Tag Archives: compliance

FDA

Routine Produce Inspections to Start in Spring, FDA Offering Compliance Support

By Food Safety Tech Staff
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FDA

After FDA delayed product inspections under FSMA to further prepare industry and ensure there was enough training and education, the agency is reminding farmers and other stakeholders in the produce industry that there are resources available to help them in preparing for the routine inspections—for large farms, these will start in the spring. The inspections will be conducted to verify compliance with the Produce Safety rule.

Resources include the FDA’s produce safety inspections page on its website to serve as a central resource for industry and state partners during the inspection preparation process and the draft guidance, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”.

An FDA Voices blog by FDA Commissioner Scott Gottlieb, M.D., Deputy Commissioner for Food Policy and Response Frank Yiannas and Associate Commissioner of Regulatory Affairs Melinda Plaisier also discussed how the agency has been supporting industry work to comply with the rule, including:

  • Granting 46 states and one territory with more than $85 million through the State Produce Implementation Cooperative Agreement Program to aid in the development of state produce safety systems that offer education, outreach and technical assistance
  • With partners, supporting the training of more than 31,000 produce farmers globally on the Produce Safety rule requirements
  • The sharing of expertise via the FDA’s Produce Safety Network
  • With partners, the creation of a new inspection form that gives farms feedback and observations that occurred during the inspection, regardless of whether non-compliance issues were found, in an effort to help explain what they’re looking at and how observations apply to the produce rule
Food Safety Tech

Call for Abstracts: Be a Part of the 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Food Safety Tech

The supply chain is a potentially weak and vulnerable part of a company’s food safety plan. The annual Food Safety Supply Chain Conference is months away and we are accepting abstracts for presentations. The conference takes place May 29–30, 2019 in Rockville, MD.

If you have expertise in the following areas, we invite you to submit an abstract to present at the conference:

  • Food Safety Supply Chain Vulnerabilities & Solutions
  • Audits & Inspections
  • How to Write Supplier Specifications
  • Blockchain Technology
  • FSMA’s Sanitary Transportation Compliance Tools & Techniques
  • Supply Chain Traceability
  • FSMA’s FSVP Compliance Tools & Best Practices
  • Data, Predictive Analysis
  • Recalls: barcode labeling, case histories and lessons learned
  • Testing Strategies of the Supply Chain
  • Supplier Verification Best Practices
  • Supply Chain Risk Management
  • Food Safety Transportation, Distribution and Logistics
  • Food Authenticity
  • Food Safety/Quality Culture measurement in supplier management
  • Supplier Management Case Histories

Each abstract will be judged based on educational merit. The submission deadline is February 8, 2019.

Rizepoint Exhibiting at #2018FSC: A Better Supplier Quality Management Solution

RizePoint, a leading provider of brand, quality, and safety management software (QMS), will be exhibiting at Food Safety Consortium (FSC) in Chicago from November 13–15, 2018.

FSC is the first event where the company is demonstrating the new functionality for frictionless supplier onboarding and upgraded supplier quality management (SQM). This product enhancement helps managers in any industry onboard, track, and communicate with suppliers and vendors to help ensure regulatory and company standards compliance. Demonstrations will take place in booth 121 during exhibition hours.

“This expanded supplier quality solution further demonstrates RizePoint’s commitment to foster brand protection. We have enhanced the supplier onboarding experience, improved communication with suppliers, and made tracking compliance documents simple and easy.” – Frank Maylett, RizePoint

The update to the RizePoint enterprise compliance SaaS solution also includes:

  • Creating clear and simple onboarding workflows
  • Configuring forms and surveys based on your specific business needs
  • Building reports and dashboards that help you see into the health of supplier compliance
  • Setting due dates with automated alerts for expiring qualifying documents
  • Automating CAPA with triggered alerts and communications

About RizePoint

RizePoint offers a robust software solution that helps companies keep brand promises through their quality and compliance efforts. Our customers gather better data, see necessary actions earlier, and act faster to correct issues before they become costly liabilities. Considered the industry standard for food service, hospitality, and retail, RizePoint mobile and cloud-based solutions serve millions of audits every year. RizePoint is headquartered in Salt Lake City, Utah. For more information, visit RizePoint.com.

