance on lead action levels for juice. The draft guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” issued in April provides action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends.
These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance the FDA’s goals in the Closer to Zero action plan.
During the webinar the FDA will provide an overview of the draft guidance and additional information, as well as answer stakeholder questions.
Featured speakers include Dr. Susan Mayne, director of the Center for Food Safety & Applied Nutrition (CFSAN), Dr. Conrad Choiniere, director of the Office of Analytics and Outreach, CFSAN, and Dr. Paul South, director of Division of Plant Products and Beverages, Office of Food Safety, CFSAN.
To register for the webinar, visit the registration page. The webinar will be recorded and posted to the FDA website.
Quality in the Cloud: 5 Tools to Remedy Food Safety Fears
The food and beverage industry has seen a big push for digital transformation over the past several years. Consumers and regulators alike are demanding increasingly high levels of safety and traceability across the global supply chain—driving food manufacturers to modernize their approach to quality control.
Now, many are looking to retire outdated software or inefficient paper-based systems that limit visibility across their production lines, plants and supply chains. They are exploring modern tools that enable proactive quality and safety monitoring. And fortunately, cloud technology is making this shift easier than ever.
Cloud-based quality management solutions offer simple deployment, rapid scalability and low up-front costs—breaking down many of the barriers to digital transformation. Food manufacturers gain anytime, anywhere access to critical resources needed to maintain product quality, ensure compliance and drive continuous improvement across their organizations.
To make it all possible, food manufacturers should select a cloud-based solution that offers the following features and tools.
1. A centralized data repository for improved visibility, compliance and collaboration
In a traditional manufacturing environment, quality and process data are locked away in paper files, Excel spreadsheets, or on-premises software. These data silos prevent manufacturers from monitoring enterprise-wide quality performance, and inhibit data sharing with external parties across the supply chain.
But the cloud can break down those silos. Cloud solutions provide a single, unified data repository where food manufacturers can standardize and centralize quality data—from all processes, production lines, and sites in their enterprise, as well as from suppliers, co-packers and third-party producers.
The resulting “big picture” view of quality enables food companies to:
- Perform enterprise-wide analyses to pinpoint problem areas, identify best practices, and prioritize resources—ultimately improving quality and compliance across the entire organization.
- Verify ongoing regulatory compliance and enforce accountability for all required checks and tests.
- View supplier data in real time to prevent food safety issues and ensure incoming ingredients meet quality standards before they are ever shipped. Only the highest-quality ingredients get accepted and incorporated into products.
- Monitor supplier performance to better manage suppliers and prevent supply chain disruptions.
- Collaborate with contract manufacturers and packers to make sure they uphold quality standards and protect the brand.
2. Real-time SPC for proactive response on the plant floor
A preventative approach to quality and safety just isn’t possible when using manual methods for data collection and analysis. Operators spend valuable time recording data with a pencil and paper, then sift through page after page of control charts—on top of all their other daily responsibilities. It’s easy to see how mistakes could be made and production issues could be missed.
Quality teams are also at a disadvantage, reviewing old data about products that have already come off the production line. Overall, everyone operates in “firefighting” mode. They try to fix one issue after another, but it’s often already too late. Some problems may not be spotted until final inspection, if even caught at all. Manufacturers end up dealing with defective products, wasted resources, and damaging recalls.
The cloud transforms how food manufacturers collect and analyze quality data. Cloud-based statistical process control (SPC) software can automatically collect measurement values from a variety of data sources, then monitor processes in real time. When the software detects specification or statistical violations, automated alarms instantly alert key personnel. The appropriate teams can take immediate action to correct any issue before it gets out of hand.
In addition, food manufacturers can put up further safeguards on the plant floor with “workflows.” Essentially, these are prescriptive guides for responding to quality issues, predefined in the cloud-based quality solution. They help all employees respond consistently and effectively to specific problems, and then document the corrective actions taken. These responses can then be analyzed across an entire company, allowing manufacturers to spot trends and prevent reoccurring issues.
