Updated 07-17-2011

Seventh - I wish to point out that usage of ASTM Standard F-138 by the APP violates the standards and principles called for by ASTM International, the authors of ASTM Standards.

Choosing Standards Based on Merit
Copyright 2010, ASTM International. www.astm.org

This paper, published by ASTM International in 2010, is written to confirm the commitment of ASTM International to the WTO TBT principles, "... the cornerstones of a liberalized trading system ..." and describes the importance of U.S. domiciled standards setting organizations arguing that U.S. contributions are used extensively around the world, formulated by experts from around the world, and that the acceptance of universal standards must not take precedence over merit interpreted as "the freedom to choose a standard based on performance, suitability, effects ..."

The TBT Agreement delegates certain responsibilities to international standards:

(1) they must function effectively and appropriately;
(2) they must fulfill legitimate objectives; and
(3) they must be relevant [based on]...regulatory and market needs ... scientific and technological developments ...[and the] ability to solve real problems in real time. (2010:4)

The more pertinent question(s) ...
(1) whether or not a standard facilitates or poses an obstacle to trade, and
(2) whether or not a standard is effective and relevant to market needs and conditions. (2010:5)

...the obligation of manufacturers and governments [is] to choose the best standards available and the standards that are most relevant to their needs. (2010:2)

III-Principles
U.S. interests strongly agree on the principles necessary for the development of national or international standards to meet societal and market needs.
In successful standards processes

* A Principle required by ASTM:
* Decisions are reached through consensus among those affected.

Consensus has not been sought because F138 316LVM would be rejected by practitioners and suppliers by a vast majority. Consensus has never been attempted knowing full well that for the past 20 years piercing jewelry uses non-F138 certified 316L. It would be disingenuous to think businesses would prefer more expensive products primarily sourced from APP member manufacturers.

* Principle
* Participation is open to all affected interests. [Note 2]

APP is portraying themselves as a standards-setting organization for body piercing while in actuality they are an advocacy group with fewer than 300 members worldwide. Their deliberations and meetings are closed door with no interest in an open dialogue.

* Principle 
*Balance is maintained among competing interests.

In APP competing interests (those who do not agree) are excluded.

* Principle
* The process is transparent, information on the process and progress is directly available.

The process behind APP standards are behind closed doors and secret.

* Principle
* Due process assures that all views will be considered and that appeals are possible.

Meetings are behind closed doors, even members are excluded from some post  discussions.

The following principles are not transparent.

* Principles
* The process is flexible, allowing the use of different methodologies to meet the needs of different technology and product sectors.
*The process is timely; purely administrative matters do not slow down the work.
*Standards activities are coherent, avoiding overlap or conflict.

Successful standards processes yield the right results

* Standards are relevant, meeting agreed criteria and satisfying real needs by providing added value.

There is no merit, no real need, no added value by specifying F138 316LVM while  invalidating a perfectly safe existing product: non-certified 316L. There is no "credible rationale" for this specification and none is offered. The APP's attempt to circumvent consensus is inappropriate and incompetent.

It can be argued that use is a benchmark of merit; that is, the standard [316L] has earned the confidence of a wide range of users. (2010:5)

*Standards are responsive to the real world; they use available, current technology and do not unnecessarily invalidate existing products or processes.

* Standards are performance-based, specifying essential characteristics rather than detailed designs.

This is a further objection because the essential characteristics are not considered.

National Standards Strategy for the United States
ASTM 2010
I-Introduction
Voluntary consensus standards for products, processes and services are at the foundation of the U.S. economy and society. The United States has a proud tradition of developing and using voluntary standards to support the needs of our citizens and the competitiveness of U.S. industry. The American National Standards Institute (ANSI) the coordinator of the U.S. standards system, has brought together public and private sector interests to make this happen....

II-Imperatives for Action
The standardization world has changed.
We can't assume that U.S. technology and practices will automatically be adopted everywhere, nor can we assume that within the U.S. everyone will be satisfied with business as usual.

Internationally
* The European Union is aggressively and successfully promoting its technology and practices to other nations around the world through its own standards processes and through its national representation in the international standards activities of the International Organization for Standardization (ISO), the... International Electrical Commission (IEC) and the International Telecommunication Union (ITU)
* Emerging economies with the potential for explosive growth are looking to ISO and IEC for standards. In some sectors these standards do not reflect U.S. needs or practices.

The exclusion of technology supporting U.S. needs from international standards can be a significant detriment to U.S. competitiveness. The U.S. will lose market share as competitors work hard to shape standards to support their own technologies and methods.

Just as the EU has shaped legal requirements to compel the use of EU produced  titanium, APP is working in the same spirit to shape legal standards to support the 316LVM fabricator-members to the exclusion of 316L.