RFID Law Blog

Several states, including California and Florida, are pursuing ePedigree requirements that may include RFID. There are also more than 20 states considering legislation to regulate RFID in some capacity. The role of the federal government versus that of the states is important for those in the RFID space to understand and determine how best to address their public policy interests. 

If you’re going to be in Washington, DC on Tuesday, June 17^th, you’ll want to check out “Congress vs. the States,” a business regulatory discussion being held at the McKenna Long & Aldridge LLP office at 1900 K Street NW. The event will be chaired by Lawrence Ebner, a partner at McKenna and presenters will include:

• S. William Becker, Executive Director, National Association of Clean Air Agencies
• Ronald A. Cass, Chairman of the Center For the Rule of Law and Dean Emeritus,Boston University School of Law
• Robin S. Conrad, Executive Vice President, National Chamber Litigation Center
• Michael S. Greve, John G. Searle Scholar, American Enterprise Institute for Public Policy Research
• Douglas T. Nelson, Executive Vice President and General Counsel, CropLife America
• Raymond C. Scheppach, Executive Director, National Governors Association
• David C. Shonka, Principal Deputy General Counsel, Federal Trade Commission

Registration is free, but make sure to RSVP here by June 9^th, as space is limited. You can view the complete agenda here.

| Posted By RFIDblogger In Drug Chain Security , Federal Legislation , Government Usage of RFID , State Legislation | Permalink | 0 Comments

On Wednesday, October 10th, 2007, SAP and the National Chamber Foundation will be co-hosting RFID Solutions: Securing the Commerce of Tomorrow. It will be a great opportunity to meet and hear government and private-sector officials including: Gerald Santucci, EU Information Society Directorate, David Nabarro, United Nations (UN), System Senior Coordinator for Avian and Human Influenza, UN Development Group, W. Ralph Basham, Commissioner, Customs and Border Protection, Department of Homeland Security, Representative Bob Goodlatte (R-VA), Co-Chair, Congressional Internet Caucus, Dan Caprio, Senior Fellow, The Progress & Freedom Foundation, Bill McDermott, President & CEO, SAP Americas, David Nabarro, United Nations (UN) System Senior Coordinator for Avian and Human Influenza, UN Development Group, Mark Roberti, Founder and Editor, RFID Journal, and Hugo Teufel III, Chief Privacy Officer, U.S. Department of Homeland Security. More information can be found here.

| Posted By RFIDblogger In Government Usage of RFID | Permalink | 0 Comments

On Tuesday, Juy 10, 2007, a subcommittee of the Senate Homeland Security and Government Affairs held a hearing on the Department of Defense Supply Chain Management. The Honorable Jack Bell, Deputy UnderSecretary of Defense (Logistics & Materiel Readiness), General Norton A. Schwartz, Commander, US Transportation Command, and Lieutenant General Dail, Director of the Defense Logistics Agency testified on behalf of DoD. Bill Solis, Director Defense Capabilities Management testified for the General Accountability Office. The hearing reviewed actions DoD has taken to implement its end-to-end logistics strategy since the last hearing in July 2006.

Senator Voinovich (R-OH) had the opportunity to ask three questions; two were on RFID. Senator Voinovich was interested in how the use of RFIDs improved DoD's supply chain process (were fewer mistakes were being made) and to what extent was DoD adapting best business practices. He also wanted to know whether there was a business case analysis to support the further use of RFIDs.

General Schwartz, US TRANSCOM, took the lead on answering both questions. With respect to the first question General Schwartz explained that he had been to the various large users of RFID, e.g. Wal-mart, Best Buy. The challenge facing the military is the uniqueness of the 'customer'. The soldier who needs the item is frequently moving and is in places where there are no zip codes or addresses. General Schwartz went on to explain the need to match properly the different kinds of technology (active vs. passive) with the proper objective. The two primary objectives being in-transit visibility and inventory management.

All three witnesses answered Senator Voinovich's second question in the affirmative.

| Posted By RFIDblogger In Government Usage of RFID | Permalink | 2 Comments

The Deparment of Transportation's Transportation Security Administration is looking for feedback on how to design a system to help them track passengers and luggage from the start to finish of their travels. This RFI process is usually designed to help educate government policymakers about new and innovative solutions to government problems for the purpose of shaping their purchasing decisions. They don't know everything about what tracking and tracing technology solutions exist, so they ask for feedback from the public -- but they will only know what people submit to them.

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In another indication of how government decisions impact private industry, the Department of Defense has reiterated its commitment to eventually require RFID Gen2 tags on all products shipped to the DOD -- no matter how small or inexpensive the items being shipped.