Ultimately, operators and quality personnel can stay on top of potential problems and prevent unsafe or defective goods from reaching customers—without having to manually monitor every line, in every plant, around the clock.
3. Timed data collections to keep everyone on the same page
Routine sampling and quality checks are critical for food safety and compliance with regulatory and industry-specific standards. But how can manufacturers ensure required checks are completed according to schedule? After all, the plant floor is a busy place and where it’s easy for operators to get sidetracked tackling other issues.
Here, cloud-based quality systems can help. These solutions enable manufacturers to set up timed data collections, which send automated notifications to remind operators when it’s time to perform HACCP, CCP, and other critical quality and safety checks. Operators can stay focused on production, without having to watch the clock or worry about missing a check. Plant supervisors also get alerts if a data collection is missed—no matter where they are working—so they can keep everyone on top of compliance.
4. Digital reporting to make audits a breeze
Every manufacturer dreads the auditing process. It is time consuming and resource intensive, adding another layer of stress and complexity to the already complex nature of food production. Those that rely on paper records and spreadsheets usually struggle to piece together and produce auditor-requested information. And failed audits can have major consequences.
Instead, quality records and other compliance documentation can be digitized, stored and made quickly accessible via the cloud. This makes it easy for food companies to pull historical data for specific timeframes. Reports can be produced in just minutes to complete regulatory, third-party certification, or internal audits—rather than the days or weeks it would typically take to put together a report from a complicated trail of paper.
5. Lot genealogy for improved traceability and recall response
Recalls are another big source of stress for food manufacturers. After all, food quality or safety incidents that result in a recall not only hurt profits and brand reputation, but also put the health and lives of consumers at risk. Fortunately, recalls can be mitigated or avoided through better traceability.
Cloud-based quality solutions can help food companies trace raw ingredient lot codes through the manufacturing process and supply chain. With all quality data stored in that centralized cloud repository mentioned earlier, manufacturers can generate genealogical “trees” showing the relationship between incoming ingredients and outgoing products.
This information in critical for preventing and responding to product recalls. If a safety issue is found within a specific ingredient lot, for example, manufacturers can quickly identify output lots where those ingredients were used. They can prevent those finished lots from being released, or in the worst-case scenario, remove those lots from store shelves in a swift, targeted recall.
A Tactical Approach to Digital Transformation
Looking at the FDA’s New Era of Smarter Food Safety blueprint, it’s clear to see that the industry at large is heading towards a new digital age. Food manufacturers shouldn’t wait to take the first steps, and cloud-based quality can get them on the right path.
While any big change comes with hesitancy, a tactical approach can help ease any fears. Some food manufacturers have started with small-scale projects, deploying cloud-based quality solution to monitor a single process or production line. Leadership teams and employees alike can see how quality in the cloud benefits everyone at all levels of their organization—and then deploy the solution on a wider scale. It is a great way to successfully introduce new digital technology and lay the foundation for future transformation.
FDA Wants to Change Agricultural Water Requirements in Produce Safety Rule
After years of foodborne illness outbreaks that have been suspected to originate in pre-harvest agricultural water, FDA is proposing changes to the FSMA Produce Safety Rule. The proposed rule would revise subpart E, changing certain pre-harvest agricultural water requirements for covered produce other than sprouts.
“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in an agency update. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”
Under the proposed rule, farms would be required to conduct yearly systems-based agricultural water assessments to assess and guide measures that would reduce risks related to pre-harvest agricultural water. According to the FDA, the assessment would consist of evaluating the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land.
With the current agricultural water compliance dates for covered produce other than sprouts set to begin in January 2022, the FDA plans to exercise enforcement discretion for those requirements while also proposing another rule that extends the compliance dates for all agricultural water requirements under the Produce Safety Rule.
The full details of the FSMA Proposed Rule on Agricultural Water are available on FDA’s website.
