Creating compliant manuals for the US

Going to sell your product on the US market? Ferry Vermeulen explains how to create compliant manuals and avoid legal pitfalls.

This article was published originally in Communicator (Autumn 2016). Communicator is the authoritative, award winning, journal for UK technical communicators. It is home to high quality, objective, and peer-reviewed features – current, relevant, and in-depth.

In this article I will show you how I create compliant user manuals for the US market. And I am able to do this either by basing my US work on, or by creating simultaneously with, the European documentation, with a minimum of extra time and effort. With this method you can do exactly the same. I will outline the strategy in detail.

How to use the U.S.er-Manual-Method to achieve compliance

This method, which I have named the U.S.er- Manual-Method, will give you the following benefits.
You will:

• get an idea of how product compliance and product safety in the US is organised.
• know how to find out which products are regulated/non-regulated in the US.
• be seen within your company, as an expert on the US market.
• know how to warn for product risks.
• know which standards to use for creating user instructions.
• know which standard to use for safety messages.
• be able to create compliant manuals for the US market.
• be able to create better documentation for the European market, which can be easily adapted to make compliant documentation for the US market.

Let’s break it all down into actionable steps.

The 8 steps to using the U.S.er-Manual-Method to drawing up compliant manuals

There are eight steps in the U.S.er-Manual-Method:

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 minimum specific requirements for adequate instructions.
6. Verify the product-specific requirements from both the voluntary and mandatory standards.
7. Implement ANSI Z535.6
8. Write the instructions (and other technical documentation) according to the requirements.

Step 1: Identify the applicable acts, laws, and regulations for your product.

Product safety in the US is regulated by various federal agencies. Once Congress has enacted a product safety law, the appropriate federal agency (for example, the Consumer Product Safety Commission, the Federal Trade Commission, the National Highway Traffic and Safety Administration) 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.

To identify the applicable acts, laws and regulations
for your product:

1. Go to www.usa.gov/laws-and-regulations
2. Have a look around to learn about some of the best-known U.S. laws and regulations

Note:

• This step is not mandatory to create compliant manuals, but it does contribute to a better understanding of product safety legislation in the US.
• The European equivalent to identify laws and regulations is http://eur-lex.europa.eu.

Step 2: Identify the competent federal agencies for your product.

The different US Federal Agencies regulating products and situations are divided into the following main groups: Health/Body, Vehicles/ Vehicle-Related Products, Hazards/Safety/ Firearms, and 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 and commercial products, radioactive materials etc.

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 Consumer Product Safety Act (CPSA) was passed in 1972 and the act established the CPSC. 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.

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

To identify the competent federal agencies for your product:

1. Go to www.cpsc.gov/en/Regulations-Laws– Standards/Regulations-Mandatory-Standards- Bans
2. Check the list of Regulated Products to make find out if your product is in CPSC’s jurisdiction.
3. Go to www.cpsc.gov/en/Regulations-Laws– Standards/Products-Outside-CPSCs-Jurisdiction
4. Check the list of Federal Agencies to find out if your product is in another jurisdiction.

Note:

• If you know the jurisdiction but your product is not on the lists of regulated products, you are most likely marketing an unregulated product. Unregulated products do not have standards or bans.
• For all unregulated products you must report defective or dangerous products at www.cpsc.gov/en/Regulations-Laws– Standards/Unregulated-Products

Step 3: Identify which standards are mandatory for your product.

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. Product-specific standards may include requirements regarding the instructions for use.

To identify which standards are mandatory for your product:

1. Go to the website of the relevant federal agency (for example, www.cpsc.gov).
2. Navigate to the page with the overview of mandatory Standards (for example, www.
   cpsc.gov/en/Regulations-Laws–Standards/Regulations-Mandatory-Standards-Bans).
3. Click on the link to see more information about your product (for example, for Toys, find Toys, mandatory standard in the left column. Click on the hyperlink in the right column. The following page opens: www.cpsc. gov/en/Business–Manufacturing/Business- Education/Toy-Safety).
4. See which standard is mandatory (for example, the toy safety standard, ASTM F963-11).

Note:

• Whereas standards in the EU as a rule are voluntary, they can be mandatory in the US. Mandatory standards in the US are freely available.

Step 4: Identify which standards are voluntary for your product.

Voluntary standards can provide product- specific requirements regarding instructions. Standards are voluntary unless “Incorporated by Reference” in a regulation.

To identify which standards are voluntary for your product:

1. Go to the website of the relevant federal agency (for example, www.cpsc.gov).
2. Navigate to the page with the overview of voluntary Standards (for example, www. cpsc.gov/en/Regulations-Laws–Standards/ Voluntary-Standards).
3. Click on any relevant link to see more information about voluntary standards for your product (for example, for Toys click on the hyperlink Toys. The following page opens: www.cpsc.gov/en/Regulations-Laws- -Standards/Voluntary-Standards/Topics/Toys).
4. See which standards are voluntary.

Step 5: Identify the minimum specific requirements for adequate instructions.

