Waiting until a product is at the tail end of R&D to examine potential food safety and regulatory compliance issues can lead to unnecessary delays and tension between teams, according to experts at the 2023 IAFP Conference in Toronto. Wendy White of the Georgia Tech Manufacturer Extension Program and Kory Anderson of Cargill co-moderated the panel discussion, “From Bench-top to Scale Up: The Unspoken Food Safety Challenges of Research and Development.” They were joined by panelists Shawn Stevens, an attorney with Industry Counsel, LLC, Benjamin Warren, Senior Science Advisor for Food Safety at the FDA, and Michael O’Rourke, North American Regional Microbiology and Food Safety Leader at Cargill.
Key food safety challenges associated with new product development highlighted by panelists included a lack of clear communication between departments, especially food safety, R&D and buyers.
Failure to bring your food safety leaders in early in product development can lead to sales and marketing decisions that are not implementable, said White. Stevens noted that traditionally there is tension between R&D and regulatory professionals in food companies that needs to be addressed in order to avoid food safety risks and delays in bringing new products to market.
Challenges when introducing new products or processing methods extend beyond in-house R&D to new suppliers as well. O’Rourke warned that risks occur when new buyers choose to purchase products from small companies that are not ready to scale up for national distribution. In addition, small companies with novel foods often have a lack of food safety know-how and may be introducing products that have not been vetted and/or do not meet regulatory standards.
O’Rourke further encouraged companies to be aware of risks when working with food brokers, as this may cloud traceability. “It may require pushback to get a clear view of the processing of the products at the primary source,” he said.
Meeting the Challenge
One way to avoid costly delays is to work with the FDA through its voluntary counseling program that encourages companies with novel products and new processing methods to meet with the FDA early in the R&D process. “This can help companies chart a regulatory path and smooth the transition to market. It helps companies understand what data is required—and what is not,” said Warren, noting that submissions to the FDA are often incomplete.
Another process that can help companies forecast safety risks and regulatory roadblocks early in the ideation and development process is a Design Hazard Analysis (DHA). “This mimics food safety plans, but begins during development to provide early consideration of regulatory requirements,” said Warren.
All panelists agreed that food safety team leaders should be brought in early in product development and be given a vote on what moves forward and what does not.
Lisa Hovey has been appointed Executive Director of the International Association for Food Protection (IAFP). She replaces David Tharp, who will officially retire on April 26, 2023, after 30 years with the Association.
Lisa joined IAFP in 1997 as Director of Finance and Administration and was promoted to Assistant Director in 1999. In addition to collaborating with the Tharp to sustain, promote, and grow IAFP’s programs and member services, Hovey helped transition IAFP’s Journal of Food Protection to an open-access publication and currently acts as the association’s liaison for its Diversity, Equity and Inclusion Council.
“Having had the privilege of knowing and working with Lisa for more than 20 years, I have seen firsthand the passion, knowledge, and expertise she brings to IAFP,” said Jeff Farber, Director, Canadian Research Institute for Food Safety; Adjunct Professor, the University of Guelph; and former IAFP President. “Lisa’s great professionalism, attention to detail, financial acumen, infectious personality, and commitment to the mission and vision of IAFP will help to ensure a smooth transition, and I am confident she will excel in her new role as the Executive Director.”
Hovey earned a bachelor’s in Accounting from the University of Northern Iowa. She holds the Certified Association Executive (CAE) credential through the American Society of Association Executives (ASAE).
The webinar, entitled “What More Do You Want to Know About Food Safety Culture?” will be broadcast live from the International Association for Food Protection 2022 Annual Meeting. Speakers and attendees will have the opportunity to engage in a question-and-answer session. Registration is available for both in-person and virtual attendance.
The webinar series was designed to bring together experts from the public and private sectors for a collaborative exchange of ideas and experiences related to the importance of food safety culture in ensuring safe food production.
As the consumer craze over plant-based meat continues, cell-cultured meat is next on the list of alternatives to “real meat”. There are several factors driving this market, including increased demand for meat as the world’s population grows and becomes more affluent, and the concern that if more sustainable solutions are not implemented, there won’t be enough protein to feed the world’s population by 2050, according to Paul Mozdziak, professor at NC State University. Mozdziak, who presented his perspective on cell-cultured meat during the IAFP Annual Meeting last month, has been working in the cell-cultured meat space for 25 years. It’s not a new concept, he pointed out, but sustainability issues, concerns over the efficiency of the animal industry (i.e., the biological limits of animals), along with a waning enthusiasm in eating animals have sparked even more interest in animal technologies during the past few years.
