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Compliance & Standards:
Key Government Organizations

     The compliance to standards, safety, materials, construction requirements and quality control is regulated by governmental and non-governmental organizations for world-wide industrial and commercial standards that are law, either through treaties or national standards. See below: See also ME Regulatory Vocabulary

Government Organizations

Organization  Title  Role
       
ADA Americans with Disabilities Act   Gov. Industry standards, regulated, mandatory by law
       
DOT 
     OST 

     NHTSA   
      FAA
      FHWA 
     FMCSA 

     FRA 
     FTA
     MARAD       
     PHMSA

     RITA 

     OIG
      STB 		Department of Transportation
 Office Secretary of Transportation
 National Highway Traffic Safety Administration
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Federal Transit Administration
Maritime Administration
Pipeline Hazardous Materials Safety Administration
 Research & Innovative Technology Administration
 Office of Inspector General
 Surface Transportation BoardRITA    		  Industry standards Gov. regulated certification by law (private and commercial travel and vehicles)
       
FDA Food and Drug Administration   Gov. Industry standards regulated - certification by law (automotive, private and commercial  vehicles)
       
USCPSC United States Consumer Product Safety Commission   Gov. regulated but not mandatory, safety reviews & product recalls
       
USDA United States Department of Agriculture Industry standards Gov. regulated - certification by law

 

International Organizations

Organization  Title  Role
       
CE   Conformité Européenne  
 (European Union - similar to US based UL)		   EU - Industry standards Gov. regulated certification, not mandatory
       
CSA Canadian Standards Association (similar to ISO 9000 series of standards)   Canadian - Industry standards Gov. regulated certification, not mandatory
       
ISO  International Standards Organization   International- industry standards Gov. regulated certification by law (automotive, private and commercial  vehicles)
       
       


USCPSC  United States Consumer Product Safety Commission

The United States Consumer Product Safety Commission USCPSC) is an independent agency of the U.S. federal government created in 1972 through the Consumer Product Safety Act to protect “against unreasonable risks of injuries associated with consumer products”.  The USCPSC has the authority to regulate the sale and manufacture of more than 15,000 different consumer products.  Products not under jurisdiction of the USCPSC include those specifically named by law as under the jurisdiction of other federal agencies; for example, automobiles are regulated by the National Highway Traffic Safety Administration (NHTSA) and the Department of Transportation (DOT), guns are regulated by the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATFE), and drugs are regulated by the Food and Drug Administration (FDA). 

The USCPSC mission is to protect consumers against unreasonable risk of injury by developing voluntary and mandatory standards, banning dangerous consumer products, issuing recalls of products already on the market, and researching potential hazards associated with consumer products.  USCPSC maintains a consumer hotline and website through which consumers may report concerns about unsafe products or injuries associated with products.  The agency also operates the National Electronic Injury Surveillance System, a probability sample of about 100 hospitals with 24-hour emergency rooms. NEISS collects data on consumer product related injuries treated in ERs and can be used to generate national estimates.

National legislation:

  • Australian Disability Discrimination Act 1992
  • Canadian Accessibility for Ontarians with Disabilities Act of 2004
  • United States Americans with Disabilities Act of 1990 and Section 508 Amendment to the Rehabilitation Act of 1973
  • United Kingdom Disability Discrimination Act 1995 and 2005

Standards under development

These standards are still under development:

  • ISO 20282-1 – Ease of operation of everyday products — Part 1: Context of use and user characteristics
  • ISO 20282-2 – Ease of operation of everyday products — Part 2: Test method

ADA  -  Americans with Disabilities Act

ADA of 1990 and Section 508 Amendment to the Rehabilitation Act of 1973 is the short title of United States Public Law 101-336, 104 Stat. 327 (July 26, 1990), codified at 42 U.S.C. § 12101 et seq.,  a wide-ranging civil rights law that prohibits, under certain circumstances, discrimination based on disability. It affords similar protections against discrimination to Americans with disabilities as the Civil Rights Act of 1964, which made discrimination based on race, religion, sex, national origin, and other characteristics illegal.  Disability is defined as "a physical or mental impairment that substantially limits a major life activity. " The determination of whether any particular condition is considered a disability is made on a case by case basis.

