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Businesses that make products with PFAS may face unexpected issues.

By Jeffrey M. Karp

Per- and polyfluoroalkyl substances (PFAS) are a class of more than 3,000 man-made chemicals that are receiving heightened public awareness due to concerns about their potential impact on human health and the environment. Many of these chemicals were used over the past 70 years in the manufacturing processes for various consumer, commercial, industrial and military-grade products because of their unique structure and physicochemical properties, such as heat resistance, oil and water repellence and friction reduction. Despite a production phase-out for some of these compounds beginning in the 2000s, the environmental persistence and mobility of PFAS contribute to continued detections in drinking water, groundwater, soil, human blood serum, plants, fish and animals. A 2018 study conducted by the Environmental Working Group estimates that as many as 110 million Americans may be consuming tap water containing PFAS.

Compared to other well-studied contaminants in the environment, the levels of ingestion at which many PFAS may pose human health risks have not yet been clearly defined, as evidenced by current state and federal guidance levels and criteria that differ by orders of magnitude. Furthermore, studies of human exposure to particular perfluoroalkyl acids (PFAAs) generally have not shown consistent associations between blood serum levels and adverse health impacts. However, general associations that have been identified include decreased fertility rates, increased risk of certain cancers, and impaired function of the immune system.

PFAS were widely used for many years by industry sectors as diverse as textiles, metal plating, semiconductors, aviation, packaging, medical devices, cosmetics and personal care products before potential health impacts were publicly disclosed. However, as health concerns about PFAS have intensified, regulators have begun reassessing the exposure, toxicity, and potential risks from some of these chemicals. In 2016, EPA established a Safe Drinking Water Act (“SDWA”) Lifetime Health Advisory (“LHA”) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) in drinking water of 70 parts per trillion (ppt). This threshold accounts for the combined concentrations of PFOA and PFOS in drinking water sources, and is designed to offer a margin of protection from adverse health effects resulting from exposure to these PFAS. However, in June 2018, the Department of Health and Human Services’ (“HHS”) Agency for Toxic Substances and Disease Registry (“ATSDR”) released an 852 page draft report in which it found the minimal risk levels (MRL) for PFOA and PFOS in drinking water to be markedly lower, at 11 and 7 ppt respectively.

Measured concentrations of legacy PFAS like PFOA and PFOS appear to be declining in the US, as many businesses phased them out of production and began switching to alternative chemistries. Despite this trend, many PFAS continue to persist in the environment and also may bioaccumulate, which has led to a proliferation of lawsuits targeting the manufacturers of PFAS products. These cases typically involve governmental bodies or private citizens seeking redress from manufacturers for polluting groundwater with PFAS. The most prevalent defendant in these lawsuits is 3M, which used PFAS to make nonstick cookware, fire extinguishers, and stain repellent. In a lawsuit settled earlier this year, the Minnesota attorney general sought $5 billion in damages from 3M for polluting groundwater that served as the drinking water source for five Minnesota cities. The parties settled for $850 million.

Presently, 3M is defending with others a series of lawsuits brought in multiple jurisdictions by individuals, municipalities, and local water authorities involving products made with aqueous fil-forming foams (AFFF). 3M has sought consolidation in one federal district court of the cases concerning AFFF, as well as cases that may not involve AFFF but feature the same underlying PFAS chemical group. Most recently, 3M and 10 other companies, including DuPont and Chemours, were named as defendants in a lawsuit in Ohio federal court seeking class action certification on behalf of every person in America with a detectable level of PFAS in their blood serum.

PFAS litigation has commenced in many other states, including Alabama, Colorado, Massachusetts, New Hampshire, New Jersey, North Carolina, Pennsylvania, and West Virginia. PFAS were used in commerce legally for decades without public knowledge of their potential health risks. However, now that the scientific community is aware of the potential risks of PFAS exposure, large financial outlays may be expected by affected companies to perform testing, treat and remove these chemicals from the environment, and compensate for harm attributed to their exposure.

