Food accounts for one-third of the 42 million products imported into the United States each year, according to Andrew J. Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA. FSMA’s risk-based FSVP rule places responsibility on importers to ensure their food is safe, yet since the rule was implemented, the most common Form 483a observation has been a failure to develop an FSVP. In fact, from FY 2017 to present, the observation was cited 552 times, outweighing any other observation, said Seaborn at the recent Food Safety Supply Chain Conference, as he shared some of the latest trends in compliance and enforcement related to FSVP.
Thus far, common citations include:
No written hazard analysis to identify and evaluate known or reasonable foreseeable hazards
No written procedures that ensure appropriate foreign supplier verification activities are occurring related to imported food
Seaborn noted several additional “significant observations” related to FSVP inspections, including incorrect entry data, and the absence of documentation in the following areas:
Approval of a foreign supplier
Evaluating foreign supplier performance, along with related risks
Establishing written procedures to ensure foreign supplier verification activities are performed
Review and assessment of another party’s evaluation of foreign supplier performance
Ensuring food was produced in compliance with low acid canned foods regulations
Related to meeting the definition of a very small importer, when applicable
Main Points of FSVP
FSVP Inspections (Completed)
U.S.-based importers responsible to ensure safety of imported food
Learn more about how to mitigate the risks of food fraud and intentional adulteration at the Food Safety Supply Chain Conference | May 29–30, 2019 | Rockville, MD or attend virtuallyThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.
The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.
FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.
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.
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
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
It is one week before your scheduled audit. Are you running around from department to department crossing the T’s and dotting the I’s, or are you cool, calm and collected, as it is just another audit? More than likely you have been in both cases, but how does one finally get to the collected stage? It is not about being nervous—even as a lead auditor I get nervous (I am human, too)— it is about being ready!
Believe it or not, I can generally gage if the audit is going to flow well within the first hour of arrival. My questions from audit to audit of course change, but overall, I am asking for the same materials and results. If the team is getting baffled by questions in the beginning stages of the audit, I know I am in for a long ride. Why does this happen? If the situation has gone down hill rather quickly, I find that whomever at the plant is responsible for the implementation of the audit standard, has never taken the time to read or review it. That, my friends, is one of the most critical mistakes you can make. I know these standards are not world-class bestselling books that you are dying to binge read by the fireplace with a glass of wine—if this was your view, you would be an auditor already. HA! The standards are not always black and white as far as requirements, but just taking the time to read the standard will enhance your understanding of where the auditor is coming from.
Now you have read the standard, you understand it and are comfortable. You have a 200,000 square-foot facility, 200 employees and four different HACCP plans to watch over. How could you possibly score an excellent, “A”, pass, whatever the top score may be defined as? I am sure you have heard the expression, it is not all about you, and that holds true for audits. So many times I have witnessed that the quality manager (or equivalent) try to undertake the entire audit from start to finish and answer all the questions. This is not a best-practice approach. A good example here would be that many audits now talk about annual objectives and key performance indicators. As an auditor, I expect that your plant manager (or equivalent key person responsible) come talk about these with their senior management. Too often I see the quality department commit to answering these questions, but as an auditor, I am interested in your system and how it works throughout your entire facility. I do not just want to know about the quality department. Get all departments involved. They, too, then get firsthand experience of understanding what the audit requirements are, instead of just reading endless emails of what needs to be accomplished.
Teamwork and understanding are now established—great! How strong are your programs? There are a few programs I want to touch on here, including your internal audit program and procedures. I can not write this article and tell you “X” is the solution, as there is not a one-size-fits-all approach. If you are spending two hours on an annual internal audit for a facility like the one mentioned above, it is possible that your program is lacking robustness. When conducting an internal audit and a requirement is in compliance, do you write what made it in compliance, what you reviewed, and with whom you spoke? This is a great way for you to compare what you see in your plant versus what an auditor sees in your plant, especially if you built your internal audit from an audit standard. How about your sanitation program? I came from a background of meat inspection, so maybe I am a bit biased, but your sanitation is encompassed with other pre-requisite programs in the facility. If your facility has untidy locker rooms, cafeterias and bathrooms, what motivates the employees to be tidy on the production floor? Sometimes it is the small things that go a very long way. In talking about sanitation, I have observed that many site managers never go in to watch your pre-operational inspections that may take place very early in the morning. Just because it is not on first shift, does not mean it is not important, and it also does not mean that it will not be audited. Likely, it will be audited!
