February 23, 2001
Mr. Jim Tozzi, Ph.D.
Member, Board of Advisors
Center for Regulatory Effectiveness
Suite 700
11 Dupont Circle, N.W.
Washington, D.C. 20036-1231

Re: ANSI Accreditation Process

Dear Dr. Tozzi:

     I am in receipt of two letters that you submitted on behalf of CRE to ANSI in connection with two separate accreditation applications. Thank you for your interest and participation in the American National Standards (ANS) process. Your public review comments are being handled in accordance with established procedures and you should expect to receive a response to them from each organization, respectively.

     The purpose of this letter is twofold: 1) to address issues that you raised relative to the ANSI accreditation process as it relates to developers of American National Standards (ANS); and 2) to explain the process that is open to all individuals seeking to change the procedures associated with the ANS process, which includes the accreditation of ANS developers and the approval of American National Standards.

     ANSI, through its Executive Standards Council (ExSC) accredits the procedures of standards developers who produce voluntary consensus standards that are candidates for approval as American National Standards. ANSI requires that the standards development procedures used by ANSI-accredited standards developers (ASDs) be characterized by and incorporate the tenets of openness, balance, due process and consensus. ANSI does not evaluate the technical content of an ANS, but rather whether ANSI's procedural requirements are met. Only standards that meet ANSI's requirements, as contained in the ANSI Procedures for the Development and Coordination of American National Standards¹ (also known as the ANSI Procedures) (https://web.ansi.org/public/library/std_proc/default.htm), are approved as American National Standards. As noted previously, an ANS is a voluntary consensus standard, not a government regulation. Thus, the requirements and processes associated with an ANS do not exactly replicate those of the Federal government rule making.

     For your information, the ExSC has promulgated a document entitled ANSI Guide for the Preparation of Standards for Use in Regulations, a copy of which is enclosed for your reference. It is also posted at https://web.ansi.org/public/library/guides/4643.html. This document is relevant to the theme of the comments that you submitted.

     Please consider the following general comments in response to some of the points and critiques that you included in your letters. They are:

• The ANSI process includes a series of checks-and-balances that provide comprehensive due process safeguards. These include:
  • Appeals provision relative to the ANSI-accredited status of ANS developers;
  • Equal access to voting member status on consensus bodies;
  • Public notice requirements at various phases in the development cycle, including an opportunity for public review and comment on all substantive drafts of the proposed standard;
  • Consideration of all comments received whether from a voting member of a consensus body or a public review commenter;
  • Appeals rights at the developer level and at ANSI;
  • Review of evidence of consensus, as appropriate, by the ANSI Board of Standards Review (BSR); and
  • Mandatory procedural audit as a condition of maintaining accreditation.
    
    
• ANSI's Standards Action, a key public review vehicle for American National Standards, is freely available on ANSI Online at https://web.ansi.org/rooms/room_14/. Anyone may view and obtain a copy: ANSI membership is not required, nor is there a fee associated with the posted version of the document. In addition, in practice, anyone may submit public review comments in response to an announcement in Standards Action. The ANSI Procedures do not define "directly and materially affected" and the interpretation of this term has been extremely broad. All comments submitted in response to a public review notice must be handled in accordance with clause 1.2.7 Consideration of views and objections of the ANSI Procedures. There is no provision in the ANSI Procedures that allows, as you state, "the standards-setting body…too much unchecked discretion to exclude disfavored parties."
  
  
• The ExSC accredits the procedures of standards developers that meet the requirements contained in the ANSI Procedures. Thus, satisfying requirements different than these, e.g., government requirements, is not a precondition for approving an application for ANSI accreditation. An ANSI-accredited standards developer may choose to incorporate other procedural provisions in their operating procedures; however, such provisions cannot be in lieu of or inconsistent with ANSI's requirements.
  
  
• ANSI's requirements ensure that the consensus process is open to all materially affected and interested parties. Thus, all stakeholders have the opportunity to participate, have their comments considered and receive due process. Due process requirements are not applied differently across interest groups, e.g., comments of small businesses would receive the same consideration as those of consumers, producers, government, etc. Further, the ANSI Procedures provide for claims of dominance to be reviewed if, in practice, equitable treatment does not take place. Please refer to clause 1.2 of the ANSI Procedures for specific provisions in this area.
  
  
• The ANSI Procedures require, in part, the following:

• Clause 1.2.2 Balance states "The standards development process should have a balance of interests and shall not be dominated by any single interest category." Thus, the "should" indicates that balance is a goal and in practice, developers strive for balance; however, the process shall not be dominated by any single interest category. In addition, the interest categories that are relevant to a standard under development may be more than three and are not limited by the procedures to user, producer and general interest. Dominance is only addressed if it is raised. Further, an apparent lack of balance does not automatically result in dominance.

• Cost-benefit analyses are not required by the ANSI Procedures. A cost/benefit assessment is not always necessary or practical when developing a standard. This is a decision that rests with the consensus body of the ANSI-accredited standards developer or is otherwise governed by an ANSI-accredited standards developer's procedures.

• The ANSI Procedures contain record retention requirements in clause 1.2.13 (Records).

• The ANSI Procedures contain maintenance requirements in clause 4 (Designation, maintenance, publication and interpretation of American National Standards).

• The ANSI Procedures provide for public review periods of three different durations: 30 days, 45 days and 60 days. Please refer to clause 1.2.6 (Notification of standards development) for further details.

• The appeals requirement, i.e., that all ANSI-accredited standards developers provide an appeals mechanism at their level, applies regardless of method, e.g., organization, committee or canvass. Prior to approval as an ANS, all appeals at the developer level relating to a candidate standard must be concluded. Then, anyone who appealed at the standards developer level has the right to file a procedural appeal with the ANSI Board of Standards Review (BSR) if the BSR approves a standard as an ANS.²

     It is my understanding that you may wish to submit comments in the future in response to accreditation applications. Certainly, that is one approach and comments related to whether or not a developer's specific procedures comply with ANSI's requirements would be considered by the ExSC. However, if you wish to propose that ANSI change its procedural requirements to address some of the comments and suggestions that you included in your recent letters, then I recommend that you submit a generic proposal to the ANSI ExSC as opposed to reiterating such suggestions in response to individual proposed accreditations.

     Anyone may propose procedural revisions for the consideration of the ANSI ExSC. All such proposals submitted are considered by the ANSI ExSC at one of their regularly scheduled meetings. As the Secretary to the ANSI ExSC, such proposals should be submitted to me in writing in advance of a meeting. The ANSI ExSC next meets in May 2001. Thus, my office should receive any such submittal, preferably in electronic format, by April 20, 2001. I recommend that you propose alternative language and provide a rationale if you believe specific text in the ANSI Procedures or in the enclosed Guide requires revision. This is a more efficient approach than submitting general comments on the document as a whole.

Thank you for your interest in the American National Standards process. Please contact me if you have any questions or if I may be of assistance to you.

Enclosures