4. Regulatory Measures and Procedures 1

General measures Include regulations or administrative rules of general applicability aimed at implementing or interpreting law or policy (such as public directives to all the operators acting in an economic sector; rules on prices or tariffs; planning). Particular measures Affirmative or negative dispositions directed at a particular addressee (such as licenses or sanctions). 2

Rulemaking procedures for formulating, amending or repealing a general measure. Adjudication procedures for the formulation of a particular measure. In many national and supranational legal orders both procedures provide for participatory guarantees. A model can be found in A.P.A., It provides for formal and informal procedures. 3

─ Other legal systems follow APA model. Limits in Italy (law n. 241/1990). ─ The E.U. pays great attention to participatory guarantees in regulatory procedures. General measures (Regulations and Directives). Prior consultation of interested parties. Particular measures. Adversary participatory procedures (Antitrust decisions of the Commission). 4

President Obama’s Executive Order of January 18, 2011, “Improving Regulation and Regulatory Review”. General principles ─ Ends: Regulation must protect public health, welfare, safety and the environment, while promoting economic growth and competitiveness The “proper balance” between free market and the public interest”. 5

─ Tools: Regulation is adopted through participatory procedures based on a open exchange of ideas. It must use the best, most innovative, and leased burdensome tools for achieving regulatory ends. It must take into account benefits and costs. ─ Form: Regulation must be accessible, consistent, written in plain language, easy to understand. ─ Measurement: the Regulatory System must measure the actual results of regulatory requirements. 6

- Proportionality: Regulations impose the least burden on society consistent with obtaining regulatory objectives. Regulations select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, distributive impacts, and equity). Regulations identify available alternatives to direct regulations including economic incentives. 7

Procedures An Internet notice and comment procedure is provided for (with a duration of 60 days). Coordination Administrative agencies promote coordination to reduce redundant, inconsistent or overlapping regulations Flexibility Regulatory approaches aim at encouraging flexibility and freedom of choice, including warnings and disclosure requirements, more than imposing command and control measure. 8

Scientific integrity Agencies shall ensure the objectivity of any scientific and technological information which supports their regulations. Periodic review Agencies shall promote retrospective analysis of rules that may be outmoded, ineffective, insufficient or excessively burdensome and to modify, streamline, expand, or repeal them. Coordination of reviews is ensured by the Office of Information and Regulatory Affairs (“OIRA”). 9