Compliance Resources to Help you Stay Current

ISO 14001:2004 outlines the requirements of an environmental management system (EMS). Whatever an organization's activity, its EMS requirements are the same. Identifying the environmental aspects of an organization's activities, products and services, and determining its relative significance, are crucial while implementing EMS or conducting an Environmental Performance Evaluation (EPE). ISO 14001, ISO 14004 and ISO 14031 provide guidance on identifying significant environmental aspects.


 

The Centers for Medicare & Medicaid Services regulate all laboratory-testing performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). CLIA covers approximately 200,000 laboratories. The Division of Laboratory Services, within the Survey and Certification Group of the Center for Medicaid and State Operations, implements the CLIA.

The Security Industry Authority (SIA) has introduced an Approved Contractor Scheme (ACS) to raise performance standards within the security industry. The ACS is the quality benchmark within the industry. It sets out criteria that companies must fulfill to qualify under the ACS.

The Occupational Health and Safety Management Systems or OHSAS 18000 is a list of specifications on international occupational health and safety management systems, which helps in substantially minimising the risks of employees, improving the existing OH&S management system and gaining assurance. It has two parts — OHSAS 18001 and OHSAS 18002 — and encompasses BS8800 and a number of other publications.

Background

OHSAS 18001 was created as a response to the widespread demand for a recognized standard against which the organization has to be certified and assessed. This certification was intended to help an organization to control occupational health and safety risks. A main driver of creating this standard was the attempt to remove confusion in the workplace as a result of the proliferation of certifiable OH&S specifications.

A number of documents were used for framing the basics of this certification, which included BS8800, DNV Standard for Certification of Occupational Health and Safety Management Systems(OHSMS), Technical Report NPR 5001: 1997 Guide to an occupational health and safety management system and Draft NSAI SR 320 Recommendation for an Occupational Health and Safety (OH and S) Management System.

A concerted effort of a number of leading national certification and standards bodies and specialist consultation organizations were responsible for putting together the codes of OHSAS 18001. These are, among others:
 

• National Standards Authority of Ireland
• Standards Australia
• South African Bureau of Standards
• British Standards Institution
• Bureau Veritas Quality International
• Det Norske Veritas
• Lloyds Register Quality Assurance
• National Quality Assurance
• SFS Certification
• SGS Yarsley International Certification Services

Objectives

The OHSAS 18001 specifications can be applied to any organization provided the organization wishes to undertake establish an OH&S management system to eliminate or minimise risk to employees and other parties who might be exposed to OH&S risks associated with its activities, assure itself that it conforms with its stated OH&S policy, demonstrate this conformance before others, implement, maintain and improve an OH&S management system, seek certification or registration of its OH&S management system by an external organisation.

Source:

http://www.ohsas-18001-occupational-health-and-safety.com/index.htm

One of the standards of the ISO 9000 family, ISO 9001 is an internationally recognised standard of quality management in businesses, applying to the processes that create and control the products and services produced by an organisation. A systematic control of activities is undertaken to ensure that the customers’ expectations and requirements are fully met.  All requirements of ISO 9001 are generic and are designed so that they can apply to almost any product or service in any part of the world, regardless of type, size and nature.

Background

ISO was published first in 1987, largely based on the earlier BS 5750, developed by the BSI Group. Since 1978, the BSI Group has been the certifying organization for quality management.

The standards of ISO 9001 are published by ISO, the International Organization for Standardization and available through national standards bodies. The fundamentals of quality management systems include eight management principles and ISO 9001 deals with the requirements that organizations have to meet if the wish to obtain the ISO 9001 certification. A certification to the effect that an organization meets the requirements of ISO 9001 can be obtained from a third party competent to provide this certificate. Currently, over a million organizations all over the world have ISO 9001 certification making it the single most effective management tool.

Why ISO 9001?