Animal cell culture technology involves a controlled growth of animal cells from livestock, poultry, fish or other animals, their subsequent differentiation into various cells types, and their collection and processing into food, according to Roberta Wagner, assistant administrator, Office of Policy and Program Development at FSIS, USDA. Wagner shared the regulatory perspective on this emerging segment at IAFP. And although the session in which Wagner and Mozdziak spoke was titled, “Is Cell-cultured Meat Really Meat?”, neither of them answered this question. Rather, they discussed the status of the sector and the challenges ahead.
Scale Up
“The technology has been around,” said Mozdziak. “The issue is getting it to scale and myogenic to actually produce product.” Muscle cells want to attach to something. The process of making cultured meat involves isolating cells, getting them to grow in suspension and transferring them to a bioreactor to grow. In order to create a fully formed muscle, the cells needs to attach to a scaffold and differentiate, he explained. The bioreactor facilitates a sterile environment, but when scaling up, the challenge is the unknowns (which could introduce food safety issues) during downstream processing. “Once it’s out of the bioreactor and in a non-sterile environment, there are a variety of ways it can be contaminated,” said Mozdziak.
The production process could be cost prohibitive as well. “Currently, serum-based media cost $25 a liter; serum-free is $104 a liter. How much lower can we go from that?” said Mozdziak. “A kilo of turkey at ALDI is $6… therefore the media costs would have to be below $12 a liter for this to ever be profitable.”
How Will It Be Regulated?
In October 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The agencies also started talking about what regulatory oversight might look like. In March of this year the USDA and FDA reached a formal agreement on joint framework for regulating cell-cultured meat and poultry products. FDA will regulate the extraction of cells from live animals and jurisdiction will be transferred to FSIS during the cell harvest stage, and FSIS will oversee production and labeling. “The agreement roughly mirrors our jurisdiction of both agencies for traditionally produced livestock,” said Wagner. She added that regarding FSIS authority over cell-cultured products, the agency does not expect there will be a need for additional legislation nor will there be new regulation to inspect the products (Establishments that harvest cells or process the cells must comply with sanitation, HACCP and any other applicable FSIS regulations). Labeling for cell-cultured meat and poultry products must be approved.
Wagner noted two major challenges ahead in the federal regulation of cell-cultured meat. “We’ve received very little information about the process and technology being developed or used by cell-cultured meat and poultry manufacturers,” she said. “If industry doesn’t share such information, there could be a delay in review of products.” She added that the agency is encouraging industry to come forward sooner than later with this information. The second big challenge involves research and science gaps—more is needed to understand the risks.
So, is cell-cultured meat really meat? “Before we can answer that, someone needs to actually have a product,” said Mozdziak. He believes industry will get there in creating marketable cell-cultured meat, but there is no telling how long it will take.
The food industry is behind high tech industries when it comes to automating certain manufacturing and warehousing processes. Although the advantages of using automation technologies can benefit many food companies in the long run, they should also be aware of the potential hurdles before moving forward. “With our growing population, we’re going to have to grow more food with [fewer] resources—automation will enable us to do that,” said Wendy White, project manager, food safety at Georgia Tech during her presentation at the IAFP annual meeting in Louisville, KY. “There are a lot of jobs in our industry that will benefit from automation—I don’t think it will necessarily eliminate jobs; I think it will help eliminate the harshness of some of the repetitive tasks.”
The benefits of automation are clear (especially for processes that involve close precision). Automation technologies can contribute to preventing injuries on the job, promote operational efficiencies, and give companies better access to records and reporting. They also can in turn enable the production of more consistent products, aid in faster product release and lower food costs. The following are the challenges that food companies may face, which include the reproduction of human senses, having the facility footprint that allows for these technologies, expense and complexity, and potential vulnerability to outages and even cybercrimes.
Challenge 1: It’s hard to replicate a human. It’s difficult to replicate any human task that requires thought. “For example, it’s hard for us to understand how many decisions go into picking off an apple from a tree,” said White. “It’s actually extremely hard for a robot to do… we underestimate how many things happen before you pick an apple.” White referred to a project at the Georgia Tech Research Institute’s Food Processing Technology Division that uses cameras to assess characteristics of an apple (i.e., insect intrusion spots, bruises, damage, ripeness, desired color), and integrates different sensing capabilities into a robotic arm. The robotic arm can sense the different gases being produced by the apple and can understand if it is at the peak of its ripeness. Yet, doing this type of work in a lab is very different from operating the robotic arm out in an actual apple orchard, so there is still a lot of work to be done.
