NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 20

As NEMA’s General Counsel is a member of the ANSI intellectual property rights policy committee,
NEMA has had an opportunity to review that portion of ANFI’s response to this RFI relative to
intellectual property rights, and directs NIST’s attention to the views expressed by ANSI on this subject.

Other Technologies:

e DICOS: The development of the DICOS v01 standard followed the NEMA patent policy° and
encountered no issues in developing a standard that was problematic for the intellectual property
rights of the companies who make imaging equipment.

e ITS: Issues from the ATC effort mostly have been related to coordination with the largest state
DOT (CalTrans) and their own equipment specifications. NTCIP issues have included adherence
to the U.S. DOT’s “Common Rule” for ownership and use of the standards publication IP, and
coordination on the use of “derivative works” from the standards. For the ATC hardware and
API standards, and for the NTCIP data directory standards, there have been few issues on the
intellectual property of the source material, and few issues on essential patent claims.

¢ Nanotechnology: With respect to nanotechnology standards-setting, federal agency participation
has had no impact on the factors listed in the RFI (e.g., technology, competition, innovation,
intellectual property rights, foreign regulations, etc.).

Adequacy of Resources

As stated in the RFI, the Sub-Committee “would like to better understand the resources that both private
sector organizations and Federal agencies commit to standards-setting activities, constraints on those
resources, and how the level of resources affects the success of the effort” (FR at 76398).

Smart Grid:

Standards-writing in the United States is a wholly voluntary activity. While many SDOs such as NEMA
have full-time staffs, the technical resources come from industry members of those SDOs who bear all
of the labor, travel, and incidental expenses to accomplish the task. In short, every standards effort must
fit into an industry business case. If the federal government wants to accelerate this process, as in the
case of Smart Grid, it should find creative ways to relieve the financial burden and incentivize the
standards-writing activity.

One easy and relatively low-cost solution would be for the government to offer various conference
facilities across the country to support SDOs who want to host their technical committees. In the case
where the government has a greater interest in accelerating the process, it also could offer a limited

5 NEMA’s patent policy is consistent with the ANSI patent policy, and differs only in that it provides greater details about the
procedures to be followed in disclosing essential patent claims in the development of NEMA standards, and it provides a
specific definition of what constitutes an “essential patent claim.”


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 14

government, as the convener of the SGIP, provides a forum through which the SDOs and their
constituents can come together to design communications models that allow for greater interoperability,
supporting both legacy and future systems.

While many federal agencies may participate in the standards activities for Smart Grid, the three who
are most involved are NIST, DOE, and the Federal Energy Regulatory Commission (FERC), with NIST
clearly being the most visible and active. However, one of the real challenges, as highlighted in the
January 31, 2011 FERC Technical Conference on Smart Grid Standards, is the process of moving
standards into regulation. While NIST shoulders the load of shepherding its industry partners through
the standard selection and development process, DOE and FERC have the luxury of sitting back and
playing the role of critic in the regulatory process. A more balanced approach is clearly needed.

The FERC policy statement on smart grid that was released in June 2009 is extremely vague and doesn’t
address any of the issues now facing NIST and the SGIP. In fact, the SGIP wasn’t formed until
November 2009, and didn’t start conducting any meetings until early 2010. At this point, it would be
beneficial for FERC to update its policy statement and provide greater detail with respect to what the
agency is looking for from the standard-setting process, as well as the features and performance
objectives the agency will look to implement through regulation. FERC also needs to define what will
satisfy its definition of “sufficient consensus” as described in EISA so that NIST and the SGIP have a
target.

While the FERC Technical Conference in January 2011 was a good starting point, the format didn’t
allow the conversation to go far enough to help FERC, NIST, or industry define effective solutions. In
particular, the testimony from the panelists indicated that there were concerns over access to the five
families of standards (cited as a cost issue) and the fact that there were no hard-and-fast methods for
securing their implementation, but at no point did any of the panelists state that standards would not
deliver Smart Grid functionality relative to the four application areas FERC mentions in its policy
statement. While every panelist responded to FERC Chairman Jon Wellinghoff’s question that sufficient
consensus did not exist around the standards, the question was not asked in a way to determine whether
or not there was an appropriate, time, place, and method for implementing the standards that could be
agreed to on a broad industry basis. It seems logical that the regulatory process within FERC needs to
tease the notions of time, place, and method from the bevy of questions that exist in the electrical
services marketplace.

