March 2015
By Ferry Vermeulen and Michael Gerrits

Image: niyazz/ 123rf.com

Ferry Vermeulen, MSc, is the founder of Manualise, a company that develops, improves and maintains instructions for use for brands. Ferry is currently working towards his PhD in product innovation.


f.vermeulen[at]manualise.com
www.manualise.com


 


Michael Gerrits, LL.M. is Product Compliance Director at Nike. As an attorney he specializes in product safety, CE marking and compliance.


mrfgerrits[at]mac.com
ce-uitspraken.eu


 


 

US regulations on instructions for use

Looking to tackle the US market? Here is an overview of the US regulatory framework and some easy-to-follow instructions on how to achieve product compliance and avoid legal pitfalls.

In the EU, a manufacturer can use European harmonized standards to comply with the relevant essential health and safety requirements of the CE marking directives and accordingly affix CE marking. Many of these CE marking directives also set requirements for user’s instructions. Although there are many similarities, the process of product compliance in the US is slightly different from the process of EU compliance.

An introduction to the US federal regulatory framework

Product safety in the US is regulated by various federal agencies. Once Congress has enacted a product safety law, the appropriate federal agency (e.g. the Consumer Product Safety Commission, the Federal Trade Commission, the National Highway Traffic and Safety Administration, et al.) may create the regulations or rules to implement the law. Together, the enabling acts and laws and the final regulations provide a framework for the implementation and enforcement of most federal laws in the United States.

The nature and characteristics of the product or situation determine which federal agency is involved. An important federal agency when it comes to consumer product safety is the US Consumer Product Safety Commission (CPSC). The CPSC aims to protect consumers from unreasonable risks of serious injury (or death) from products under its jurisdiction. The CPSC has jurisdiction over thousands of types of consumer products used at home, in schools, in recreation, or otherwise. This includes products that pose a fire, electrical, chemical, or mechanical hazard or products that can injure children – such as toys, children’s apparel and textiles, cribs, power tools, cigarette lighters, and household chemicals.

The federal agencies are all independent agencies. Congress created the CPSC in the Consumer Product Safety Act (CPSA). In that law, Congress directed the Commission to "protect the public against unreasonable risks of injuries and deaths associated with consumer products". In addition to the CPSA, the Consumer Product Safety Improvement Act (CPSIA) of 2008 is a United States law imposing new testing and documentation requirements. The CPSIA sets new acceptable levels of several substances and imposes new requirements on manufacturers of products covered by the CPSIA.

The CPSC attempts to achieve the goal to protect the public against unreasonable risks of injuries and deaths associated with consumer products through education, (mandatory) safety standards activities, developing and publishing regulations, enforcement of the statutes and, if necessary, banning products. When Congress has enacted a law, the federal agencies often develop or use existing standards to implement the law.

Section 102 of the CPSIA requires every manufacturer or importer of consumer products that are subject to a consumer product safety rule enforced by the CPSC, to issue a certificate stating that the product complies with the applicable standard, regulation, or ban. Besides, it is or can be made mandatory by regulations and standards that a product is tested by a third party, the product is marked with the country of origin, and that a manufacturer conducts recalls, if necessary.  

The CPSC also inspects if a product violates a specific statute or regulation. When CPSC staff determines violating cases, the CPSC Office of Compliance and Field Operations generally notifies the responsible firm and requests a specific remediation of the problem. The CPSA further requires importers, manufacturers, distributors, and retailers of consumer products to report to the CPSC about product risks. Specifically, these entities must report “immediately” to the CPSC any information that reasonably supports the conclusion that a product

  • does not comply with CPSC safety regulations;
  • contains a defect, which creates a substantial product hazard;
  • creates an unreasonable risk of serious injury or death.

Regulated products in the US

The different US Federal Agencies regulating products and situations are divided in the following main groups:

  • Health/ Body
  • Vehicles/ Vehicle-Related Products
  • Hazards/ Safety/ Firearms
  • Other

The Health/Body group contains federal agencies covering alcohol, food, cosmetics and tobacco.

The Vehicles group covers, amongst others, aircrafts, amusement rides, cars, boats and car seats.

The Hazard/Safety/Firearms group contains agencies taking care of ammunition, industrial & commercial products, radioactive materials etc. Besides products the list contains many chemicals and substances that cause injuries.

