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Compliance Regulations and Guidance Affecting your Industry

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UK Bribery Act 2010 - Full Text

  • Industry: Banking and Financial Services

By July 1, 2011 any commercial organization either formed in the UK or having a business interest in the UK has to comply with the UK Bribery Act 2010. The Act defines what constitutes a bribe, what sort of payments are acceptable or not and the penalties for violators.

SAFE Port Act - Full Text

  • Industry: Trade and Logistics Compliance

The Security and Accountability For Every Port Act or SAFE Port Act of 2006 was passed by the United States Congress on September 30, 2006 and President Bush signed the Act into law on October 13, 2006. While the majority of the Act covers the security of US ports, titles VI to VIII provide new requirements in the areas of emergency response to disasters, trucking security, trade of precursor chemicals and internet gambling regulations.

Foreign Corrupt Practices Act - Full Text

  • Industry: Banking and Financial Services

The Foreign Corrupt Practices Act (FCPA) of 1977 was created to implement stricter regulations against bribery. The act also includes requirements for transparency in accountancy under the SEC Act.

Clause 49 of the Listing Agreement - SEBI

  • Industry: Banking and Financial Services

Clause 49 of the Listing Agreement to the Indian Stock Exchange was added to the original agreement in 2000 by the Securities Exchange Board of India (SEBI). The clause was created to improve corporate governance of all companies listed in all Indian stock exchanges including the NSE and BSE. The clause was revised and SEBI issued the new guidelines in October 2004.

Gramm-Leach-Bliley Act - Full Text

  • Industry: Banking and Financial Services

The Gramm–Leach–Bliley Act (GLB), also known as the Financial Services Modernization Act of 1999, was signed into law by President Bill Clinton and it repealed part of the Glass–Steagall Act of 1933. The Act opened up the market among banking, securities and insurance companies.

Safety and Health Regulations for Construction

  • Industry: OSHA Compliance

The safety and health standards promulgated by the Secretary of Labor under section 107 of the Contract Work Hours and Safety Standards Act.

General safety and health provisions.

  • Contractor requirements.

             (1) Section 107 of the Act requires  that it shall be a condition of each contract which is entered into  under legislation subject to Reorganization Plan Number 14 of 1950 (64 Stat. 1267), as defined in Sec.  1926.12, and is for construction, alteration, and/or repair, including painting and decorating, that no contractor or subcontractor for any part of the contract work shall require any laborer or mechanic employed in the performance of the  contract to work in surroundings or under working conditions which are unsanitary, hazardous, or dangerous to his health or safety.

  • Accident prevention responsibilities.

             (1) It shall be the responsibility of the employer to initiate and maintain such programs as may be necessary to comply with this part.

             (2) Such programs shall provide for frequent and regular inspections of the job sites, materials, and equipment to be made by competent persons designated by the employers.

             (3) The use of any machinery, tool, material, or equipment which is not in compliance with any applicable requirement of this part is prohibited. Such machine, tool, material, or equipment shall either be identified as unsafe by tagging or locking the controls to render them inoperable or shall be physically removed from its place of operation.

             (4) The employer shall permit only those employees qualified by training or experience to operate equipment and machinery.

  • The standards contained in this part shall apply with respect to employments performed in a workplace in a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, Guam, Trust Territory of the Pacific Islands, Wake Island, Outer Continental Shelf lands defined in the Outer Continental Shelf Lands  Act, Johnston Island, and the Canal Zone.

 

  • If a particular standard is specifically applicable to a condition, practice, means, method, operation, or process, it shall prevail over any different general standard which might otherwise be applicable to the same condition, practice, means, method, operation, or process. On the other hand, any standard shall apply according to its terms to any employment and place of employment in any industry, even though particular standards are also prescribed for the industry to the extent that none of such particular standards applies.

 

  • In the event a standard protects on its face a class of persons larger than employees, the standard shall be applicable under this part only to employees and their employment and places of employment.