It’s Official: FDA Designates New Webpage to Food Fraud
Food fraud has become such an important issue that many governments are monitoring it much more closely. To keep producers and consumers informed on the latest developments, the FDA has generated a new web page on economically motivated adulteration (EMA). The page includes links on how to report food fraud (including a list of consumer complaint coordinators), important examples of adulteration (i.e., honey, olive oil and seafood), how food fraud is detected and monitored, enforcement and legal consequences such as recalls, seizures and import refusals, guidance documents to assist manufacturers and importers, and a list of import alerts.
- FDA. (November 4, 2021). “Economically Motivated Adulteration (Food Fraud)”.
Digital Transformation of EMP: Best Practices and Outcomes for Food Manufacturers
In today’s digital-first world, it might be surprising for those outside of the food manufacturing industry to learn that paper and pen are still considered state-of-the-art documentation tools. Answering food safety and quality questions such as: “What was the underlying cause of this customer complaint?” or “What caused the production halt this morning?” still require hours of research across paper documents, emails and spreadsheets. Maybe even the odd phone call or text message.
The good news is that many food safety and quality problems can be solved by leveraging modern-day technology. The challenge is taking that first step. By applying the following best practices, organizations can take small steps that lead to substantial benefits, including optimized food safety and quality programs, happier employees and safer operations.
Digital Transformation Best Practices
What if all the information food safety professionals require could be accessible through one unified interface and could proactively point to actions that should be taken? It can, with the right mindset and the right strategy.
While there is no “flip of a switch” to become digitally empowered, best practices exist for where to start. And, early adopters are injecting innovation into food safety programs with simple, but powerful technology.
Too often, food safety professionals push forward on a path to digital transformation by evaluating software and business applications against features and/or cost. But before taking this approach, it is important to look at existing food safety programs, identify where incremental improvements can be made and determine the potential return on a new technology investment.
Self-awareness is a beneficial leadership skill, but it’s also the key driver in understanding an organization’s business needs for food safety. Food safety professionals need to get real about common pain points, such as inconsistent or insufficient data, non-standardized practices, and delayed reporting. This is not the time to gloss over problems with processes or tools. Only by clearly documenting the challenges upfront will organizations be able to find the best solutions.
As one example, a common pain point is managing different formats and timing of reporting across facilities. See if this sounds familiar: “Well, Dallas sends an Excel spreadsheet every week, but Toledo only sends it on a monthly basis, while Wichita sends it monthly most of the time, but it’s never in the same format.”
Start out by identifying similar problems to help define the business objective, which will help determine how technology can be most effectively applied.
Eat, Sleep, Food Safety, Repeat
Food safety processes should constantly evolve to enable continued improvements in food safety outcomes. With that in mind, it’s helpful to dust off the corporate SOP and review it, especially if an organization is moving to a digital program. A common mistake many food manufacturers make is asking technology providers to configure an application based solely off the corporate protocol, only to discover at go-live that users don’t follow that protocol.
To avoid this situation, consider the following questions:
- Why are food safety professionals not completing processes by the book?
- Is that similar with every site?
- Why has it been that way for so long?
- Why did food safety professionals start to stray?
By locking down processes and identifying the desired way forward, leaders can configure a new application with the latest information and updated decisions. At a minimum, this step will help identify current issues that should be addressed, which can become measurable goals for the use of the new technology, ideally emphasizing the most pressing problems.
Less is More
Digital transformation doesn’t always need to become a “fix-all” project. Instead, it may revolve around a single operational initiative or business decision. For example, food safety professionals often maintain a spreadsheet with usernames and passwords for countless applications, some of which overlap in functionality and/or require a separate login for each facility. This is not only a safety concern, it’s an easy entry point when moving to a digital approach.
Consolidation of applications is a natural step from the standpoint of feasibility and fiscal responsibility. So, look for digital transformation opportunities that result in fewer applications and more consolidation.
Don’t Rush It
While digital transformation is inevitable, Rome wasn’t built in a day and neither should be an organization’s digital strategy. Unfortunately, the decision to go digital is often made, and a go-live date chosen, before determining what transformation requires, which is a clear-cut recipe for failure.