About Food Safety Consortium

The Food Safety Consortium is a premier educational and networking event for food safety solutions. Attracting the most influential minds in Food Safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore five diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. Learn more about FSC at http://foodsafetyconsortium.net/.

Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection
FST Soapbox

The True Costs You Endure During a Food Recall

By Michael Koeris, Ph.D.
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Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection

When you think about the expense of a recall, you probably automatically focus on the costs to pull the affected product from shelves and reimburse customers. Yes, this can be an expensive undertaking. But the true, comprehensive cost of a recall involves immensely more than these obvious financial tolls. Do you fully understand the price to be paid when your organization is up against a food recall?

The recall process in the food manufacturing industry is a highly expensive one, averaging more than $10 million in costs to cover activities such as communicating the recall across the supply chain, retrieving and handling the recalled product, investigating the event and implementing corrective actions to prevent reoccurrence.

Of course, this average doesn’t address the possibility of litigation costs, decreased sales, reputational damage or brand crisis management, which can add up to millions—even billions— of dollars more. The public has become much more informed and aware of food safety events, and a single breach of trust could result in resounding losses to your brand. This makes it critical to understand the true costs you endure when faced with a food recall.

Immediate, Direct Costs

A recall can be a company-defining event. The vast majority of recalls are voluntary and a reflection of conscientious behavior by the retailers, wholesalers and producers, but that doesn’t mean you won’t incur serious expenses. The most obvious, immediate and direct ones include:

  • Pausing production to carry out recall response initiatives
  • Alerting necessary parties within and outside the organization, including regulatory agencies and relevant retailers
  • Managing the logistics of removing affected or mislabeled products
  • Examining the source of the recall, including issues with suppliers, equipment, processes or contamination prevention plans
  • Remediating the identified problems to prevent similar occurrences
  • Planning for expanded human resources to handle recall tasks in addition to routine operations

Again, these expenses could equate to millions of dollars from your bottom line, but the truth is they may be the most minor of your concerns in the face of a food recall.

Compliance Penalties

As you likely know by now, there’s a monumental shift happening in the regulatory arena. FSMA has enacted strict laws that place a greater emphasis on proactive and preventive approaches to food safety. In addition, the USDA has been focusing on strong enforcement of its guidelines for years.

For manufacturers, this means adjusting processes and procedures to comply with legal requirements for monitoring, testing, documentation, risk assessment and more. It is not enough for companies to have a plan for taking corrective action on contaminated products; they must also have a strong preventive plan in place to identify pathogens in the production environment before they affect the product and/or leave the facility. If your company undergoes an FDA or USDA audit or investigation that reveals noncompliance with government-mandated prevention efforts, you could be looking at significant consequences like criminal fines and forfeitures to the U.S. government.

FSMA laws and USDA regulations stipulate that depending on the nature of the violation, and whether the food is adulterated or misbranded, the FDA or USDA may consider regulatory actions, including:

  • Issuing advisory letters
  • Initiating court actions, such as seizure or injunction
  • Implementing administrative detention to gain control of adulterated or misbranded products
  • Mandating a recall of violative food
  • Suspending a facility’s food registration to prevent the shipment of food

Lawsuits and Litigation

According to the CDC, 48 million people get sick from foodborne illness each year, 128,000 are hospitalized and 3,000 die. If your organization is sued on the basis of a contaminated or unsafe product, you can expect to deal with attorney fees, court costs and settlements. In the worst cases, you may even need to pay damages to harmed consumers.

Yes, prosecutions are rare. But they are a reflection of a failure to protect consumers, as well as potential negligence or (in the rarest of cases) malicious intent. The financial effects of these reputational scars go well beyond obvious litigation expenses.