 

  • Compliance duties owed to each employee

             (1) Personal protective equipment. Standards in this part requiring the employer to provide personal protective equipment (PPE), including respirators and other types of PPE, because of hazards to employees impose a separate compliance duty with respect to each employee covered by the requirement. The employer must provide PPE to each employee required to use the PPE, and each failure to provide PPE to an employee may be considered a separate violation.

             (2)Training. Standards in this part requiring training on hazards and related matters, such as standards requiring that employees receive training or that the employer train employees, provide training to employees, or institute or implement a training program, impose a separate compliance duty with respect to each employee covered by the requirement. The employer must train each affected employee in the manner required by the standard, and each failure to train an employee may be considered a separate violation.

ComplianceOnline Webinars Construction Compliance

Military Construction Contracting Safety Regulations – OSHA & the EM385-1-1, what you don’t know could cost you your contract!

To know more about: - Safety and Health Regulations for Construction

Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

  • Industry: All FDA Regulated Industry

This document address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. It also addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

The National Environmental Policy Act of 1969

  • Industry: EH&S, Green Compliance

The purposes of this Act are: To declare a national policy which will encourage productive and enjoyable harmony between man and his environment; to promote efforts which will prevent or eliminate damage to the environment and biosphere and stimulate the health and welfare of man; to enrich the understanding of the ecological systems and natural resources important to the Nation; and to establish a Council on Environmental Quality.

 NEPA contains three important sections:

  • The declaration of national environmental policies and goals.
  • The establishment of action-forcing provisions for federal agencies to enforce those policies and goals.
  • The establishment of a Council on Environmental Quality (CEQ) in the Executive Office of the President.

NEPA requirements are invoked when airports, buildings, military complexes, highways, parkland purchases, and other federal activities are proposed. Environmental Assessments (EAs) and Environmental Impact Statements (EISs), which are assessments of the likelihood of impacts from alternative courses of action, are required from all Federal agencies and are the most visible NEPA requirements.

ComplianceOnline Webinars Related Environmental Compliance

How to Avoid the Environmental Compliance Nightmare

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Approach to comply with federal Mandatory GHG Reporting Rule, perhaps the most complex environmental rule yet

To know more about: - The National Environmental Policy Act

The Hazardous Materials Transportation Act (HMTA)

  • Industry: OSHA Compliance

The Hazardous Materials Transportation Act (HMTA) regulates the marking, manifesting, labeling, packaging, placarding, and spill reporting provisions for hazardous materials in transit.

Under the law, shippers must certify that they are in compliance with Department of Transportation (DOT) regulations. When Environmental Protection Agency- regulated hazardous wastes are shipped, they must be accompanied by a uniform hazardous waste manifest.

During the reauthorization, the Act was amended to settle the issue of Federal pre-emption of State hazardous materials laws by delineating areas of: 

  • Exclusive Federal jurisdiction
  • Joint Federal and State jurisdiction
  • Areas open to State and local jurisdiction
  • The hazardous materials regulations initially applied only to interstate transit
  • In 1997, the hazardous materials regulations were extended to cover intrastate transit.

Objectives

Terminal Objective Given the Environmental Laws and Regulations course manual as a reference, you will be able to: 

  • Explain how the Hazardous Materials Transportation Act (HMTA) affects the DOE and its transportation and shipping of hazardous wastes and materials. 

Enabling Objectives 

  • Describe the requirements set forth in DOT Dockets HM-126F and HM-181.
  • List the HMTA provisions presented in 49 CFR.

ComplianceOnline Webinars Related Hazardous Materials

How to Identify Hazardous Wastes at the Work Place

Hazardous Waste Regulation: 10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations

To know more about The Hazardous Materials Transportation Act (HMTA)

Validation of Cleaning Processes

  • Industry: Drugs and Chemicals (Pharma)

This document serves as a guide to investigators and other FDA personnel inspecting and validating cleaning processes.

