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AMERICAN NUCTEAR SOCIETY

555 North Kensington Avenue

La Grange Park, Illinois

60526-5535 USA

Tel:7081 352-6611

E-Mail: NUCLEUS@ans. org

http://www.ans.org

March 3,2011 Fax:7081 352-1499

National Science and Technology Council's Sub-Committee on Standards

c/o National lnstitute of Standards and Technology

100 Bureau Drive, Stop 1060

Gaithersburg, MD 20899-1060

RE: sTANDARDIZATION FEEDBACK FoR suB-coMMtrrEE oN STANDARDS

Docket No. 0909 1 0 0442-0563-02

The attached is a detailed response from the American Nuclear Society (ANS) addressing the

Federal Register notice on "Effectiveness of FederalAgency Participation in Standardization in

Select Technology Sectors for National Science and Technology Council's Sub-Committee on

Standardization." The ANS Standards Committee mission is to develop voluntary consensus

standards to be certified by the American National Standards lnstitute (ANSI) as American

National Standards. The Standards Committee is responsible for the development and

maintenance of standards that address the design, analysis, and operation of components,

systems, and facilities related to the application óf nucbâr science and technotogy. tre RtrtS

works closely with federal agencies in the development and maintenance of our èiandards to

gain their input and work towards their endorsement or adoption.

The responses are a compilation of comments from Standards Committee members with

extensive experience in standards. These members recognize the benefit of developing

voluntary consensus standards for the industry and support from federal agencies throughout

the development process in staff resources and funding. This has become even more aþparent

as the nuclear industry prepares for the construction of new nuclear power plants after 30-years.

While ANS understands the significance of federal agency support, we acknowledge the nêed

of industry organizations to encourage their staff's participation and coordination bétween

standards development organizations.

We very much appreciate the opportunity to provide input to this important issue and hope that

the responses are found beneficial. Should you wish to discuss these responses, feelfree to

contact Mr. Donald J. Spellman, ANS Standards Board Vice Chair, at spellmandi(ôornl.sov or

865-574-7891.

Respectfully yours,

-N--{-!% \

Joe F. Colvin

ANS President

Attachment

Leaders in the tlevelopment, ilisseminøtion and applicutíon of nuclear science and technolosv to benefrt humanitv.

Joe F. Golvin, P.E.

President

Tel:202 / 439-0952

Fax: 708 / 579-8283

Email: jfc@nei.org
  1

1) to cont

                                                       

Specific Responses to Direct Questions Extracted from FR 2010-3086 

Provided by the American Nuclear Society 

A. Standards Development: Who participates in standards-setting activities? 

The American Nuclear Society (ANS)a Standards Committee consists of the ANS Standards 

Board and four consensus committees that are made up of members from industry as well as 

government agencies [primarily the U.S. Department of Energy (DOE) and the U.S. Nuclear 

Regulatory Commission (NRC)]. The industry sector includes utilities; architect engineers; 

constructors; consultants; manufacturer/suppliers; and industry-supported organizations such 

as the Electric Power Research Institute (EPRI), the Institute of Nuclear Power Operations 

(INPO), and the Nuclear Energy Institute (NEI). Government agencies include DOE, national 

laboratories, NRC, and the National Institute of Standards and Technology (NIST), among 

others. Nuclear standards development organizations (SDOs) include the American Society of 

Mechanical Engineers (ASME), American Society of Testing and Materials (ASTM), 

Institute of Electrical and Electronics Engineers (IEEE), and many others. [The American 

National Standards Institute (ANSI) has hundreds of members.] Many industry consultants 

also participate in national consensus standards writing, balloting, and obtaining approvals. 

Some nuclear industry organizations, e.g., INPO, EPRI, and NEI, do not routinely participate 

in national consensus standards development processes. They think that the consensus process 

takes too long, so they write quasi-standards for their members or develop their own 

“standards” as administrative procedures. Such activity has led to incongruous results. NRC 

may treat quasi-standards the same as true consensus standards, which may lead to higher 

costs, nonuse, or both. Some “standards” are not particularly clear or useful. NEI 00-04 (“10 

CFR 50.69 SSC Categorization Guideline”) provided the basis for 10 CFR 50.69 (“Title 10, 

“Energy,” Part 50, “Domestic Licensing of Production and Utilization Facilities,” Sec. 69, 

“Risk-Informed Categorization and Treatment of Structures, Systems and Components for 

Nuclear Power Reactors”), which is a complex, confusing rule that is rarely used for light 

water reactors (LWRs) (use is voluntary). In addition, some utilities choose not to participate 

in writing consensus standards but become engaged at the review/approval stage. 

1. What are the most important reasons for participation? 

Standards support the general welfare by providing methods that are based on extensive 

professional experience of the most cost-effective, concise, risk-informed ways to ensure 

nuclear safety through regulation. Standards provide the "how" to safely meet federal 

regulations. 