Lastly, take all nonconformities that you have found either through internal or external audits, respond to them in a timely fashion, and get the root causes and preventative actions in place! Nothing pains me more then to see sites repeat a nonconformance, just to possibly get a major conformity. It’s like shooting yourself in the foot and your audit score takes an unnecessary plunge that could have been avoided.
Audits are not a fad and are not going away. It does take way more time to get to the cool, calm and collected stage for audits, but in the end, being audit ready all the time looks good on you and your site!
The end of the year is always a time of reflection. At Food Safety Tech, it is also a time when we like to share with you, our readers, the most popular articles over the last 12 months. Enjoy, and thank you to our loyal and new readers, as well as our contributors!
Stephen Ostroff, M.D. deputy commissioner for foods and veterinary medicine, sounds excited about the promise of blockchain. He also continues to enthusiastically wave the flag for whole genome sequencing (WGS) in solving foodborne illness cases. At the recent GMA Science Forum, Ostroff shared his usual update on incidents involving pathogens, agency progress in inspections and FSMA, and what the future holds.
The 2018 Food Safety Supply Chain conference features a Blockchain panel discussion | June 12–13 | Learn morePathogens
“There’s been essentially zero change in incidents of pathogens, and in some [cases there have been] increases—despite the fact that we’ve been doing quite a bit to improve the profile of food safety in the United States,” said Ostroff. This isn’t the first time that Ostroff pointed to the fact that foodborne illness is resistant to change, but he still emphasized the disappointment that industry is “way off” from the Healthy People 2020 target rate for pathogens established by the government. “None of these are close to where we thought we would be,” he said, referring to the government’s established target rates for Campylobacter, E.coli O157, Listeria, Salmonella, Vibrio and Yersinia.
Ostroff has previously pointed to improved diagnostics and surveillance systems as being partially responsible for a lack of improvement in the number of foodborne illness cases (due to higher detection rates), but during this particular presentation he brought attention to culture independent diagnostic tests (CIDTs)—which he said are having a “major impact on data collected in FoodNet.” CIDT is relatively new and is more rapid than the culture method, but it doesn’t allow for subtyping or antimicrobial resistance testing.
According to Ostroff, CIDTs have major implications for folks who work in food safety. The overall incidence of infection with foodborne pathogens is not decreasing, and the use of CIDTs makes assessment of trends difficult. CIDTs appear to be finding infections previously undiagnosed or unrecognized. In addition, they could affect the agency’s ability to monitor FSMA impact measures.
The agency continues to look at inspection data from both the perspective of the number of inspections and their outcomes. During FY 2017, there were 1253 domestic and 146 foreign inspections. For FY 2018, there have already been 1610 domestic inspections to date.
In January, FDA issued new enforcement discretion for certain provisions in four FSMA rules. This included resolving issues related to the “farm” definition, requirements for food contact substances under FSVP, and certain written assurances in place for the Preventive Controls (human and animal) rule until FDA comes up with a practical solution to issues raised by stakeholders, Ostroff said.
Oversight of Food Imports
FDA continues to take a risk-based approach to FSVP and overseas inspections. Part of these efforts includes the agency’s systems recognition program where it looks at other mature food safety systems around the world to recognize countries that have programs similar to the United States. Thus far FDA has recognized Australia, Canada and New Zealand food safety systems; It is currently in the process of evaluating European Union members.
Intentional Adulteration Rule
The International Adulteration rule continues to be a hot topic of discussion, especially as it relates to associated costs. FDA is actively working on putting out a draft guidance that will discuss how to conduct vulnerability assessments, along with its interpretation of the rule, according to Ostroff. Part one of the draft should be out “in the very near future”, he said. He added that the agency is trying to be flexible with the rule and although food defense is an important component of food safety, companies should never do anything in the context of food defense that could pose a food safety risk.
Whole Genome Sequencing
WGS provides more precise identification at a genetic level and helps expedite recognition and response time for nearly all current foodborne illness and outbreak investigations. “It’s the new normal—it’s here and it’s here big time,” said Ostroff, adding that the GenomeTrakr network has more than 167,000 isolates sequences in the database and is becoming more and more powerful. “It’s amazing what this tool can do,” he said, citing two recent cases involving strains of Salmonella in papayas and kratom.