It is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). Simultaneously, one must recognize that for cleaning validation, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that the system consistently does as expected and produces a result that consistently meets predetermined specifications.

This guide is intended to cover equipment cleaning for chemical residues only.

Laboratory GMP Systems

  • Industry: Laboratory Compliance
  • Publisher: ComplianceOnline

21 CFR Part 211 requires Pharmaceutical laboratories to comply with the cGMPs.  Implementation of good cGMPs can also serve the business needs of the organization if implemented appropriately. 

Bank Secrecy Act compliance

  • Industry: Banking and Financial Services

Congress passed the Bank Secrecy Act in 1970 as the first laws to fight money laundering in the United States. The BSA requires businesses to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, and regulatory matters. The documents filed by businesses under the BSA requirements are heavily used by law enforcement agencies, both domestic and international to identify, detect and deter money laundering whether it is in furtherance of a criminal enterprise, terrorism, tax evasion or other unlawful activity.

Purpose

This subpart is issued to assure that all national banks establish and maintain procedures reasonably designed to assure and monitor their compliance with the requirements of subchapter II of chapter 53 of title 31, United States Code, and the implementing regulations promulgated there under by the Department of Treasury at 31 CFR part 103.

Compliance procedures

On or before April 27, 1987, each bank shall develop and provide for the continued administration of a program reasonably designed to assure and monitor compliance with the recordkeeping and reporting requirements set forth in subchapter II of chapter 53 of title 31, United States Code, and the implementing regulations promulgated there under by the Department of Treasury at 31 CFR part 103. The compliance program shall be reduced to writing, approved by the board of directors and noted in the minutes.

Contents of compliance program

The compliance program shall, at a minimum

  • Provide for a system of internal controls to assure ongoing compliance;
  • Provide for independent testing for compliance to be conducted by bank personnel or by an outside party;
  • Designate an individual or individuals responsible for coordinating and monitoring day-to-day compliance; and
  • Provide training for appropriate personnel.

(Approved by the Office of Management and Budget under control number 1557-0180)

 Effective Date Jan. 27, 1987

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Federal Insurance Contributions Act

  • Industry: Banking and Financial Services

The Federal Insurance Contributions Act (FICA) is a United States payroll (or employment) tax imposed by the federal government on both employees and employers to fund Social Security and Medicare federal programs that provide benefits for retirees, the disabled, and children of deceased workers. Social Security benefits include old-age, survivors, and disability insurance (OASDI).

Social Security payroll taxes are collected under authority of the Federal Insurance Contributions Act (FICA). The payroll taxes are sometimes even called "FICA taxes.”.

 In the original 1935 law the benefit provisions were in Title II of the Act (which is why we sometimes call Social Security the "Title II" program.) The taxing provisions were in a separate title, Title VIII. There is a deep reason for this, having to do with the constitutionality of the law (see discussion of the Constitutionality of the 1935 Act).  As part of the 1939 Amendments, the Title VIII taxing provisions were taken out of the Social Security Act and placed in the Internal Revenue Code. Since it wouldn't make any sense to call this new section of the Internal Revenue Code "Title VIII," it was renamed the "Federal Insurance Contributions Act."

So FICA is nothing more than the tax provisions of the Social Security Act, as they appear in the Internal Revenue Code.

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Understanding the new NAIC (National Association of Insurance Commissioners) Model Regulation

To Download the summary of major changes to Federal Insurance Contributions Act (FICA).

The FDA Food Safety Modernization Act (FSMA)

  • Industry: Food Safety Compliance

The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.


