Regulations
R. A. Libby The Procter & Gamble Co. Cincinnati, Ohio 45247
Regulation Formation: Procedures for Notification and Comment
In last month's column [ A N A L . C H E M . , 50 (11), 975 A (1978)], we re-
ported on the growing impact t h a t Federal regulations will have on the conduct of analytical chemistry. This month we will describe in some detail how regulations are formed and how you, as a scientist, can become an appropriate influential part of this regulation formation process.
Regulation Formation Process T h e regulation formation process is well defined by the Administrative Procedures Act and occurs through a series of steps over a considerable time span. T h e following describes typical steps in this process.
Phase I—Agency Preparation A unit within a governmental agency drafts a proposed regulation based on a perceived need and under the authority of enabling legislation passed by Congress giving them authority to regulate an area. For example, the G L P regulations of the Food and Drug Administration were proposed under the Federal Food, Drug and Cosmetic Act. Often in this preproposed drafting stage the agency unit will seek selected input from others outside the agency, such as other Government agencies, advisory groups or technical societies such as the ACS to aid their thinking in making the regulations effective, practical, and feasible. This is the first opportunity for technical experts to influence the regulation. T h e first draft is circulated through the originating unit and then to other units in the agency for comments. When a draft has been finalized by the originating unit, it is then approved by agency administrative units, including the legal arm of the agency, with final concurrence by the agency head. 0003-2700/78/A350-1119S01.00/0 © 1978 American Chemical Society
Phase II—Initial Publication for Public Comment T h e regulatory proposal is published in the Federal Register, along with a preamble explaining the need for and basis of the proposal, and it usually includes a deadline for submitting written comments on the proposal, where to send comments, and a name to contact for further information. T h e agency seeks written public response to most proposed regulations so t h a t the agency can obtain a better understanding of the total breadth and depth of impact on those who will be regulated. During the comment period provided, interested parties may formulate their comments individually or contact others for a collective presentation of such comment. Collective comments are often sent in by scientific associations, universities, professional societies, trade associations, etc. In addition, those who have contributed to the collective comments often separately file their own submission to reinforce specific points t h a t are particularly troublesome to them. This is where you as a scientist can contribute in a meaningful way to the regulations. T o be most influential, comments should be specific and alternative suggestions given. It is helpful to the agency if one not only gives the reason for objection, but also provides suggestions on how the intent of the regulation can be met by a more workable alternative. If the issues contained within the proposed regulation are very complex or controversial, a public hearing may also be scheduled by the agency to provide interested parties an additional opportunity for dialogue and input on the regulatory issues. T h e time available for these written
comments typically ranges from 30 to 120 days from Federal Register publication date; comment deadline extensions are often sought by interested parties and are frequently granted by the agency when reasonable cause is shown.
Phase III—Agency Consideration of Comments and Public Input Following the close of the "official" comment period, including any extensions, the agency begins a period of internal review of all the information made available to it on the regulatory proposal. Each individual comment is read by an agency staffer and is somehow reconciled against the existing regulatory proposal. T h e agency's proposal can be modified or left as drafted; often agency reasoning on how some or all of the public comments are viewed accompanies the published revised proposal. This period of agency comment consideration can extend anywhere from several months to several years, but typically it is 3-9 months. When the public comment period is officially closed, it is still possible to transmit additional public comments. While the agency is not required by law to consider these additional comments, as a matter of courtesy, especially if filed early in the agency internal review process, they tend to be viewed in the same way as those comments submitted by the official deadline.
Phase IV—Agency Republication Following the agency's consideration of their proposal and all input made available to them, several options become available as follows: Publication of a revised proposal for
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additional public comment—this usu ally occurs when substantial modifica tions have been made in the initial proposal. Publication as a "tentative final" regulation with further public com ment solicited. This "tentative final" form usually designates a "firmer" proposal by the agency, and one which is less likely to change in significant respects when eventually issued in final text. Issuance of final regulations—no comments solicited. This represents the final phase in an agency's regula tory development. Dissatisfaction by interested parties with this promul gated regulation must now be taken up via the judicial process, which can involve court challenge, a request for stay of the effective date, etc. No publication at all or publication of a statement that terminates agency efforts to issue regulations at this time could also occur.
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Phase V—Final Regulation All regulations when finally promul gated bear an effective date for com pliance, which is usually at least 30 days after the final regulations appear in the Federal Register unless good cause is shown. Following the year in which final regulations appear in the Federal Register, they become incor porated into the Code of Federal Reg ulations, which contains all regula tions in effect for the Federal agencies. Pesticide Testing A case in point is provided by the pesticide testing guidelines (rules) proposed by the EPA in the Federal Register on July 10,1978 (comment deadline 9/8/78), under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Pesticides in this sense means agricultural and house hold pesticides ranging from chlordane to household disinfectant. While these regulations impact on many ana lytical laboratories in their own right, the real impact of these proposed FIFRA rules is reflected in their intro ductory text where the EPA states it plans to propose similar testing rules under the Toxic Substances Control Act (TSCA). While the FIFRA testing guidelines only affect the pesticide in dustry, the TSCA rules will apply broadly across the whole chemical in dustry and thus affect nearly every analytical facility. Comments on these FIFRA guide lines can be sent to: Federal Register Section Technical Services Division (WH-569) Office of Pesticide Programs, EPA Room 401, East Tower 401 M Street, S.W. Washington, D.C. 20460