More-detailed reasons for participation are the following: 

ribute to the profession and ANS at large; 

a

 The acronym “ANS” is defined as “American Nuclear Society” and is not to be confused with other definitions of 

“ANS” used in the industry. 
  2

2) to enhance personal professional development by gaining knowledge of new 

developments and by networking with industry peers; 

3) to be exposed to new technology or processes; 

4) to represent company interests in new technology development areas; 

5) to fix historical problems; some NRC and Occupational Safety and Health 

Administration rules from the 1970s and 1980s have needed to be more clearly 

expressed; 

6) to meet the requirement of organizations that their employees participate in 

SDOs, for reasons ranging from developing contacts for future business 

development to personal growth; 

7) to discover how other organizations approach regulatory interests so that a 

common position on requirements imposed by law can be developed; 

8) to support professional bodies, e.g., supporting SDOs like ANS or ASME, as 

professionals in the field; 

9) to establish common standards for component or software interchangeability, 

compatibility, or related functionality; 

10) to solve problems where opinions diverge on ways to meet safety requirements 

and regulations and in-house procedures. 

2. What are the benefits of developing standards for the nuclear industry? 

Benefits are derived in professional development as well as in the areas of equipment and 

simplified specification. 

From a professional perspective, participating in standards activities broadens a participant’s 

scope and depth of knowledge. Industry sectors have common, interfacing compatibility and 

interchangeability needs so that awareness of standards not only provides a participant a 

competitive advantage but also benefits users of his or her products. 

Participants from companies that integrate huge amounts of equipment, such as architectural 

engineering companies, benefit from learning common formats and scopes for technical 

literature and other similar materials. For nuclear plants, with more than 100,000 discrete 

components at a single plant, standards improve how those components are used. 

Citing a common standard in lieu of writing unique specifications or procedures simplifies 

contracts. A supplier can assess its product’s applicability and fit immediately at lower cost 

because there is less customization. 

3. How do the standards impact organizations and their competitiveness? 

Standards provide nuclear suppliers, constructors, and operators with logical, consensus-based 

methods so that they can perform in a manner that has been judged by their peers to be 

acceptable and in some cases satisfy federal regulations and enhance safety. 

For suppliers, having an entire industry provide input to a given standard can make supplying 

use-specific equipment (safety related) and services easier. Designing to proven standards 

reduces errors. Suppliers and individuals benefit, though in different ways. Organizations that 

work to continuously improve process integration need standards for guidance. 
  3

Standards development is an investment to which many companies are unable to contribute. 

Unless they see an immediate benefit, companies are not always willing to commit people, 

time, and travel expenses. The cost to send people on travel for three days two or three times a 

year is significant. In addition, writing standards demands focused technical time in addition 

to face-to-face meetings and is generally not supported during company working hours. There 

are also coordination demands and related administrative needs. 

Some companies indirectly support standards through groups like NEI, EPRI, or owners’ 

groups. These include the Boiling Water Reactor Owners’ Group and the Pressurized Water 

Reactor Owners’ Group. INPO rates industry participation for organizations, including 

support of standards. NRC “Safety Culture” measures similar criteria using consensus safety 

standards development participation. 

4. How has standardization spurred innovation in the technology sector(s) that is the 

subject of your comment? 

Nuclear suppliers spend millions of dollars each year to improve their products and enhance 

nuclear performance. For instance, fuel fabricators are constantly conducting research and 

development of nuclear fuel, cladding, and structural components. Pump, valve, and piping 

fabricators are constantly developing more efficient, longer-lasting components that meet 

safety criteria. Reactor designers are routinely trying to develop new, more efficient reactor 

heat sources and systems. 

However, it is not clear that standards have actually spurred nuclear design innovation. The 

absence of standards may have hurt nuclear design innovation in many ways. 

Nuclear design technology has not changed fundamentally for many years. Recently, ANS 

has begun to receive new recommendations from industry for standards development 

particularly for safety enhancements and cost savings. 

In the past, design requirements were so complex and poorly documented that few people 

actually understood them. Few up-to-date nuclear design standards are available. The 

organizations that actually performed nuclear design seemed to develop them in direct concert 

with NRC regulatory changes. LWR design requirements are well known conceptually. For 

operating plants, however, design issues recur many times in the life of a plant. Without 

design process knowledge, answering specific regulatory questions on design can be difficult, 

especially for conceptual heat source designs. For those who perform nuclear design, wanting 

to know current design methods has stimulated interest in standards participation. 

Construction promotes nuclear standards. Now that construction is imminent, the need for 

new nuclear standards is clear. New nuclear standards’ needs have not been recognized for 

many years. 

