Agencies use their special expertise to develop rules and technical standards that are binding as
law. An example would be restaurant inspection standards. Public health agencies can make
rules if they are authorized by the legislature. While rulemaking is important in public health, many
agencies, such as the CDC, have limited or no authority to make rules. These agencies either do
not do enforcement or enforcement statutes or rules made by other agencies.
Regulations give direction to regulated parties and the general public. While general powers are
valuable to dealing with unexpected events, they give little direction to people engaged in routine
activities such as running restaurants. By adopting standards such as food sanitation code, the
health department can give detailed guidance on how to prepare and serve food safely.
Regulations allow public participation. Regulations are usually published before they become
effective and the public is allowed to comment on them. In the federal system, there is no right to a
hearing on a rule unless specifically required by Congress. All comments must be made in
writing. Some states require that the agency have a hearing and allow oral testimony on rules if
requested by a certain number of persons. Public comment is important for regulations that raise
difficult public policy issues, such as whether volunteer organizations such as churches have to
meet the same sanitary regulations as businesses. If an agency does not comply with the
statutory requirements for promulgating regulations, the court can suspend the regulation until it
has been properly promulgated.[Chocolate Manufacturers Assoc. of the United States, Appellant,
v. John R. Block, Sec. U.S. Dept. of Agriculture; Samuel J. Cornelius, Administrator, Food and
Nutrition Service and U.S. Department of Agriculture, 755 F.2d 1098 (1985)]
Regulations harmonize practices between jurisdictions. While most public health enforcement is
local or state based, businesses operate across many jurisdictions and need consistent
standards. It is also important that public health standards reflect best practices. By adopting
national standards, health departments across the country assure best practices and make it
easier for national businesses to operate
Once a regulation has been properly issued, its validity cannot be challenged in court. This allows
an agency to limit the grounds for challenging an agency action.[Heckler v. Campbell, 461 US 458
(1983)] For example, once the standards for food inspection are adopted, a restaurant cannot
litigate the proper temperature for keeping food cold or whether their alternative dishwashing
method is acceptable if these are specified in the rules. Challenges to the rule must be made
when the rule is promulgated, not in later litigation challenging the enforcement of the rule.
Challenges to the agency's legal authority to make the rule or the constitutionality of the rule can
be made at anytime since the rule cannot be valid if the agency does not have the power to issue it.