Technical vendors should play a key role in developing an effective implementation strategy, including sharing onboarding, planning, configuration and go-live best practices.
While technology is here to help the world become smarter about food safety, it is not here to replace human experience. Food safety leaders should continue to augment processes through supplemental technologies, rather than view technology as a full takeover of current approaches.
Barriers to entry for digital transformation are being lowered, as the ease of adoption of the underlying technologies continues to advance and access via cloud-based applications improves.
What to Do With All This Data? 5 Outcomes Food Manufacturers Can Achieve
Food manufacturers have benefited from digitally transforming environmental monitoring programs (EMPs) using workflow and analytics tools in a variety of ways. In the end, what matters is that the resulting data access and usability enables new insights and accelerates decisions that result in reduced risk and improved quality. Keep in mind these key outcomes that food manufacturers can achieve from digital transformation.
Outcome #1: Formalized Audit & Compliance Readiness
Enhancing an internal audit framework with digital tools will greatly reduce the burden of ensuring compliance for schemes such as BRC, SQF and FSSC food safety standards. Flexible report formats and filtering capabilities empower users with the right information at the right time.
Imagine, no more sifting manually through binders of CoA’s and test records to find a needle in a haystack. Exposing teams to a digital means of performing internal audits will not only boost confidence to handle requests from an auditor but will also help drive continuous improvement by providing easier access to insights about the effectiveness of internal policies. At the same time, digital tools will help ensure that only the required information is shared, reducing confusion and uncertainty as well as audit time and cost.
Outcome #2: Proactive Alerting and Automated Reporting
Threshold-based report alerts are an excellent way to reduce the noise often associated with notification systems. Providing quality and safety managers with automated alerts of scheduled maintenance or pending test counts can help them focus on activities that need attention, without distractions.
The benefit of threshold-based reporting is that it is a “set it and forget it” method. While regular “Monday Reports” are still a necessity, alerts and reports can be generated only when attention is needed for anomalies. A great example of this is being able to set proactive alerts for test counts in a facility that are approaching nonconformance levels. Understanding the corrective action requirements needed to control an environmental issue before it impacts quality, production and unplanned sanitation measures is a critical component of risk management and brand protection. In addition, reports can be automatically generated and delivered on a regular schedule to help meet reporting needs without spending time collecting data.
In other words—imagine a world where data comes and finds users when needed, rather than having to search for it in a binder or spreadsheet. Digital tools can provide email reports showing that a threshold has (or has not) been met and link the user directly to the information needed to take action. This is called “actionable information” and is something to consider when deploying technology within an organization’s food safety program processes.
Outcome #3: Optimize Performance with Tracking, Trending and Drilling
The Pareto Principle specifies that for many outcomes, about 80% of consequences come from 20% of causes. Historical data that is digitized can be used to quickly identify the root cause of top failures in a facility in order to drive process improvements. Knowing where to invest money will help avoid the cost of failure and aid in the prevention of a recall situation.
Dashboards are a powerful tool that organizations can use to understand the risk level across facilities to make better, data-driven decisions. Reports can be configured through a thoughtful dashboard setup that enables users to easily identify hot spots and trends, drill down to specific test locations, and enable clear communication to stakeholders. Figure 1 provides an example of a heat map that can be used to speed response and take corrective actions when needed.
Outcome #4: Simplified Data Governance and Interoperability
Smarter food safety will drive standardization of data formats, which allows information to flow seamlessly between internal and external systems. One of the major benefits of shifting away from paper-based solutions is the ability to be proactive to reduce risk and cost. FSQA managers, within and across facilities, can benefit from a 360-degree operational view that reveals hidden connections between information silos that exist in the plant and across the organization. This includes:
- Product tracing through product testing to environment monitoring and sanitation efforts
- Tracing back a product quality issue reported from a customer to the sanitation efforts
- Understanding why compliance is on track but quality results aren’t correcting
Outcome #5: Reduce the Cost of High Turnover
Successful GMPs, SSOPs and a HACCP program require leaders that continually ensure that employees are properly trained, which can be difficult with high turnover rates. To address this challenge, digital tools can aid in providing easily accessible documentation to empower users and reduce the cost, time and risk associated with having to re-train new employees on the EMP process. While training cannot be replaced with technology, it can be accelerated.