Lost Sales

Once a recall is ordered, a series of actions unfold that drastically impact your income. Manufacturers halt production, and retailers pull products from their shelves. Worse, a loss in consumer trust can initiate a long-lasting sales depression. Your customers want to know that the products they’re buying are safe. In response to a recall, they may change their purchasing, food preparation and consumption practices, or they may avoid the product for months or years after the recall has ended.

Insurance Impacts

Most food companies have recall insurance to protect their assets if a recall occurs. But, are you fully informed on what it means to work through a recall with your underwriter or how a recall affects your premiums? Is there a possibility of losing your insurance? It’s crucial to understand how your insurance is affected by a recall and what is contractually covered under your plan.

Brand Deterioration

Recalls are happening more frequently today than ever before, for reasons including stricter compliance regulations and supercharged government testing regimes using novel technologies like next-generation sequencing. This increased focus on testing by the government has led to a greater discovery rate of contamination, which is a good thing for the public. It means that improvements will be made to yield an even safer food production environment.

Nonetheless, recalls are alarming to your customers, and the last thing you want to risk is their trust in your brand. At the end of the day, your brand is your primary asset. It is a representation of who you are and how you do business. When recalls happen, customers lose faith in your brand, which comes with a hefty price tag for your company. If your brand deteriorates due to consumer mistrust, you’re risking business failure.

Unfortunately for the food industry, stories exposing scandals are a proven way to catch the public’s eye. Therefore, any news of a recall receives immediate and aggressive media coverage from both traditional and social media platforms. In the event of a recall, publicity is inevitable, and it’s an expense that spans every aspect from public relations management to eroded sales.

Prop 65 label

California Proposition 65 To Impact Food Labels

By Nick Recht
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Prop 65 label

The fast-approaching August 30th deadline for California’s Proposition 65 has food manufacturers of all sizes working to make sure affected labels comply with the new labeling requirements. According to the California Office of Environmental Health Hazard Assessment (OEHHA), Proposition 65:

“…requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. These chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals.”

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act, is intended to help better equip Californians to make informed decisions about the products they purchase. The OEHHA is responsible for determining which chemicals meet the legal and scientific requirements for inclusion on the Proposition 65 list, a list which has grown to more than 900 chemicals since it was originally published in 1987.

The new law will be enforced by the California Attorney General’s Office as well as any district attorney or city attorney for cities whose population exceeds 750,000. Individuals acting in the public’s interest may also seek to enforce Proposition 65 by filing a lawsuit against companies alleged to be in violation. Companies that are found to be in violation may be fined as high as $2,500 per violation per day.

To ensure compliance with the new law, food manufacturers must reference the list of included chemicals to determine which of their products, if any, are impacted. Manufacturers must then provide “clear and reasonable warnings” that chemicals used in the production of their goods or products sold in California are known to cause cancer, birth defects and/or other reproductive harm. The ruling impacts goods sold in California as well as those sold via catalog or the internet.

Proposition 65 underscores the importance of an agile labeling environment for food manufacturers, particularly as it relates to their ability to adjust labels prior to compliance deadlines. It also implores manufacturers to look to automation to reduce the room for human error. For example, labeling software can be leveraged to create a table look up so if an impacted ingredient is included in a product and printed on a label, the required warning statement is also automatically included on the label.

Leveraging a database connection to apply such warnings can help businesses mitigate risk, as failing to include a required warning could result in fines, business disruption and lost revenue. It is also important to note that compliance with Proposition 65 will require food manufacturers to stay up to date on changes, as new chemicals may be added and/or revisions to law may continue to occur. Food retailers must also stay abreast of labeling changes required by Proposition 65 to ensure the products they sell are in compliance. Learn more about Proposition 65 at the OEHHA’s official website: https://www.p65warnings.ca.gov.