5. What is the current phase of the standards development process for this technology? 

National consensus standards focus on ways to develop, clarify, and document technical 

information, design, and operational experience that can be used to lower nuclear costs and 

enhance safety, like common methods to integrate information from a number of relevant 

sources. Designers understand current deterministic LWR nuclear design processes very well. 
  4

They understand risk-informed LWR processes less well because of a coherent lack of source 

guidance to follow. Furthermore, ways to implement designs effectively, both during 

construction and later in operations, remain poorly understood by regulatory bodies, nuclear 

plant suppliers, and their operating entities. Because these areas posed such problems during 

nuclear construction in the 1980s, they are candidates to reexamine today. Lack of 

promulgation of exact requirements to the designers and engineers tends to cost much more for 

rework, adequacy of completed work, change control issues, and so on, as the industry 

addresses new construction again. Adequate consensus standards greatly simplify and provide 

straightforward work processes to follow. Consensus standards developers are constantly in 

discussions with nuclear regulators to continue to develop an understanding of where 

regulations are headed such that the supporting consensus standards are viable to provide an 

approach to meet or exceed those regulatory and safety requirements. The development process 

is quite adequate; the clear path forward for changing regulations is not. 

6. How has the process worked so far? 

So far, the process has usually worked very well, but development times are excessive. 

However, increased cost for participants to actively engage in standards activities has put a 

strain on employers to allow the required participation. Electronic systems are not developed 

well enough to allow online participation, nor are the standards societies funded well enough 

to support the necessary electronic means (i.e., online development, comment collection, and 

comment resolution). 

7. When developing standards, how are the standards-setting processes managed and 

coordinated? 

The standards-setting processes are managed and coordinated through consensus procedures 

approved by each SDO and approved and audited by ANSI. 

SDOs seek the most knowledgeable experts to present and discuss various views, based on 

experience, related to the best and safest methods to accomplish a required task such as design 

of a nuclear safety-related system. Once reaching draft agreement, they document that 

agreement and prepare for group consensus review. Standards-setting processes vary greatly, 

but participants with standards development experience and writing skills provide a benefit to 

the timely development of standards by speeding the process. Having standards models (good 

and bad) with explanations and examples of what to do (and what not to do) also helps the 

process. The long absence of nuclear construction has been detrimental to standards 

development proficiency. 

Writing consensus standards is a volunteer effort. Enforcing schedules and commitments is 

extremely difficult, if not impossible, as participants have other responsibilities. Having one 

or two committed persons to lead the work and development of a project plan is critical to 

successful standards development. The fastest approach to provide useful content is to get 

people to provide material in whatever form they can, put it into an appropriate format, and 

present it before the group. The group then evaluates the material to modify and use. Periodic 

face-to-face meetings are required to recalibrate the process and mark progress to the plan. 

Most of the actual writing is completed by working group members off-line and after normal 

working hours. An electronic "home" is a most useful tool for presentation of off-line material 

to the working group and to allow for online comments and resolutions. Only a few SDOs 
  5

have this electronic capability. 

8. Is there a strategic plan that identifies the standards needs and defines the standards 

development life cycle? 

Standards needs are developed within each SDO and generally not shared throughout the 

entire community for nuclear standards. The life cycle is well developed, documented, 

approved, and audited between the SDOs and ANSI. A recent effort has just begun through 

NIST and ANSI to coordinate efforts across all the nuclear SDOs, but a lack of funding for 

participants has severely limited any progress. 

ANS uses a Project Initiation Notification System (PINS) as required by ANSI to authorize 

new work. A new standard requires support in addition to project approval. ANS provides the 

infrastructure and coordination essential to develop a standard; without this, there would be 

no standard. 

In the 1980s, post-Three Mile Island corrective actions left little time to recognize the need 

and develop post-accident response standards when they were needed the most. Today, post9/11 security issues again show the need for new standards. Both design and security could 

benefit from more standards development. Industry and regulators have ineffective processes 

to reveal where new standards are needed that can provide the most benefit. Once those 

standards have been identified, they should be prioritized by the national standards authority 

that will then assign the appropriate development efforts to the appropriate development 

organizations. These SDOs could then initiate development of the standards on a normal, 

nonemergency basis and focus available funds on higher-priority efforts. 

9. Are there barriers to developing high-level strategies for standard-setting activities? 

Yes, there are barriers. One barrier is adequate financial support to one top-level 

organizational entity. A combination of ANSI, NIST, the International Science and 

Technology Center, and the nuclear regulators would provide the much needed coordination 

and development of one strategic plan for all nuclear SDOs that could define the needs, 

determine the priorities, assign action plans to small groups, and develop a tracking system of 

completion. 

Complacency and focus are significant barriers. When a need is urgent, there is no time to 

develop consensus standards. Once past the crisis, impetus and focus to develop standards are 

lost. Very often, organizations learn to live with urgently developed new rules, although at 

high costs. Industry should work even more closely with SDOs and regulators to improve 

how they select areas to develop standards. Very often, regulators perceive different needs 

than industry or others. Industry and SDOs may also overextend. They sometimes seek to do 

far more in an area than the regulator envisioned. Standards development alone does not 

guarantee a successful outcome. Some risk-informed standards [like NFPA 805, 

“Performance-Based Standard for Fire Protection for Light Water Reactor Electric Generating 

Plants,” or probabilistic risk assessment (PRA) standards] are so complex that their cost of 

implementation is high. 