Companies facing potential PFAS liability must be cognizant of new and rapidly evolving regulatory regimes. While EPA has issued an advisory under the SDWA that recommends lifetime safe levels for PFAS ingestion, it has yet to promulgate enforceable Maximum Contaminant Levels (“MCLs”) for any of these compounds. Thus, individual states have stepped in to fill that void with a wide range of advisories, guidelines, and regulations. For example, Massachusetts and Connecticut have followed EPA guidance, adopting PFAS regulatory thresholds of 70 ppt in drinking water. New Jersey recently promulgated a drinking water MCL of 13 ppt for perfluorononanoic acid (“PFNA”), a PFAS used in the manufacture of high performance plastics. Vermont issued a health advisory for groundwater and drinking water, establishing a health advisory level of 20 ppt for five PFAS: PFOA, PFOS, PFHxS, PFHpA, and PFNA. Moreover, other states have pending or recently enacted labeling requirements for PFAS-containing products, restrictions on the use of PFAS in products such as firefighting foams and food packaging, prohibitions on the discharge of PFAS into drinking water sources, and requirements to remediate PFAS released into the environment.

Although the EPA has not listed PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “Superfund”), EPA is requiring testing for such “emerging contaminants” (which EPA defines as “characterized by a perceived, potential, or real threat to human health or the environment or by a lack of published health standards…or because a new source or a new pathway to humans has been discovered”) in the context of performing Five Year Remedy Reviews to assess the continuing effectiveness of remedial actions. Under CERCLA, EPA is required to review remedial actions involving “hazardous substances, pollutants, or contaminants remaining at the site” no less than each five years after the initial remedial action. Therefore, where PFAS are detected, the Agency may require additional investigations to assess whether further site remediation is needed to protect human health and the environment. For example, in 2017, a Five Year Review at the Hanscom Air Force Base Superfund Site in Massachusetts found elevated levels of PFOA and PFOS in a fire training area. Further sampling is ongoing, and if PFAS levels exceed the advisory level, EPA may seek to require additional site remediation.

In addition to federal and state regulatory activities, two Senate bills ? the PFAS Accountability Act of 2018 (S.3381) and the PFAS Detection Act of 2018 (S.3382) ? have been introduced and referred to the Environment and Public Works Committee. S.3381 seeks to “encourage” Federal agencies to enter into or amend cooperative agreements with states to address PFAS removal and remedial actions. S.3382 would require the United States Geological Survey (“USGS”) to perform a nationwide survey of perfluorinated compounds, beginning with sampling sources of drinking water near locations with known or suspected releases of PFAS.

As awareness of PFAS health concerns grow, so too must the attention level of businesses that have used PFAS in their manufacturing processes. Although more stringent regulatory standards and cleanup requirements are being imposed, the test methods needed to meet these standards and requirements are not well established. For example, in November 2018, EPA released a drinking water testing detection method for four additional PFAS compounds (GenX, ADONA, 11C1-PF3OUdS, and 9CI-PF3ONS). The addition of this testing method brings to 18 the number of PFAS compounds out of the many thousands found in the environment for which a drinking water testing method exists.

Moreover, concern regarding the validity of the PFAS testing methods has been raised due to the potential for sample contamination from testing equipment that may contain trace amounts of PFAS. Precise, replicable testing methods are needed to properly measure samples for detectable levels of PFAS. Further, when testing identifies the presence of PFAS above regulatory limits or standards, cost-efficient technologies must be available that effectively treat and remediate PFAS in a variety of environmental media.

The potential for costly litigation is upon us, evidenced by the growing number of lawsuits across the United States. Thus, it behooves potentially affected businesses to create a response plan to proactively address the impending PFAS storm.

Jeffrey Karp is a partner at the law firm of Sullivan & Worcester LLP and the leader of the firm’s Environment, Energy, and Natural Resources practice group. Assistance in preparing this article was provided by associates Zachary Altman and Ryan Rosenblatt, and law clerk Kevin Fink.

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By Dr. Denis Maier

Manufacturing supply chains, especially in the automotive industry, are characterized by a significant volume that is outsourced to suppliers. The added value inhouse can be as low as 20%. Sophisticated supplier selection and management systems combined with supplier development activities are essential tools to manage the inherent supply chain challenges. However, the enormous efforts for every new product launch are an indicator of the lack of sustainability. Manufacturing 4.0 will impose additional challenges on top of that and require a focus shift on supplier development.   