Another example is the process of deboning a chicken carcass. “We have to figure out a way to get the bones off faster,” said White, adding that with American consumption of chicken reaching about 92 pounds annually, the poultry industry is trying to keep up. There are safety concerns with deboning, including making sure that a sliver of bone or cartilage is not left on the end product. It’s another task that is not easy for a robot to execute. She discussed current work that is using cameras and x-ray technology to understand the joint location, and from there this information is fed into an algorithm to help the robot make decisions that a trained human would intrinsically make. Once again, it takes a lot of effort for a robot to make those decisions, White pointed out.
Challenge 2: Facility footprint. Implementing automation technologies usually requires a larger facility footprint, and many food companies simply don’t have the space.
Challenge 3: Robot injuries. According to OSHA, about 4,500 injuries occurred in food facilities in 2013, two of which were robot related. However, those two robot-related injuries resulted in death. Although robot injuries are less likely to occur, they are usually more serious when they do happen, cautioned White. She stated between 1984 and 2013, 38 robot-related accidents were reported and 28 resulted in fatalities.
Challenge 4: Finding increasingly skilled labor. An employee needs to operate the robot. Although this may not seem like it would be difficult, the question is whether the existing workforce at a company can handle a completely different way of doing their jobs. Finding the level of skill required to either operate these robots or finding the employee who is willing to even work with these technologies could be a hurdle. White added that she is seeing a lot of research around co-bots, or collaborative robots, which is the term for robots that provide assistance to humans in conducting tasks such as heavy lifting.
Challenge 5: Complexity. The more complex the technology, the more likely there is to be an issue. And when this issue occurs, how long will it take to fix? Will it shut down an entire product line? This is also a consideration for companies that are considering retrofitting their existing facilities.
“We owe it to our workforce to make their jobs as safe and as easy as possible,” said White. She encourages industry to pursue automation but to also be aware of these challenges and vulnerabilities to ensure that companies are approaching implementation in the right way.
As the popularity of home delivery services for food (i.e., online grocery shopping, prepared meals from restaurants, meal kits) continues to gain traction, the industry has been grappling with clear-cut guidance on how to ensure food safety during what is known as the “last mile” of delivery to the consumer. For example, how do third-party delivery services address concerns such as maintaining the right temperature of food during transit? How are allergen risks controlled? Do the people who deliver the food undergo any food safety training?
“It’s kind of a wild west out there,” said Donald Schaffner, Ph.D., professor at Rutgers University during a panel discussion on the topic of home food delivery at the IAFP annual meeting last week in Louisville, Kentucky.
In April, Acting FDA Commissioner Ned Sharpless, M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas acknowledged that there are food safety challenges presented by “evolving business models” such as e-commerce, and stated that the agency will be looking at ways to work with federal, state and local stakeholders to address the issues. During the IAFP panel, food safety professionals from Amazon, Uber Eats, The Kroger Company and FSIS shed some light on how their respective organizations are handling the food safety risks associated with home delivery.
Training the People Who Deliver Your Food
The overarching consensus among panelists was that there is not a one-size-fits all approach to training the people who deliver food to the consumer, because there are so many different business models out there. The key to developing successful training will be to first understand the risks associated with each of those different models.
“Everyone needs training, but we don’t want to over-engineering it—not everyone needs ServeSafe training,” said Schaffner. For example, training the person who is simply putting food in the car and delivering it to an address should be different from the training necessary for an employee selecting food in the grocery store versus the warehouse employee packing food. “Figuring out the right-size training and what kind is currently available is one of the things that we’re trying to figure out on the [Conference for Food Protection] committee.” (Note, the Conference for Food Protection committee is developing guidance that addresses home food delivery.) Schaffner indicated that training surrounding time and temperature, allergens and product tampering are important considerations.
Howard Popoola, vice president, corporate food technology and regulatory compliance at The Kroger Company provided the retailer perspective. “Our challenge is multiple in nature,” he said, emphasizing that stores try to keep labor at a minimum. Designing training for workers who are getting a $.25-per-hour raise presents a different hurdle. “What we’re doing in the store today is something we’ve never done before, and [we’re] asking individuals to do things they’ve never done before,” said Popoola. “The training we’ve done before is slowly becoming obsolete.” He said that The Kroger Company is evaluating its current basic food safety training and is looking at building on the segments of its stores that are involved in picking, packing and preparing food—especially the fresh items that are more susceptible to potential microbial contamination.