In terms of “pure criticism” of the federal government’s approach to Smart Grid standards, there are
two. First, neither the aforementioned U.S. Department of Commerce Roundtable nor the FERC
Technical Conference included a speaker from a standards development organization. It is unrealistic to
have an effective public forum on standards-setting without involving the SDOs. Second, the DOE
needs to weigh in on Smart Grid standards. While NIST and FERC have “put a stake in the ground”
through the publication of the NIST Framework and FERC Policy Statement, DOE noticeably has failed
to declare its intentions.


readily available for implementation. Adoption and use of this standard is key to achievement of
the NHIN and work must begin now to ensure its implementation.

Specific Comments

MITA agrees with the findings of the President’s Council of Advisors on Science and
Technology (PCAST) Report, which found that the Federal government had not optimized its
activities for achievement of the NHIN. MITA supports the Report’s recommendation that ONC
redirect its focus toward achieving a robust health information exchange and an effective
functioning infrastructure in which clinical information can be communicated and shared among
providers regardless of their location.

One of the key components of the NHIN is the capability to exchange images and imaging
reports among providers. This can only be accomplished by adoption and use of universally
recognized standards. The DICOM Standard is currently the nearly universally accepted tool
which enables communication of images and imaging reports. DICOM is in widespread use by
providers worldwide and is available now for implementation.

MITA offered to help ONC implement these capabilities. At meetings with ONC on April 9,
2009 and August 13, 2009, MITA described its experience and expertise on development,
deployment and testing of the DICOM Standard, and offered its assistance to facilitate the
implementation of NHIN.

In addition, in response to a solicitation for input from the White House Office of Science and

Technology Policy, MITA’s letter of November 12, 2009 cited those areas where MITA’s
expertise and experience can provide valuable advice to the Health Information Technology
(HIT) Policy Committee. These areas include, for example:

1. Providing actual field examples of clinical facilities which have successfully
implemented the DICOM Standard;

2. Conducting a feasibility analysis to demonstrate the benefits of DICOM implementation;

3. Analyzing how providers are likely to receive various proposed solutions based on their
individual health information technology capabilities

In our letter of March 15, 2010, in response to the Interim Final Rule issued on January 13, 2010,
in 75 Federal Register 2014, MITA recommended that the DICOM Standard be adopted in the
initial set of standards as an essential step to achieve the goal of systems’ interoperability and
Meaningful Use of EHR technology. MITA requested that ONC promptly provide the
opportunity for imaging equipment manufacturers to describe and explain the value of the
DICOM Standard to achieve this goal. MITA emphasized that it was important that discussions
begin promptly to ensure an orderly transition from Stage 1 to Stage 2.

Medical imaging device manufacturers have extensive expertise and experience with respect to
the DICOM Standard, and with other standards-based tools, to coordinate radiology report
sharing among providers. However, ONC has not yet effectively utilized this expertise, or
collaborated with medical imaging device manufacturers to implement these capabilities. As a
result, this has created confusion, and in effect has hampered, rather than facilitated, progress
toward achievement of the NHIN.


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 5

cost-effective regulatory mechanism, too often federal agencies cannot keep pace with
modifications to the consensus standards, failing to update any regulatory references in a timely
manner.

For example, OSHA is required to rely on national consensus standards whenever possible, and
has cited references to roughly 200 separate standards in approximately 500 places in OSHA
rules and guidance. However, many of these standards are woefully outdated. OSHA’s existing
regulations for workplace and facility safety signs, for example, cite a 1968 American Standards
Association (ASA) standard, which has been replaced by a successor series of American
National Standards Institute (ANSI) standards, the most recent of which will be published in
2011. Employers wishing to use state-of-the-art signs conforming to the new ANSI standards
face the possibility of being issued a “de minimus” non-compliance citation by OSHA because of
the agency’s legal reliance on 1968-compliant signs. The process for OSHA to update references
to standards is burdensome, and there is only one individual within the agency’s Directorate of
Standards and Guidance assigned to review and update all of OSHA’s references to consensus
standards. Any benefit OSHA derives from incorporating state-of-the-art consensus standards is
virtually negated by the impossible task of keeping them properly updated.

