Having the ability to apply barcodes directly to food could change the game of food traceability. One company has developed a patented technology that involves applying a DNA barcode directly to raw materials and finished product to enable traceability of a product throughout the entire supply chain.
Last month SafeTraces, Inc. was granted a U.S. Patent for a new method that encodes and decodes digital information to and from DNA strands. Called safeTracers, these seaweed-based DNA barcodes have been deemed generally recognized as safe (GRAS) by FDA, are non-GMO and Kosher, and can be applied to all food and beverage products, according to SafeTraces. The DNA barcodes were initially developed for low margin industries such as fresh produce, and bulk foods and grains. The safeTracers are generated via the company’s IoT miniDART solution, which creates a unique batch for each lot of product. They are directly applied to food during processing, giving the food item or batch of commodity food a unique tag that contains traceability information.
This technology could be fill a critical piece of the puzzle during a recall, as information about a product could be accessed within minutes.
There are two key points that Kevin Otto of GS1 wants people to understand about blockchain: It is not a traceability solution in itself, and data standards are critical. Otto is the lead for the GS1 US Cross-Industry Blockchain Discussion Group (launched in November 2018) and the Foodservice GS1 US Standards Initiative at GS1 US. Recently the blockchain buzz has been transforming into a more realistic conversation about the future role of the technology in supply chain visibility and the necessary steps to achieve interoperability. In a Q&A with Food Safety Tech, Otto shares what GS1 is trying to accomplish with its relatively new blockchain discussion group, the important role of data standards, and supply chain traceability.
Food Safety Tech: Can you explain the role and goals of GS1’s blockchain discussion group?
Kevin Otto, lead for the GS1 US Cross-Industry Blockchain Discussion Group and the Foodservice GS1 US Standards Initiative at GS1 US.
Kevin Otto: It’s a cross industry discussion group, so it’s a bit of departure from how we typically approach industry with verticals such as foodservice or retail/grocery. For the blockchain discussion group, we decided to bring different industries together under one umbrella—leading companies within foodservice, retail/grocery, healthcare, and apparel/merchandise—to discuss the use cases and implementations for blockchain. The common thread among so many industries was a focus on improving supply chain visibility. We thought it was a good opportunity to see where we could get alignment and be industry agnostic around how blockchain can be leveraged.
There were a few overarching goals that we were trying to accomplish with the group: The first thing we heard from industry is they’d really like some education without the hype. There seemed to be some confusion with some industry partners that blockchain itself is a traceability solution, which it isn’t. We know that a blockchain implementation is only as good as the data that is feeding it. We want to help various players in these industries clear up confusion, [and understand] that there’s still a need for data standards in order for blockchain to produce meaningful results. As a neutral not-for-profit organization, we thought we’d be a good place to provide education and industry insight.
In terms of other things that this group is trying to do: One thing that we thought was abundantly clear was the need to identify and align on the necessary core standards and master data elements to even approach a trading partner with a supply chain visibility proof of concept leveraging blockchain. If you want to talk about supply chain visibility with your trading partners and you’re not capturing and sharing any standardized data about how product moves through your supply chains today, there’s really no way you can even begin to discuss blockchain with them.
This goes back to the confusion in the industry where people think they can adopt “blockchain” and therefore have traceability. Supply chain visibility is a priority across all of these industries. Now is the time for them to decide what separate pieces of traceability data and master data are needed in order to have these discussions with trading partners. The discussion group will be putting out guidance on what is specifically needed for a blockchain traceability proof of concept.
Another major thing industry had asked from us: A knowledge management center, which is an interactive space where participants in the industry discussion group can post articles, ask probing questions, and interact with people outside of their four walls, and discuss progress of their own proofs of concept. We have been developing this tool over the last couple of months and will launch this summer.
FST: Are there additional the concerns about the use and implementation of blockchain technology?
Otto: There’s a lot of investment that goes into blockchain technology, and we saw a lot of people jumping in with both feet before understanding what the benefit really was to their organization. It’s almost as though blockchain was being positioned as a solution for all supply chain problems. We thought that being able to provide some of this education and insight from industry would help to elevate some of those issues.
