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Volume 27, Issue 4

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Jon Seals

 

Microscopic view of Ebola virusCDC is responsible for protecting the public from a host of health threats, including some pretty scary pathogens, like Ebola virus or anthrax for example. One way we do this is through our Select Agents Program which is responsible for governing and regulating the use of certain pathogens by research facilities and labs around the world. In the beginning of December I had the remarkable opportunity to accompany the inspection team who helps regulate the Select Agents Program on one of their routine lab inspections. I was invited to an inspection of a laboratory in the Southeast region of the U.S. that handles rare and dangerous pathogens to get a glimpse of how the Inspection team operates, what they look for, and what they do to protect us.

Laboratory inspections are an important aspect of the Select Agents Program since they ensure that labs and research facilities are complying with guidelines and regulations specific to biological research. In order to improve our understanding of human health and disease, some laboratories handle rare and potentially dangerous biologic agents and toxins, which are known to cause severe infection, illness, and sometimes death in humans. Laboratories that possess and use these types of biologic agents and toxins for manufacturing purposes, research use, or diagnostics must be registered through this program. When they register with the program, they agree to follow all requirements in the regulation (42 CFR Part 73 – Possession, Use and Transfer of Select Agents and Toxins) including, safety, incident response, security, and having appropriate training in place. CDC’s job is to ensure that all precautions are being taken at laboratories so that the public remain unexposed and unharmed by these potential health threats.

Suiting Up

Man inspecting door seal

The inspection that I joined actually began one week prior to the inspection date when I met with the Inspection Team to prepare a folder with all of the Southeast facility’s biosafety plans, incidence response plans, and security plans. The following week, I flew to the site to meet with the inspection team. I was set to be with the team for the first and most active day of their inspection.

The inspection started with introductions and a briefing among the group. Then there was a visitor’s training to instruct all personnel of potential hazards as well as actions to take in the event of an emergency. To avoid workplace injuries and hazards, personnel must meet all occupational health qualifications. In this laboratory, personnel must perform an exercise test to confirm adequate fitness to wear a respirator. There are two types of respirators at this facility, one that is simply a facemask and another that is a full-body suit. The team thought that I would opt for the full body respirator because it did not require that I shave my beard. However, I gladly accepted the challenge to dawn the facemask respirator (and shave my beard!) to earn my place as member of the team.

Suited up in gowns, gloves, shoe covers, masks and other inspector accessories, we were ready to begin our inspection. Our goal was to go through all of their laboratory space to check that the facility was adhering to appropriate biosafety measures. We checked biological safety cabinets and animal cages, catalogued inventory, and performed other tasks associated with laboratory compliance. Lab personnel graciously halted their work during our visit

The devoted team sought to conduct as much of the laboratory-based inspection as possible the first day. We were successful. After seven hours of tireless work and a brief stint for lunch, we had canvassed the entire facility. The personnel at the Southeast facility were pleasant, welcoming, and grateful for the visit, remarking that they looked forward to an external perspective. Having thoroughly inspected the lab, we finally retired for the day.

A Days Work is Never Done

Man and woman wearing protective gear and holding note books in a laboratory

Though I remained for only the first day, the team continued diligently throughout the week. They reviewed all of the Southeast facility’s documents, checked its security, and evaluated its waste, storage, and laboratory maintenance procedures. The team is then responsible for generating a report that lists observations that deviate from regulatory requirements. After much collaboration between the Select Agents Program and the Southeast facility, the Southeast facility is expected to implement changes to receive standard renewal.

I was incredibly impressed with the Select Agents Program’s laboratory inspection. I know that because of them, we can rest assured that high containment facilities operate at the toughest standards. Thanks to this program, the biosafety measures in place consistently enhance the safety and security that the CDC promises to uphold to the American people.

I admit it took me awhile to finally get it. I have long wondered what could have caused the explosion in Department of Justice (DOJ) and Securities and Exchange Commission (SEC) enforcement of the Foreign Corrupt Practices Act (FCPA). Starting in about 2004, FCPA enforcement has not only been on the increase from the previous 25 years of its previous existence but literally exploded. Of course, I had heard Dick Cassin and Dan Chapman, most prominently among others, talk and write about FCPA enforcement as an anti-terrorism security issue post 9/11, but I never quite bought into it because I did not understand the theoretical underpinnings of such an analysis.