NEMA also has worked with OSHA’s Nationally Recognized Testing Laboratory (NRTL)
Office, particularly with respect to urging adoption of the IEC Certification for Standards for
Electrical Equipment in Explosive Atmospheres (IECEx Scheme) and NRTL acceptance of
manufacturers’ test data for hazardous location products. OSHA has delayed its review and
acceptance of the IECEx Scheme, which facilitates international trade in equipment and services
for use in explosive atmospheres while ensuring the required level of safety. Although the U.S.
participates with 29 other nations in the IECEx Scheme, OSHA appears reluctant to recognize
the IEC 60079, 61241, and 61779 series of standards recognized by the IECEx Scheme as
American National Standards (ANS) designated by ANSI.

Similarly, NEMA has attempted to work with the OSHA NRTL office to address the need for
NRTL acceptance of manufacturers’ test data for hazardous location products. Manufacturers of
such products, who had been qualified for and engage in a Client Test Data Program (CTDP),
previously were able to perform their own testing. However, toward the end of 2003 one NRTL
offering CTDP that included hazardous location products testing was forced to exclude
manufacturers’ tests from its program. Not allowing NRTLs to accept manufacturers’ test data
results in an increase in the time-to-market for new products from American manufacturers. To
date, OSHA has not provided any substantiation relating to problems encountered with
hazardous location CTDP products that have been installed in the market prior to the agency’s
1995 interpretation. NEMA has proposed that Procedure 5 of the Notice of Interpretation
published in the Federal Register (March 9, 1995) be expanded to include test data for products
intended for use in hazardous (classified) locations.

The OSHA NRTL office is small, with an inadequate number of personnel assigned to review
such matters. Although OSHA NRTL staff have participated in NEMA discussions on both


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 21

number of fixed-price contracts to the participants to partially relieve them from some of the financial
burdens.

Other Technologies:

e ITS: The ATC and NTCIP efforts remain based on the volunteer, consensus-based standards
development process. Even with funded expert consulting resources and paid staff and travel, the
availability of the volunteer contributors and reviewers limits the progress.

e Nanotechnology: In order to be competitive in global nanotechnology products markets, the
United States must be proactive in standards-setting so that other countries and regions are not
setting standards for us. Proactive participation requires funding for travel to face-to-face
meetings, which cannot completely replace meetings held remotely.

Process Review and Performance Metrics

The RFI states that the Sub-Committee would like to “better understand what methods have facilitated
or hindered Federal agencies participation in standardization, recognizing that some standards-setting
activities in the case-study technologies may not yet be completed” (FR at 76398). The Sub-Committee
poses a series of questions designed to learn from standard-setting processes and determine the
appropriate performance methods to assess the effectiveness of such processes. The responses to these
questions, where available, are provided below.

Other Technologies:
What lessons about standards development in complex technologies have been learned so far?

e DICOS: Achieving consensus in standards development is, by its nature, time-consuming, more
so where complex technologies are concerned. While the “best” approach may not be selected,
consensus is the only known means to achieve the “buy-in” of stakeholders.

In general, two lessons were reinforced: (1) get to written, standards-ready text as soon as
possible (this avoids long oral discussions, without text for the standard, decreasing development
time); and (2) webex-enabled meetings, complemented by individual participant contributions
between meetings, are an effective and efficient alternative to face-to-face meetings (again,
decreasing development time).

e ITS: Oral communication solely is inadequate for effective standard-setting; proposals must be
presented in writing. This is particularly important when standards-setting work is conducted via
teleconference due to travel funding constraints. Another key lesson is to start with a system
block diagram to show the scope of the standardization effort, with expansion to UML diagrams
and other graphical methods to unambiguously define the technical specifications being
standardized.


