OSHA evaluates product safety compliance mechanisms in the interest of U.S.-European trade agreements
For the second time since 2005, the Occupational Safety and Health Administration (OSHA) is considering a proposal permitting the use of a Supplier's Declaration of Conformity (SDoC) in the United States as an alternative to third-party, independent testing laboratories' certification for certain low-risk electrical and electronic products. SDoC is a written statement, produced by an equipment manufacturer or supplier, confirming that a product meets or conforms to a specified test standard or a set of requirements. In the European Union (EU), SDoC is currently accepted for electrical products that use between 50V and 1,000VAC and between 75V and 1,500VDC, which are covered by the European Commission's (EC) Low-Voltage Directive. The products are labeled with a CE mark.
On Oct. 20, 2008, in response to a proposal from the EC, OSHA issued a 90-day request for information (RFI), Docket No. OSHA-2008-0032. The proposal was issued as part of the “Framework for Advancing Transatlantic Economic Integration Between the U.S. and the EU” agreement, signed by then-U.S. President George W. Bush and President of the European Commission José Manuel Barroso, which established the Transatlantic Economic Council (TEC) to monitor progress toward meeting the goals of the agreement, including “initiating an exchange on conformity-assessment procedures for the safety of electrical equipment.”
The 2008 OSHA RFI received more than 60 responses from both U.S. and European organizations. Proponents of the U.S. adoption of the SDoC system claim it will reduce manufacturers' compliance costs and improve product time-to-market. Opponents of the SDoC system for electrical products (but not necessarily other products) — including a coalition of organizations that includes the National Electrical Manufacturers Association (NEMA), Rosslyn, Va.; Electrical Safety Foundation International (ESFi), Rossyln, Va.; International Association of Electrical Inspectors (IAEI), Richardson, Texas; Independent Electrical Contractors (IEC), Alexandria, Va.; and National Electrical Contractors Association (NECA), Bethesda, Md. — argue electrical product safety will suffer and that manufacturers' abilities to test their own products vary too much to be trusted.
According to Northbrook, Ill.-based independent, third-party testing lab Underwriters Laboratories (UL), on average, about 20% of all first-time submissions to UL's testing facilities fail. “The manufacturers around the world have their own testing capabilities and many have their own labs,” says Clyde Kofman, senior VP of commercial operations for UL. “They have the primary responsibility to make sure their products are compliant. But it's a variety of skills and capabilities, depending on the size and perspective of those individual manufacturers.”
Currently, OSHA is reviewing submissions, including four from European-based SDoC advocates, that allege insufficient time to offer data supporting the proposal. As a result, OSHA may reopen the RFI this fall or decide to wait to take these concerns into consideration when it deliberates the proposal later this year.
In 2005, OSHA's first RFI regarding SDoC — prompted by a proposal requesting the option for information technology (IT) products from the Washington, D.C-based lobbying group for the IT industry, Information Technology Industry Council (ITI) — concluded with no change to the U.S. product-approval process. The agency cited “insufficient data” contained in the 26 responses from both sides of the issue, as well as a lack of reasonable assurance that adopting SDoC would not compromise the safety of electrical products used in the U.S. workplace. In addition, the agency was concerned it did not have sufficient authority and appropriations required to enforce the SDoC system, such as product recalls, bans, confiscation, and prosecution. On April 30, 2007, OSHA announced it would take no further action on the proposal.
“Not only is there no comparison data saying the SDoC system is better than the U.S. third-party system, but there is a lot of evidence that argues the other way, including some studies done by the Europeans, some studies done by the EC, and some done by the European Free Trade Association (EFTA),” says Heinz Rosen, P.E., director of engineering at PDCS, LLC, Orlando, Fla., electrical inspector, and former employee of UL. “There's even a mistrust of the SDoC CE marking by the Europeans. So there is a lot of data available — although it may not be compelling data — that seem to imply that the third-party system is safer than the SDoC system.”
In the two years following the decision, OSHA claims to have gathered more information on SDoC through meetings with the EC, and, in the latest RFI, provided numerous specific questions to which it requested “specific and detailed scientific, technical, statistical, or similar data and studies, of a credible nature, supporting any claims made by commenters' detailed responses.”