Traditional Supplier Development. Typical efforts to improve supplier performance range from hands-off monitoring to extensive on-site support, depending on supplier stability and performance. Even external consultants are sent in on behalf of OEM’s. Over time sophisticated systems have been developed that cover all relevant areas to get the best possible overview and status of supplier performance. When new product launches are ahead, the efforts usually intensify significantly. Increasing product complexity and customization, combined with digitization efforts, add another layer of challenges to the supply chain. The repeated efforts to bring suppliers to a desired performance level are not effective enough to be on a sustainable path. More launch curves will be flatter due to suppliers not being able to keep up or even launch dates have to be postponed.

The Right Focus. A closer look at supplier development activities reveals two underlying tendencies. On one side, the list for supplier audit questions, addressing all possible issues and risks, becomes longer and longer. The other observation that can be made is that the on-site activities have exponentially increased with resources outside of suppliers. They all have the same goal to increase the supplier performance and to ensure their launch capability. However, all efforts still focus on results, more specific on fast results. Supplier performance might increase and the launch could be somehow managed, but it will not be sustainable and the efforts have to be repeated. The reason for this "Groundhog Day" syndrome is a lack of focus on the root causes that prevent suppliers from performing at a higher level and keep them struggling with every new launch.

Lack of Focus - Substandard Worker Skills. Producing innovative products with unskilled and low-trained workers are an impossible task. Even though the majority of work stations are designed and automated in a way that the necessary skill level is rather low on the surface, the daily operational challenges require additional competencies to achieve high quality and efficiency. As automation and connectivity of systems grow further, the level of simple operator tasks will be even more reduced with new responsibilities for direct workers. At the same time indirect workers will have to be more equipped with advanced analytical and soft skills to monitor and manage the higher complexity of processes. Both direct and indirect workers will need more capabilities that need to be actively managed and monitored. Skills inventory will become a fundamental tool for Manufacturing 4.0.

Lack of Focus - Weak Shop Floor Execution Capability. Effective leadership on the shop floor can make the difference between high performance and low performance. There are mainly two issues: a shop floor leadership structure that is too lean and leaders that lack the required abilities. Strong shop floor management requires enough leadership positions, saving here is the wrong place. Team leaders and supervisors often grow into these positions without having the adequate leadership and coaching skills. It has been sufficient in the past to keep operations going, but it is certainly not enough to operate on a world-class level, to master future launch challenges and to motivate and empower workers. Analyzing key performance indicators, communicating effectively and orchestrating the work force by being a role model, teacher and mentor is crucial to stabilize production and to master the implications of Manufacturing 4.0.

Lack of Focus - Excessive Workforce Turnover. The average annual employee turnover rate in the manufacturing industry in the United States is about 16%, however with a huge variance. Excellent companies have an employee turnover rate of less than 5%. Not only is the average more than 10% away from this international benchmark, turnover rates of 30+% are also very common. At these levels, there is no possibility of sustaining any gains in skills and knowledge. Employee turnover is one of the most underrated metrics and at the same time probably the most important metric in the future. There will be a significant invest in the workforce that cannot be constantly replicated. It is not all about wages, it is also about culture to feel appreciated and inspired, a sense of belonging and an outlook for the future with a path forward to grow.

Effective and Sustainable Supplier Development. Instead of repeating the same activities over and over again, a more forward-looking supplier development process is needed that reflects current and future challenges. The focus needs to be more on the enabler side and not so much on the performance side to ensure sustainability. And monitoring supplier development activities needs a set of additional metrics that will help to get suppliers to the desired level and remain there, not just temporary for one launch.

1. Reversed Approach. Supplier development activities have to be at the peak during series production to ensure that suppliers are ready for the launch. The ground work has to be done before a new launch so there is a better chance of suppliers succeeding. The additional efforts for a new launch can be significantly reduced as the supplier will be in a much better position to absorb the requirements and to be able to manage the new processes. The goal is to get out of the vicious cycle of iterated and ineffective supplier development activities.