For example, testing locations within facilities can be documented with images and related information enabling new employees to visually see the floorplan and relevant testing protocols with accompanying video and click-through visualization of underlying data. Additionally, corrective action protocols can be enhanced with videos and standardized form inputs to ensure proper data is being collected at all times.
The Path Ahead
As the digital transformation of the food safety industry continues, food manufacturers should seek out and apply proven best practices to make the process as efficient and effective for their organization as possible. By avoiding common pitfalls, companies can achieve transformation objectives and realize substantial benefits from more easily accessible and actionable food safety data.
CEA Food Safety Coalition Establishes First Food Safety Certification for Leafy Greens Grown Indoors
Last week the CEA Food Safety Coalition announced the first food safety certification program for leafy greens grown indoors. The food safety addendum intends to address the distinct attributes of controlled environment agriculture (CEA) as it relates to leafy greens and is a certification in addition to demonstrating GFSI compliance.
“Current food safety standards were written for the field, and many do not address the unique attributes of controlled, indoor environments,” said Marni Karlin, executive director of the Coalition in a press release. “This new certification process and the accompanying on-pack seal helps to unify CEA growers while also differentiating them from traditional field agriculture. It also better informs consumers and provides a quick-glance image to know when produce has been grown safely indoors, with a high standard of quality and without some of the hazards of the field, such as potential contamination from animal byproducts.”
CEA is a technology-forward method that establishes optimal growing conditions in controlled environments such as greenhouses and indoor vertical farms. The certification program is for CEA FSC members (at a cost) and is completed annually. It assesses CEA grower sites in the four main areas:
- Hazard analysis.: Including use of water, nutrients, growing media, seeds, inputs and site control.
- Water use. Any contact with the plant and food contact surfaces, along with the use of recirculating water.
- Site control, infrastructure and system design. Including direct and adjacent food contact surfaces, and physical hazards such as lighting, robotics, sensors, and equipment.
- Pesticide and herbicide use and testing during the plant lifecycle.
California Proposition 65: Every Company Should Know Their Risk
Known officially as The California Safe Drinking Water and Toxic Enforcement Act of 1986, California Proposition 65 reaches far beyond state boundaries and has potential regulatory implications for almost any company that manufactures, imports, and / or sells products containing listed chemicals in the state. California Prop 65 prohibits the sale of a product in California that knowingly and intentionally exposes an individual to a California Office of Environmental Health Hazard Assessment (OEHHA) listed chemical without a specific stated warning. For many food and supplement companies, the risk of opportunistic litigation based on California Prop 65 drives the need to monitor updates, new amendments and enforcement of the law.
Prop 65 Background
California Proposition 65, also known by the shortened name Prop 65, is not a ban on products or ingredients. The law is intended to inform consumers in California about exposure to a list of chemicals exceeding a defined level in products for sale, including product packaging. The regulation mandates a warning label for exposure to chemicals at a level that could cause cancer, birth defects or other reproductive harm. Guidance for upper limits (“Safe Harbor Level”) on chemicals is based on expected daily exposure. If no Safe Harbor Level exists for a chemical, the product containing a listed chemical must include a warning, unless the exposure level can be proven to not pose a significant risk of causing harm.
With the size of the California economy and the interconnected U.S. supply chain, the state law effectively reaches other states and U.S. importers. More recently, the Prop 65 requirements impact online and catalog sales, which have increased significantly during the global pandemic.
Know Your Suppliers
All companies need to proactively evaluate and document Prop 65 risks. Enforcement occurs primarily through civil litigation, resulting in specialized legal firms profiting from a company’s ignorance of the law’s extent. Even the threat of publicity from a lawsuit can cause targeted companies to settle a case.