“I think blockchain can be really transformational in the world of food safety,” said Ostroff, calling it “traceability on steroids without question”. He thinks the technology could also be useful in addressing food fraud and economically motivated adulteration, and provide more consumer transparency. Right now the FDA is looking very closely at blockchain in context of traceability and FSMA.
Another day, another potentially brand damaging story—just ask Little Caesars. On February 7, the health department closed down an Indianapolis-based location because customers found some rodent feces on their pizza—it was clearly a food safety violation, and pretty disgusting. Meanwhile on the other side of the planet, athletes prepared their entire lives to compete in the Olympics. More than 100 people contracted Norovirus around the Olympic sites in Pyeongchang, where the athletes were in danger of getting a violent, contagious stomach illness that would derail their dreams and prohibit them from competing.
We live in a world that eats out, and if we don’t develop new techniques to protect customers in restaurants and food service settings, more people are going to get sick (or worse) from foodborne illnesses. The current food safety process is broken, and needs to be fixed in restaurants nationwide and globally.
At Google, Larry Page has spent two decades managing the speed of a search result for the company’s core service. From 1997 forward, Page has obsessed about the right results as fast as possible. When has Google ever been slow? People use the search engine daily because it always works.
For restaurants to grow and thrive, they need habit formation from fickle consumers. Habits are formed when restaurants deliver on their value proposition slice after slice, burger after burger, and salad after salad. So what is your organization doing to make sure that every meal is extraordinary— not only delicious, but also safe? What are you doing to prevent Norovirus and other foodborne illnesses?
Well, you’re probably not studying the data to create better processes. A 2017 survey of the top 500 restaurant chains found that 85% use paper logs or spreadsheets as their core technology for safety, quality and standards management. Paper logs, line check clipboards or homemade Excel sheets on a laptop are inefficient and ineffective systems to manage something as critical as food safety.
Many restaurants have upgraded their mobile ordering software and relaunched their menus on LED screens, but still make employees use clipboards to conduct food safety line checks and QA audits. This devalues the importance of their food safety operating protocols. Restaurant teams are comprised mostly of millennials and Generation Z— the mobile generations. They expect to be trained, do work and solve problems with their phones. But when their employers train with paper manuals and complete work with paper forms, it’s a huge disconnect for them.
Moreover, how did people at Little Caesars HQ in Detroit have insight into that recent incident in their Indianapolis store? What operating data do they have to examine? What line checks happened in store on the day in question? When was their last third-party food safety audit? What corrective actions were taken? That information would be hard for them to know, if, like the vast majority of restaurant chains, they were not collecting and analyzing data with modern tools.
Upgrading your operating technology so that your people have digital tools is not expensive. Software is much more affordable today because of the software-as-a-service revolution and the extraordinary computing power and proliferation of mobile devices. An emerging ecosystem of safety and software companies is ready to take your facilities into the 21st century. But the C-Suite has to decide it wants to empower its employees to do their best work and commit to having real-time data that is actionable and accurate.
Having mobile ordering software and LED screens for menus is helpful and valuable. But food safety is the most important component of every restaurant (and other food service companies). It is imperative that the food service industry embraces digital solutions to elevate their food safety standards. Without proper food safety standards, any organization could face a crisis like Little Caesars and the Olympics recently experienced. All it takes is one tainted meal to harm your guests—and your brand.
FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Among the items on the spreadsheet are food safety hazards, failure to clean, sanitation records, corrective action plan, and lack of sanitation.
“These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.” – FDA
The following are the top five (most frequent) observations.
5. Contamination: Cleaning and sanitizing operations for utensils and equipment not conducted in a manner that protects against contamination of food, food contact surfaces and food packaging materials.
4. Failure to implement HACCP plan procedures.
3. Facility not constructed in a way that enables floors, walls and ceilings to be adequately cleaned; buildings, fixtures and other physical facilities not kept in sanitary condition.
2. Sanitation monitoring: Sanitation conditions and practices not monitored with enough frequency to be in conformance with CGMP.
1. Pests: Lack of effective pest exclusion from processing areas and contamination of foods, and failure to provide adequate screen against pests.