I think one of the other concerns that plays a role is interoperability. When you talk about the ability for these different blockchain ecosystems to effectively speak to one another, there’s certainly a need for data standards in that space. There isn’t going to be just one blockchain solution; there are going to be several different players out there and they will need to leverage standards as one step toward interoperability. Our perspective is that we have companies that are already leveraging GS1 standards today through other data sharing mechanisms, and there’s no need to reinvent the wheel. These standards already exist; let’s make sure we’re using what’s been tested over time, which is a key step in helping ecosystems speak to one another.
FST: How is the use of digitized data provoking a shift in supply chain processes?
Otto: There are still smaller players within the food space who are leveraging paper-based data exchange with their trading partners. As the supply chain grows increasingly more global, the idea that you can have effective track and trace, for example, when the only thing you know is where a product was immediately before it came to you and immediately where it went after it left just doesn’t work anymore. It’s too slow and, quick frankly, dangerous if you have that much manual interaction and that much reliance on paper-based processes in a global supply chain. Certainly we’re seeing more trading partners make digital data exchange one of the prerequisites of their sourcing. The supply chain has gotten so complex that it just isn’t realistic to expect people to play “whisper down the lane” in figuring out where their product went in the event of a recall.
And when you think about the impact of social media and how quickly a recall can become much bigger, it’s imperative that some of these companies within the food and retail industries make sure their processes are buttoned up and that they can communicate with their trading partners quickly, and pull that product out of the supply chain. I think we’re seeing companies saying, if you don’t have a mechanism to electronically exchange data, then we may have to take our business elsewhere.
FST: Talk about your thoughts related to traceability and the need for companies to “speak the same language”. Where are companies in this journey, and where do they need assistance?
Otto: Speaking the same language is imperative. The most sophisticated data sharing methods in the world are of very little use if I don’t understand the data being sent to me. There aren’t any manufacturers, retailers, operators, etc. in the food supply chain whose stated core competency is translating data from their trading partners. That’s why so many of these different companies are relying on GS1 standards—the global language of business—so they can focus on what they do best—providing high quality, safe products to their consumers
In terms of where companies are on this journey: It varies. There are companies that have been adopting standards for traceability for years, and there are always other companies being on-boarded. This is a marathon, not a sprint. The important thing to realize is that this is a business process, not a project. Food traceability is something we need to work at everyday. As we work with all these different companies, they’re increasingly saying that food safety isn’t a competitive advantage—it’s something we all need to do and we all benefit from.
Where assistance might be needed: The food service supply chain is large and complex. When looking at the tens of thousands of independent growers as you get further upstream in the supply chain, we work with other industry associations to make sure they understand our messaging and how GS1 standards can provide value for their business. The challenge is always going to be that if we want to get to farm-to-fork traceability, we have to make sure we are talking to all the independent farmers and growers that you just can’t simply call or talk to on a daily basis. We leverage partnerships to be our voice in those discussions so we can truly connect with the entire food supply chain. That will be a continuous ongoing effort.
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
Last week industry gathered for the Food Safety Supply Chain conference at USP in Rockville, MD. The following are some quick highlights of insights they shared.
Most Common Form 483 Observations
Following FSVP inspections, the most common Form 483 observation was a company’s failure to develop an FSVP. From FY 2017 to present, the observation was cited 552 times, outweighing any other observation and underscoring the need for an educational component. – AJ Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA
(left to right) AJ Seaborn, Lisa Ross and Priya Rathnam of FDA share an update on FSMA implementation at the 2019 Food Safety Supply Chain Conference
Top Citations for FY 2018
Hazard analysis (when a facility is not identifying a hazard that requires a preventive control)
Lack of a food safety plan. “There’s still work to be done on the education and outreach on this one.”
Equipment and utensils (GMP deficiency)
Allergen controls monitoring
Sanitation control verification procedures
Personnel (usually, this is related to a repeated issue)
– Priya Rathnam, supervisory consumer safety officer, CFSAN, FDA
Critical Supplier Questions Must Be Asked
How do you choose and approve your suppliers?
What must be done to ensure that we aren’t receiving hazards from suppliers?
What requirements must be defined?
Does every supplier need to be audited?