OSHA's request for information included: data or a rationale that demonstrates the effectiveness of SDoC in assuring product safety, clarification of product risk under the SDoC system and specifications for electrical products to be covered by SDoC, changes to OSHA's current operations in the running and enforcement of the SDoC system, costs associated with the administration of the SDoC system and the source of funds (taxpayer money) and compliance costs for manufacturers, an increase in enforcement procedures for the SDoC system, improvements or barriers to international trade, and extent of transition to SDoC system, meaning partial (as an option) or complete.
Such “evidentiary information” will be examined by the agency to ascertain whether to initiate rulemaking to allow the adoption of SDoC for approval of certain electrical products, specifically those that use between 50V and 1,000VAC and between 75V and 1,500VDC, such as with the EU Low-Voltage Directive.
Up to Code
In the United States, certain federal agencies allow manufacturers' self-approval for some types of products. However, under current standards for workplace safety in the United States, OSHA requires certification of 37 different types of products by an approved third-party, private-sector testing lab designated as a nationally recognized testing laboratory (NRTL) that meets the necessary qualifications specified in the regulations for the NRTL program, which is part of OSHA's Directorate of Technical Support and Emergency Management (Nationally Recognized Testing Laboratories on page 27). Electrical equipment is the largest of these product categories.
Although there is no actual national legal requirement that an electrical product must have NRTL certification, OSHA is empowered by the Occupational Safety and Health (OSH) Act to consider the consequences to U.S. workers that could arise from exposure to products that are not compliant with electrical safety requirements, explains Rosen. In addition, there are legal requirements at the state and local levels, determined by the authority having jurisdiction (AHJ), in accordance with the National Electrical Code (NEC), which contains specific requirements for the installation of electrical products. “The current OSHA NRTL approval process complements the requirements of the NEC, here in the United States,” says Sarah Owen, manager, Government Relations at NEMA. “We make the argument that you can't guarantee that products that have gone through an SDoC system — as opposed to a third-party system — would necessarily complement the requirements.”
Typically, NRTLs certify manufacturers' products before they make it onto the shelves. First, NRTLs evaluate and test a sample product or prototype. “Many tests required by U.S. standards consist at least partially of ‘destructive testing,’ where electrical equipment and materials are subject to high amounts of voltage and/or current, for example, and possibly destroyed to see if there are any inherent hazards to people or property by use of the product,” says Michael Weitzel, electrical AHJ for Bechtel, Inc. and IAEI's codes and standards specialist.
At this stage, the NRTL may oversee and accept testing performed by independent laboratories or even product manufacturers. Once the tests prove the product conforms to the technical requirements specified in testing standards, the NRTL certifies the product by issuing a listing and authorizing use of a certification mark.
To maintain product listing, manufacturers must then allow agents from the NRTL on their premises to perform random, unannounced follow-up inspections at the place of manufacture to ensure products continue to conform to the standard that the sample or prototype was originally tested against. The NRTL may use a contractor under its control to conduct the inspections. “That's how all credible third-party certifications work,” says Rosen.”It's more than just a one-time look-see at the product to see whether or not it complies.”
Although products are not required to bear an NRTL mark, it often makes an electrical inspector's job easier. “This is where the inspection authorities throughout the United States give credence to NRTL marks,” continues Rosen. “They say, “'If I'm looking at this product — and it carries an NRTL mark — I know that it complies with Code as long as it is properly installed. It makes it easier for the inspection community. The mark provides immediate evidence that the product complies with the NEC.”
In the absence of an NRTL mark, electrical contractors and installers carry the burden of proving to electrical inspectors that the product is in compliance with the NEC — or changing elements on the product to make it compliant. Such is the case with the BrassCraft plant in Lancaster, Texas, which uses European-made machines to manufacture brass shut-off valves, water connectors, flares, and compression pipe fittings. Although the machinery is certified to meet standards put forth by the International Electrotechnical Commission (IEC), it often doesn't meet NEC regulations, particularly the machines with through-the-door disconnect. “The lockout/tagout must stay in a locked-out position no matter what position the door is in,” explains Gerald Atwood, facilities manager at the plant.
To make the equipment comply, Atwood and Rex Vanwey, an electrician at the plant, modify the equipment. “We installed standard fuse disconnects on the outside of the machine and wired into them and then into the machines,” says Vanwey. “That wasn't too bad because those are 30A disconnects, but one of the machines we have back there is a 400A disconnect. That's a little more difficult to hang on the side of the cabinet.”