In clarifying how it intends to apply the new Gen2 contract requirment, DOD reiterated that the tags will be required for "suppliers of packaged field rations such as Meals Ready to Eat, clothing and individual equipment, tools, tents, and weapons systems repair parts and components; ...lubricants, oils, preservatives, chemicals, additives, construction and barrier materials, and medical materials ."
While clarifying the deadlines and reiterating its support for Gen2 tags, the DOD responded to government contractors concerned about the stockpiles of Generation 1 tags they purchased at the urging of the DOD -- tags that would be immediately obsolete under the new rules. DOD gave them a small extension of time to continue using their surplus of Generation 1 tags.

This maneuver has obvious business consequences for those in the RFID space - either technology providers or their customers. Government contractors - especially smaller businesses shipping inexpensive merchandise -- may be reluctant to again invest a lot of time and money upgrading their systems to accept Gen2 tags if they are stuck holding a lot of Generation 1 inventory from previous requirements. While DOD has demonstrated some flexibility and has telegraphed its intentions well over time, implementing RFID systems can be expensive and challenging especially for smaller businesses. Anyone not paying attention to what the DOD's intentions were regarding RFID could be working overtime now to address an expensive mistake.

| Posted By RFIDblogger In Government Usage of RFID | Permalink | 0 Comments

"Radio Frequency in Document Identification: "Roundtable Discussion on Passports, Real IDs, and Other Digital Devices"
RFID Roundtable: A project of the Advisory Committee to the Congressional Internet Caucus Dec. 14, 2006 U.S. Capitol Building

Roger Cochetti of CompTIA opened the meeting saying that Congress will be "consumed by RFID issues" for the next several years. The meeting was then divided into three issues, 1) the ePassport, 2) the Western Hemisphere Travel Initiative, and 3) Real ID.

The State Department's Deputy Assistant Secretary for Passport Services Frank Moss spoke about the newest ePassport, noting that most likely by next March, all passports issued by the US Government will contain an RFID chip. However, three new security measures have been implemented. First, in order to combat skimming, new ePassports have a metal film built into the passport cover, wrapping around both sides and blocking the RFID chip from any stimulation from and unwelcome contact from outside radio frequency readers. Additionally, the information on the RFID chip, which is the same information printed on your current passport including a detailed digital photograph, is essentially locked by a key code called Basic Access Control. Therefore, though the information on the chip is not encrypted, it cannot be communicated until it is. The third security measure taken by the State Department is the usage of a Random Unique ID Number, in which the computational power of the chip runs an algorithm that generates a new number each time it is read, so that one passport cannot be tracked from one location to the next. As the reason for choosing radio frequency technology for use in the new passports Moss cited the need for a "globally interoperable system". RFID was seen as the technology that would be most easily adopted by other countries and standardized for global usage. Moss, however, stopped before pushing to include biometric information on the embedded RFID passport chip. He claimed that it would be "hard to keep fingerprints secure on a passport". I wonder why personal information is easier to keep secure on a passport than biometric information?

| Posted By RFIDblogger In Government Usage of RFID , Homeland Security | Permalink | 1 Comments

As RFID Update reports, The Smart Card Alliance has released a statement to the State Department, disagreeing with the State Department's choice of RFID standard for use in new passport cards.  The SCA says Gen2 technology, chosen for the passport cards, is more suited for use in a supply chain, whereas the ISO/IEC 14443 standard would be a better choice for the cards. 

| Posted By RFIDblogger In Government Usage of RFID | Permalink | 0 Comments

The FDA, which has been strongly supporting the use of RFID tags to reduce counterfeiting drugs, saw their Federal ePedigree regulation blocked by the courts. The court agreed with the small drug wholesalers, who argued that the statute required so-called “pedigree” information be transmitted with every wholesale distribution of pharmaceuticals. The court did acknowledge that the statute, exempts so-called “authorized distributors” from the pedigree requirement. Thus, the court said that “authorized distributors” are permitted to sell pharmaceuticals without having to convey any accompanying pedigree information. The requirement, which was scheduled to take effect on December 1, was successfully opposed by small, independent drug wholesalers who claimed it would have been too complicated and costly to implement.