Should we treat all suppliers equally? (No, it depends on their risk profile)
How do we ensure that our program is effective?
When working with suppliers, it’s important that your decisions are reproducible and that you apply the same risk methodology across the board. – Erika Miller, food safety specialist, D.L. Newslow & Associates, Inc.
“Before you can do anything to transform your business, you have to have visibility in your supply chain.” – George Dyche, senior director, innovations & solutions, Avery Dennison
“’Compliance’ should be replaced in industry with ‘commitment’…when you’re committed, compliance will follow.” – Felix Amiri, food sector chair, Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP)
Putting the “P” in CAPA = Getting out in front of issues before they happen. “Don’t wait for the consumer to get sick… if you have a recall, it means you haven’t done your work on the CAPA side.” – Andrew Kennedy, director, Global Traceability Center, IFT
(left to right) Felix Amiri, Lucy Angarita and Andy Kennedy discusss supply chain vulnerabilities and solutions.
On critical success factors to establish a traceability program: Technology will never fix a company’s data quality or process issues. If you don’t already have it defined, you won’t get there. And after you understand the KPIs and goals, don’t give up. This doesn’t happen overnight. Engage your leadership, because the vision has to be from the top for others to also allocate the time and effort. “It’s a journey, not a destination. If you take your eyes off data quality, data quality goes down.” – Lucy Angarita, director, supply chain traceability, IPC/Subway
In 2018, 47% of recalls were allergen related, and this rate has increased. “People still don’t get [allergen labeling]”. – Barry Parsons, senior consultant, PTI Consulting Group (Division of Paster Training)
On the significance of teaching truck drivers the importance of food safety risks: “They are part of our supply chain, and we need to incorporate them. It shouldn’t be out of sight, out of mind.” – Holly Mockus, senior industry analyst, Alchemy
Trish Wester, chair of The Association of Food Safety Auditing Professionals, leads an FDA panel discussion about the Third-Party Certification Program. (left to right) Doriliz De Leon, program coordinator, accredited third-party certification program, FDA; Marla Keller, biologist, FDA; Marianne Fatica, policy analyst, Office of Compliance, FDA; Clinton Priestley, consumer safety officer, audit staff, human and animal food operations, ORA, FDA
As the use of technology in manufacturing and quality continues to expand, there are many opportunities to help food companies streamline operations and enhance efficiencies. During a brief chat with Food Safety Tech, Melody Ge, head of compliance at Corvium, Inc. talks about the benefits of using technology in manufacturing and why some companies may be hesitant to take the leap.
Food Safety Tech:Your recent Food Safety Tech article, “Changes in the Food Safety Industry: Face Them or Ignore Them”, highlighted the role of technology in improving efficiency. What are the top areas in which companies are challenged to streamline processes?
Melody Ge, head of compliance at Corvium, Inc.
Melody Ge: When talking about a company’s production process, the challenge usually comes from where to start. A company may have difficulty figuring out which areas in the processing line can either be automated or how they can use technology as an advantage.
The challenge could also come from the fact that only parts of the process can be automated with the current technology. For example, with hazard analysis or risk assessment—those processes still need the human brain. So within a process, part of it can be automated, and part of it can’t—that could be another challenge.
FST: What technologies can food companies use to better help them manage risk in manufacturing?
Ge: It depends on what’s out there and what products a company is producing. From a manufacturing perspective, they can use supply chain management software or document management software to help them manage their approved supplier program. Using technology can make it easier and more efficient for companies to manage the risks from incoming goods and suppliers as it centralizes their documentation to make it easy to access.
Technology also helps companies use online software to centralize training documents on one corporate site and deploy it to all employees at different levels.
And from a HACCP and Preventive Controls perspective, companies can use digital technology to document temperature, pH Value, humidity, pathogen testing results, etc.—all the types of data that help execute a HACCP plan can be automated and help manage risk. After all the information is centralized and digitalized, you can see the data and easily translate that to help manage risk.
FST: What are the current technology adoption hurdles, and how are you helping companies understand the value of technology versus a paper-based system?