I recently finished listening to the Teaching Company’s “Masters of War: History’s Greatest Strategic Thinkers” by Professor Andrew Wilson of the Naval War College. It is a 24 lecture series on the content and historical context of the world’s greatest war strategists. In his lecture on ‘Terrorism as Strategy” Professor Wilson explained that corruption is both a part of the strategy of terrorism and a cause of terrorism. After listening to his lecture and reflecting on some of the world events which invoked both parts of his explanation, it became clear to me why FCPA enforcement exploded and, more importantly, why the US government needs to continue aggressive enforcement of the FCPA and encourage other countries across the globe to enact and enforce strong international and domestic anti-corruption and anti-bribery laws.

...

http://tfoxlaw.wordpress.com/2014/02/06/the-fcpa-and-fight-against-terrorism/

At the start of each year, there’s always a long list of IT offerings vying for attention. With many solutions still looking for a problem, it pays to take a moment to consider the business impact rather than being seduced by the high-tech glitter. Here’s a quick rundown of what might affect business continuity in 2014.

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http://www.opscentre.com.au/blog/tons-of-technology-for-2014-but-does-it-help-business-continuity/

Experts generally see Big Data as a disruptive technology. Of course, you never know with these things: Sometimes you think something is amazing and it turns out to be more evolutionary than revolutionary.

But if the tech analysts are right and Big Data is a disruptive technology, then it would follow that it could also change the structure of organizations. We saw this happen a few decades ago when the proliferation of enterprise apps and personal computers led to the elevation of the CIO.

It begs the question: Will Big Data elevate data management to a CXO level?

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http://www.itbusinessedge.com/blogs/integration/will-the-big-data-disruption-impact-corporate-leadership.html

February 6, 2014

Translating Compliance

At a time when several large companies are being investigated for bribery in China, organizations doing business there would do well to have strong policies and training programs in place, experts advise. They also caution that using a “cookie cutter” approach for compliance is not enough.

“There are several ongoing investigations right now for hiring of relatives of foreign officials,” Michael Volkov, chief executive officer of the Volkov Law Group, LLC said in a webinar, “Navigating the Waters of Anti-Corruption Compliance in China.”

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http://www.riskmanagementmonitor.com/translating-compliance/

HP has published its Cyber Risk Report 2013, identifying top enterprise security vulnerabilities and providing analysis of the expanding threat landscape.

Developed by HP Security Research, the annual report provides in-depth data and analysis around the most pressing security issues plaguing enterprises. This year’s report details factors that contributed most to the growing attack surface in 2013 — increased reliance on mobile devices, proliferation of insecure software and the growing use of Java—and outlines recommendations for organizations to minimize security risk and the overall impact of attacks.

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http://www.continuitycentral.com/news07090.html

LINCROFT, N.J. -- With a new year upon us, now is an ideal time for people to review their insurance policies. Understanding the details of what specific policies cover and what the policyholder is responsible for after a disaster is important as both clients’ needs and insurance companies’ rules change.

Insurers’ decisions and legislative changes have the biggest effect on changes in policies. Consumers should make themselves aware of possible changes in these areas and know what to look for while reviewing their policies.

What’s Covered

The first check is the most obvious: the actual coverage. Policyholders should look at the specifics of which property is covered and the type of damage that is covered. Property owners should know that floods are not covered by standard insurance policies and that separate flood insurance is available. Flood insurance is required for homes and buildings located in federally designated high risk areas with federally backed mortgages, referred to as Special Flood Hazard Areas (SFHAs). Residents of communities that participate in the National Flood Insurance Program (NFIP) are automatically eligible to buy flood insurance. According to www.floodsmart.gov, mortgage lenders can also require property owners in moderate to low-risk areas to purchase flood insurance.

There are two types of flood insurance coverage: Building Property and Personal Property. Building Property covers the structure, electrical, plumbing, and heating and air conditioning systems. Personal Property, which is purchased separately, covers furniture, portable kitchen appliances, food freezers, laundry equipment, and service vehicles such as tractors.

What’s Not Covered

Policy exclusions describe coverage limits or how coverage can be purchased separately, if possible. Property owners should know that not only is flood insurance separate from property (homeowners) insurance, but that standard policies may not cover personal items damaged by flooding. In these cases, additional contents insurance can be purchased as an add-on at an additional cost. Some policies may include coverage, but set coverage limits that will pay only a percentage of the entire loss or a specific dollar amount.

The Federal Emergency Management Agency’s Standard Flood Insurance Program (SFIP) “only covers direct physical loss to structures by flooding,” FEMA officials said. The SFIP has very specific definitions of what a flood is and what it considers flood damage. “Earth movement” caused by flooding, such as a landslide, sinkholes and destabilization of land, is not covered by SFIP.

Structures that are elevated must be built up to Base Flood Elevation (BFE) standards as determined by the Flood Insurance Rate Maps (FIRMs). There may be coverage limitations regarding personal property in areas below the lowest elevated floor of an elevated building.