At each point of manufacturing and distribution—supplier, manufacturer, packager, importer or distributor—regulatory teams should ask about Prop 65 compliance. The main point of responsibility is at the manufacturer, but a retailer can also be obligated for introducing a chemical at point-of-sale.
What’s New with Prop 65
The OEHHA issues notices regarding amendments to the California Code of Regulations Title 27, Article 6, covering “Clear and Reasonable Warnings”. Recently the OEHHA requested public comments on proposed amendments that would modify the content and methods for providing “short-form” warnings. The short form was originally intended for products with restricted label space.
The proposed rule would modify the existing short-form warning provisions to:
- Only allow use of the short-form warning on products with five square inches or less of label space.
- Eliminate use of short-form warnings for products sold via the Internet and catalogs.
- Clarify how short-form warnings can be used for food products.
- Require the name of at least one chemical be included in the short-form warning.
Bottomline: Know Your Business and Risk
As an advisor with more than 20 years of regulatory compliance experience in food and food ingredients, my guidance for business best practice on Prop 65 is to be proactive, maintain supply chain knowledge, and understand risk. Regulatory or legal staff, or consultant teams specializing in Prop 65, should regularly monitor for additions to the chemical list and rulemaking changes to the far-reaching law.
Our Petition to USDA: The Time for Change Is Now
On January 25, 2021 Stop Foodborne Illness (STOP), in collaboration with Center for Science in the Public Interest, Consumer Reports, Consumer Federation of America and five STOP constituent advocates filed a petition with USDA Food Safety Inspection Service (FSIS) to reform and modernize poultry inspections. The goal of these reforms is to reduce the incidence of Salmonella and Campylobacter contamination in raw poultry thus drastically decreasing foodborne illnesses due to these pathogens.
According to the CDC, in 2019, these two pathogens combined were responsible for more than 70% of foodborne illnesses in the United States. As Mike Taylor, former FDA Deputy Commissioner for Foods and Veterinary Medicine, shares in his
Op-Ed, the time for change is now as the current regulatory framework is inadequate and has not delivered the desired results of reducing Salmonella and Campylobacter outbreaks.
Today, the USDA’s mark of inspection is stamped on poultry, although birds may exceed the performance standards; there are no clear consequences for establishments that do not meet the current guidelines. Without science-based standards or penalties for non-compliance, the burden of this problem falls upon consumers.
At STOP, we share the voices of consumers whose lives have been altered due to preventable problems such as this. Our constituent advocates share their journeys through severe foodborne illness to share the WHY of food safety. Real people, real lives are impacted when we do not demand action. STOP board member, Amanda Craten, shares her son Noah’s story:
“My toddler suddenly came down with a fever and diarrhea, but it wasn’t until weeks later that I learned that his symptoms, which nearly killed him, were caused by a multi-drug resistant strain of Salmonella.
After being admitted to the hospital, his doctors found abscesses in the front of his brain caused by infection and they were creating pressure on his brain. He underwent surgery and weeks of antibiotic treatments.
My 18-month son was seriously injured and permanently disabled as a result of Salmonella-contaminated chicken.” – Amanda Craten.
Unfortunately, Noah’s story is not rare, which is why Amanda supports this petition for change and has provided a powerful video about Noah’s foodborne disease journey and his life now.
Because there are too many stories like Noah’s, STOP and its partner consumer advocacy organizations want to work with FSIS and industry to:
- Develop real benchmarks that focus on reduction of known, harmful pathogens in poultry
- Modernize standards to reflect current science
- Implement on-farm control measures
- Re-envision the standards to focus on the risk to public health
As a new administration begins, capitalizing on this opportunity to modernize poultry inspection that can benefit consumers and the food industry makes sense. STOP and its partners are hopeful that leadership at USDA/FSIS will take this opportunity to create consequential and relevant change. Ultimately, this transformation will reduce the incidence of foodborne illness due to contamination of poultry and increase consumer confidence in the USDA’s mark of inspection. Please comment on this petition.
Have you been impacted by foodborne illness? Tell STOP Foodborne Illness about it.