Here, organizations such as NEI, INPO, reactor vendor owners’ groups, and even the 

International Atomic Energy Agency (IAEA) could, because of their paid staffs, quickly 
  6

develop a guidance document to respond to an immediate need while the SDOs were actively 

developing the high-priority standard to meet the identified need. 

B. Coordination Efforts

1. What methods of engagement are used by federal agencies to participate in private 

sector–led standards development? 

Federal agencies promote involvement in the development of standards. This development 

includes employing common and repeated use of rules, conditions, and guidelines for 

products or related processes as well as related management systems practices that are 

developed by these federal agencies. 

An example is the DOE involvement in national nuclear energy standards. DOE has an 

organization called the DOE Technical Standards Program Office (HS-22) that is very 

involved in national standards development with all the nuclear-related SDOs. DOE writes 

and approves internal standards that are specifically applicable only to DOE activities. When 

national standards can be used, as required by Office of Management and Budget Circular A119, DOE complies. When DOE has reliable expertise in an area where national standards are 

being written, it actively participates in those management committees, consensus 

committees, and working groups. 

Other federal agencies such as the U.S. Department of Defense (DOD), U.S. Department of 

Commerce, and NRC likewise are heavily involved in national consensus standards activities. 

When developing standards, the government agencies are often directed to take a 

deterministic approach rather than a design-based, risk-informed approach. This is why 

government standards at all levels tend to address needs or applications specific to their 

missions and functions rather than developing a standard for general application such as for a 

federal regulation. The DOD standards are primarily procurement based, and the DOE 

standards are process based. 

NRC, DOE, and the National Energy Reliability Commission develop mandatory standards or 

guidelines for their specific line of responsibility. These agencies’ involvement is highly 

visible owing to the fact that their focus is on public safety and reliability. Thus, any industry 

standards that are developed by these agencies have their direct or indirect involvement and 

are promulgated by an industry for materials, products, and services related to that industry. 

Therefore, engagement is driven by the nature of the federal agency’s involvement, meaning 

either they have a leadership role, or they are a participant. Examples of technical leadership 

by a federal agency is the role played by the NRC in (a) simplifying the reactor licensing 

process from the original two-step process of 10 CFR 50 (“Title 10, “Energy,” Part 50, 

“Domestic Licensing of Production and Utilization Facilities”) to the more efficient singlestep process of 10 CFR 52 (“Title 10, “Energy,” Part 52, “Licenses, Certifications, and 

Approvals for Nuclear Power Plants”) and (b) improving the technical basis for safety 

regulation using risk-informed and performance-based approaches. 

A second avenue of engagement is in the regulatory application of voluntary consensus 

standards (VCSs) developed by SDOs. In some cases the standard is codified by incorporation 
  7

into regulation, such as happened with ASME’s Boiler & Pressure Vessel standards. In many 

cases, VCSs are incorporated in parts by regulatory guidance documents. In still other cases, 

VCSs may not be taken note of at all within the regulatory structure. In the nuclear field, 

VCSs that are not given a role in the regulatory structure face the possibility of being 

orphaned and used in ways that may be at odds with the SDO’s intent in developing the 

standard. 

A third avenue of engagement is related to funding of standards development. A federal 

agency’s funding decisions can make a difference relative to whether a standards project goes 

forward or not. With respect to ANS, DOE funding was critical to progress made with a gasreactor standard and NRC funding with PRA methodology standards. 

2. How transparent is each method? 

It does not appear that decision making on standards engagement is part of a systematic and 

holistic process as much as it is ad hoc and “hit or miss.” Hence, the level of transparency is 

spotty. 

The process to develop a standard takes on the role “of its priority,” either mandatory or 

voluntary. A mandatory standard is generally published as part of a code, rule, or regulation 

by a regulatory government body and imposes an obligation on specified parties to conform to 

it. When the classification of standards distinguishes between voluntary consensus standards, 

which by themselves impose no obligations regarding use, and mandatory standard, then the 

process to fulfill completion of a standard by a specified date becomes almost a moot issue. It 

is a known fact that a standard will take on the role of high visibility and will be completed in 

a timely manner when that standard must fulfill a national or international requirement, less so 

with a VCS. 

3. How effective is each method? 

Only mandated standards or requirements driving standards receive full attention and are an 

effective method for completing standards. Voluntary standards are voluntary regarding their 

use. VCSs are developed outside the federal agencies as federal standards are not subject to a 

consensus process. These VCSs generally do not receive the attention they need to complete 

within some reasonable time frame. This is probably because they are voluntary for use and 

do not impose a commitment. Each industry sector, government or private, sets its priorities 

according to the commitment upon which it must act. Cross-cooperation between government 

and national standards is generally very good, at least in the nuclear energy arena. 