The worldwide adoption of ISO 9001 is attributable to a number of factors, the principal among them being major purchasers requiring their suppliers to hold ISO 9001 certification, significant financial benefits identified for organizations certified with ISO 9001, organizations achieving palpably better return on assets compared with those without this certification, superior operational performance of an organisation after receiving the certification, superior performance in the stock market and investments in an ISO 9001 organization reaping huge rewards in comparison with its peers without such certification.

The mechanism of improved results has been subject to much research and has been largely attributed to a psychological boost of employees from the sheer aura of this certification.

Consequences of Violation

Even after an Organization has been granted the ISO 9001 certification, regular audits are conducted to check whether they still conform to the standards. If these checks reveal that the organization at any point falls short, non-compliance is issued and the certification is withdrawn.

Sources:

http://www.isoqar.com/iso9001/qualintro.htm

http://www.iso.org/iso/catalogue_detail?csnumber=46486

http://en.wikipedia.org/wiki/ISO_9000

Through its News Release dated Jan 24, 2010, the US Environmental Protection Agency (EPA) Region 7 has advised that all water dispensed by the Omaha Tribe’s Macy, Neb., public water system used for purposes like drinking, brushing teeth, cooking, making ice, washing dishes, or otherwise used for human consumption be boiled. The water should be boiled for up to three minutes so any bacteria or organism that may have entered the water will be killed. It has issued the notice concurrently with the Omaha Tribe to assure that the public is fully informed.

The Securities & Exchange Commission (SEC) on Jan 24, 2011 charged a former CEO of Innospec, Inc., with violating the Foreign Corrupt Practices Act (FCPA) by approving bribes to government officials to mobilize and retain business.  Innospec is a manufacturer and distributor of fuel additives and other specialty chemicals.  

According to SEC, Paul W Jennings, when he was the CFO, knew of his company’s practice of paying bribes to bag orders for sale of tetraethyl lead (TEL) during the period mid-2004 to late-2004.  After be-coming the CEO in 2005, he and others from the management approved bribery payments to officials of the Iraqi Ministry of Oil (MoO) to bag orders.  The company released the payments through its third-party agent in Iraq.

Regulations and Innospec’s Violations

SEC will act against individuals who commit bribery and sign false SOX certifications and other docu-ments to cover up the wrongdoing.

The SEC's complaint alleges that from 2004 to February 2009, Jennings signed annual certifications that were provided to auditors where he falsely stated that he had complied with Innospec's Code of Ethics incorporating the Company's FCPA policy. Jennings also signed annual and quarterly personal certifica-tions pursuant to the Sarbanes-Oxley Act of 2002 in which he made false certifications concerning the company's books and records and internal controls.

Jennings has consented, without admitting or denying the SEC's allegations, to the entry of a final judgment that permanently enjoins him from violating Sections 30A and 13(b) (5) of the Securities Exchange Act of 1934 and Rules 13a-14, 13b2-1 and 13b2-2 there under, and from aiding and abetting Innospec's violations of Exchange Act Sections 30A, 13(b) (2) (A) and 13(b)(2)(B). Jennings will disgorge USD 116,092 plus prejudgment interest of USD 12,945, and pay a penalty of USD 100,000 that takes into consideration Jennings's cooperation in this matter.

Source:

http://www.sec.gov/news/press/2011/2011-21.htm

The Environmental Defense Fund (EDF) obviously wants private equity (PE) firms to improve the environmental and financial performance of their portfolios. Towards this end it has designed a new program for use by PE firms.

A Securities and Exchange Commission (SEC) study recommends that the same fiduciary standard be applied to brokers and financial advisers, according to a published media report.  But the SEC’s two Republican members argued that the study did not present enough evidence to support such a conclusion, according to the report, published Saturday on the Wall Street Journal’s web site.  

The bone of contention is whether brokers should be held to the same fiduciary standard that already governs investment advisers.  The fiduciary standard requires investment advisers to put their clients’ interests before their own. But brokers must only make sure that the products they sell are suitable for clients. The Dodd-Frank financial reform legislation says that the SEC can hold brokers to the fiduciary duty standard.  According to the report, the two Republican commissioners, namely Kathleen Casey and Troy Paredes were not opposed to establishing a common fiduciary standard for brokers and advisers, but wanted the SEC to do more work to demonstrate that such a change would not hurt investors.