The pair have also traded out aluminum screw-bottle bus fuses for copper fuses. “That reduced most of our problems,” Vanway says.
However, in some cases, the installer or inspector does not have the capabilities to modify or test for Code compliance. “As an authority having jurisdiction, I am unafraid to approve some non-listed electrical equipment when I have the perspective and knowledge to do so — as described by NEC Sec. 110.3(A),” says Scott Davis, electrical plan examiner in the Planning & Building Agency for the City of Santa Ana, Calif. “However I am not ordinarily able to perform significant measurements, stress testing, or electrical safety experimentations in the field to evaluate the safety and appropriate conditions for use of a particular electrical equipment or apparatus. In my experience, self-assessment as a replacement for third-party party oversight is unreliable.”
A pound of cure
The adoption of the SDoC system wouldn't mean an end to compliance testing altogether. “It really begs the question of when the test is performed, either on the front end or on some kind of audit sample on the back end,” says Kofman, who explains that the SDoC system is a two-tier mode.
The CE mark is more of a trade symbol, and then individual European countries enforce their own safety standards, some with third-party compliance testing. For example, Germany requires a “GS” mark and Denmark a “D” mark from third-party labs. “The CE mark is not a safety mark,” he explains. “It's really more of a mark to promote cross-border collaboration, almost like a passport for trade. One doesn't replace the other. In many countries, they do have very clear safety regulations and guidelines that require separate marks.”
Notwithstanding this explanation, many European manufacturers and a few U.S. companies, particularly the ones represented by the IT lobby, have submitted comments to OSHA in favor of conversion to an SDoC system. They argue that self-declaration will reduce the costs associated with compliance testing and certification, speed up the time it takes to get their products to market, and improve trade relations with European countries. “The argument against third-party system by manufacturers is really twofold,” Rosen explains. “One is time. The other is money. It takes time to have products certified and tested, and it costs money to keep the certifications because these third-party certifiers do go out no matter where the manufacturer is, and knock on the door. Somebody's got to pay them. Ultimately, it reflects in a higher cost of the product.”
On the surface, the SDoC system seems stricter than the NRTL process. Manufacturers in violation of SDoC face recalls, bans, and even prosecution. However, enforcing the CE mark can be difficult. “The CE mark is only an attestation of conformity that the product complies and is done by the manufacturer,” Rosen explains. “It's a bit of a ‘fox guarding the hen house’ situation. There's a credibility issue regarding the mark.” Many products that carry the CE mark are manufactured outside of Europe. Although an authorized representative of the company that imports the product oversees the application of the mark, there can still be problems with traceability of manufacture within the SDoC system, as well as enforcement once a product has been found to be non-compliant.
OSHA admits the transition from pre-market certification to post-market surveillance would be a huge undertaking. “Adequate administrative and enforcement resources and procedures in this area, based on the information obtained to date, would need to be extensive, and are critical in assuring product safety under an SDoC system,” states the agency. “Such a system appears to include its infrastructure, along with appropriate rules for assuring SDoC effectiveness, and penalties for breaking those rules.” Currently, OSHA does not have the authority to bring about product recalls or bans or confiscate products reported to be noncompliant. In addition, it would have to ask Congress for the jurisdiction to dole out criminal and financial penalties, such as those issued by the EC.
These changes in infrastructure required to enforce SDoC may cancel out any compliance testing cost savings. “If OSHA were to adopt an SDoC system, it would have to find a way to put in some post-market surveillance, because it would no longer have the assurance from the third-party certifier that the product has met the standards before it comes to market,” Owen says. “You would have to have more federal regulators testing products off-shelf, meaning buying products, testing them, and making sure they actually meet the standards of the SDoC statement.”
OSHA claims it's difficult to calculate an accurate total for costs to manufacturers from total NRTL revenues, because NRTLs often perform other non-NRTL work. Nevertheless, the NRTL program currently has an annual operating budget of approximately $1 million, a portion of which may be reimbursed to the government by the NRTLs. The cost to manufacturers using NRTLs consists of fees charged for initial testing of the product sample — plus fees paid to the NRTLs to cover factory inspection costs and certification-mark licensing. In comparison, extrapolating figures from the cost of post-market surveillance in smaller EU countries, OSHA estimates that the cost of post-market surveillance in the United States could range from $180 million to $360 million.