Prop 65 label
Label design products can help a company add a warning statement to a current label. Image courtesy of TEKLYNX.
Question mark

Return of FSMA IQ Test: Part IV

By Food Safety Tech Staff
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Question mark

Two years ago, Food Safety Tech published a series of six FSMA IQ tests to “test” industry’s knowledge about FSMA. It seemed appropriate, as at that point in time, folks still had a lot of unanswered questions. Now that we have a couple of years under our belt, how much to we know? We will publish each section of the test every week for the next six weeks. Then at this year’s Food Safety Consortium, the creators of the test–Bill Bremer, principal of food safety compliance at Kestrel Management, LLC and his team–will compare 2016 vs. 2018 during an interactive session. And if you have questions or comments on any of the elements brought up in the IQ test, please include them comments section below the test, so Bremer’s team can address them either live on our site or during the Consortium session.

Take Part III here.

Create your own user feedback survey

Question mark

Return of FSMA IQ Test: Part II

By Food Safety Tech Staff
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Question mark

Two years ago, Food Safety Tech published a series of six FSMA IQ tests to “test” industry’s knowledge about FSMA. It seemed appropriate, as at that point in time, folks still had a lot of unanswered questions. Now that we have a couple of years under our belt, how much to we know? We will publish each section of the test every week for the next six weeks. Then at this year’s Food Safety Consortium, the creators of the test–Bill Bremer, principal of food safety compliance at Kestrel Management, LLC and his team–will compare 2016 vs. 2018 during an interactive session. And if you have questions or comments on any of the elements brought up in the IQ test, please include them comments section below the test, so Bremer’s team can address them either live on our site or during the Consortium session.

Take Part I here. 

Create your own user feedback survey

2018 Food Safety Supply Chain Conference, Blockchain

Beyond Supply Chain Trends: Blockchain, FSMA, Food Fraud, Audits and More

By Maria Fontanazza
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2018 Food Safety Supply Chain Conference, Blockchain
Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew Seaborn Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA

How well do you know your suppliers? Can you trust your supplier’s suppliers? What kind of technology are you using to assess and ensure your suppliers are in compliance with regulatory requirements? These are common questions food companies must ask themselves on a regular basis. These and more were addressed at the 2018 Food Safety Supply Chain Conference, held last week at USP in Rockville, MD. Stay tuned for coverage of the event in upcoming articles. In the meantime, here are some top insights shared by FDA and others in industry.

“We’ve issued a limited number of warning letters (two), and they were due to really egregious issues. Where there were previously warning letters issued, we’re seeing a lot more ‘regulatory meetings’.” – Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN, on FDA’s enforcement this fiscal year.

Criteria for FSMA auditors also includes the “soft skills”, aka ISO 19011, auditor personal attributes. –Josh Grauso, Senior Manager, Food Safety & Quality System Audits, UL

Fabien Robert, Nestle 2018 Food Safety Supply Chain Conference
Food fraud costs the industry up to $15 billion annually. – Fabien Robert, Ph.D., Director, Nestle Zone America

It’s concerning that so many QA managers (and other pros) today don’t know extent of risk assessment they need to carry out. – Chris Domenico, Safefood360, Territory Manager for North America

“Blockchain is more than a buzzword at the moment.”- Simon Batters, Vice President of Technology Solutions, Lloyd’s Register

2018 Food Safety Supply Chain Conference, Blockchain
A dynamic panel about blockchain, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV Business Assurance; Simon Batters,Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Sometimes food safety doesn’t win; sometimes you need the business acumen to show that implementing supply chain efficiencies will create the win. – Gina Kramer, Executive Director, Savour Food Safety International

Bryan Cohn, 2018 Food Safety Supply Chain Conference
Building a robust & smart supply chain = reduce food miles, shrink carbon footprint, and save food waste to increase revenue/acre. – Bryan Cohn, Vice President of Operations, Seal the Seasons