M | I A 1300 North 17% Street » Suite 1752

Arlington, Virginia 22209

MEDICAL IMAGING Tel: 703.841.3200
& TECHNOLOGY ALLIANCE Fax: 703.841.3392
A DIVISION OF FRREEMEAS www.medicalimaging.ora

March 1, 2011

U.S. Department of Commerce
National Institute of Standards and Technology
National Science and Technology’s Subcommittee on Technology

RE: Standardization feedback for Subcommittee on Standards
Dear Sir/Madam:

This letter represents the comments of the Medical Imaging & Technology Alliance (MITA), and
comes in response to the Request for Information by the National Institute of Standards and
Technology (NIST), on behalf of the National Science and Technology Council’s Subcommittee
on Standards, which was issued on December 8, 2010 in the Federal Register, 75 Federal
Register 76397, Docket No. 0909100442-0563-02. The Request for Information is seeking
comments on the effectiveness of Federal agencies’ participation in the development and
implementation of standards, and the adequacy and availability of Federal resources for
standards-setting activities.

The purpose of the Request for Information is to help the Subcommittee on Standards develop
case studies that Federal agencies can consider in their future engagement in standards
development and conformity assessment, in key technology areas. MITA’s comments will focus
on the key area of health information technology, with regard to implementation of a Nationwide
Health Information Network (NHIN).

MITA is the Medical Division of the National Electrical Manufacturers Association (NEMA)
and is the collective voice of medical imaging equipment and radiopharmaceutical
manufacturers, innovators and product developers. These technologies include:

Medical X-ray equipment

Computed tomography (CT) scanners

Ultrasound

Nuclear medicine imaging equipment (including radiopharmaceuticals)
Radiation therapy equipment

Magnetic resonance imaging (MRI)

Imaging Informatics Systems

MITA appreciates the opportunity to share its views with you, and commends NIST for its
interest in improving Federal agency participation in standards activities. MITA believes that the
Office of the National Coordinator (ONC) has not fully recognized that imaging is central to
clinical practice, and that the Digital Imaging and Communications in Medicine (DICOM)
Standard, which is essential to communication of imaging information, already exists, and is


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 18

e ITS: Federal agency involvement in ITS standards development resulted both in an acceleration
of the process with respect to funding for expert consultants, and a slowing down of the process
by content, method, and contracting issues.

e Nanotechnology: Federal agencies have been involved from the beginning in the development
of nanotechnology standards.

Are Federal agencies generally receptive to input from other participants in standards-setting
activities?

e ITS: Yes, federal agencies are receptive to input from other participants for ITS standards
development activities.

¢ Nanotechnology: Yes, federal agencies have been receptive to input from other participants in
nanotechnology standards-setting activities.

Does receptiveness tend to depend on whether the Federal agency is a regulator or a customer?

e ITS: No, the RITA and FHWA program managers are experienced transportation professionals
who recognize that the relatively small highway transportation industry often requires switching
perspectives.

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?

e ITS: The ATC and NTCIP standards are very timely and valuable. Agency procurement
documents sometimes reference draft standards, or the procurement issuance is held up waiting
for the approved standard(s) that are referenced.

¢ Nanotechnology: For nanotechnology, federal agency input is significant since NIST plays a
vital role in nanotechnology research and development.

Issues Considered During the Standards Setting Process

The RFI acknowledges that “various factors (e.g., technology, competition, innovation, intellectual
property rights, foreign regulations, etc.) arise and are considered and addressed during standards
development” (FR at 76398). The Sub-Committee has requested information on how federal agency
participation in standards-setting activities has impacted the consideration and resolution of these issues.

Smart Grid:

An issue that needs further clarification is the role that the National Technology Transfer and
Advancement Act (NTTAA), as implemented in the Office of Management and Budget Circular A-119,


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 10

The benefit of a standards-based approach is inter-manufacturer data exchange, e.g.,
interoperability, data integration and data fusion are enabled. A standards-based approach also
encourages enhanced data mining, pattern recognition, comparative analysis, predictive analysis,
and automatic inspection (algorithm-based inspection) techniques. System architectures evolve
into system-of-systems architectures. Point decisions become increasingly targeted against actual
threats.

ITS: The benefits include the potential for interoperability of remotely-controlled traffic
management devices (traffic signals, message signs, sensing stations), the potential for
interchangeability of replacement equipment and major subsystems, and the potential for reduced
life cycle costs. In the United States, there are over 300,000 intersections with traffic signals,
many of which are operated from Traffic Management Centers. Section 1201 of the SAFETEA-
LU requires the Secretary of Transportation to establish a Real-time System Management
Information Program to provide, in all states, the capability to monitor in real-time the traffic and
travel conditions of the major U.S. highways and to share that information to (1) improve the
security of the surface transportation system, (2) address congestion problems, (3) support
improved response to weather events and surface transportation incidents, and (4) facilitate
national and regional highway traveler information.