A lot is in the public domain about the standards to which financial advisers are held, in the context of the passage of the Dodd-Frank Wall Street Reform and Consumer Protection Act, which included a provision requiring the SEC to study the oversight of brokers and registered investment advisers (RIAs). Brokers oppose the fiduciary standard, because it will be costly to implement and leave certain lower-end consumers without an affordable choice.

But there is a way out of this stalemate.  If the consumer is in the market for a financial product and knows what he wants to buy, he can approach the broker.  If he is looking for advice in his best interests, he should look for a fiduciary.

Sources:

1.    http://www.thestreet.com/story/10982257/1/sec-study-backs-common-fiduciary-standard.html?cm_ven=RSSFeed

http://www.thestreet.com/story/10908574/1/making-the-f-word-standard-fiduciary.html

For the Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin-Madison it is important to maintain strict cleanroom cleanliness and sterility in their Class 7 and 8 cleanrooms. If contaminated with microorganisms, the products the WCBF manufactures can adversely harm patients. In addition, the steep price of product rejects and recalls makes it crucial to ensure high product yields.

The US Food & Drug Administration (FDA) announced on Jan 20, 2011 that the following have signed a consent decree:

• Portland Shellfish Co.
• Jeffrey D. Holden, company president
• Satyavan Singh, quality manager
• John A. Maloney, general manager

The consent decree prohibits them from distributing seafood in interstate commerce until the FDA has approved in writing Portland’s Hazard Analysis and Critical Control Point (HACCP) plans, sanitation program and Listeria monocytogenes (L. mono) testing program.

The violation

The Portland, Maine-based seafood processor sells ready-to-eat lobster, shrimp and crab products to retailers in Massachusetts, California, Georgia, Illinois, Nevada, Washington, New Jersey and Louisiana. Portland Shellfish violated the Federal Food, Drug & Cosmetic Act by introducing into interstate commerce, food that was prepared, packed or held under insanitary conditions.

FDA investigators documented significant deviations from the seafood HACCP regulation. The FDA’s laboratory analysis of samples collected by investigators during the company’s 2010 inspection confirmed the presence of L. mono within a Portland Shellfish food processing facility and in a ready-to-eat product. L. mono is a pathogenic bacterium that, when ingested, can cause the disease listeriosis.

Previous FDA inspections documented insanitary conditions at Portland Shellfish’s facilities and ongoing violations of applicable regulations. Despite the FDA’s warnings Portland Shellfish Co., Inc. continued to violate FDA regulations and the Act. The decree also allows the FDA to order a shutdown, recall or other corrective action in the event of future violations. Failure to abide by the agreement can also lead to civil or criminal penalties.

Regulations

The FDA enforces the seafood HACCP regulation to ensure the safety of fish and fishery products distributed to the public. Failure to comply with the seafood HACCP regulation renders food adulterated under the Act.

Source:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239108.htm

According its Press Release dated Jan 21, 2011, the Federal Aviation Administration (FAA) is proposing a USD 170,000 civil penalty against Pemco World Air Services of Dothan, Ala.

The violation

The latter allegedly failed to subject two individuals to pre-employment drug tests while hiring their services for safety-sensitive positions in the company. The FAA has also cited Pemco’s failure to carry out the prescribed follow-up drug or alcohol testing on eight other individuals reinstated after completing return-to-duty training during 2008. In all, the company failed to carry out twenty-four prescribed follow-up tests. Failure to administer the pre-employment and reinstatement tests violate the provisions of the Federal Aviation Regulations.

A news release dated Jan 20, 2011 issued by the US Environmental Protection Agency (EPA) states that a federal District Court judge in Washington D.C. issued an order on Jan 20, 2011 extending by 30 days EPA’s deadline to issue emission standards concerning large and small boilers and solid waste and sewage sludge incinerators. EPA would have been happier with a longer extension.