The FSMA Sanitary transportation rule is not as straightforward as you think. We need more training. – Cathy Crawford, President, HACCP Consulting Group

Steven Burton, Icicle Technologies
FST Soapbox

Automation Is Happening—Don’t Miss The Boat

By Steven Burton
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Steven Burton, Icicle Technologies

Successful businesses move fast. They stay ahead of their competition by keeping their eye on the newest and most innovative emerging technologies. Failure to embrace the newest, fastest means of production and communication allows other businesses to muscle ahead of slow-to-change competitors, especially in the food industry. This is why embracing automation—even if it requires a commitment from you and your whole organization — is absolutely necessary for every food company.

Guarantee Growth and Compliance with the Internet of Things

The innovation at the forefront of automation technology is the Internet of Things (IoT): Multiple devices interconnected to monitor, communicate and control in real time. Today, a farmer can monitor a crop located in Australia from North America. Ingredients from anywhere in the world can be brought together in a matter of days and distributed just as quickly. Agricultural robots that reduce the risk of contamination and food safety expectations have risen as a result. As exciting as it is to be a part of a constantly innovating food industry, it’s also becoming more challenging to keep up and adapt.

It’s also becoming more necessary. Regulatory agencies are working to keep pace with technological innovations. The standards of food safety—more global than ever—have grown in complexity and will continue to grow as improved, real-time monitoring of products and facilities extends into every type and size of food production company. Properly planned and applied food safety programs are vital to ensuring that globally sourced ingredients and production facilities adhere to regulations to avoid the consequences of failed audits and expensive recalls.

Even for those on top of their regulatory requirements, IoT and other automation technologies are friends, not foes. Automation means that preparation for audits and inspections is reduced to bare minimum, eliminating the need for binders, spreadsheets and months of prep work. Furthermore, one of the greatest challenges of today’s food chain is ensuring not only your own compliance, but the compliance of your vendors. Dealing with hundreds or thousands of incoming ingredients and other materials at any given time is a massive undertaking, let alone dealing with vendor certifications. Integrated, automated systems for food production management streamlines processes and communication and reduces the risk of error and recall throughout the supply chain.

Don’t Be Paralyzed by the F-word: Fear

It is clear to see that staying competitive and staying in business in an interconnected world is possible only if the newest technology is embraced. Why are some companies reluctant to adapt, even when they know it is crucial to a successful future?

Some fear that their managers and employees may not adapt, that their functioning programs already in place may be interrupted, and that ever-present fear of a price tag.

To alleviate these fears and embrace the power of the future, it is vital that the company’s new automation and IoT utilize a software that is:

  • User-friendly so that employees, new or existing, can hit the ground running
  • Capable of building upon an existing food safety program and continue its success
  • Able to improve existing food safety programs to ensure updated compliance
  • Cost-effective and a good business decision when compared to the cost of manpower and recalls

One of the most common reasons a company chooses not to implement a new technology concerns the last point: Cost. To maximize the benefit of automation and IoT, expenses like laptops, tablets and phones are advisable in addition to software. The cost of the software itself when there is a paper or spreadsheet system that is working may seem unnecessary—after all, why buy a telephone when the telegrams are working just fine? In the high-speed world we now live in, a low-speed business approach is fatal.

There is good news when it comes to automation adoption: In response to the growing need for technology and the reluctance of companies to take on the expense, new incentives are being put in place in order support businesses and keep a country’s economy competitive. For example, the U.S. Tax Cuts and Job Act of 2017 allow write-offs of new automation technology in the first year of purchase, vastly reducing the initial cost impact of implementing automation technologies. Many state and provincial governments provide grants for updating technology to improve safety and traceability.

Automation Will Feed the World

Technology and automation in agriculture and food production make a company competitive, but it is also an unavoidable requirement going forward. Looking at the big picture, it’s also necessary to meet the demands of a booming global population. Food is, in many ways, the most essential industry to human life.