Nanotechnology: Nanotechnology standards will facilitate mass manufacture of reliable nano-
enabled products and systems.

How do the standards impact organizations and their competitiveness?

DICOS: Prior to DICOS v01, a number of manufacturers provided proprietary solutions to TSA
for airport security scanning. Should future acquisitions be based on DICOS v01 (or a successor
standard), interoperability is likely to increase, and reliance on proprietary solutions likely will
decrease. Since DHS and TSA represent a significant portion of the “market” for such solutions,
it is likely that the relative placement of various companies within the marketplace might change,
as individual companies are more or less successful in implementing DICOS v01 as part of the
solutions offered to TSA.

DICOS functions as an enabler of change from a proprietary focus to a focus on interoperability,
and the value added through interoperability. In this environment, companies evolve to solution
and system providers, as opposed to single-point solution providers.

Initially, participating companies expressed concern regarding a perceived negative impact on
individual companies’ competitiveness. Some concern was also expressed regarding prospects
for additional use of non-commercial entities’ products, such as the use of university-developed
search algorithms.


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 7

commercialization of nano-enabled products, and the need for active U.S. participation in
standards-setting.

NEMA submitted a number of comments in this regard during the public comment period,
because the NNI Strategic Plan is the vehicle by which NIST can drive interagency
communication through the NNCO on further participation in standards-setting. NIST
participation in nanotechnology standards as an agency has been very positive, with experts
appointed to projects involving terminology, measurement and characterization, performance
assessments, and EHS. Other agencies, however, such as DOD, DOE, DHS, and others also
need to participate in the work of nanomanufacturing standardization for end product
applications of interest to them.

The Medical Imaging Technology Alliance (MITA), a division of NEMA, is submitting separate
comments in response to the RFI with respect to “Health Information Technology.” A copy of those
comments is attached. These comments represent NEMA’s perspective on federal agency participation
in Health IT standardization activities.

Responses are not provided for every question by each technology area; however, NEMA hopes that the
following answers and comments will benefit the NSTC Sub-Committee’s understanding of federal
agency participation in the standardization process.

Standards-Setting Processes

Smart Grid:

The best example of government participation in standards-setting for Smart Grid is the National
Institute of Standards and Technology’s (NIST) Tom Nelson, who currently chairs the ANSI C12
committee. As the chair, Mr. Nelson is an open, unbiased facilitator who has integrated seamlessly with
industry in every aspect of the committee’s business and doesn’t attempt to sway or influence the
activities of the committee. Because of the role C12 plays in Advanced Metering Infrastructure (AMI),
the intersection of the customer and the utility in Smart Grid, it is extremely important that the
government, and particularly NIST, have a detailed understanding of the functionality of standards such
as C12.

Currently, C12 is used widely in the United States as a metering standard and in select other areas within
the Americas. Europe, Asia, and the African continent use a patchwork of other standards, which is
largely dominated by the metering standard propagated by the IEC. Going forward, the impact on
competitiveness will be the ability of C12 to out-maneuver the IEC and update and improve their
standard at a faster rate. With the release of C12.22 in April 2009, the standard now has the ability to
support an underlying communications network in the operational development. Future improvements to
the standard will include the development of a testing methodology to verify accuracy and
interoperability and a standardized methodology for upgrading deployed meters. This ability to “future-


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 6

adoption of the IECEx Scheme and the acceptance of manufacturers’ test data, little progress has
been made in addressing the needs and concerns. OSHA’s lack of action impedes U.S.
competitiveness, and without committed staff and monetary resources to participate in, review,
and ultimately adopt the recommended policies, the NRTL office will continue to encounter
challenges to keeping pace with the evolving world of standards.