The Securities & Exchange Commission (SEC) voted on Jan 20, 2011 to adopt two sets of new rules. The said rules are meant to help revive the important asset-backed securities (ABS) market by encouraging better disclosure for investors. The first set of rules requires issuers of asset-backed securities to disclose the history of the requests they received and the repurchases they made related to their outstanding asset-backed securities. The second set of rules requires issuers of asset-backed securities to conduct a review of the assets underlying those securities.  

Disclosure for Asset-Backed Securities Related to Representations, Warranties and Repurchase

Section 943 of the Dodd-Frank Act requires the SEC to prescribe regulations on the use of representa-tions and warranties in the market for asset-backed securities. The final rules approved on Jan 20, 2011, and proposed in October 2010, implement Section 943.

Requirements of the Final Rules (adopted new rules)

The final rules require:

• Disclosure of Repurchase History on New Form ABS-15G
• Disclosure of Repurchase History in Prospectuses and Ongoing Reports
• Disclosure in Any Report Accompanying a Credit Rating by an NRSRO

Issuer Review of Assets Underlying Asset-Backed Securities

Section 945 of the Dodd-Frank Act requires the Commission to adopt rules regarding the review of as-sets, such as loans, underlying asset-backed securities. The final rules approved today, which were proposed in October 2010, implement Section 945.

Requirements of the Final Rules (adopted new rules)

The final rules require:

• Issuers of ABS in Registered Offerings to Perform a Review of the Assets
• Issuers of ABS to Disclose Information about their Reviews

Any registered offering of ABS commencing with an initial offer after Dec. 31, 2011, must comply with the new rules if they're adopted by the Commission.

  Source:

http://www.sec.gov/news/press/2011/2011-18.htm

PepsiCo is well on its way to becoming one of the world’s most sustainable companies. About a couple of years after it launched its Path to Zero program, the company has released an update on the progress it has made in respect of its environmental targets and its pursuit to become a fossil fuel-free operation by 2023.

According to documents associated with the case, the Mine had 11 unpermitted discharges into the Nenana River, Hoseanna Creek, Sanderson Creek, and Francis Creek between April 2007 and July 2010. During that time, the mine also had 10 violations of their discharge permit limits.

FDA regulates medical devices and places them under one of the three classes, viz., Class I, Class II and Class III, based on the level of risk they carry. Class I and Class II devices are generally regarded as low-risk devices. They require FDA Clearance of an application called Premarket Notification ((or 510(k)) if the device is to be permitted to be sold in US. Class III devices, which tend to be high-risk devices and first-of-a-kind devices, require FDA Approval in the form of a Premarket Approval (PMA) Application.

On Jan 14, 2011, the Securities & Exchange Commission (SEC) charged an upstate New York-based penny stock promoter Christopher Wheeler and his affiliated website OTCStockExchange.com with fraud for failing to disclose that he was paid by certain issuers to promote their stock. Simultaneously he liquidated millions of his own shares and profited by at least USD 2.95 million.  

According to SEC, Wheeler received compensation at various times in 2007 and 2008 to promote several thinly-traded penny stocks on his website.  The website claimed it had compiled a long list of successful stock picks which afforded an opportunity to investors to make a fortune.  Wheeler featured the issuers’ stock on his website, recommending that investors purchase the securities.  He posted lofty price predictions for the stock without any reasonable basis.  The promotional efforts often led to dramatic but temporary increases in the volume of shares traded and the price of the issuers’ securities.  Once the prices went up, Wheeler dumped shares from his personal brokerage account onto the market.  

Regulations

Wheeler and OTCStockExchange.com concealed from investors that Wheeler was paid to hype the very stocks that he was unloading from his own account.  Securities laws require stock promoters to disclose their compensation so investors can make informed decisions about the credibility of the information they are being provided. Wheeler’s failure to disclose that he was paid by certain issuers to promote their stock thus violated the securities laws.  