2. Recalibrated Efforts. Work with suppliers has to focus on root causes for inferior performance. Otherwise it will be just a band aid and the next challenge will again throw off the supplier. Unless suppliers are enabled, all efforts will fade and are in vain. Employee turnover can be analyzed to see where the company is lacking. Creating a motivated and enabled workforce is a several phase process and the basis for stability. Employee turnover can be broken down: within the first month after hiring, between one and three months, between three month and a year and after more than a year of working for the company. It will allow to focus countermeasures on the appropriate onboarding, integration and development processes of new employees, but will also give a good indication about structural issues like wages and benefits.

A simple review of the structure on the shop floor provides a first good indication of the strength of the organization. Enough leadership is necessary so there is not only time for firefighting, but also to coach and develop people. Employee turnover is also a good reflection of shop floor leadership and culture. How well can leaders create a culture of trust and commitment and make employees a part of their organization and the company? How much do employees feel valued for their work and being motivated and inspired to do their best?

Similar to the approach with employee turnover rate, a classification of the skill set will help to develop an effective roadmap for workforce development. There is a fundamental set of skills that is essential for both direct and indirect workers beyond the basic work ethic and intrinsic motivation (most companies already experience a lack there): a high flexibility to do multiple tasks, a thorough understanding and mindset of Lean Thinking as well as substantial soft-skills like critical thinking team work and effective communication. This will take the workforce from a capable to an effective level. Workforce development is not a one-time effort that can be checked off, it has to be genuine, effective and ongoing to get workers to a level that matches future requirements.

3. Refocused Metrics. In order to see improvements on the enabler side, respective metrics need to be established and monitored. Metrics that close the gap in terms of employee turnover, vital job skills and shop floor leadership. Together with the supplier, goals and timelines can be defined and reviewed in common supplier management meetings. Improving these metrics will eventually allow suppliers to have a more stable production and being equipped to face new challenges instead of struggling with every new launch.


Dr. Denis Maier is a Professor for Operations at the Business School of Wake Forest University in Winston-Salem, NC. He has more than 20 years of international industry and management consulting experience in manufacturing operations and was a Group Vice President at BMW.



Maximize efficiency when engaging in supply chain planning.

By Rahul Mital

As the global marketplace expands, the need for more efficient supply chain planning and management tools follows suit. Manufacturers have to be able to match demand to supply—no matter where that supply may be located or how widespread the organization may be. To accomplish that goal requires a commitment to the planning for, integration of and continual evaluation of the latest technology available. This is where the relatively new and untested concept of global cross-pegging comes in to play. It is the next step beyond some of the most current practices when it comes to planning, scheduling, material ordering and inventory control.

To maximize the efficiency of supply chain management, it is important to use all the technology tools available, including:

  • Enterprise Resource Planning (ERP): business process management software that enables organizations to use a system of integrated applications to manage the business (i.e. planning, development, sales, manufacturing, marketing) and to automate many back-office functions. It does this via a single database, application and user interface. (
  • Materials Requirement Planning (MRP): a sales forecast-based system used to schedule raw material deliveries and quantities  , using assumptions on the machine and labor units required to fulfill that sales forecast. ( MRP is a subset of ERP.
  • Cross-pegging: linking demand to incoming supply (per It creates a “peg chain” between a supply transaction and a demand transaction from either side of the equation. A peg prevents the incoming supply from being reserved or allocated to another demand transaction. Through data analytics or business intelligence (BI) that supplies historical, current and predictive views of business operations, global cross-pegging is the next step beyond the report generation now typically employed by those companies that do use the pegging methodology. It is using the information supplied by cross-pegging to actually execute critical decisions related to supply chain management. Cross-pegging should also be thought of as one of the techniques used in the overall planning process.

Supply Chain Mapping

In adopting these tools to their fullest extent, manufacturers need to chart a course that identifies the best available supply of materials with the agreed to due date or ship date. Then they have to reserve the materials required and identify those already in house by pegging them—in other words tying them to specific orders. Global supply chain cross-pegging helps eliminate the issuing of new purchase orders for materials needed for a customer build, thus reducing excess inventory levels and saving the company resources. It is the logical next step beyond local pegging, which treats each location for the same company as its own autonomous entity.   