Ge: I think some hurdles come from fear: What’s going to happen as a result of technology is unknown, and especially at this stage, how FDA will respond is unknown. FDA already announced that this smarter food safety era is coming, but no one knows whether there will be new requirements as a result. Will requirements change because manufacturers are using new technology? Those unknowns make manufacturers fearful about what’s going to happen.
Another fear factor is job loss. For example, if processes are automated, or AI is used to capture data, or record keeping is automated, then what am I going to do? Does the company still need me as a QA professional or supervisor? I think those can stand in the way of making changes. However, [companies or employees] shouldn’t think that way. Technology is not replacing QA professionals, but [rather it] helps them do higher-level jobs. For example, in the time saved by technology, QA professionals can read and digest the data results, and study the trends and recommend best practices to continuously improve their food safety management system. It makes their time more valuable to the company.
Another hurdle is understanding which steps in processes can be automated. There are so many technologies out there that have pros and cons, and whether it will fit with the manufacturer or the facility—there’s an overwhelming amount of information, and the QA technician needs time to digest and understand the process at the facility as well as the technology out there to then select the most suitable technology for a process.
As far as helping companies understand the ROI of technology, there are four areas where I think technology can add value:
It provides increased efficiencies and accuracy of daily operations and data collection. It reduces human error. Let the technology help the food safety professionals document daily operational data.
It streamlines the food safety management system for continuous improvement. Because technology helps the food safety professional do the job of daily data collection, the time saved can be used wisely to study the data and outcomes, and truly understand how they can bring their food safety management system to another level.
It centralizes all the documents and records for management. Using technology, the food safety professional can see their SOPs, records and any related documents in one place. They don’t have to physically go to several places to see what’s happening operationally. This can also help increase efficiency during the audit process.
Centralized data helps the food safety professional more easily see where the deficiencies are located.
Ultimately, the ROI is that advanced technology can help the food safety professional increase operational efficiency, reduce product waste and production downtime.
FST: Any additional comments about the role of technology in food manufacturing?
Ge: In echoing on FDA’s announcement, although the smarter food safety era comes with using advanced technology, the mentality has not changed as all—it’s always FSMA based and people led. We need people to use the technology, and that foundation isn’t changing. We are protecting our consumers from any potential food safety risk. We’re just using a more efficient way to help all of us achieve this goal. I believe in the future, all food facilities will use at least one technology out there to help them automate one or more processing steps. And if you start with one step at a time, it will generally take over the entire production process.
Food Fraud: Problem Solved? Learn more at the 2019 Food Safety Supply Chain Conference | May 29–30, 2019 | Attend in Rockville, MD or virtually The typical motivation for food fraud is replacing a more expensive ingredient with a less expensive one, thereby increasing profits or competitiveness on the market. Another form of fraud involves the use of active pharmaceutical ingredients in products marketed as dietary supplements or foods containing dietary supplements.
Last month, an instant coffee drink purportedly containing “natural herbs” tongkat ali, guarana, and maca was reported to actually contain two pharmaceutical ingredients (APIs) approved by the FDA for the treatment of male erectile dysfunction. In this case, the motivation for fraud is “spiking” with the “intent to impart an effect that cannot be achieved by the dietary ingredients alone.” This is an ongoing challenge for regulators and other stakeholders who work to ensure the safety of the supplements market. This type of fraud in dietary supplements is also an important health risk to consumers, since unintentional consumption of APIs can result in unintended side effects or adverse interactions with other drugs. A quick glance at the FDA’s Medication Health Fraud Page illustrates how common this type of adulteration is, most notably in products advertised for erectile dysfunction, weight loss and sports performance.
In March, an energy drink was banned in Zambia after Ugandan authorities determined it contained sildenafil citrate (the active ingredient in Viagra). In 2015, Chinese authorities investigated distillers of a popular liquor under suspicion of adding the same substance. Adding to the challenge of this type of fraud is the fact that certain consumers may view food and dietary supplement products containing APIs as more appealing, not less.
Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.
We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.
Control limits must be included within the hazard analysis and preventive controls for HACCP.
FALSE. More clarification is needed here, as 96% of respondents said this is true.
CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
TRUE. 91% got this right.
Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
FALSE. 87% answered correctly.
You must document justification of records not required by a food safety plan in a food operation under FSMA.
TRUE. Just 44% responded “true”.