The Allergen Risk
A question was raised about whether delivery services use the same bags over and over, introducing the potential for cross-contamination. As part of its restaurant community guidelines, UberEats encourages restaurants to put food in tamper-resistant packaging. According to Joseph Navin, senior manager of global safety at the company, in order to reduce the possibility of cross contamination, all food should be placed in a bag before it is put in the insulated bag for transport. UberEats also has guidelines for how those bags should be cleaned. Further addressing the allergen risk: “How do we optimize the way that consumers can disclose that they have a food allergy? We don’t want to have food allergies going in the same free form text [box] that says ‘send extra napkins’,” said Navin. He added that UberEats is developing ways in which dealing with allergens is more conspicuous for restaurants when their employees are preparing food.
Allison Jennings, director food safety and compliance North America at Amazon, said the company has experimented with multiple types of packaging, but there isn’t one perfect set of variables and inputs. Amazon currently uses single-use bags for delivery to mitigate risks with re-cleaning, she said.
Consumer Complaints
As a best practice, integrating relevant information from consumer complaints should become part of a company’s food safety program, said Schaffner. An important role of technology will be its ability to collect feedback that allows companies to generate actionable insights related to food safety, identify any gaps, strengthen controls and be able to develop ways to mitigate risks, said Navin. Amazon currently monitors customer feedback using automatic detection for keywords related to food safety and quality that arrives via the phone, online chats with customer service and social media outlets. When necessary, the method can prompt an investigation, look for trends or help engage in continuous improvement processes. “We are constantly looking for any potential blind spots with our processes,” said Jennings. “We also mystery shop ourselves and make sure we’re meeting our requirements.”
The most common consumer complaints reported among the panelists were not related to food safety, but rather food quality—the product was crushed, didn’t look appealing, etc. “Since we rely on third party partners, we’ve walked through with them on those processes…[and are] challenging our third party partners on who they hire to deliver food, training, etc. and taking caution on delivering food,” said Popoola.
Schaffner said common complaints noted during a study conducted by Rutgers University and Tennessee State University were the following: The product was received out of temperature control; there was evidence of packages leaking (meat, poultry, and fish); a lack of cooking directions; and no mechanism to provide feedback to the company if you have a complaint.
According to Navin, among the top complaints that UberEats receives is missing food or a replacement for items that might be out of stock.
Recalls
In general, recalls in the home delivery segment would apply to products that are received via online grocery shopping services. Since consumers must sign up for these services by providing either an email or phone number, companies can contact customers in the event of a recall. For example, Amazon requires an email account, so it directly emails customers when there is recall or known safety risk associated with a product purchased. Similarly, when a customer uses a loyalty card at a grocery store such as Kroger, the retailer can use its robocall system to notify customers if they purchased an item that is subject to a recall or is associated with an outbreak.
I recently attended two webinars that highlighted distinct perspectives on two challenging aspects of food fraud prevention. First, Chris Elliott from Queen’s University Belfast discussed the current situation with meat fraud. He cited his “top three” fraud-prone foods as meat, olive oil and honey. While we cannot determine the true scope of food fraud globally, looking at the data we have collected from the past 10 years, meat is also in our “top three.”
Top 10 Commodity Groups. Source: Decernis Food Fraud Database
Meat is prone to fraud in many ways, including misrepresenting the animal species, fraudulent labeling of production practices (organic, kosher, halal, etc.), the use of unapproved additives, the addition of non-meat-based protein ingredients, and misrepresentation of geographic origin (among others).
Elliott discussed some of the reasons that meat is prone to fraud, which included the fact that the industry is highly competitive, relies on low profit margins, and the supply network can be complex. Discussing specifically the horsemeat scandal in Europe a few years ago, he cited the “mess of subcontracts” involved in the adulterated meat, which were based primarily on price. He finished his presentation by noting that certain aspects of meat authentication are still challenging from an analytical perspective, such as ensuring country of origin and verifying the claims about animal feed consumption.
The final in a series of food fraud webinars sponsored by the IAFP Food Fraud Professional Development Group (PDG) focused on another aspect of food fraud: E-commerce. One of the big challenges with food fraud is the intentional nature of the crime, which can make anticipation of adulterants and fraud methods difficult.
