“How can European standards affect me, especially since I only use machines built in the US?” This is a common question, and one way to answer this is to look at how machine safety is enforced, where the information comes from, and how well you can prove you followed the regulations.
There is a difference between regulations and standards. Requiring each employer to provide a safe work environment, the Occupational Safety and Health Administration (OSHA) issues citations, fines, and even jail time for companies violating one of its regulations. One of the most commonly known regulations is the “general requirements for all machines -- (a)(1) of 29 CFR 1910.212,” which states, “One or more methods of machine guarding shall be provided to protect the operator and other employees in the machine area from hazards… Examples of guarding methods are barrier-guards, two hand tripping devices, electronic safety devices, etc.”
(Source: Google images)
This is normally the point where panic starts to settle in, and the next common question is, “How?” OSHA realized it would be unrealistic to write regulations for every machine type and to keep up with new technology. And since it is a federal agency, it takes an act of Congress to pass an OSHA regulation. So OSHA uses industry consensus standards as guidance of the industry-accepted practice for safe operations.
In fact, on OSHA’s website in “Chapter 5 -- the Utilization of Industry Consensus Standards,” referring to the American National Standards Institute, it says, “Many of the various ANSI safety standards devoted to the safe use of equipment and machines are pertinent and provide valuable guidance as they relate to the multitude of safe operating procedures regularly discussed in ANSI safety standards.”
If OSHA issues a citation, it won’t be specified by the ANSI standard it references. Instead, it will be against one of their regulations, perhaps 1910.212(a)(3)(ii), “The guarding device shall be in conformity with any appropriate standards thereof, or, in the absence of applicable specific standards, shall be so designed and constructed as to prevent the operator from having any part of his body in the danger zone during the operating cycle.”
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Standards are documents compiled by industry experts. In many cases, the experts include those who have experience with the equipment, the safety devices, and even the effects of an unfortunate event. In the US, the most widely used standards are those provided by ANSI; the use of standards is voluntary. The forward of the ANSI/PMMI 155.1-2011 states, “As a voluntary standard to establish safety requirements for packaging machinery and packaging-related converting machinery.”
As more OEMs began building machinery used around the globe, it only made sense that similar standards became harmonized. In the forward of ANSI/PMM 155.1-2011, it says, “This version of the standard has been harmonized with international (ISO) and European (EN) standards … that integrates the requirements of ISO 12100 parts 1 and 2, and ISO 14121 (now ISO 12100), as well as US standards.” So with the exception of minor wording changes to make it easier to read and understand, the content remains the same.
So what force do the European and international standards have in the US? The same force of the marketplace as ANSI and other US standards. Now, instead of just having the consensus of experts from the US, experiences from all over the world are shared and used to come up with guidelines. After all, many topics in the standards are discovered through accidents and close calls.
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The next common question is, “Does following the standards mean no one will ever get hurt?” No hazard can be eliminated or completely avoided. Unfortunately, employees continue to find the most unexpected ways to bypass safeguarding and get injured. In fact, that is one reason why standards sometimes state the obvious and give reasonable solutions. An example is in section 7.21, “A machine shall have sufficient stability to allow it to be used safely under the conditions of use and reasonably foreseeable misuse.” It includes a list of ways the machine could become unstable, in the informative notes section.
Before an accident could occur, a well-known anecdotal comment to remember is, “The proof of the guarding is in the litigation.” It is after an incident where the real value of standard usage comes to light. If a machine operator died due to nitrogen suffocation on a vertical form, fill, and seal machine, would you rather have the argument of “here is the documentation showing proper detection and ventilation was provided to prevent accumulated nitrogen per section 7.16 of the standard, with the operator bypassing the safeguarding in an unforeseen and unlikely method” or “at the time, putting a sign on the door to tell the operator not to open it seemed like the right thing to do”?
Through the use of standards the manufacturer can demonstrate requirements have been met. Do the standards have to be used to prove it? No, but it is the easiest way to do so, as the standards provide a method that is commonly accepted as valid. A manufacturer could simply provide a set of detailed analyses and tests as proof instead.
So in specific regard to the packaging industry and ISO 12100, can it be used in the US? Absolutely. Does it need to be used? No more than any other standard needs to be used.
If you are already using ANSI/PMMI 155.1-2011, it is already the same information as ISO 12100. If you will be shipping equipment to Europe that needs to meet the machine directive, then use ISO 12100. Using standards are voluntary but may provide a sound legal position if something bad happens.
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