CE   (EU  European Standards - similar to US based UL)  

The CE mark (officially CE marking) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The formal "EC Mark" & latter "CE Marking" in the Directive 93/68/EEC in 1993 are used. Officially, CE has no meaning as an abbreviation, but may have originally stood for Communauté Européenne or Conformité Européenne, French for European Conformity.

By affixing the CE marking, the manufacturer, its authorized representative, or person placing the product on the market or putting it into service asserts that the item meets all the essential requirements of all applicable EU directives and that the applicable conformity assessment procedures have been applied.  The CE marking is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives.

To permit the use of a CE mark on a product, proof that the item meets the relevant requirements must be documented. The responsible organization (manufacturer, representative, importer) has to issue a EC-Declaration of Conformity (EC-DoC) indicating his identity (location, etc.), the list of European Directives he declares compliance with, a list of standards the product complies, a number that identifies the so called Notified Body and a legally binding signature on behalf of the organization.  The EC-DoC underlines the sole responsibility of the manufacturer.  Parts of the certification process for the CE marking could be performed by 3rd party certified testing lab or certification bodies;  Directives providing the requirements for the CE marking are created by the European Union (EU), but the markings are required throughout the European Economic Area (EEA), which also includes the European Free Trade Association (EFTA) members Norway, Iceland, and Liechtenstein, and in Turkey, which is not a part of the EU or the EFTA. (Switzerland is the only nation that is part of the EFTA (or the EU), but not the EEA.  Swiss government requirements for Swiss Exporters of the CE Mark is not compulsory except for products for export to the European Union)

The similar "e mark", rather than the CE logo, is used on motor vehicles and components for motor vehicles [1] [2] [3]. (The "e mark" for motor vehicles is not to be confused with the 'e' mark for food labels[4]).

The Automotive EMC directives use an e-Mark logo rather than the CE logo to indicate compliance. The logo is accompanied by other numbers which show which member state authority issued the product approval, which directive has been applied and which body did the testing.  For the sales of motor vehicles and their components, approvals according to the standards of the destination countries are essential.

Our experts assist you efficiently in obtaining these approvals and provide their expertise concerning the homologation (= type approval) tests and all relevant administrative matters.  Reference the CE organization for EU and non EU - European country requirements.

CSA

Canadian Standards Association (CSA) is a leader in standards development. CSA is a not-for-profit association composed of representatives from industry. Its mark appears on billions of qualified products sold annually, around the world. Approval by CSA or another recognized national testing laboratory is required by law for many products sold within Canada. Due to the legal requirement and the cost of standards testing, counterfeit marks are not uncommon

CSA develops product safety and performance standards including those for electrical and electronic equipment, industrial equipment, compressed gas handling appliances, environmental protection, and construction materials.

DOT  Department of Transportation

The Department of Transportation (DOT) is the most common name for a government agency in North America devoted to transportation. The largest is the United States Department of Transportation, which oversees interstate travel. All U.S. states, Canadian provinces, and many local agencies also have similar organizations. Each state has individual laws, requirements and interpretation of federal and state law


FDA  Food and Drug Administration  

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.     The FDA is an agency within the United States Department of Health and Human Services.  The agency is currently organized into the following major subdivisions, each focused on a major area of regulatory responsibility:

  • The Center for Food Safety and Applied Nutrition (CFSAN)
  • The Center for Drug Evaluation and Research (CDER)
  • The Center for Biologics Evaluation and Research (CBER)
  • The Center for Devices and Radiological Health (CDRH)
  • The Center for Veterinary Medicine (CVM)
  • The National Center for Toxicological Research (NCTR)
  • The Office of Regulatory Affairs (ORA)
  • The Office of the Commissioner (OC)


USDA  U.S. Department of Agriculture

The United States Department of Agriculture (USDA) is responsible for the safety of meat, poultry, and processed egg products, while the Food and Drug Administration (FDA), which is responsible for virtually all other foods.



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