This action by the courts demonstrates a point I have made repeatedly on this blogsite.  Some of those selling RFID products and services are hoping for a "quick fix" from the government to create a market for their products, with government mandates requiring their use in certain situations -- like on drugs.  But without cooperating and collaborating with your customers -- those who will actually have to comply with those requirements, you run the risk of turning potential advocates of RFID into hostile adversaries.  This was simply a lawsuit to delay implementation of the rule due to cost.  Others could raise arguments -- in the press, to policymakers -- that RFID is risky or dangerous or an invasion of privacy.  Or any other argument that has been already been spread by anti-RFID forces.

| Posted By RFIDblogger In Drug Chain Security , Government Usage of RFID | Permalink | 4 Comments

The State Department and the Department of Homeland Security both see RFID as a tool to address their needs at the border, but they each have different needs.

The State Department, hearing concerns from privacy advocates and others, has weighed in with a preference for border documents with chips that can only be read at close range - less than 10 centimeters.

DHS, however, already uses RFID at some ports and borders, and prefers a longer read range - several meters - to help facilitate traffic and commerce at the borders. The Department of Commerce has begun to weigh in on that side too, after hearing concerns from US manufacturers that delays at ports and borders could cripple the economy.

In an unusual move, the US Senate passed an Amendment this summer that delays the implementation of this border technology initiative in order to give more time to resolve these differences within the federal government. At the same time, they picked sides, mandating that the State Department standard be adopted after a one year delay.

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Undersecretary of Commerce for Technology Administration was in San Diego and Orange County last week, speaking to a number of business organizations about his role in the Administration on a variety of federal technology policies. Undersecretary Robert Cresanti also co-chairs the RFID Interagency Working Group within the Administration, working with Alan Estevez at the US Department of Defense and other Federal Departments and agencies exploring the use of RFID for various applications.

I had the honor of introducing Robert to about 225 industry representatives at the University of California, Irvine through an organization called OCTANe and to about 50 IT and biotechnology executives in San Diego through an organization called CONNECT.

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Senators John Cornyn (R-TX) and Byron Dorgan (D-ND) gave the opening remarks at the first meeting of the Senate's RFID Caucus earlier today. National Journal quotes Senator Dorgan saying: "RFID promises dramatic benefits in areas as diverse as national security, food and drug safety, and supply chain management, and the United States needs to be at the forefront of its development and implementation,"

A dozen or so companies, including data software leader SAP and security tag manufacturer HID, showcased their technology today to a full room of Senate and Congressional staff. The purpose of the event was to introduce Senators and their staff to the emerging technology and allow them to express their interest in learning more about the benefits and risks of RFID.

According to Caucus staff, this event was intended as a technology showcase, to increase interest among key staff and Senators in the emerging technology. They intend to have additional meetings throughout the year with more opportunities for companies to showcase their wares and to discuss emerging public policies.

| Posted By RFIDblogger In Government Usage of RFID | Permalink | 3 Comments

As growing evidence of the Federal government's interest in the use of RFID, the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources held a hearing on Tuesday, July 10 on the FDA's requirements for electronic chain of custody tools to eliminate counterfeiting.

While acknowledging that there are still technology and public policy questions to be resolved, Subcommittee Chairman Mark Souder (R-IN) and all of the witnesses said that RFID was the most promising technology known to help address the need to track drug supply chains to reduce counterfeiting.

Two significant public policy questions arose that should be of interest to both RFID vendors and pharmaceutical companies:

1) Interoperability and standards/ state government pre-emption: Several of the witnesses spoke of the fact that the FDA is pursuing these RFID--related requirements at the same time as California, Florida and other emerging states. Concerns were raised about the development of multiple incompatible requirements -- both domestically and internationally.

2) Liability: A representative from the American Pharmacists Association spoke positively about the benefits of RFID to limit counterfeiting and improve patient health, but also worried about the assignment of liabilty and costs for implementing the system. In his written testimony, he wrote:

| Posted By RFIDblogger In Government Usage of RFID | Permalink | 0 Comments

The Inspector General of the Department of Homeland Security has issued a report saying that the RFID system being used on certain immigration documents are not adequately secured for protecting privacy and data security. This is an additional blow to the use of RFID, following the report from the Privacy Advisory Board.

Beyond the implications to this specific program, these kinds of reports add fuel to the fire that will have consequences for private sector use of RFID. A federal government program like this attracts a lot of media attention - much more than any private company's use of RFID. And if the technology becomes labled as "risky" or "dangerous" for government use, anti-RFID forces will have lots of ammunition to argue that RFID shouldn't be used in the private sector either. Everyone in the RFID space has an interest in reversing this trend within the Federal government.

| Posted By RFIDblogger In Government Usage of RFID , Immigration | Permalink | 1 Comments

Tomorrow at 10am, the House Subcommittee on Criminal Justice, Drug Policy, and Human Resources will be holding a hearing titled "Pharmaceutical Supply Chain Security." In light of the most recent recommendation to use RFID technology from the FDA's Task Force on Counterfeit Drugs, the speakers will most likely have some interesting things to say about RFID. We'll keep you posted.

