The federal government is making a great effort to simplify the language in its documents. Several agencies have issued directives on writing clear documents, and legislation requiring simple writing is close to passing in Congress. In at least one case an Appeals Court has held that due process rights were violated because a notification document was so hard to read.

Complex information doesn't have to result in unreadable documents. For over forty years the Information Mapping® method has helped writers create clear, easy-to-understand documents. This month we'll look at how the Method™ can use plain language to clarify a government document.

 

The "Before"
This is a government regulation as originally published.

BACKGROUND: Section 535(e) of the Federal Food, Drug, and Cosmetic Act, (Act) Subchapter C-Electronic Product Radiation Control (P.L. 90-602), and 1003.11 of the implementing regulations (21 CFR 1003.11) state that if the Food and Drug Administration determines that any electronic product either does not comply with an applicable Federal performance standard, or has a defect that relates to the safety or use of such product, the manufacturer shall immediately be notified in writing of the alleged defect or noncompliance, the findings of the FDA, and all information on which the findings are based. The notification shall also state a reasonable period of time during which the manufacturer may present his view and evidence to establish that there is no failure of compliance, or that the alleged defect does not exist. If the FDA alleges a defect or noncompliance which the manufacturer believes was caused by the user rather than through any fault in manufacture, the manufacturer will have an opportunity to present evidence in substantiation of his position. POLICY: As a general rule, a manufacturer is responsible for defects or noncompliance. However, if it can be shown that a product no longer meets a performance standard because of modification of the equipment by unauthorized personnel, installation of improper replacement parts or materials, or unforeseeable abuse of the equipment by the owner or user, there may be a basis for a finding that certain of the notification requirements and the repair, replace and refund provisions (21 CFR 1003 and 1004) will not apply. The manufacturer bears the burden of proof in establishing that a defect or noncompliance is due to a cause other than faulty manufacture. The FDA's mandate to protect the public health and safety under P.L. 90-602, together with the Act's specification that measures to enforce the control of electronic product radiation be directed against the manufacturer of a product, requires that the primary responsibility of a manufacturer for the safety of his product not be lifted unless the responsibility can clearly be placed on another. FDA will refrain from requiring the manufacturer to repair, replace, or refund only in those situations where there is no reasonable basis for believing that a violation of the Act resulted from a manufacturer's act or omission. For example, a certain amount of normal wear will occur in electronic products. If such normal wear results in radiation emitted by the product exceeding the limit prescribed in an applicable standard, the manufacturer may be charged with noncompliance because of his failure to design the product to maintain an acceptable level of radiation leakage over its useful life. The distinction between normal wear and damage resulting from misuse of the equipment is something which the manufacturer would have to justify.

 

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Analysis and Recommendations
This information could be made easier for the reader to follow and understand in several ways.

Information is buried: The reader may miss the policy when it is presented in this way. The policy is in a paragraph with other information, and it follows the kind of large bulky paragraph that tempts readers to skim quickly or avoid.

Implementation is unclear: Understanding the details of policy implementation is difficult. The sequence isn't clear, and the section includes some tangential information (for example, the FDA mandate).

Multiple kinds of information: This document contains information about policy, various people's responsibilities, an implementation process, examples, and references to other regulations. These are not clearly separated from each other or labeled to help the reader find specific information easily.

Misleading labels: Where labels are used in the source they are too inclusive. The "Background" section contains much more than background, the "Policy" information goes beyond simple statement of a policy.

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The "After"

Electronic Product Defect/ Non-compliance Policy
Regulations	This policy originates from the following regulations: Section 535(a) of the Federal Food, Drug, and Cosmetic Act Subchapter C - Electron Product Radiation Control (P.L. 90-602), and 1003.11 of the implementing regulations (21 CFR 1003.11).
____________ Policy	The manufacturer is responsible for product defects or non-compliance.
____________ Secretary responsibility	The Secretary determines whether an electronic product does not comply with an applicable Federal performance standard, or has a defect affecting the safety or use of the product.
____________ Manufacturer responsibility	The manufacturer must defend an allegation of product defect or non-compliance.
____________ Process	The table below describes the process for resolving alleged product defect or non-compliance. Stage Description 1 FDA determines that an electronic product has a defect or is not in compliance. 2 FDA notifies the manufacturer in writing, giving an explanation of the alleged defect or non-compliance FDA findings and all relevant information, and a reasonable timeframe for the manufacturer to defend the allegation. 3 The manufacturer presents evidence to establish that the defect or non-compliance was not caused by faulty manufacture. Examples or other causes include modification of equipment by unauthorized personnel improper replacement parts or materials used, or equipment abuse by an owner or user. 4 The information in the table below explains that happens next. When the manufacturer... Then the FDA... can prove that faulty manufacture did not cause the defect or non -compliance does not require the manufacturer to repair, replace, or refund the product cannot prove that faulty manufacture did not cause the defect or non-compliance requires the manufacturer to repair, replace, or refund the product.
____________ Example of non-compliance	With normal wear and tear a product emits radiation over the limit specified in the standard. The manufacturer may then be charged with non-compliance because the product design does not maintain an acceptable level of radiation leakage in normal use.

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Conclusion
The government's approach to "plain language" goes beyond just choosing simple words, and requires clear sentence structure and logical organization of information for the reader.

A focus on plain language goes far beyond just government documents, of course. Any complex information is easier to read and use if written in straightforward language and presented in small, clear, well-organized sections.

In the reworked document above I've broken the information down into smaller pieces. Each piece is then labeled to prepare the reader for the information, and the pieces are in a logical sequence. The focus on policy implementation is clearer. I've also tried to simplify some awkward language and remove some non-relevant or repetitive information.

A writer of policies might prefer to change or remove some kinds of wording in the source that are required for legal reasons. It's important to get the legal department's approval of the revision before it is published.

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About Stu Rubinow
Doc Advisor Stu Rubinow has designed and delivered standard and customized training courses since 1989. Since joining Information Mapping in 2000, he has taught a variety of Information Mapping courses throughout the United States, in Canada, and abroad. He is the primary instructor for one of Information Mapping’s online courses, and has also certified other Information Mapping instructors.