Apart from product-specific mandatory and voluntary standards, there are some commonly used international standards that set out requirements for just the instructions for use. Some of these 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

To identify which standard suits your product best:

1. Choose the standard that fits your product best.
2. Purchase the relevant standard.

Step 6: Verify the product-specific requirements from both the voluntary and mandatory standards.

Now that you have an overview of both the mandatory and voluntary standards and the standards for user instructions, it is time to acquire and search them to find the specific requirements on the instructions.

To identify the requirements on the instructions:

1. Acquire the relevant standards(s).
2. Use Ctrl + F and type instructions to find the requirements regarding the instructions. Key in labelling to find the requirements regarding the labelling.

As an example, the ASTM F963-11 standard gives the requirement shown in Figure 1.

Step 7: Implement ANSI Z535.6

Warnings play a very important role in the US due to:

• The way product liability is organised
• Case laws
• The requirement for importers, manufacturers, distributors, and retailers of consumer products to report
• The requirements of ANSI Z535.6

Product liability

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 the manufacturer rather than the defect of the product),
• fraud (‘intentional tort’) or
• warranty theory (contract).

Furthermore, 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 (for example, unclear or incomplete) warnings or instructions are given;
• The foreseeable danger of the product might have been minimised 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 in 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. In the US, as well as in the EU, for product liability claims, the causation standard states that the injured person bears the burden of proving the product defect caused this person’s injury.

Case law

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.

Requirement to report

Federal agencies like the CPSA require importers, manufacturers, distributors, and retailers of (consumer) products to report product risks. Specifically, these entities must report “immediately” 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 or creates an unreasonable risk of serious injury or death.

As an example, under Section 15 (b) of the Consumer Product Safety Act (CPSA), manufacturers, importers, distributors, and retailers are required to report to CPSC within 24 hours of obtaining information, which reasonably supports the conclusion that an unregulated 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.

ANSI Z535.6

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 provides guidance to any entity involved in creating collateral materials. The standard defines collateral materials as printed information that accompanies a product (for example, product manuals, instructions and other materials containing safety messages). According to 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, see Figure 2.

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, see Figure 3.

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 (for example, “Highly corrosive chemicals. Risk of severe eye and skin injuries. Avoid contact. Wear eye 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, for example, 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 (for example, “read all instructions before use to avoid injury”)
• Generic messages regarding the handling of safety information (for example, “Keep these instructions for future reference”)
• General safety implications of grouped safety messages (for example, “to avoid serious injury, follow the safety information in this section”)

To implement ANSI Z535.6:

1. Purchase a copy of ANSI Z535.6 and fully read and understand the standard.
2. Determine product defects and draw up warnings according to the requirements of ANSI Z535.6

Step 8: Write the instructions according to the requirements.

At this point we have all the information to make your documentation US-compliant.
To make your documentation US compliant:

1. Analyse the following gathered information:
   1. The requirements from the mandatory standards
   2. The requirements from the voluntary standards
   3. The requirements from the standards for adequate user instructions
   4. The safety messages and requirements from ANSI Z535.6
2. Draw up or optimise your documentation taking these requirements into account

Post conclusion

In the EU, a manufacturer can use European harmonised 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. By following the steps of the methods described, you should be able to create compliant documentation for the US market.

References

USA

CPSC ‘Products Under the Jurisdiction of Other Federal Agencies and Federal Links’ www.cpsc. gov/en/Regulations-Laws–Standards/Products- Outside-CPSCs-Jurisdiction (accessed July 2016) CPSC ‘Regulations, Mandatory
Standards and Bans’ www.cpsc.gov/en/ Regulations-Laws–Standards/Regulations- Mandatory-Standards-Bans (accessed July 2016) CPSC ‘The Consumer Product Safety Improvement Act (CPSIA) 2008’ www.cpsc.gov/ en/Regulations-Laws–Standards/Statutes/ The-Consumer-Product-Safety-Improvement-Act (accessed July 2016)
CPSC ‘Toys’ www.cpsc.gov/en/Regulations-Laws- -Standards/Voluntary-Standards/Topics/Toys (accessed July 2016)
CPSC ‘Unregulated Products’ www.cpsc.gov/ en/Regulations-Laws–Standards/Unregulated- Products (accessed July 2016)
CPSC ‘Voluntary Standards’ www.cpsc.gov/ en/Regulations-Laws–Standards/Voluntary- Standards (accessed July 2016)
CPSC www.cpsc.gov (accessed July 2016) USA.gov ‘Popular Federal Laws and Regulations’ www.usa.gov/laws-and-regulations (accessed July 2016)

European

EUR-lex ‘ European Union law’ http://eur-lex. europa.eu (accessed July 2016)

Further reading

Kundinger M (2008) ‘ANSI Z535.6 and product safety’ Communicator, Autumn 2008: 14-16
Kundinger M (2012) ‘ANSI Z535.6: new and improved part 1’ Communicator, Summer 2012: 23-25
Kundinger M (2013) ‘ANSI Z535.6: new and improved part 2’ Communicator, Summer 2013: 42-45

Ferry Vermeulen is director at Berlin based INSTRKTIV GmbH. INSTRKTIV helps brands to create compliant and user-friendly documentation. .