In The Future of Food: Food Production, Innovation, and Technology, authors David B. Schmidt and Kimberly Reed say it clearly:

“Each U.S. farmer feeds more people worldwide than ever before, at 155 people per farmer. In 1960, that number was 25.8 people. By 2050, the same farmer will need to feed 232 people… With finite resources, it will take innovation and a variety of technologies to meet the world’s food demand. This includes using new technologies. At every step of the journey from farm to fork, technology is helping us produce a safe, abundant, sustainable, and nutritious food supply.”

It took centuries for the writing of letters to be replaced by telegrams. It took only 130 years from the invention of telegrams to the use of email. A farmer with a shovel is now a robot, with the agricultural robot market expected to increase by more than fivefold to $12.8 billion over six years. 94% of packaging operations use robotic technology today. A recent survey found that half of food companies interviewed plan to increase their use of automation in the next two years.

Where will food production be in 2020? And where will your company be in that near future?

Randy Fields, Repositrak
FST Soapbox

Technology’s Role In The Future Of Food Safety

By Randy Fields
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Randy Fields, Repositrak

As we have all read in the media, when a food safety emergency occurs, a company’s reputation stands to take a significant hit that may be unrecoverable. This phenomenon isn’t going away soon, nor are compliance requirements that pose a threat to the personal freedom of executives. If these aren’t enough reasons to get busy automating your food safety programs, read on.

Learn more about the future of food safety and technology at this year’s Food Safety Consortium, November 12–16 in Schaumburg, IL

The trends toward social and health-related product claims, like organic, the ‘free-froms’ and locally-grown, have had the impact of adding dozens if not hundreds of new suppliers to a retailer’s procurement list. And, it’s important to note, that these generally smaller suppliers are just now approaching their compliance deadlines for FSMA, and if they are very small, still have another year. New trends appear every year, and they will compound the challenge for retailers and wholesalers of knowing exactly who all of their suppliers are, which in turn will worsen compliance issues.

Our studies show that at least 12% of documents that certify organic, ‘free-froms’ and other product label claims have some level of discrepancy or inaccuracy making them invalid, and rendering the systems that rely on vendor self-disclosure near useless. With sales expected to skyrocket within these categories during the next few years, companies need to leverage technology to protect the supply chain, and consider having the system hold purchase orders generated for vendors who are not compliant with requirements.

An alternative is to have the system add a compliance fee to the purchase order that escalates over time or swiftly replace suppliers if they are not willing or not able to comply. That also speeds compliance as news travels quickly if there is a hard-hitting consequence for non-compliance. Either way, it’s important to be able to substantiate any claims to the consumer, since if those assertions are deemed unreliable, retailers and their suppliers risk a breach in consumer confidence and will suffer economically when shoppers turn away from them at the shelf.

And while retailers and wholesalers have begun to turn the Titanic on regulatory and business compliance, they need to continue to diligently find the risks in their supply chain, working even more aggressively to automate their current food safety and quality programs using new technology and procedures. Otherwise, their reputation and their existence are in jeopardy.

Cloud-based compliance management solutions that help retailers, wholesalers and suppliers meet the new food safety requirements can be configured to manage documentation requirements by supplier type vs. requiring the same documents from all suppliers. These systems also go beyond just storing digital copies of documents, and actually manage any form of compliance by reading inside the document to confirm it meets requirements. The benefits of these compliance management tools extend to streamlining new vendor approvals, which can save time and enable the redeployment of resources to more productive business-building activities.

Make no mistake: business and regulatory compliance will continue to be a focal point in the future. This includes addressing potential safety, certification and quality challenges throughout the extended supply chain as nearly one-third of all recalls are due to ingredient suppliers. We believe that in less than three years, retailers will require supply chain visibility from the shelf all the way back to “dirt”. It’s been proven too risky not to have that kind of visibility for ultimately everyone’s customer – the consumer. And now technology companies are on the hook to deliver it.