The Federal Unemployment Tax Act (FUTA)

  • Industry: Banking and Financial Services

The Federal Unemployment Tax Act (FUTA) provides for cooperation between state and federal governments in the establishment and administration of unemployment insurance. Under this dual system, the employer is subject to a payroll tax levied by the federal and state governments. The taxpayer is allowed a maximum credit of 5.4% against the Federal tax of 6.2%, provided that all payments were made to the state by the due date. Employers whose payments are received by the state after the due date are allowed 90% of the credit that would have been allowed had the payments been made on time. The FUTA Certification program is the method IRS uses to verify with the states that the credit claimed on the Form 940 and/or Schedule H was actually paid into the state’s unemployment funds. There are currently 53 participating agencies which encompass the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.

The American Recovery and Reinvestment Act of 2009

  • Industry: Energy & Utility

The ARRA was signed into law by President Barack Obama on February 17, 2009. The ARRA is a wide-ranging effort to jumpstart the weakened economy and to lay the groundwork for developing an economy that will be able to meet the challenges of the 21st century through investment in infrastructure, energy, education, and tax cuts. If successful, ARRA could create up to 3.5 million jobs by the end of 2010. The ARRA includes a large number of funding opportunities and tax incentives to support investment in clean energy at the local level. These incentives are designed to strengthen the economy and to promote clean and renewable energy.

The purposes of this Act

  • To preserve and create jobs and promote economic recovery.
  • To assist those most impacted by the recession.
  • To provide investments needed to increase economic efficiency by spurring technological advances in science and health.
  • To invest in transportation, environmental protection, and other infrastructure that will provide long-term economic benefits.
  • To stabilize State and local government budgets, in order to minimize and avoid reductions in essential services and counterproductive state and local tax increases.

Bioequivalence Recommendations for Specific Products

  • Industry: All FDA Regulated Industry

This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site,2 rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. This process also will provide a meaningful opportunity for the public to consider and comment on BE study recommendations for specific drug products.

Bioequivalence Recommendations for Specific Products

  • Industry: All FDA Regulated Industry

This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site,  rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. This process also will provide a meaningful opportunity for the public to consider and comment on BE study recommendations for specific drug products.

Energy Independence and Security Act 2007

  • Industry: Energy & Utility

The Energy Independence and Security Act (EISA) of 2007 aims to improve vehicle fuel economy and reduce U.S. dependence on petroleum. EISA includes provisions to increase the supply of renewable alternative fuel sources by setting a mandatory Renewable Fuel Standard, which requires transportation fuel sold in the United States to contain a minimum of 36 billion gallons of renewable fuels annually by 2022. In addition, the law sets the Corporate Average Fuel Economy (CAFE) standard at 35 miles per gallon for passenger cars and light trucks by the year 2020. EISA also includes grant programs to encourage the development of cellulosic biofuels, plug-in hybrid electric vehicles, and other emerging electric vehicle technologies. The law is projected to reduce greenhouse gas emissions by 9% by 2030.

Community Reinvestment Act regulations

  • Industry: Banking and Financial Services

The OCC, the Board, the FDIC, and the OTS (collectively, ‘‘the agencies’’) are adopting revisions to our rules implementing the Community Reinvestment Act (CRA). The agencies are revising the term ‘‘community development’’ to include loans, investments, and services by financial institutions that support, enable, or facilitate projects or activities that meet the ‘‘eligible uses’’ criteria described in Section 2301(c) of the Housing and Economic Recovery Act of 2008 (HERA), as amended, and are conducted in designated target areas identified in plans approved by the United States Department of Housing and Urban Development (HUD) under the Neighborhood Stabilization Program (NSP).

 The final rule provides favorable CRA consideration of such activities that, pursuant to the requirements of the program, benefit low-, moderate-, and middle-income individuals and geographies in NSP target areas designated as ‘‘areas of greatest need.’’ Covered activities are considered both within an institution’s assessment area(s) and outside of its assessment area(s), as long as the institution has adequately addressed the community development needs of its assessment area(s). Favorable consideration under the revised rule will be available until no later than two years after the last date appropriated funds for the program are required to be spent by the grantees.
 
Effective Date: This joint final rule is effective January 19, 2011.
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