Consider the local MRP for an order as the starting point. Then retrieve all of the applicable data via global cross-pegging to find the optimal solution when it comes to sourcing raw materials or parts, to meet a customer ship date with a finished product. Go beyond those preconceived boundaries in the way supply chain management is typically conducted. Global cross-pegging allows factors like transit times for materials and shipment times to be factored in. For example, it may be that another purchase order will indeed be needed to source parts if the only in-house inventory is halfway around the world, can only come by ship and would push out the promised must-have due date. This goes beyond the typical approach now employed, where cross-pegging is most often used to produce reports but does not go further in the supply chain management and ordering process to make the best possible decisions on material ordering.

Global Cross-Pegging Software Technology: A Starting Point

Oracle ERP and SAP SE offer effective and well-regarded software programs that can be used for the “base planning” functions. Yet, in many cases, customized software programming for each user will be needed to establish a true global cross-pegging system. The Oracle and SAP SE off-the-shelf products do not come with that type of logic built in. Customized software reaches beyond the imaginary and artificial local boundaries to which that large corporations often fall prey. While the upfront costs to customize a software package may require a substantial expense for programming, the return on investment (ROI) is soon evident and occurs within a relatively short period of time.

How it Works in Real Time

Before planners execute an order they should look outside of their local environment to the company’s global platform, checking if the materials or parts needed are elsewhere in the system. They can also check transit time if that inventory is in a remote location, which may be a deciding factor as to whether or not another purchase order must be issued as an alternative.

Using cross-pegging, planners are spared from having to pore over a data analytics or a BI report manually, looking for clues as to where available inventory might be found. Simply put it is the jump from local pegging to global pegging in securing the materials required for a customer order, with functions in this digitally connected world performed automatically, based on the parameters or “rules” (ship date, maximum part costs, etc.) preset upfront.

The Case for Cross-Pegging

Cross-pegging is the best way of utilizing existing inventories. It consumes excess inventory and prevents the piling up of excess stock. In competitive business environments where profit margins are especially thin, keeping unused inventory off the shelf is made easier with global supply chain cross-pegging. This methodology checks for excess inventory anywhere in the world (and automatically) when all the relative departments are tied together via a custom software package built on a reliable base program. Key Performance Indicators (KPI) that can be programmed include material costs if sourced locally versus the base costs to make or buy material or a part is already inventoried somewhere else within the organization. That is where shipping and transit costs may become a factor. The customized software could factor in shipping costs, customs fees, tariffs and other variables.

Global cross-pegging means taking the next step beyond running large, cumbersome, time consuming reports on a daily basis, then having to sit down and analyze that data manually. Cross-pegging allows for more visibility within the company on specific orders, which can also enhance corporate communication. It combines multiple resources into one connected, cohesive software system—in other words, one tool to do everything. Current ERP software packages that use a system of integrated applications to manage the business simply do not take the last step to true global cross-pegging. Asking an Oracle or an SAP SE to make the necessary changes to their planning software programs may be years away from happening and will only occur if they see a sizable market for it. That typically means software customization is the only option at this point.

Global Sourcing, Global Planning

Global supply chain cross-pegging systems provide important benefits. They streamline operations and result in lower maintenance costs. These tools save larger companies millions of dollars a year by consuming excess inventory, reducing the man hours spent producing and analyzing reports, and fostering ease of operation that can reduce the overall cost of doing business (overhead). For companies that are spending millions of dollars on data collection and business intelligence already, key players involved in the decision making chain can find the information they need in one place. No longer are they forced to search in multiple locations to find the information required.  

Second, global sourcing and planning streamlines inventory management. When excess inventory gnaws away at the bottom line, the automatic decision making that comes with global cross-pegging is a viable option. It serves as the company’s backbone and foundation, not only for increased profitability but as a leg up on the competition. In this scenario, ordinary planners become true global planners when they employ global sourcing and supply chain cross-pegging, identifying the parts or materials they need, assigning it to work orders and tying it all to due dates.

Not Yet There

Even the largest multinational companies that would benefit the most from global supply chain cross-pegging have not made the jump. Taking it from the reporting level to the “execution level” is that next step. Cross-pegging works best for large manufacturing companies and major distribution systems, where extensive parts ordering and operations scattered across the country or across several continents are the norm. For smaller firms, the upfront cost to develop a custom software package on top of the base program may not produce a suitable return on investment in a short enough time period versus the overall volume of business.