Hence, the effectiveness is unpredictable. Where a federal agency engages with technical 

leadership, a well-defined regulatory purpose, and funding support, the VCS process can be 

highly effective in meeting a national purpose or need. The caution that must be exercised in 

such cases is that the integrity of the consensus process should not fall victim to an 

overbearing government role. 

4. How could the methods be improved? 

Methods can be improved only if the need for the product is prioritized. Prioritization 

establishes involvement. Involvement means participation from all impacted parties. The time 
  8

must be taken to prioritize our industry needs both domestically and internationally; 

otherwise, each entity will set its own priorities, which will never achieve a common 

objective of standardization. 

One way to improve may be by SDOs and agencies working together to assure that no VCSs 

are ignored. It should be a matter of simple fairness to the volunteers who labor to produce a 

standard that the SDO ensure that agencies and industry take note of a VCS and that some 

feedback is forthcoming so that it can serve to inform future standards development efforts. If 

a new VCS that incorporates latest technology is ignored, there can be adverse safety and cost 

implications. 

5. What other methods should the federal agencies explore? 

Federal agencies must establish a single department, if not already in place, with a mission 

and charter established to support standards for their focused area(s). Without such an 

infrastructure, developing standards for the industry will never become transparent. In the 

past, the Interagency Committee on Standards Policy at NIST has done a very poor job of 

this. 

6. What impact have federal agencies had on standards activities? 

For the federal agencies noted in B1 above, support for standards has been mixed. Some 

standards are completed in a timely manner; some are completed beyond a targeted due date. 

This completion date is based on the priority and need for that standard. Standards that are not 

given a priority will probably never receive the attention they need to complete the product. 

7. How well do federal agencies coordinate their roles in standards activities in the 

sector of interest? 

Federal agencies need to be more involved in projecting the needs of the future. In addition, 

federal agencies do not appear to be proactive in implementing the policies, procedures, and 

programs that they develop. The industry knows that every agency has a strategic and tactical 

plan, but implementing and monitoring those plans seem to fall short. 

8. When federal agencies have been involved in standards-setting efforts in a 

technology sector, how has the progress of standards-setting efforts in this technology 

sector changed after federal agencies became involved? 

When federal agencies become involved, the process of developing a standard, for the most 

part, appears to run more smoothly. This positive impact is for two reasons: 

1) Other participants tend to look to the federal agency for its input since it is the 

“keeper” of items of which the other industry participants may not be aware; 

2) Federal agencies can provide leverage on others to set criteria and schedules for 

targeted completion dates. 

However, agency involvement can also have detrimental effects if it is not properly managed. 

Agency endorsement of a VCS may “fossilize” development by creating a disincentive to 

bring in technology improvements that occur with time. 
  9

9. Are federal agencies generally receptive to input from other participants in 

standards-setting activities? 

Generally speaking, the answer is “yes.” But, being receptive to ideas is one thing; budget and 

personnel support are quite another. National consensus standards would definitely benefit by 

greater federal budget and personnel involvement. 

10.Does receptiveness tend to depend on whether the federal agency is a regulator or a 

customer? 

No, as a regulator, the federal agency generally moves forward with the proposed regulation 

based primarily on input from the industry. Regulators then depend on the standards 

community to follow draft regulations with the “how to” to meet those regulations in a safe, 

efficient manner based on years of technical experience in that area. Different SDOs respond 

to different regulations depending on the charter of the SDO. 

As a customer, federal agencies have routinely participated in national standards at a level so 

that needs of the agencies are generally included as the standards are drafted. If not, the 

standards maintenance process allows for periodic updates to approved standards to include 

those needs based upon a consensus of the industry (i.e., balance of interest). However, it 

should be noted that regulatory language may not be subjected to any updating requirements 

resulting in regulatory obsolescence. This can be a source of significant disconnection 

between federal agencies and SDOs. 

11.In those sectors where federal agencies play a significant role in standards activities, 

how valuable and timely is the work product associated with this effort? 

If the work is a priority especially if it benefits public safety, the federal agencies will play a 

significant role in both the quality of the product and the timing for completion of that 

standard. Their participation will be visible. 

Credibility of all participants and the priority of the standard appear to be the key factors in 

completing a “quality” standard by the targeted date. 

C. International Cooperation 

 

1. Are efforts made to determine whether there is potential for overlap or duplication 

with existing international standards? 

Such efforts are limited to those U.S. experts that participate in the initiation, review, 

comment, and balloting of International Organization for Standardization (ISO) standards 

through the ANSI Technical Advisory Groups (TAGs). For nuclear issues, the Nuclear TAG 

provides a direct link between ISO Technical Committee 85 on Nuclear Energy and ANSI. 

However, because of lack of any direct funding, the U.S. NTAG is not very active. Very little 

information is passed routinely among ISO, ANSI, and the U.S. SDOs. Evaluation of overlaps 

is nearly nonexistent. 
  10

2. How are other appropriate international standards that may be of interest 

identified? 