In order to better assist the NSTC Sub-Committee in its review of the specific program areas highlighted
in the RFI, NEMA has broken down its responses to many of the questions posed by providing specific
examples for “Smart Grid”and “Other technologies involving significant Federal agency participation in
standards setting,” including--

Digital Imaging and Communications in Security (DICOS): DICOS v01, published in
August 2010, provides a data interchange protocol and interoperable, extensible file format to
facilitate data information interchange (demographic information, digital x-rays, computed
tomography (CT) images, and threat detection reports) for airport security screening
purposes. Specifically, DICOS is a file and data interchange format that permits exchange of
meta-data and images irrespective of the brand of screening device that is used to capture a
security image, and associated meta-data related to checked baggage, carry-on luggage,
parcels, and personnel in an airport environment.

Intelligent Transportation Systems (ITS): Technology Area 6 as identified in the RFI
should also be expanded to include Transportation. The U.S. Department of Transportation
has expended resources for 15 years in support of Intelligent Transportation Systems (ITS)
standards development. A summary of the DOT’s program can be found at
hitp://www.standards.its.dot.gov. Of particular interest to NEMA and its member companies
are the National Transportation Communications for ITS Protocol (NTCIP) family of data
communications protocol standards, and the Advanced Transportation Controller (ATC)
family of hardware and software standard specifications.

Nanotechnology: Nanotechnology standards setting is carried out through ISO TC 229,
Nanotechnologies, and IEC TC 113, Nanotechnology standardization for electrical and
electronic products and systems. Ina broad sense, ISO TC 229 establishes fundamental
standards for terminology and nomenclature, measurement and characterization, and for
environmental health and safety (EHS) aspects. IEC TC 113, formed in 2006, establishes
standards for performance assessments of nanoscale subassemblies used in electrical and
electronic applications.

The Draft 2010 Strategic Plan of the National Nanotechnology Initiative, the coordinating
document that sets forth the role of each government agency in nanotechnology
advancements, pointed to the need for continual support in the area of research into novel
applications and environmental health and safety aspects of nanotechnology; however, it
lacked emphasis on the importance of international standards-setting to facilitate the


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 19

will play in the federal standards-setting process. While the NITAA is widely seen as a valuable guide,
some context is necessary for determine how it will be interpreted for the Smart Grid. For illustrative
purposes, TCP/IP is a perfect example.

The proponent of TCP/IP, the Internet Engineering Task Force (IETF), is not an accredited standards
body, does not ballot standards amongst its membership, and for the most part, instead of publishing a
“standard” simply releases it to the public in the form of an approved “Request For Comment” (RFC).
Using the strictest interpretation of the NTTAA, because of these factors TCP/IP should not be
permitted anywhere, at anytime within the federal government. In reality, however, practically every
federal agency has an Internet web page, and networks as critical as the Department of Defense Secure
IP Routing Network (SIPRnet) use the protocol. It would be beneficial to clarify how this concept
squares with the NTTAA so the rule can be applied consistently across various product types.

Foreign Smart Grid regulations are considered and applied in the same manner as any U.S. developed
standards. One of the challenges we face is gaining access to the foreign standards in order to conduct a
proper review of their applicability. This was one of the points discussed during the FERC Technical
Conference related to the International Electrotechnical Commission (IEC) standards. The U.S. federal
government can help by encouraging foreign interests to provide access to the standards as the SGIP
goes through the review process. The American National Standards Institute (ANSI) is coordinating this
effort for U.S. SDOs, and could do the same for IEC standards as the host of the IEC U.S. National
Committee.

As a SDO, NEMA is very sensitive to the issue of simply giving standards away, even if it is part of a
sanctioned review process. Standard sales are a line of business for many SDOs, and our business case
for publishing standards could be seriously damaged if the so-called “review copies” were distributed
and re-distributed on a wide-scale basis. One recommended solution would be that for these large
national priorities, the U.S. federal government could consider a grant to the involved SDO to make
their library available to the Committee.

Perhaps the biggest threat to intellectual property rights is misinformation. One concept that is
continually debated in the context of Smart Grid is the notion of “open” or “openness.” It is one thing
for a device to be built to an open standard (such as an ANSI standard that is available to anyone in a
non-discriminatory manner); it is another thing altogether for a manufacturer to disclose the methods
they use inside of their devices to conform to that standard. Open architectures in the grid, based on
publicly available specifications, are a good thing; asking manufacturers to expose their method of
accomplishment in the name of “openness” is not.

