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To determine if you need a regulation, consider the following questions or issues:

• Could better enforcement of existing laws and regulations achieve the desired goal?
• Is the problem the regulation seeks to address an isolated case or of sufficiently broad concern to justify a state regulation?
• Is the proposed regulation simply a response to a crisis which may subside on its own or is it designed to address a persistent lasting concern?
• Have alternatives to regulatory action been fully considered? Such alternatives include taking no action, exploring profit or non-profit solutions, working out voluntary agreements with affected parties, public education, and local government or federal action.
• Is this regulatory subject matter? Regulations contain provisions with which people must comply and which programs must follow. They are general rules governing people's rights or conduct. On the other hand, regulations do not contain recommendations, model procedures, lists of resources, or information on agency internal practice or procedures (except for public participation guidelines), otherwise known as guidance documents.
• Do you have authority to promulgate a regulation? A regulation must be authorized by law. This means that in your agency’s basic statute in the Code of Virginia or somewhere in the U.S. Code or Code of Federal Regulations, your agency has been granted express or implied authority to promulgate the regulation.

Your goal is to craft a regulation with clear and simple language that is logically organized, accomplishes its purpose with no unintended consequences, permits and facilitates day-to-day agency decisions, and sustains and protects the agency in the event the regulation is challenged in a court of law. Now put your mind in a brainstorming mode. Consider the following questions before you start writing:

• What is the overall objective of the regulation? Put another way, what is the problem or situation that the regulation is intended to address?
• Who and what areas do you need to regulate? What will the regulation permit, prevent, encourage, discourage, and require?
• If there is a statutory mandate for promulgating this regulation, does it set out specific areas that the regulation must address?
• Can you incorporate by reference any documents into your regulation, e.g., federal law and regulation, court decisions, or standards set by a national organization, rather than repeating language verbatim in the regulation?
• Is your agency regulating anything like it now? If yes, how is this regulatory action the same or different from what you are already regulating? If no, be sure you have the authority to regulate this new area.
• What is the scope of your authority to regulate? Keep a copy of this authority handy because you may need to refer to it when you’re writing.
• Put yourself in the place of the regulated community as you think about imposing a new requirement. What would the compliance costs, including paperwork requirements, be? Would the new requirement provide maximum flexibility to regulated parties?
• What do the agency’s public participation guidelines (PPGs) require? Are you required to convene an ad hoc committee of affected entities to develop the regulation? If the subject is large and complex or there are multiple approaches to regulation, and you believe input would be helpful, you may wish to convene an ad hoc committee anyway.
• Review the Notice of Intended Regulatory Action (NOIRA) form or other form you will be filing on the Town Hall to see what information is required. This is especially useful if your action is subject to executive branch review because there will be a full review of these issues at that time.

First, look at the following suggestions on how to write a user-friendly. This federal website has a really good handbook on writing user friendly documents. These are links to particular sections.

• Identify your audience
• Limit each paragraph to one topic
• Use the present tense
• Use lots of informative headings
• Address one person, not a group
• Use if-then tables
• Use short sentences
• Use a question and answer format
• Divide your material into short sections

Think about the big picture.

Start with big general topics and work down to smaller specific ones. It is very easy to get lost in the details, so you may wish to prepare an outline of your big topics. An outline will permit you to sort through the big topics and rearrange them into a more logical order before you delve into the details. Also, if someone else in your agency will actually be writing the major substance of the regulation, an outline of large topics will help to focus his writing.

Get everything down on paper.

At this stage, the objective is to include everything in the regulation that may need to be addressed. Content omissions can be especially troublesome and executive branch reviewers do not always pick up on these. It is better to insert something you are not sure about and later delete it, than to leave it out and realize after implementation that the regulation would be better enforceable, complete, clear, etc., if the provisions had been added.

Write without worrying about proper citations, syntax, grammar, and spelling. Plenty of people will review the regulation behind you who will catch such details and point them out to you.

Put yourself in the place of the regulated entity.

As you capture the needed content, try to imagine yourself as the regulated entity who must comply with the regulation. What problems do you encounter? Are there needs that the regulation does not address? Are there provisions in the regulation that now seem unnecessary?

Organizing the regulation.

Many regulations begin with definitions and then list general requirements that apply to all regulants. Some regulations follow the organization of their enabling statue or federal regulations, if applicable. Whatever approach you take, try to make the organization of the regulation as intuitive as possible so that the regulated community can easily find and understand the requirements that apply to them. Typically, regulations are organized into parts (e.g., Part I, II, III), sections (e.g., 12 VAC 24-45), and subsections (e.g., 12 VAC 24-45 (A)).

Once you have drafted your regulation and feel reasonably comfortable with it, it is a good idea to get feedback from inside the agency and out. Distribute the regulatory package widely—to any technical advisory committee associated with the regulation, and even across the agency, especially if it is complex and multi-faceted. You might also arrange a meeting of some members of the regulated community to get their reaction to the draft regulations. Pick your test subjects carefully so that you can ensure the best possible feedback.

After you have written the regulation and received feedback, go back to the text of the regulation and focus on the details, e.g., proper citations, syntax, grammar, and spelling. All regulations submitted to the Registrar must conform to The Virginia Register Form, Style, and Procedure Manual, particularly "Part V: Style Guidelines" (pages 29-48). The Manual states on page 6 that, "Regulations will be edited, as necessary, for grammatical correctness and consistency of language to conform with the journalistic style of the Virginia Register." If you wish to minimize the chance that the Registrar will change the text of your regulation, be sure to comply with the style requirements set out in the Manual. The following are areas to pay special attention to, along with references to the Manual:

• Page headings, § 5.2, page 29
• Strikeouts and underlines to indicate proposed changes to text, § 5.3, page 30
• Strikeouts, underlines, and brackets to indicate proposed changes to final stage text, § 5.3, page 30
• Citations to the Code of Virginia, § 5.15, page 35
• Citations to the Virginia Administrative Code, § 5.17, page 36
• Do not use and/or; instead, use "A or B or both," § 5.39, page 48
• Material incorporated by reference, Part VII, page 55