The SEC's complaint seeks a final judgment permanently enjoining Wheeler and OTCStockExchange.com from future violations of the federal securities laws, and an order permanently barring Wheeler from participating in any offering of penny stock, requiring the defendants to pay financial penalties, and requiring the defendants and North Coast to disgorge all ill-gotten gains plus prejudgment interest.

Source:

http://www.sec.gov/news/press/2011/2011-12.htm

On Jan 14, 2011, the Securities & Exchange Commission (SEC) voted to propose a rule to define how certain security-based swap transactions are acknowledged and verified by the parties thereto. Under the rule, SBS entities should furnish to their counterparties a trade acknowledgement detailing transaction-specific information. It is another step by the SEC to raise the transparency associated with the security-based swap market. SBS entities should provide their counterparties with an electronic record containing the security-based swap transaction-specific information.

Specifically, the SBS entity would:

• Provide a trade acknowledgment to its counterparty in a security-based swap transaction within 15 minutes, 30 minutes or 24 hours of execution, depending on whether the transaction is executed or processed electronically.
• Electronically process security-based swap transactions if the SBS entity has the ability to do so.
• Have written policies and procedures in place that are reasonably designed to obtain verification of the terms outlined in the trade acknowledgment.

Additionally, it would:

• Specify which SBS entity is responsible for providing the trade acknowledgment.
• Permit an SBS entity to satisfy the requirements of the proposed rule by processing the transaction through the facilities of a registered clearing agency.
• Identify the transaction details that must be included in the trade acknowledgement.
• Provide limited exemption from the requirements of Rule 10b-10 under the Exchange Act for SBS entities that are also brokers.

Regulations

The new rule, Rule 15Fi-1, is being proposed under Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act.  The Act generally authorizes the SEC to regulate security-based swaps. Among other things, the new law gives the SEC the authority to establish standards for the confirmation and documentation of security-based swap transactions entered into by SBS entities.

Source:

http://www.sec.gov/news/press/2011/2011-13.htm

Walmart’s charity arm is donating USD 2 million to a dozen plus food banks in the U.S to fund energy-efficiency programs.  The Walmart Foundation is allocating the money to 16 different organizations.  The latter will use the grants to upgrade lighting, refrigeration, heating and air-conditioning.  The improvements effected with the grants are likely to bring down energy use by 5.2 million kilowatt hours a year and save more than USD 625,000 annually, a sum good enough to buy more than 300,000 meals.  

America’s Second Harvest of the Big Bend in Florida, Bay Area Food Bank in Alabama, Feeding America — Kentucky’s Heartland, Feeding South Florida, Food Bank of Central & Eastern North Carolina, Food Bank For New York City, Food Bank of Western New York, Gleaners Community Food Bank in southeast Michigan, Gleaners Food Bank of Indiana, Greater Baton Rouge Food Bank, Huntington Area Food Bank in West Virginia, Los Angeles Regional Food Bank, Oregon Food Bank, Roadrunner Food Bank in New Mexico, Second Harvest Food Bank of Greater New Orleans and Acadiana, and Second Harvest Food Bank of Metrolina in North Carolina are the recipients of the grant.  The USD 2 million donation is part of a larger commitment made by Walmart Foundation to food banks in May.  Walmart intends to release USD 250,000,000 in grants to food banks along with 1.1 billion pounds of food.  

Promotion of Energy Efficiency

Energy efficiency has become a sensible environmental and business practice. It will reduce greenhouse gas emissions and costs. Thus,
 

• Empire State Building has turned to 100% green power.
• Kaiser Hospital in California's Silicon Valley Taps Solar Power.
• BNY Mellon's Energy Star Data Center Saves Millions in Energy Costs by resorting to relatively basic measures.

Source:

http://www.greenbiz.com/news/2011/01/18/walmart-donates-2m-food-bank-energy-efficiency?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+Greenbuzz+(GreenBiz+Feed)