Yet, cross-pegging deserves thorough consideration and evaluation. It’s an out-of-the-box solution because it is one tool that can perform multiple functions based on rules set in place during the upfront planning process. At its core, it is simply a better way to reduce excess inventory, adhere to promised due dates, improve interdepartmental coordination/communication and enhance the bottom line.

Rahul Mital is a project and supply chain management specialist currently working in the oil and gas industry along the Texas Gulf Coast. He also has a background as a solutions architect and is well versed in Oracle applications. For questions or comments, please contact via email at:



The Pool of RCRA Universal Waste May Get Bigger

By Lynn L. Bergeson

On March 16, 2018, the U.S. Environmental Protection Agency (EPA) proposed to add hazardous waste aerosol cans to the category of “universal wastes” regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations, codified at Title 40 of the C.F.R., Part 273. 83 Fed. Reg. 11654. According to EPA, this action would benefit the many manufacturing facilities and others that generate and manage large quantities of hazardous waste aerosol cans.


At one Pennsylvania manufacturer, women play important roles and find success with tangible results.

By Susan Towers

A recent study by Deloitte found that women constitute one of U.S. manufacturing’s largest pools of untapped talent. Women made up about 47 percent of the U.S. labor force in 2016, but accounted for a small portion of manufacturing jobs. Underrepresentation of females in manufacturing may be due in part to the perception that jobs in the industry are “too difficult” or “too dirty” for women. At Miller Welding and Machine Co. (MWM), a strategic metal fabrication partner for original equipment manufacturers (OEMs), in Brookville, Pa., women are a vital part of the workforce. Female employees put their skills to use, whether on the shop floor or in the C-suite. While they work in various roles, these women all agree on one thing: anyone can have a successful career in manufacturing, regardless of gender.


Mobile Tech Is Key to Solving Manufacturing Sector’s Employee Engagement Crisis

By Bulent Osman

The words “manufacturing” and “innovation” are almost synonymous. A report from McKinsey Global Institute describes this important sector as “a vital source of innovation and competitiveness, making outsized contributions to research and development,” noting that the industry contributes disproportionately to innovation when compared to all other sectors.

Yet despite this emphasis on pursuing leading-edge R&D and advanced technologies when making products, manufacturers are not ahead of the curve when it comes to optimization of employee engagement solutions. This is evidenced by the fact that in an industry that would logically be linked with the excitement of continuous development, manufacturing workers instead rank lowest of all U.S. industries when it comes to employee engagement, with just one-quarter of workers feeling engaged according to 2017 figures from Gallup. This disheartening stat puts the manufacturing industry on the lowest rung possible as the least-engaged occupation in the most recent State of the American Workplace report.



Mexican University Innovation Leads to International Partnerships

By Juan Terrazas 

When people hear “manufacturing in Mexico” many immediately and unfortunately think cheap labor.  But in Baja California, manufacturing sectors can boast of qualified labor, which has evolved significantly in the past decade. Going from the early 1900s where industry in the area consisted of recreation and commerce, to the 1930s where the region experienced industrialization attempts before moving to the then traditional maquiladora or factories in the 1960s, and then to Asian consumer electronics in the 1990s. But since the 2010s, labor has advanced in sector specialization and tech automation in Cali-Baja, a binational megaregion – which combines Southern California and Baja California.

In the midst of the renegotiation of the North American Free Trade Agreement (NAFTA) and President Trump’s recent tariff proposals, a university in Mexico, CETYS, is working on continued collaboration with manufacturing industries and building global relationships from both an education and an industrial perspective.


Electrification and The Next Generation of American Manufacturing

By Baskar Vairamohan

Since the Great Recession, American manufacturing has seen slow, but sustained growth. A hockey stick graph shows the steep declines after 2008 with consistent — yet restrained — growth in manufacturing in the subsequent years. Data from the U.S. Bureau of Labor Statistics show the sector is adding jobs at a faster rate than almost any other part of the economy in recent months.

What is driving these changes, especially in such a turbulent economic environment, is unclear. With pending changes to international trade norms, widely discussed but yet to be proposed government-funded infrastructure investment programs, and the recent overhaul of U.S. tax codes, there is substantial uncertainty in segments of the economy impacting manufacturing. While some of these changes, such as those to the tax code, will lead to investment in this space, others provide more questions than answers.

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