International standards that may be of interest are nearly nonexistent. ISO has a project 

identification notice that allows an international standard to be developed or revised based on 

member country approvals. The U.S. Nuclear TAG receives these notices, but they are not 

routinely passed to SDOs. 

3. Are efforts made to identify existing or planned regional or national standards that 

may be considered for use as the basis for foreign technical regulations, rather than the 

committee considering the international standard? 

No, this in not routinely done. No consideration is routinely made for use of any U.S. 

standards as potential input for foreign country regulations. 

However, inclusion of U.S. national consensus standards has been considered as a baseline for 

development of adoption as ISO standards. On one occasion, ASTM proposed that a number 

of ASTM standards be adopted directly by ISO Technical Committee 85 and published as 

joint ISO/ASTM standards. This project was completed for nine ASTM standards. 

D. Intellectual Property 

1. How does the need for access to intellectual property rights by federal agencies 

factor into the use or development of standards? 

Intellectual property rights are not divulged in national consensus standards. To do so would 

unbalance competition between vendors who hold these rights. All national consensus 

standards are unclassified in any form except for copyright laws of the individual SDOs. 

An intellectual property issue often overlooked is the value to an SDO of the contents of a 

VCS. Especially in the international arena where enforcement is difficult, use of U.S. SDO 

intellectual property without appropriate compensation is a problem that should be given 

attention. 

2. To what extent, if any, has the development, adoption, or use of a standard by 

federal agencies in this technology sector been affected by holders of intellectual 

property? 

The principal holders of intellectual property are the members of the working groups that 

create national consensus standards. These members are charged with protecting any 

intellectual property of their companies and organizations. Since all national consensus 

standards are openly available to the public, intellectual property is protected by not having 

been included in the consensus standard in the first place. 

Mandatory standards that are developed by a specific company such as Caterpillar or Boeing 

do, in general, contain intellectual property but are not releasable to the general public by 

internal rules and regulations. Federal agencies often have access to these proprietary 

company standards under special disclosure agreements between federal agencies such as 

DOD and Boeing for protection of these rights. 
  11

How a federal agency deals with a VCS can affect the value of the intellectual property asset 

that an SDO possesses in any given standard. It should be incumbent on an agency to be 

appropriately concerned about protecting an SDO’s intellectual property value. 

3. How have such circumstances been addressed? 

It is not clear that these circumstances have been addressed systematically and consistently in 

national consensus standards. NRC is trying to create new guidance for digital controls for 

nuclear plant safety applications where these issues will certainly arise. NRC is attempting to 

resolve intellectual property issues that other industries have kept company internal through 

mandatory company standards. No guidance has been promulgated as yet. 

4. Are there particular obstacles that either prevent intellectual property owners from 

obtaining reasonable returns or cause such owners to make intellectual property 

available on terms resulting in unreasonable returns when their intellectual property is 

included in the standard? 

Inclusion of company intellectual property information in national consensus standards would 

impose an undue burden on the SDO. Methods to compensate a company for a small amount 

of intellectual property that was included in a national standard may be difficult. These issues 

are most likely much more prevalent in DOD standards because of their ability to apply 

security classifications to their standards. 

One action that should be considered for implementation is that proper attribution should be 

required when the content of a VCS is used in any way by industry or a federal agency. This 

should be seen as a matter of fairness to the volunteers involved as well as creating the right 

incentives for SDOs to pursue their useful work. 

5. What strategies have been effective in mitigating risks, if any, associated with holdup or buyers’ cartels? 

This issue does not occur in national consensus standards because of their open public 

approval process and balance of interest. 

E. Adequacy of Resources 

1. What resources are needed to successfully complete the efforts? 

Successfully scoping the accurate number of new nuclear standards that is needed will require 

a survey, a priority assignment, and a cost estimate based on the relative breadth of the 

standards work proposed. NIST should conduct this survey through the Nuclear Energy 

Standards Coordination Collaborative. Once needed standards are identified and prioritized, 

SDO assignments should be made with funding provided to support an expedited 

development schedule. 

2. Taking into account budget constraints and competing initiatives, have federal 

agencies committed adequate resources? 
  12

No, very minimal budget resources have been allocated, from time to time, by the DOE 

Office of Nuclear Energy and NRC. DOE and NRC do provide in-kind services to populate 

working groups to develop standards as well as service on consensus committees. 

Resource requirements vary by agency. NIST resources should identify and prioritize new 

standards that need to be developed or revised. Industry should share responsibility for 

helping identify the scope of the work needed for new and revised standards. Events like 

Constellation’s Calvert Cliffs 3 cancellation due to inability to predict capital costs stress this 

point. The most important standards should specify requirements that would allow control of 

nuclear project costs. These standards would be used to define currently vague regulatory 

requirements, such as reliability assurance program requirements, and provide a path for 

compliance with those regulations. This would remove a large amount of risk to help control 

new nuclear project costs. 

