US Industrie Standards

Is there a comparable Machinery Directive?

As a mechanical and plant engineering lawyer, Mr. Galaniuk advises on all contractual and business-related issues, taking into account the special features of US standards. For the sake of simplicity, these can be described as a comparable US Machinery Directive in the USA.

As an expert for the US market, Galaniuk ensures that the risk arising from product liability in the USA is adequately taken into account and minimized as far as possible when drafting contracts.

Introduction

In the wake of geopolitical changes (bloc formation and friend-shoring), the USA is an even more important trading partner. But what needs to be considered when supplying machines and systems to the USA? Are there standards for machines in the USA that are comparable to the EU Machinery Directive and CE marking requirements? Is UL certification or similar required?

German manufacturers and exporters cannot avoid dealing with the legal framework in the USA. On the one hand, a customer in the USA will usually (but not always) require compliance with the standards prescribed by public law. On the other hand, the extent of the product liability risk also depends on whether conformity with the standards has been guaranteed. These issues relate to requirements under both federal and state law.

Nameplates

The relevant import regulations are regulated at federal level and require that all goods imported into the USA must be labeled with a country of origin. In addition, the relevant federal OSHA (Occupational Safety and Health Administration) workplace safety regulations require that equipment with electrical connections be labeled with (i) the manufacturer's name or brand, and (ii) watts, volts and amperage.

Incidentally, these OSHA obligations have been partly adopted from the even more extensive parallel regulations at state level. All 50 states have adopted the NEC (National Electric Code) or NFPA 70 (National Fire Protection Association) as part of their building code legislation. NFPA 70 and NFPA 79 prescribe further requirements for nameplates (Machine Nameplate Data), mainly for switch boxes.

Conformity

Conformity regulations for machines were developed for reasons of safety and health protection. In Europe, the Machinery Directive 2006/42/EC applies, which in turn prescribes the CE marking requirement. The latter is largely affixed by the manufacturer himself through self-testing. In view of the fact that the standards organizations in the respective countries are striving for international harmonization of standards (at least for the respective trading bloc), the safety standards in Germany/EU are largely comparable with the American standards. However, there are significant differences between the two countries when it comes to the conformity assessment procedure.

Conformity in the USA is regulated in parallel (usually in parallel) at both federal and state level. With regard to the federal level, a machine (equipment) that is an electrical consumer and its installation must be approved in accordance with OSHA regulations. Approval is granted by fictitious approval if the equipment and installation are “acceptable”. “Acceptable” is assumed if the machine has been accepted, certified, listed, labeled, or otherwise declared safe by a nationally recognized testing laboratory, or “NRTL”. This means that testing and acceptance must be carried out by an independent assessor. In the case of individual machines and systems, this is usually carried out by means of an on-site test (field evaluation) or, if necessary, a process-optimized pre-test at the place of manufacture (pre-field). The aim of all this is to issue a label or certificate to prove formal approval.

The situation is somewhat more complex at state level. All 50 US states have made the NEC (or NFPA 70) part of their respective building codes by reference. In turn, the NEC stipulates that an official authority having jurisdiction (AHJ) is responsible for enforcement. Therefore, an AHJ may be involved at the state level for pre-approval or inspection and post-approval (or warning with cure period). However, NEC does not regulate the conformity assessment process itself very clearly. Therefore, different conditions may be required depending on the state/municipality.

However, it may be possible to build on the confirmation of an NRTL, as NEC stipulates that an AHJ can accept a machine that has been certified by a recognized expert with a certificate of conformity (“Labeled”). NRTLs are also required to comply not only with NFPA standards, but also with standards developed by UL, ASTM, ANSI, etc., where relevant.

The path to conformity

For the manufacturer, the discussion of the topic begins relatively early in the production process. When selecting components, the manufacturer should ensure that the enclosures in particular meet the requirements of NFPA 70/79. Before manufacturing for the US market, the manufacturer can also discuss the “Technical documentation for machinery” (see Machinery Directive, Annex VII) with an NRTL. The NRTL can then draw up a catalog of measures for the conversion.

NRTLs also offer a pre-field evaluation service to proactively support the success of the compliance process.

Whether an AHJ inspection is required prior to commissioning depends on the individual state. However, with an NRTL label already issued, the inspection risk can be significantly mitigated.