Proper sanitation plays a crucial role in the FSMA Preventive Controls rule, and FDA is paying more attention during facility inspections. However, many companies currently have deficient sanitation programs, according to Bill Bremer, principal at Kestrel Management, LLC. “It’s a key aspect of FSMA and requires that you have key personnel or a qualified sanitation manager either at each site or over each site (if it’s not local). That’s in FSMA,” he says. “In most cases, and for high-risk companies, sanitation must be supported by validated environmental testing programs (i.e., the typical swab-a-thons that FDA has done under FSMA). Sanitation chemicals that are used must be diligently approved for use and validated. In addition, chemicals must be appropriately applied, which is a big issue. These areas are key inspection points for FDA under FSMA, as well as for customer requirements. Sanitation has been elevated with FSMA and Preventive Controls, and it has to be addressed at a higher level—and for the most part, it isn’t.”
Bremer was invited by DNV-GL to discuss the importance of sanitation as a goal of FSMA in a Q&A with Food Safety Tech.
Food Safety Tech: Let’s first talk about the importance of a proper sanitation program. What are the factors at play here and what are the deficiencies with current sanitation programs?
Bill Bremer: We’re starting to conduct major sanitation program process improvements or process assessments for companies big and small. What we’re seeing in some of the key areas is that chemicals are not validated with the chemical provider. That includes the fit for use for them as well as the training of the people using them (i.e., if it’s liquid, it has to be diluted at right level and confirmed at right parts per billion).
Before you sanitize, you’re supposed to clean (in some cases it’s called debris removal). You can’t sanitize unless surfaces that are being sanitized are clean. We’re finding that cleaning isn’t done appropriately and thus companies are sanitizing over dirt, and you can’t sanitize over dirt or debris.
We’re also running into cases where the cleaning is done, and because it looks clean, a company is not sanitizing, so you run into another issue with those missed steps. And, this entire process needs to be validated and you must have records on it. You also have to support it with environmental programs, especially for high risk. So that means swabbing to make sure that once you clean and sanitize, you prove that the activities have ultimately removed any bacteria, germs or allergens from the process.
This is a high-profile area for FDA to inspect.
Some of the common deficiencies are with the program itself and the documented procedures to follow. It’s a weak area. Sometimes, a company will have different cleaning and sanitation programs documented (e.g., shift-by-shift or site-by-site), which leads to people who do the cleaning not following a standard set of instructions. It really gets down to both the programs and lack of qualified supervision and management of the cleaning and sanitation process.
Food Safety Tech: What methods should companies employ to meet FSMA requirements?
Bremer: This is an area where a diligent documentation program review is not always conducted. It’s assumed that we see the cleaning process—you see the foaming up of the cleaner, the sanitizer is all good—and we may see the cleaning record, but it’s not an SSOP, or standardized sanitation operating procedure.
However, when you look deeper and look at the documented programs, there very weak and unclear, and they need to be updated. That is one of the first things that we would investigate for a company. It’s also the qualification and training of the people—whether at the lower level or the management level, you have to be trained appropriately and the training has to be current.
Then we look at the physical process: Are they really doing debris removal in the cleaning process prior to sanitizing to make sure there’s no residue left for sanitation to be effective?
We also look at the environmental programs: Do they have a well-developed environmental program swab test? Are they using a third-party lab to validate their results? Today there are automatic test readers [that enable in-house] results. If you perform this in house, you need to have qualified people do it—and you should be checking those results with a third-party laboratory or service.
A proper sanitation program is an imperative. It’s an area where FDA is going to be investigating companies, even if they don’t have any record of products being recalled. If you look at the Blue Bell case, the big issue was that they didn’t do a good job of sanitizing their drains for Listeria, which got out of control and then it spread through the air system and to their suppliers, as well.
Food industry inspection and audit protocols are evolving at a rapid pace, and rightly so. This is not surprising given today’s regulatory, audit and ever-changing risk landscapes, which are driving further complexity and expansion of requirements to ensure the industry is, “audit ready, all the time.”
This evolution of inspections and audits has been primarily triggered by newer regulations such as FSMA and private standards, such as GFSI and its certification programme owners (CPO’s, fka Scheme Owners) like SQF, BRC, FSSC 22000, IFS, etc. Heightened customer demand and consumer visibility into food safety incidents –many thanks to mainstream and social media– and the resulting increased demand for information has also fueled this evolution, compelling industry to focus on higher levels of transparency, both internally and throughout the supply chain.