3. What resource constraints impact the successful completion of the standards efforts? 

 The major impact comes from an inability of many of the standards working group members 

to meet at least four times a year. Face-to-face meetings are a necessity to ensure a proper 

dialog between experts on the group, resolve complex issues, and provide somewhat of an 

incentive to participate. Working group meetings generally require two to four days at a 

central, inexpensive travel location. 

F. Lessons Learned 

1. What lessons about standards development in complex technologies has ANS 

learned so far, as pertaining to ANS work? 

The following approaches are the most important for standards development: 

1) technical expertise: agency support with technical expertise; 

2) identification: agency coordinating identification of standards needed; 

3) relevance: agency efforts to keep regulatory requirements updated and to 

reference only up-to-date standards; 

4) participation: focus brought by those who use standards; 

5) communication: telephone conversations and online access to perform work; 

6) technical writing: agency support for technical writing for new standards 

publication; 

7) funding: agency trip funding for periodic face-to-face workshops. 

The following approaches are secondarily important in standards development: 

1) project management: performing better project management to do the work 

effectively; 

2) writing skills/pride of authorship: getting effective standards written with no 

technical writers available; 

3) schedules: completing standards to fixed schedules; applying project 

management techniques for getting standards published expediently; 

4) brainstorming: developing workarounds to break through impasses; 
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5) perfection versus adequate: writing good standards, not perfect ones; avoiding 

obsessive focus (minutia on details); 

6) focus: prioritizing the right work to do, maintaining effort, and sustaining 

projects to timely completion; 

7) industry support: giving industry people assigned to standards the time to 

develop them; 

8) duplication: avoiding duplication through appropriate allocation; 

9) review and resolution: providing fair reviews and comment resolution to reach 

consensus. 

The following approaches are suggested to speed and improve standards development: 

1) Assign section technical content providers early in the process; 

2) Get a draft out quickly, rough as it may be; 

3) Provide assets so technical writers can assemble content between group 

meetings; 

4) Limit meeting discussion per topic; 

5) Monitor processes online; 

6) Ensure that reviewers follow ANSI guidance. 

2. How have these lessons learned been implemented? 

The lessons have been partially and inconsistently implemented. These approaches need 

further discussion and evaluation. For the secondarily important approaches, the status is the 

following: 

1) Project management: ANS leadership is evaluating methods to improve project 

management through the use of a project plan; 

2) Writing skills/pride of ownership: Better methods of controlling pride of 

ownership are being discussed; how to assign company sponsorship and/or 

professional writer support for each new or revised standard (potential pride of 

ownership) is being addressed; 

3) Schedules: ANS regularly informs government agencies and other stakeholders 

of standards developments and follows up with information dissemination; 

4) Brainstorming: Meeting control and preparation are being implemented; 

5) Perfection versus adequate: A proposed authorization commitment has been 

proposed to address this situation; the authorization relates to project 

management and how committee leaders are selected; 

6) Focus: ANS has been discussing how to change the focus to emphasize value, 

which needs to be built into the structure of development of standards by all 

SDOs; 

7) Industry support: An organizational sponsor should be developed for each 

standard; 

8) Duplication: ANSI needs to strengthen its support to provide standards 

allocation to organizations using PINS forms to avoid duplication. 

9) Review and resolution: Standards need to be consistent with the ANS standards 

policy guide and the PINS form. 

 

3. Have there been any impediments to implementing these lessons? 
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The primary impediment is that there is insufficient knowledge and appreciation for the 

structures, processes, and value of the U.S. VCS system. This extends to the management and 

staff of the various institutional stakeholders. In addition, there are issues related to past 

practice, resources (those with available skills), and impetus to improve standards processes. 

Until the recent nuclear renaissance, there has been little perceived need to improve standards 

processes. 

4. How has this information been documented or disseminated, and implemented? 

Within ANS, the Standards Board and the consensus committees have discussed methods to 

improve processes as presented here. Participation by the industry coordinating body, NEI, 

has been significantly improved. Information exchange between the Standards Committee 

leadership and institutions such as NRC, DOE, INPO, and IAEA has significantly increased. 

The documented proceedings of the Standards Committee meetings reflect ongoing 

improvements. 

5. What kinds of performance metrics are appropriate to measure the effectiveness of 

the standards-setting process? 

Project and process performance metrics would be appropriate. These include total numbers 

of projects; percentage completion of each; percentage completion to schedule; active projects 

in progress; active projects completed in the year; projects with scopes defined; projects 

approved; percentage schedule adherence, overall. 

In addition, federal agencies should be required to document any beneficial use of the 

contents of VCSs, which should be noted even if the standard is not explicitly reviewed and 

endorsed. The reporting requirements should include some kind of tally of the useful 

contributions made by standards use. 

Modern information technology tools should also be employed to track industry use of the 

contents of standards, even if only parts of the standard are used. However, this should be 

done judiciously, without adding significantly to the cost of using a standard. 