Most likely, this money would come from tax dollars. “If this is done in America, it would be paid through taxes,” Rosen says. “There's no way of identifying the people who use the products so that only they can be taxed. So everybody has to pay for the product that is used by only some.”
NRTL firms have an active interest in guarding the integrity of their marks. “It's in the interest of these grantors of the marks to protect their integrity,” Rosen says. “So third-party certification, although it may appear to be less strict because it's voluntary, is more credible than SDoC, which has the force of law — particularly if the manufacturer is in some distant land somewhere where there would be great difficulty in pursuing and getting justice.”
Even under the NRTL system, many of the labs have increased their mark security. UL has introduced holographic labels and color-changing inks in an effort to combat counterfeiters. “We think it's important to help protect against that, and we work closely with various border patrol agencies, Interpol, and other governments to help them understand how to verify the products that are coming into their market have a legitimate mark from us,” Kofman says. “The idea is to make it more difficult for people to reproduce our labels. A consistent mark applied with a state-of-the-art labeling process simplifies the border patrol's review of what's coming in. That's not saying it's not possible in self-declaration, but it's easier than having border patrol have to distinguish hundreds and thousands of different declaration marks.”
Owen agrees. In NEMA's arguments to OSHA, the organization claimed there are already safety threats posed by counterfeit products. “We believe if you open the market to products that a supplier simply says meets the standard, but aren't tested by a third party to demonstrate that it's met the standard, then that could actually further jeopardize safety,” she says. “Many SDoC products meet the standard, but then you also open a loophole for those manufacturers that think this is their way into the market. We just want to make sure we're not cutting corners for safety. That's the biggest concern.”
Sidebar: Nationally Recognized Testing Laboratories (NRTLs)
Although the Occupational Safety and Health Administration (OSHA) requires assurance that specific products used in the U.S. workplace meet consensus-based standards of safety, the organization does not perform any product approvals. Instead, OSHA relies on third-party, private-sector testing labs that have met the necessary qualifications specified in the regulations for the Nationally Recognized Testing Laboratory (NRTL) program, which is part of OSHA's Directorate of Technical Support and Emergency Management.
These qualified labs, designated NRTLs by the program, meet the requirements in OSHA regulations under 29 CFR Sec. 1910.7 to perform independent safety testing and product certification that includes listing and labeling, as well as follow-up inspection programs. Three of the requirements set forth the definition for an organization's testing and certification capabilities. The remaining requirement mandates an organization's complete independence from any manufacturers, vendors, and major users of equipment subject to the requirements. This last requirement ensures organizations within the program are third parties.
The NRTL recognition process involves an analysis of an NRTL applicant's policies and procedures and a comprehensive on-site review of the applicant's testing and certification facilities. OSHA's staff also conducts annual on-site audits to ensure that existing NRTLs adequately perform their testing and certification activities and maintain the quality of those operations.
NRTLs may be based in the United States or in other countries. Currently, there are 15 NRTLs, of which 13 are located in the United States and two are foreign-based. For purposes of meeting the NRTL product-approval requirements in OSHA standards, OSHA only accepts equipment or products approved by one of the following designated NRTLs:
- Canadian Standards Association (CSA), Etobicoke, Canada
- Communication Certification Laboratory, Inc. (CCL), Salt Lake City
- Curtis-Straus LLC (CSL), Littleton, Mass.
- FM Approvals LLC (FM), Norwood, Mass.
- Intertek Testing Services NA, Inc. (ITSNA), Cortland, N.Y.
- MET Laboratories, Inc. (MET), Baltimore
- NSF International (NSF), Ann Arbor, Mich.
- National Technical Systems, Inc. (NTS), Boxborough, Mass.
- SGS U.S. Testing Company, Inc. (SGSUS), Fairfield, N.J.
- Southwest Research Institute (SWRI), San Antonio
- TUV America, Inc. (TUVAM), Danvers, Mass.
- TUV Product Services GmbH (TUVPSG), Munich, Germany
- TUV Rheinland of North America, Inc. (TUV), Newtown, Conn.
- Underwriters Laboratories, Inc. (UL), Northbrook, Ill.
- Wyle Laboratories, Inc. (WL), Huntsville, Ala.