To collect the necessary information on the legal requirements applying to your product, first make sure in which jurisdiction your product is to be marketed and then which federal agency or federal agencies is/are responsible.

Non-regulated products in the US

If you know the jurisdiction but if your product is not on the lists of regulated products, you most likely market an unregulated product.

Unregulated products do not have standards or bans. For all unregulated products you must report defective or dangerous products.

For most firms there are two reporting requirements: Dangerous products and lawsuits. Regarding dangerous products, manufacturers, importers, distributors, and retailers are required to report to CPSC under Section 15 (b) of the Consumer Product Safety Act (CPSA) within 24 hours of obtaining information, which reasonably supports the conclusion that a product does not comply with a safety rule issued under the CPSA, or contains a defect, which could create a substantial risk of injury to the public or presents an unreasonable risk of serious injury or death. Regarding lawsuits, manufacturers of a consumer product are also required to report information about settled or adjudicated lawsuits to CPSC.

Product liability in the US

In the United States, there is no uniform product liability statute or common law. Each of the 50 states defines product liability law under its own standards. Typically, however, product liability claims are brought under strict liability theory (is the product defective, irrespective of whether the manufacturer’s conduct was negligent), tort as in negligence (focus on the conduct of the manufacturer rather than the defect of the product), fraud (‘intentional tort’) or the warranty theory (contract). Further, most states have some form of consumer protective statute.

Within the US product defects may be determined under a consumers’ expectations test or a risk utility test. The risk utility test tries to balance the utility of the product against the risks of its specific design. A product may be deemed defective on the basis of:

  • a manufacturing defect
  • a design defect
  • a warning defect

The failure to warn or to adequately warn of a reasonably foreseeable risk of the product sets a warning defect. Typical warning defects arise where

  • inadequate (e.g. unclear or incomplete) warnings or instructions are given;
  • the foreseeable danger of the product might have been minimized or avoided if the manufacturer (or another person responsible for the product compliance) had provided reasonable warnings or instructions;
  • the failure to provide such warnings or instructions rendered the product not reasonably safe.

The test for defects in design and warnings and instructions is very subjective and based on reasonableness factors to be decided by a jury. Determining when there is a duty to warn or instruct and how far that duty extends is a difficult question that every manufacturer needs to answer.

The (final) manufacturer, the manufacturer of individual components of the product, or the importer may be liable under a strict product liability claim for damage caused by a defective product. Here, as well as in the EU product strict liability claims, the causation standard applies that the injured person bears the burden of proving that the product defect caused this person’s injury.

US regulatory framework and instructions

Both, mandatory standards and voluntary standards can provide product-specific requirements regarding instructions. Standards are voluntary unless “Incorporated by Reference” in a regulation. Regulations are always mandatory. Guidelines may be voluntary but are often de facto industry standards. Product specific standards may include requirements regarding the instructions for use. Apart from this there are some commonly used standards that set out requirements for just the instructions for use. Some commonly used standards for user’s instructions are:

  •  IEC 82079-1 Preparation of instructions for use
  •  ISO/IEC Guide 37:2012 - Instructions for use of products by consumers

Due to case law warnings play a very important role in the US. According to case law a manufacturer has a duty to warn where: (1) the product is dangerous; (2) the danger is or should be known by the manufacturer; (3) the danger is present when the product is used in the usual and expected manner; and (4) the danger is not obvious or well-known to the user.

Another way to state this is that there is a defect in the warnings when reasonably foreseeable risks of harm posed by the product could have been reduced or avoided by providing reasonable instructions or warnings, and the omission renders the product not reasonably safe.

The fact that adequate instructions are provided, assisting the operator in the correct operation of the product, does not necessarily discharge the duty to provide an adequate warning. A warning may still be required to call attention to the dangers of using the product. Instructions affirmatively inform persons about how to use and consume products safely. Warnings alert users and consumers to the existence and nature of product risks. Generally, warnings tend to be negative statements about things not to do or affirmative statements about things always to do. Instructions tend to describe in more detail how to do something safely and correctly.

Because of the importance of warnings in the US, a specific standard has been developed dealing with the content, location and presentation of warnings: ANSI Z535.6, Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials.