You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
TRUE. Congratulations, 100% got this one right!
Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
Under FSMA supply chain requirements, you must document approved suppliers.
TRUE. Once again, great job—100% answered correctly!
A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
TRUE. 91% knew this one.
A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
FALSE. 91% answered correctly.
Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
TRUE. 74% answered correctly.
Only the personnel of the carriers transporting food product require training and training records.
FALSE. 96% got this one right.
Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
Food Safety Tech’s FSMA Supply Chain IQ test series continues with Part II. The test was put together by the subject matter experts at Kestrel Management, LLC. Before taking Part II, let’s review the results from Part I below. (If you have not taken Part I, take the test now!)
FSMA requires all records for the reevaluation of cGMPs every three years.
FALSE. Only 28% knew this.
Implementation records are required for every FSMA requirement.
TRUE. 74% got this right.
Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required.
TRUE. 90% answered correctly.
Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product.
FALSE. Respondents were almost evenly split. 51% answered correctly.
Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan.
TRUE. 92% answered on target.
Written supply chain plans are not included in FSMA food safety plans.
FALSE. 81% answered correctly.
Mandatory recalls are provided under FSMA as a new requirement.
TRUE. 63% answered correctly.
Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA.
FALSE. 74% got this right.
cGMPs under FSMA require that outer garments be suitable to protect against allergen contamination.
TRUE. 77% answered correctly.
You do not need to document records of all product testing under FSMA.
FALSE. 82% answered correctly.
FSMA preventive controls does not require hazards be addressed under the HACCP plan.
FALSE. 69% got this right.
The food safety plan does not require hazards that are unintentionally introduced within an operation’s processes.
FALSE. 82% answered correctly.
Surprised by the results? Provide feedback in the comments section.
We invite you to take Part II below and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.
2018 Recap: As VQIP implementation began, confusion among the accreditation bodies (ABs) and certification bodies (CBs) was clearly evident, and options for explanations from FDA were limited. To facilitate information sharing, AFSAP hosted an open gathering of all interested parties to hear from FDA. The inaugural AFSAP Auditing Stakeholders meeting provided a unique opportunity for the auditing community at large to interact with FDA and expand their knowledge on the regulatory use of audits in FSMA. CB attendees gained valuable insight into their hybrid role as part Scheme Owner under the Third-Party Certification Program (TPP) and its operational challenges in the global community. After vigorous discussion, the development of a consensus program for FDA’s TPP audits emerged, although the definitive mechanism to achieve this objective was still to be determined. AFSAP established a membership category for CB’s, and has continued to pursue solutions to these and other audit related issues, but information sharing has been limited to members.
2019: Although progress has been made, there is still a need for information sharing among all interested parties. Once again, the 2nd Auditing Stakeholders Meeting will be co-located with the Food Safety Supply Chain Conference in Rockville, MD, May 29–30, 2019.
AFSAP extends a gracious thank you to them for supporting AFSAP’s mission and goals.
The 2019 Auditing Stakeholder meeting will build on the TPP knowledge base, incorporating other areas that overlap with auditing and auditor development in general. FDA has a new TPP management team participating this year, along with some familiar faces from 2018. Join AFSAP in welcoming them to our event!
We have an exciting agenda planned for this year that includes a members-only session, an at-large session, and updates from FDA’s new TPP team. Association announcements will be provided after the Association’s members meeting has concluded.
AFSAP Membership Meeting
Association updates; Accomplishments, Partnerships & Alliances, Plans and Activities
Committee Updates
The Auditor Development Committee/Chair introductions
AFSAP’s Voluntary Consensus Standard (VCS) for FDA’s 3rd Party Audit
VCS Board: Introductions and Nominations
The review and publication process for a VCS
Auditing Community Meeting Highlights
SGS’ Hank Karayan
The Accreditation Experience – Lessons Learned
Just the FAQ’s – Common questions and misconceptions
The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.
About the Food Safety Supply Chain Conference
A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.
Food Safety Tech’s FSMA IQ test series continues with a two-part series that addresses supply chain considerations under FSMA. Once again, the test was put together by the subject matter experts at Kestrel Management, LLC. We invite you to take the 12-question test and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.
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