Compliance Resources to Help you Stay Current

A new Cyber Security bill was introduced in IT security legislation. A new division for cyber security compliance will be created within the Department of Homeland Security (DHS) under the Homeland Security Cyber and Physical Infrastructure Protection Act of 2010. It will manage the set up of performance-based standards to tackle particular security risks faced by the nation’s critical infrastructure information networks and IT systems of civilian federal government agencies.

The Federal Energy Regulatory Commission (FERC) put forward modifications to its rules with the intention to establish integration of variable energy resources, which are rapidly emerging, with the nation’s power grid. This is in line with maintaining dependability and introducing prospective savings to consumers.

The Special Symposium on Climate Change and Impact Assessment held at the World Bank was hosted by the International Association for Impact Assessment (IAIA) at Washington, D.C. Experts talked about the impact of climate change on projects. They went further to discuss impact assessment and how it can be applied to responding to climate change and understanding associated risks. Ken Markowitz, the Managing Director for INECE commented on the topic.

Yves M. Benhamou, M.D., a French doctor and medical researcher, has been charged by the Securities and Exchange Commission (SEC) of breaking security laws by tipping a hedge fund manager with confidential information with respect to a clinical trial in which he was involved.
 

As many as three pesticide distributors working in Washington State – Skyline Chemical, LLC, Axss USA and Pace International – will be fined more than $35,000 for the illegal import of pesticides as well as misleading labelling of products. These distributors will pay penalties violating the Federal Insecticide, Fungicide and Rodenticide Act.

The United States and European Union regulatory reform efforts were discussed in a high-level meeting between the top honchos of the Committee of European Securities Regulators (CESR) and the Securities and Exchange Commission (SEC). Mary L. Schapiro, the SEC Chairman, Carlos Tavares, the CESR Chairman, and 29 CESR member regulators participated in the dialogue.

The U.S Agency for International Development and Global Health Bureaus collaborated to prepare the report: Changing Glaciers and Hydrology in Asia: Addressing Vulnerability to Glacier Melt Impacts. Climate change has long been in the news, and it is time for development agencies to educate regional communities on the impact of the slowly melting Himalayan glaciers. The report indicates the necessity to integrate education, environment, health, and social organizations in different programs.

The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) urges 14 retailers to ensure safety measures during the holiday season’s primary sales events and Black Friday. The notification to the CEO’s is on a letter and fact sheet on ‘Crowd Management Safety Guidelines for Retailers’.

The Centers for Disease Control and Prevention (CDC) observes the annual Get Smart About Antibiotics Week from 15-21 November 2010. This is the third annual meeting. The theme for this meet is antibiotic resistance.

The 2011 Fuel Economy Guide was released by the Department of Energy (DOE) and U.S. Environmental Protection Agency (EPA). The guide provides information on fuel costs and estimated mileage for vehicles released in 2011.

The Federal Aviation Administration (FAA) issued a Safety Briefing that highlights the most basic aspect of pilot safety: how to handle abnormal and emergency situations. The November/December 2010 issue (available online) outlines the intricacy of planning for the unexpected in addition to directing pilots to tools and resources made available for handling emergencies.

The Securities and Exchange Commission (SEC) launched a new whistleblower program to boost their efforts to uncover fraud. This program offers individuals compensation for valuable tips/leads that are considered critical to the agency. The rule comes under the Dodd-Frank Wall Street Reform and Consumer Protection Act. The procedure is clear-cut, mapping out a transparent process for prospective whistleblowers on how to qualify for the award, provide information and stake their claim for the award.

The Securities and Exchange Commission (SEC) adopted a new rule, making it imperative for brokers and dealers to engage risk controls before allowing customers to trade in the market.

New York State Department of Agriculture and Markets Food Inspectors conducted routine sampling of Tuv Taam Salads Nova Lox Salad manufactured by Kosher First LLC. The product was analyzed thereafter and tested positive for Listeria monocytogenes.
According to aFood & Drug Administration (FDA) recall news report,Listeriamonocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frails, or elderly people and others with weakened immune systems. Although healthy persons may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.

Consumers who meet the criteria for Medicaid or those who are looking for health insurance now benefit with the announcement from the U.S. Department of Health and Human Services (HHS) providing states with a simple and seamless enrollment experience for health insurance in state exchanges. This comes under the Affordable Care Act.

The fresh&easy™ Ginger Spice Cookie Dough (16 oz.) is being voluntarily recalled by the Fresh & Easy Neighborhood Market. This comes with the alert of undeclared peanuts, which could prove a grave risk to those individuals allergic to it, if consumed by them.
The cookies in question were sold in California, Nevada and Arizona in Fresh & Easy Neighborhood Market stores.

The U.S. Food and Drug Administration (FDA) and the University of Rochester have formed a partnership to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.

Reports about patients’ accidental exposure to excess radiation led to the U.S. Food and Drug Administration (FDA) investigate into computed tomography (CT) brain perfusion scans. The findings reported no malfunction when CT scanners were used correctly. The probable cause for overdose was determined as improper scanner use. Nonetheless, FDA came up with a set of steps designed to improve safety procedures. The chances of overexposure to radiation could be lessened with these steps, if the CT scanners were not used in the correct manner.

The U.S. Department of Transportation (DOT) and U.S. Environmental Protection Agency (EPA) brought out the first national standards to reduce carbon dioxide (CO2) emissions as well as to improve fuel efficiency in buses and heavy-duty trucks starting from the model year 2014.
 

The FDA has classified CareFusion’s decision to recall approximately 17,000 Alaris® PC units (model 8015) which had been manufactured or serviced between December 2008 and September 2009 as Class I recall. CareFusion (denoted as CFN in the NYSE) is a leading global medical device company. The FDA classifies the recall of those items as Class I recall when there is substantial possibility that the use or exposure to the product will call serious health hazards or even death.

CareFusion, on August 24, 2010, issued an urgent Medical Device Recall Notification to the customers of its Alaris PC unit model 8015. The Notification stated that the affected units may face certain intermittent error in communication under specific wireless network conditions. This would freezes the PC unit screen and finally result in a delay in therapy and the inability in making programming changes to the current infusions. If there is a communication during infusion, the infusion would continue on all channels, as has been programmed originally, but it cannot be modified. Halting the infusion, as a result of this error, to make any modification or changes in programming causes the unit to shut down delaying the therapy. This can cause serious injury or even death.

CarreFusion is still in the process of conducting a corrective action plan to rectify the problems in the hardware of the affected PC units. In the Notification issue, the customers were provided with clinical tip sheets and informed of warning tags for each affected units. Customers were also provided with instructions on the method of temporarily or permanently disabling the wireless mode of the PC unit so as to further allay the risk of serious injury.

Recent Similar Recall

In a recent incident reported in September, the FDA classified another recall of certain makes of AngioSculpt PTCA Scoring Balloon Catheter as Class I recall. This recall applied only to EX catheters — to those with part/REF numbers 2034-XXYY and lot numbers less than F09060003. In December 2009, the manufacturer had informed customers that the PTCA catheters may disintegrate during use and get lodged in the coronary arteries.

Class I, II and III Recalls Described by the FDA

It must be mentioned here that all recalls by manufacturers are categorised by FDA as Class I, Class II or Class III recall based on level of health hazard involved. While in some cases, the manufacturing company itself discovers the snag the product and recalls it from the market, in others, FDA informs the company concerned of its findings on a product and suggests a recall with which the company usually complies. In case the company does not recall, the FDA is authorised to seek legal action under the provisions of the FD&C Act.