GFSI has stated “any plans and activities to mitigate, prevent or even understand the risks associated with food fraud should consider an entire company’s activities, including some that may not be within the traditional food safety or even HACCP scope, applying methods closer to criminal investigation.” This is particularly true for fraud involving intellectual property (IP) infringement, which adds another layer of complexity to detection and prevention strategies. We have more than 200 records documenting fraud involving “counterfeit” products. Counterfeit products are a problem both because of the IP infringement and because, often, the actual contents of the product cannot be verified. Many of the records we have documented involve counterfeit vodka, whiskey, and wine, as well as non-alcoholic soft drinks.
As part of the IAFP webinar, Axel Hein from ApiraSol discussed their work using global customs data to detect counterfeit products, so-called “fantasy trademarks,” and geographical indication infringements.
Many countries provide public access to customs data which, when aggregated and combined with other sources (such as Alibaba transactions), allows mapping of supply chains and detection of unusual patterns that may indicate fraud. In school, I spent many months digging through U.S. customs data trying to uncover patterns that might indicate fraud, so I was very interested to see this being done on a larger scale.
Although each webinar was distinct in its focus, each highlighted the importance of supply chain control and monitoring in mitigating food fraud risk. To paraphrase a point made by Elliott, each arrow in a supply network is a potential vulnerability. The continued globalization of the food supply requires new and innovative ways to reduce these supply chain vulnerabilities.
The importance of accountability at the employee level should not be underestimated. Food safety professionals recognize this, and gaining support from management is key. In this video interview from the 2015 IAFP conference, Laura Nelson, vice president of business development at Alchemy, shares her thoughts on how companies should not only train their employees but also track the effectiveness of that training.
This year’s Food Safety Consortium Conference (November 17-20, 2015 in Schaumburg, IL) features sessions on employee engagement and involvement in Food Safety Culture. Register now.
Next month Stewart Parnell, the former CEO of Peanut Corporation of America (PCA), is scheduled to be sentenced for his role in a deadly salmonella outbreak involving shipping contaminated peanut products nationwide. Parnell, who could spend the rest of his life in jail, was found guilty on 71 counts, including conspiracy, obstruction of justice and wire fraud. This landmark case sends a strong message about accountability to both industry and consumers, said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness, at the IAFP 2015 conference in July.
“His actions resulted in technically more deaths than that of Charles Manson,” said Detwiler, who indicated that Parnell is still very much in denial over his role in the salmonella outbreak. “This might be one snapshot—one look at one person in one industry, in one business—but think about how many companies are out there [and] of this mindset—the idea that they’ll never get caught.”
Food companies should be held strictly liable when it comes to consumer safety, ensuring that they take preventive measures so that illness and death never happen. The sentencing of Parnell next month could set a precedent for how future cases involving companies responsible for foodborne illnesses and outbreaks are handled.
As FSMA promises to increase the responsibility of food laboratories, companies must pave a path forward by working more closely with industry as a whole, government and non-government organizations, as well as with each other. This was the clear message relayed by Pamela Wilger , assistant director of global food safety at Cargill, at IAFP 2015.
“We consider a lab any person generating data,” said Wilger, who emphasized the “lab” is not just the room itself. Lab testing should not focus on a single narrow view (i.e., one test); companies should be efficiently applying their resources, considering both science and risk. “Non-science based testing can lead to conflicts between suppliers and customers and manufacturers and regulators, and destruction of wholesome product.”
Here’s where improvement is needed in food labs:
Disseminating best practices. “We don’t even share that [as an industry],” said Wilger. “We don’t have time to replicate the same work.”
Aligning international rules
Cooperating with national regulators, including local/regional entities.
Testing and improving compliance policies
Building consumer trust and confidence
Training/competency development. Finding the right people, and encouraging employee knowledge sharing
Being prepared for the next intentional economic adulteration
Palmer Orlandi, Ph.D., CAPT, U.S. Public Health Service Sr. Science Advisor in the Office of Foods and Veterinary Medicine at FDA, shared insights on how FSMA will affect lab responsibilities moving forward, with a focus on prevention versus reaction. The objective for lab capacity programs is to facilitate submission and acceptance of meaningful and actionable data to all regulatory agencies, he said.
Reset, expand and integrate: A need to focus on resources
Method performance and “fit for purpose”, harmonized standards
Large-scale focused surveillance activities; statistical significance, real-time evaluation of data generated
Real-time communications, bioinformatics, IT infrastructure, data-sharing platforms
Technology and innovation partnerships, including on an international basis
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