Cost Impact of Biggert-Waters

The Biggert-Waters Flood Insurance Reform Act of 2012 extends and reforms the NFIP for five years by adjusting rate subsidies and premium rates. Approximately 20 percent of NFIP policies pay subsidized premiums, and the 5 percent of those policyholders with subsidized policies for non-primary residences and businesses will see a 25 percent annual increase immediately. A Reserve Fund assessment charge will be added to the 80 percent of policies that pay full-risk premiums. Un-elevated properties constructed in a SFHA before a community adopted its initial FIRMs will be affected most by rate changes. Congress is still debating the implementation of Biggert-Waters.

Other Conditions

The General Conditions section informs the consumer and the insurer of their responsibilities, including fraud, policy cancellation, subrogation (in this case, the insurer’s right to claim damages caused by a third party) and payment plans. Policies also have a section that offers guidance on the steps to take when damage or loss occurs. It includes notifying the insurer as soon as practically possible, notifying the police (if appropriate or necessary) and taking steps to protect property from further damage.

“FEMA’s top priority is to provide assistance to those in need as quickly as possible, while also meeting our requirements under the law,” FEMA press secretary Dan Watson said. “To do this, FEMA works with its private sector, write-your-own insurance (WYO) company partners who sell flood insurance under their own names and are responsible for the adjustment of their policy holders’ claims.”

Policyholders should speak with their insurance agent or representative if they have any questions about coverage. For further assistance with Sandy-related flood insurance cases in New Jersey and New York, call the NFIP hotline at 1-877-287-9804. Comprehensive information about NFIP, Biggert-Waters and flood insurance in general can be found at www.floodsmart.gov.

http://www.fema.gov/disaster/4086/updates/sandy-one-year-later

FEMA's mission is to support our citizens and first responders to ensure that as a nation we work together to build, sustain, and improve our capability to prepare for, protect against, respond to, recover from, and mitigate all hazards.

Follow FEMA online at www.fema.gov/blog, www.twitter.com/fema, www.facebook.com/fema, and www.youtube.com/fema. Also, follow Administrator Craig Fugate's activities at www.twitter.com/craigatfema.

The idea of cars that communicate with each other to enhance safety and that drive themselves is counterintuitive. Airplanes, of course, have had autopilot functions for years. But Boeing 757s don’t have to pull into a parking space at Kmart or ease into traffic on the highway.

The reality is that advanced communications is playing a big role in getting from here to there. Indeed, the trend is accelerating. PCWorld and other sites report that the United States Department of Transportation (DoT) is taking steps to implement vehicle-to-vehicle (V2V) communications. The idea is straightforward:

Vehicle-to-vehicle communications refers to the emergence of Wi-Fi-like radios that could be mounted in cars and communicate with one another. Also known as Dedicated Short-Range Communications, V2V car-mounted radios would constantly communicate with other vehicles within range, providing speed and directional data to other cars' safety and navigation systems. The idea is that a car racing around a blind curve would "know" that a car was heading in the opposite direction, or a car would receive warnings that cars ahead were coming to an unexpected stop.

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http://www.itbusinessedge.com/blogs/data-and-telecom/technology-in-the-drivers-seat.html

While every organization has its risks to deal with, mining companies—local or international—must consider myriad risks from every angle in every location. There are the risks that any company should consider, such as return on capital, supply chain and natural catastrophes, but there are others that mining operations must also pay careful attention to, which can vary by location. These include political risks, corruption, weather and even piracy and kidnapping.

A new report by Willis, “Mining Risk Review: Spring 2014” found that a top concern for a mining operation is its capital. The mining sector continues to face low commodity prices, combined with rising operational costs and supply and demand imbalances. Here are the top 10 risks reported by mining operations:

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http://www.riskmanagementmonitor.com/mining-gives-risk-management-a-workout

By Michael Vizard

Becoming a truly digital business involves leveraging data to create a sustainable business advantage. Clearly, there is an incredible amount of interest in creating a new generation of IT systems that leverage big data from different sources. However, while IT has never had more tools available for deriving business value from its IT investments, the biggest impediment may well be the fact that business executives often doesn't trust the data that IT has collected.

recent survey of 442 business executives conducted by Harvard Business Review Analytics Services at the behest of QlickTech, provider of QlickView business intelligence software, finds that only 16 percent of the executives surveyed were confident in the accuracy of the data they used to make business decisions. Another 42 percent said they were not confident in their decisions simply because they couldn't get access to all the relevant data they needed.

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http://www.itbusinessedge.com/articles/a-crisis-of-data-confidence.html