Operating instructions

Similar to the relevant regulations in the Machinery Directive 2006/42/EC, various standards contain specifications for operating instructions for machinery. Furthermore, operating instructions must be examined from a product liability perspective. This is because product liability can arise in the event of breaches of information obligations (instruction and notification obligations),

such as a lack of information and warnings. The determination and consideration of these standards are the responsibility of the technical writer and, if applicable, the NRTL.

Mitigation of the product liability risk

Although it is the operator of the machine who is responsible for compliance with the safety standards (OSHA, NEC, etc.) from a public law perspective, the machine manufacturer and seller will, however, want to consider the standards for US machine approval for the following important reasons: firstly, to ensure US marketability and saleability and, secondly, to mitigate the US product liability risk. This is because compliance with the safety standards can provide preventive protection against claims for damages (including product liability) by the buyer (and third parties, such as the buyer's employees).

The confirmation therefore serves as strong evidence that there is no fault or liability towards the manufacturer. Confirmation by the NRTL can therefore be important for the German manufacturer supplying to the USA in order to minimize risk. This assumes that the internal risk analysis recognizes hazards and that the probability of damage (or liability) cannot necessarily be ruled out, but can at least be reduced to an acceptable level.

Contract design

For this very specific risk class in the machinery and equipment business, however, there are ways of limiting the risk when drafting the contract. This has to do with the special features of US accident insurance (workers compensation) on the one hand and the limited group of potentially injured parties on the other. As a US-American, native speaker and expert in US commercial law, Attorney Galaniuk ensures that the right provisions for risk management are included in the contract - provided the negotiating position permits this.

Disclaimer: The content of this website is abstract and intended for educational purposes only. It does not constitute legal advice. The article is not suitable for solving specific cases, which always require individual legal advice and solutions. Claims in connection with this article are excluded.

UL certification

German manufacturers of machines and systems often ask themselves whether UL certification is required if business and sales are made in the USA. Sometimes the view is expressed that a declaration of conformity in accordance with the EU Machinery Directive with CE marking should actually be sufficient to prove the safety of the machine. Unfortunately, this view must be rejected, as a product must be approved in accordance with US regulations at the latest when installing and using machines and systems in the USA that are electrical consumers.

Briefly summarized: A machine is considered approved, at least under federal law, if it has been confirmed as compliant by UL (Underwriters Laboratory) or another official certification body (nationally recognized testing laboratory or “NRTL”) by certificate or similar. In this respect, UL certification is one of several options for the required NRTL certification and approval for use in the USA. Another very popular official NRTL certification body is TÜV-SÜD. A certificate from TÜV-SÜD therefore usually fulfills exactly the same purpose as a UL certification. Depending on the scope of the project, the customer may have certain preferences and in this case it must be clarified which NRTL is to be preferred. Both UL certification and certification by TÜV-SÜD can be approached from Germany at the place of manufacture. However, the final certification (and labeling) may have to be completed directly at the place of use.

In the field of industry standards, UL is one of many standards organizations, testing bodies and service providers. However, UL has a history of 128 years (as of 2022). The name “underwriters laboratory” comes from the first orders from insurers (underwriters) to examine and test insurable risks with reference points to electricity as a scientific laboratory.

UL published its first standards back in 1903. Today, UL is active worldwide in the areas of safety, standards and consumer protection. UL's scope extends far beyond the approval of industrial equipment and encompasses almost all industrial and consumer products in the modern economy. UL today consists of three main business units: UL Standards & Engagement, UL Research Institutes and UL Solutions. UL Solutions is the division that performs testing and certification services as NRTL.

UL is also designated by ANSI (American National Standards Institute) as an official SDO (standards developing organization). ANSI does not publish its own standards, but coordinates the development and publication of standards that are relevant to the US market. ANSI is a member of the International Organization for Standards (ISO) and the International Electrotechnical Commission (IEC), both based in Switzerland.

Whether and to what extent a German manufacturer has to take care of a machine or system approval in the USA depends on various circumstances. For more information on the topic of a US Machinery Directive comparable to the EU Machinery Directive, machinery approval in the USA, including NRTL or UL certification, click here:_________

Attorney Galaniuk is a US American and a longtime expert and practitioner in business matters relating to German and US law. He advises German medium-sized companies on US contract law, taking into account the special features of US product liability law and machine approval.