Equipment Safety and Manufacturer Responsibility in the United States.

The CE marking process is not recognised in the United States, so equipment importers must comply with local requirements and contract terms set by the purchaser. In the United States, the local Occupational Safety and Health Administration (OSHA) is responsible for safety and health. OSHA is responsible for local occupational safety laws and also publishes and maintains standards that local employers must comply with. OSHA standards establish, among other things, minimum safety requirements for equipment. These requirements do not apply directly to equipment manufacturers, but machines must be designed to comply with OSHA standards.

Another important player in equipment safety is the American National Standards Institute (ANSI) in the United States, which is responsible for developing standards. ANSI is also the official representative of the United States in the International Organisation for Standardisation (ISO). Compliance with ANSI standards is generally voluntary, but many mandatory OSHA standards are based on earlier versions of ANSI standards. In addition, equipment purchasers often require that equipment be designed in accordance with relevant ANSI standards as a condition of contract.

ANSI has published several standards relating to machine safety, the most important of which is the B11 series of standards. The series includes more than 30 different standards and is intended for use by both equipment suppliers and users. Its objectives are largely consistent with those of the Machinery Directive: to establish requirements for various stages of the machine life cycle in order to prevent injuries.

The unifying standard for this series is ANSI B11.0–2020, which describes the process of assessing risks and ways to eliminate or reduce them through design. The standard in question is largely consistent with the European standard EN ISO 12100:2010 and introduces, among other things, a classification of types according to standards A, B and C. Risk assessment is not mandatory in the United States and is not as widespread as in Europe. However, its value is recognised, and experts believe that its importance will grow in the future.

In addition to OSHA and ANSI standards, a company exporting equipment to the United States must comply with the Product Liability Act. The Product Liability Act is known throughout the world, but its meaning and scope vary from region to region. In the United States, violations carry significant financial consequences, including reputational damage and potential fines.

Under product liability law, a manufacturer must ensure that a product is safe and that all possible risks have been adequately addressed. In a product liability lawsuit in the United States, the plaintiff must prove that the product was defective and created an unreasonable risk. A product liability lawsuit may seek compensation for bodily injury, death, and property damage. Product defects fall into three categories: design defects, manufacturing defects, and failure to warn of potential problems.

Design and manufacturing defects can be eliminated through a systematic design process in which risk assessment, design analysis, and the use of standards play a key role. US product safety legislation, like the Machinery Directive, requires the manufacturer to choose a reasonable alternative design that can reduce the foreseeable risks associated with the product. The manufacturer must present the measures taken to minimise risks and ensure product safety, and demonstrate that product safety has been comprehensively considered throughout the product development process.

In the United States, less attention is paid to warning about the risks and hazards associated with product use than in Europe. In the EU, the responsibility for safe operation of the machine lies primarily with the employer, while in the United States, the machine manufacturer has an increased responsibility to warn the user about the risks associated with using the product. In addition to instructions, the duty to warn is regulated by various warning labels on the machine and warning texts in the user manual. When creating warnings, it is recommended that the manufacturer follow the ANSI Z535.4 standard, as US courts use it as a basis for determining what is considered ‘best practice’ in product safety labelling.

When shipping equipment to the US, the product safety team plays a key role in ensuring that the equipment complies with local requirements and market specifics. Since CE marking is not recognised in the US, manufacturers and importers must pay special attention to OSHA and ANSI requirements, as well as contractual obligations. The product safety team is responsible for all aspects, combining technical safety, legal liability and documented risk management.