6. If any such performance metrics have been used, what are the results? 

Although ANS keeps track of the progress of projects, ANS does not report progress against 

performance metrics. Guidelines are provided in the standard development project plan. 

Because the writing group members are volunteers, many factors can affect the timing of 

completion of the standard. Additional travel funding for working group members to meet at 

least four times per year would greatly improve the schedule of completion. A note of caution 

is that such monitoring should not be allowed to reflect poorly on the tremendous value of the 

volunteer’s work. 

G. General Assessments 

1. Effectiveness of the methods federal agencies have used to engage in standardssetting activities by identifying which methods have enhanced or limited the publicprivate standards-setting processes 
  15

The first step revealing candidate standards as available for use requires an effective method 

for cataloging standards to present to potential users. Given Office of Management and 

Budget Circular A-119 and the mandate of the National Technology Transfer Act of 1995, 

this should be a first step. In the past, available applications (MS Word, Excel, printed 

catalogs, etc.) limited the identification of available standards that could interest potential 

users. To a large degree, hard-copy catalogs presented standards sorted by title and simple 

topical content descriptions. Now, newer technologies allow keyword sorts. Recognition that 

the Web can also access, present, and disseminate standards information supersedes those 

capabilities. Even updated to PDF formats, those methods are now obsolete. Standards 

content can vary tremendously, for example, from addressing offshore petroleum production 

to electric grid reliability applications to new nuclear design. To develop and present 

standards that could apply in many areas requires a common approach. 

2. Effectiveness of Federal agencies’ coordination with the private sector 

In nuclear design, standards development with the private sector has been limited. In riskinformed design, private-sector participation has been passive. Since the Three Mile Island 

accident, for all practical purposes, NRC has dictated design, and private industry has 

followed its lead. As a result, tedious highly complex probabilistic methods are required to 

certify nuclear designs today. Nuclear digital controls provide a good example. Although the 

absence of nuclear construction contributed, the lack of nuclear design innovation reflects (in 

part) failure to develop effective standards. Attempting to apply complex risk methods to 

digital circuits, NRC has yet to license digital controls. The U.S. commercial nuclear industry 

lags behind other industries; for example, it is now decades behind commercial aviation. It is 

widely recognized that digital controls are substantially safer than analog ones. Foreign 

designers are developing newer, more innovative ways of performing nuclear safety design. 

Many have already licensed nuclear digital controls. 

Ineffective design processes result in very high new nuclear design costs. Westinghouse cites 

excess of $400 million developing the AP-1000 design, today. Obviously, prohibitive costs 

block small modular reactor development. Consequently, nuclear design innovation is moving 

offshore. To reverse this trend requires improving design standards, devising better rules, or 

both. 

It should be noted that NRC is only now developing a database to identify regulatory 

reference to standards content. This effort recognizes that similar cataloging by industry is 

also needed. However, the schedules associated with this activity are so long drawn out that 

the usefulness is foreseen only for a long time from now. 

3. Adequacy and availability of federal resources 

The single greatest resource lack within agencies is leadership to promote innovative 

approaches to the development and application of standards. Ideally, standards would simplify 

ways to achieve important goals and lower costs by identifying acceptable, effective 

approaches for regulatory approval. In nuclear design, they do not. 

New nuclear plants require solutions, today. The primary missing resource is timely and 

appropriate agency leadership. Other high-risk industries—aerospace, for example—solved 
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the technical problems of licensing digital controls decades ago. To build a new nuclear 

generation and maintain older nuclear plants safely at reasonable cost, agencies need to 

resolve nuclear digital controls application. (Digital controls exhibit much lower drift and 

fewer intrinsic failures. The resulting safety improvements and cost savings are substantial.) 

Federal agencies should support, but not control, nuclear standards development. 

4. Other issues that arise and are considered during the standards-setting process that 

impact the process, and the timeliness, adoption, and use of the resulting standards 

The single greatest issue among federal agencies that affects the timely development, 

adoption, and use of standards is the capacity to tolerate innovative thinking. For example, for 

nuclear work can other safety design processes provide “risk-informed” design control (NRC 

code words)? There are no logical reasons to exclude other methods for licensing digital 

controls, although NRC’s regulatory position is to apply traditional PRA. The question of 

acceptability of other design processes (other than PRA-based design) hampers U.S. nuclear 

development. The challenge is to produce safer designs, regardless of the safety process. The 

application of LWR PRA processes to other non-LWR designs significantly hampers U.S. 

nuclear design of new, innovative reactors. Therefore, the design of these innovative small 

modular reactors will move offshore. For example, Bill Gates envisions licensing the 

traveling wave reactor in China, first. 

The principal strategic goal for federal standards support should be finding better, more 

innovative methods of doing work. They should help open markets and cut costs, rather than 

promote restrictive, inefficient processes originating from past regulatory efforts. Promoting 

innovative standards thinking needs more federal support.