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Last week at a Congressional hearing looking at Department of Defense's presence around the globe, Secretary Ryan Henry, Principal Under Secretary of Defense for Policy, said that technologies, such as RFID, will enable DoD to deliver logistics with the same precision DoD delivers weapons - on target.

Statement made -
House Armed Services Committee Holds Hearing on Defense Department Realignment, June 20, 2006.

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In a recent article entitled "Drug Supply Security Expert Points to Weakness in RFID" (FDA Week - www.InsideHealthPolicy.com - June 9, 2006), the Institute of Health Law Studies Executive Director Bryan Liang warns that the FDA "should not rely on" RFID technology to stop the counterfeiting of prescription drugs, which has risen sharply in the past few years. Liang argues that using RFID chips on the packaging of pharmaceuticals will not stop the counterfeiting because drugs are removed from their original packaging and repackaged into smaller quantities for retail sale, and therefore any protection provided by the RFID chip is lost at that point.

"Repackaging defeats everything the manufacturer does to combat counterfeiting," according to Alan Goldhammer of The Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA agrees with Liang, and has expressed these concerns as far back as 2003, when they noted in a letter to the FDA that, "the FDA should look for opportunities to reduce the level of repackaging for resale which exists today." PhRMA does not discount the advantages of using RFID for drug security, but warns that it alone is not sufficient.

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The FDA's decision to ramp up their requirements for tracking drugs creates both great opportunities and risks for those in the RFID industry.

On the one hand, if executed well - it could create a huge market opportunity for RFID technology manufacturers and a clear pathway for more efficient, safe and cost-saving inventory management systems for the pharmaceutical industry. Consumers, too, could benefit from safer, less expensive drugs.

However, there are also risks. Since pharmaceutical companies provide drugs to government markets too-- the VA, DoD, CDC-- poorly executed strategy could create different technology standards depending on who they are tracking for.

There are also signifigant questions about who controls the tracking data - and who is legally liable for its accuracy and completeness. If someone takes contaminated drugs because a chip reader missed a stage in the distribution process that could have alerted consumers of a problem - who can be sued? The drug company, the hardware manufacturer, the software company managing the data, the government?

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In reaction to recent mining incidents, where rescuers could not locate trapped miners, the US Senate is moving legislation updating the 1977 Federal Mine Safety and Health Act. The Committee on Health, Education, Labor and Pensions yesterday passed this bill.
The bill provides new initiatives of potential interest to providers of RFID and similar technologies, particularly requirements for tracking technologies for miners and communications capabilities. See the language below:

``(ii) POST ACCIDENT COMMUNICATIONS.--Not later than 3 years after the date of enactment of the Mine Improvement and New Emergency Response Act of 2006, a plan shall, to be approved, provide for post accident communication between underground and surface personnel via a wireless two-way medium, and provide for an electronic tracking system permitting surface personnel to determine the location of any persons trapped underground or set forth within the plan the reasons such provisions can not be adopted. Where such plan sets forth the reasons such provisions can not be adopted, the plan shall also set forth the operator's alternative means of compliance. Such alternative shall approximate, as closely as possible, the degree of functional utility and safety protection provided by the wireless two-way medium and tracking system referred to in this subpart."

The legislation also creates a grant program to develop, test, and deliver the kind of technology required above:

| Posted By RFIDblogger In Federal Legislation , Government Usage of RFID | Permalink | 1 Comments

According to a source at the Department of Transportation, the DoT has numerous RFID-related initiatives, including:

<>Federal Highway Administration: The Intelligent Transportation Systems Joint Program Office (ITS JPO) has supported the use of RFID technologies for electronic toll collection. EZ-Pass is perhaps the largest implementation of this system.

<>Federal Transit Administration: In collaboration with the ITS JPO, FTA has supported local transit use of RFID technologies for transit payment.

<>Federal Motor Carrier Safety Administration: They are testing the installation of RFID tags for use in electronic clearance of tractor trailers at automated weigh and safety stations.

<>There is also a program to develop methods of integrating technologies such as GPS and RFID devices.

Though the Department of Transportation has been participating in the Interagency Working Group within the Federal government, and is planning to develop its own internal Working Group within in the near future, as of now, their RFID initiatives have yet to be conducted in a coordinated way the promotes interoperability or consistency. This example is just one of many within the Federal Government at this stage. The rule, not the exception.

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