ANSI Z535.6: a standard for safety messages

The ANSI Z535.6 provides guidance to any entity involved in creating collateral materials. The standard defines collateral materials as printed information that accompanies a product (e.g. product manuals, instructions and other materials containing safety messages).

According to the ANSI Z535.6 safety messages can contain a signal word (DANGER, WARNING, CAUTION or NOTICE) in combination with a safety alert symbol. The signal word and safety alert symbol are placed in a so-called signal word panel. The standard defines the type, style and size of the signal words as well.



Figure 1: Example of a signal word panel


Together the signal word panel (or in some cases just the safety alert symbol) and the conveyed safety message form the safety message as it can be used in collateral materials.


Figure 2: Example of a safety message


The ANSI Z353.6 gives four types of safety messages:

  • Grouped safety messages
  • Section safety messages
  • Embedded safety messages
  • Supplemental directives

Grouped, section and embedded safety messages should identify hazards, give an indication on how to avoid them and explain the consequences when not avoiding the hazards (e.g. “Highly corrosive chemicals. Risk of severe eye and skin injuries. Avoid contact. Wear eyes and body protection”).

Grouped safety messages need to be provided in a separate chapter or in a different document. They are more general in nature and apply to the entire document. Section safety messages are placed in the first part of the specific section to which they apply. Embedded safety messages have to be integrated with the non-safety messages, e.g. with the specific task to which the embedded safety message applies.

Supplemental directives, normally placed in the introduction of a document, may often be generic. For example:

  • General safety implications of a document (e.g. “read all instructions before use to avoid injury”)
  • Generic messages regarding the handling of safety information (e.g. “Keep these instructions for future reference”)
  • General safety implications of grouped safety messages (e.g. “to avoid serious injury, follow the safety information in this section”)

Steps to US consumer product compliance

A business that makes, imports or distributes consumer products has a variety of acts, laws, and final regulations to follow. The kind of product, and thus the applicable federal agency, determines which exact steps you need to follow so that your product complies with the legislation. For example, the following steps, as described on the CPSC website, will help guide you through the process of complying with federal government safety regulations concerning the products CPSC has jurisdiction over:

  1.  Do I make a product for children?
  2.  What regulations apply to my product?
  3.  How do I test and certify my product?
  4.  What are required labels for my product?
  5.  What is mandatory reporting?
  6.  I still need more help


The following steps will guide you through the process to fully comply the documentation of your product with US standards, laws etc.:

  1. Identify the applicable acts, laws, and regulations for your product.
  2. Identify the competent federal agencies for your product.
  3. Identify which standards are mandatory for your product.
  4. Identify which standards are voluntary for your product.
  5. Identify the specific requirement for adequate instructions for use
  6. Identify the harmonized standards for user instructions. The EN-IEC 82079-1 and ANSI Z 535.6 are commonly used.
  7. Verify the product-specific requirements from both the voluntary and mandatory standards.
  8. Draw up the instructions (and other technical documentation) according to the requirements.


The EU and US compared

These are the main differences between the EU and the US when it comes to product safety:

  1. The US system does not use CE marking or any other (general) conformity marking.
  2. In the EU there is just one procedure to comply your regulated product with the applicable legislation, namely by following the steps towards CE marking. In the US the kind of product and thus the responsible federal agency determines which steps to follow for product compliance.
  3. In the US both, the design of the product safety requirements as well as the inspection of compliance are done by the same federal agencies. In the EU, the European Commission is responsible for the design but national authorities perform the inspection.
  4. In the EU new directives are designed from scratch. In the US product requirements are based on national laws as enacted by Congress.
  5. Whereas standards in the EU as a rule are voluntary, they can be mandatory in the US.
  6. In the US certain state laws and regulations are more stringent than the federal laws. In the EU European laws are harmonized at the same level for all member states.
  7. Case law in the US emphasizes a ‘general duty to warn’ against product risks.

These differences also affect instructions for use that accompany a product. The requirements regarding instructions for use, as set out by mandatory standards, should be followed strictly in the US. In the EU, the essential requirements as defined in the legislation are mandatory, and standards can be used on a voluntary basis in order to comply with these essential requirements. Warnings play a more central role in the US and are designed, placed, and formulated differently than in the EU. When trading with the US, these differences need be taken into account, so that the instructions comply with the respective laws and product liability will be minimized.