The changes above are driving the food industry to face a new reality. One where the following questions continue to rise to the surface:
How have “yesterday’s” inspection and audit expectations changed from what companies are experiencing today?
Based on this evolution, how will “tomorrow’s” inspection and audit expectations change?
In short, what does the new reality or the “new normal” look like now for inspection and audit readiness?
We will take a look at what some of the first inspections are shaping up to look like under the Preventive Controls for Human Food (PCHF) Rule and the Foreign Supplier Verification Program (FSVP) Rule. Some common themes and some tips to successfully manage regulatory inspections as well as audit readiness tips are set forth below.
Roll out the welcome mat because more inspectors are coming to the party. We are seeing an average of three to upwards of six regulatory inspectors performing the inspections under the PCHF rule. This may cause an initial shock wave but when you stop to consider the rationale it has a certain level of reasonableness to it. Industry has invested in its personnel for nearly two years in updated training to meet new FSMA regulations such as preventive controls qualified individual (PCQI) training, updated current GMP training and perhaps qualified auditor training, if applicable. It makes sense that FDA needs to make a similar investment in its people to ensure its inspectors are prepared to knowledgeably perform FSMA-related inspections.
FDA has implemented a robust training program for its inspectors. Regarding PCHF inspections for example, only inspectors who have successfully completed the PCQI training plus FDA’s internal training will lead other inspectors through the facility inspections as an in-field training exercise. So, the good news is at least one inspector is fully trained under FDA’s training program standards. This said, with more inspectors, there are more eyes, and with more eyes, more opportunities to see risk through different perspectives. It’s best to be on your game, with a tested playbook so you have confidence you are prepared when the team of inspectors arrive at your facility. Conduct a mock inspection against your policies, procedures and food safety plan that have been updated for the new PCHF and other applicable FSMA requirements. You will be thankful you did.
Into Records: FSMA and the seven rules that comprise it requires more controls, monitoring and verification activities by the food industry, thus naturally giving inspectors more records to access and review. Further, FDA received expanded records access authority upon the signing of FSMA. FSMA allows FDA to access records relating to articles of food for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals. Before FSMA the standard FDA had to meet to access records was “credible evidence”; now its “reasonable probability”—a standard that is far lower and subjective—allowing access to more types of records than before. Another new addition is FDA now may access records beyond those relating to the specific suspect food if the agency reasonably believes that other food articles are likely to be affected in a similar manner.
Example: If you have a potential problem on production line 1, and you firmly believe the issue is contained to line 1, but that line is in even arguably close physical proximity to line 2, depending on the issue an inspector may invoke this new authority and ask for all records associated with line 2 in addition to line 1 for the same time period to be sure that the situation indeed did not spread or otherwise impact line 2. (e.g. confirm no risk for cross contamination or allergen cross-contact).
This should not mean it’s open season on all your records, but it certainly means more records are open to review and scrutiny, so having a robust record retention and management system becomes mission-critical. How sound is yours? Record-keeping and document management have long been important to GFSI / CPO’s. However, many food companies do not have a certification from one of these entities, which begs the question whether the scope of your third-party audit, or that of a supplier you are currently evaluating for approval, adequately evaluates this important area.
Into your Hazard Analysis: Inspectors are spending significant time reviewing the adequacy of the hazard analysis performed as part of the requirement of the food safety plan under the PCHF Rule and as part of the foreign supplier verification plan requirement under the FSVP rule. If facilities do not identify all the hazards of concern that require a preventive control associated with their facility and foods they produce, then the rest of the food safety plan falls apart. If you work with peanuts to produce peanut butter and identify Salmonella as a hazard requiring a preventive control but not aflatoxin or peanut allergen you have likely missed the mark.You may not have the appropriate preventive controls, monitoring, verification activities, validations and corrective actions identified in your hazard analysis and food safety plan to control for the most significant hazards your facility / the finished food is facing from a food safety risk perspective. (note the identification of hazards requiring preventive controls is highly dependent on the food, facility, processing methods of the manufacturer, upstream supplier and will vary if products are RTE or nRTE)
How are auditors tackling this issue? Many third-party audit firms have invested in providing PCQI training for its auditors so they are better prepared to evaluate the sufficiency or gaps in the hazard analysis. It is a good idea to ask your audit firm what updated skills and training have been given to its auditors to ensure you are getting the assistance you need.
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