NEMA is an ANSI-accredited SDO and consequently follows the ANSI requirements for inclusion of
intellectual property rights in standards. Generally, that policy has worked well and very few issues have
arisen over the years.


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 9

What are the most important reasons for participation?

DICOS: The important reasons for commercial company participation are the same as the
reasons for participation in any standards development organization—an opportunity for a
company’s voice to be heard and its opinion reflected in a standard that may subsequently be
adopted as the basis for regulation or procurement. Government agency participation via DHS-
and TSA-designates ensured that the needs and requirements of DHS and the TSA were
considered in a timely fashion during the development of DICOS v01, and that DICOS v01, as
published, appropriately reflected agency interests.

In addition, because homeland security needs are “immediate,” to expedite the development and
completion of DICOS v01 DHS and TSA participated financially in the funding of the standard.
With this funding incentive provided by DHS and TSA, additional company and NEMA
personnel resources were devoted to DICOS v01 development to ensure project completion
within the (approximately) one-year timeframe dictated by DHS and TSA needs.

For some sectors, standards serve as one element of agency procurement specifications, and
DICOS v01 is now available for consideration as one such element. This was one driver
encouraging DHS and TSA financial support.

ITS: The private sector wants input on standards with which their products hope to conform; the
public sector desires input on standards for the products and systems their agencies procure,
install, operate, and maintain. Both sides hope that standardization produces open market
opportunities and reduces life cycle costs.

Nanotechnology: For national metrology institutes, the key reason for participating in
nanotechnology standardization activities is to ensure uniformity in testing and measurement
methods. For the private sector, the value of participation is derived from setting appropriate
reliability and durability assessment methods.

What are the benefits of developing standards for this sector?

DICOS: In the airport security sector, there are a number of known participants, many of which
have provided hardware, software, integration, and/or maintenance services to DHS and TSA.
However, a number of these solutions are proprietary, and it is understood that one
manufacturer’s security scans are not, generally, “readable” on another manufacturer’s devices.
By developing DICOS v01 as a single standard for data and meta-data representation and data
transmission, interoperability is encouraged—permitting, for example, images captured on one
manufacturer’s device to be read on the device of another manufacturer. For government
agencies, this interoperability is vital in that scans produced by one manufacturer’s equipment
can be viewed on another manufacturer’s equipment, enabling viewing and evaluation at
locations in addition to the original screening location, both within and outside of the original
airport.


MITA Recommendations

MITA believes that ONC’s, and CMS’ leadership and participation in the development of the
NHIN need to be significantly improved and increased in order to successfully implement this
capability. To achieve this goal, we make the following recommendations:

1. ONC and CMS should immediately and publicly acknowledge the criticality of the
adoption and use of the DICOM Standard for communication of images and imaging
information, and the importance of the use of Integrating the Healthcare Enterprise (IHE)
Profiles, such as XDS-I.b, for addressing clinical workflow and interoperability issues.

2. ONC should make the adoption and use of the DICOM Standard and IHE Profiles key
goals for the implementation of Meaningful Use of EHR technology in 2013 and 2015,
and industry should be a full participant in this process.

3. ONC should revise its strategic planning process to include as full participants not only
provider representatives, but also representatives of medical imaging device
manufacturers, information technology companies and those organizations with expertise
in creation, implementation and testing of health data infrastructure. Based on their
participation, and fully utilizing their expertise and experience, the ONC Strategic Plan
should be thoroughly evaluated and revised in order to achieve the NHIN.

4. ONC should recognize that by following the DICOM Standard and IHE models, much of
the cost of adoption and government overhead can be removed by allowing self-
certification of conformance to both DICOM and IHE by manufacturers. This self-
certification system has worked well for industry and has been in place for over 20 years.

Conclusion

The foundation of the NHIN rests on achievement of systems interoperability, adoption of a
robust health information exchange capability, and an effectively functioning infrastructure. The
adoption and use of the DICOM Standard, as well as other standards-based tools, must be given
top priority to ensure the Meaningful Use of electronic health record technology. This work
must begin now to ensure that the necessary steps will be taken in a careful, coordinated fashion.

The active participation and leadership of ONC in the process of development of the NHIN is
vital to saving lives, reducing healthcare costs and improving the quality of healthcare delivery
for all Americans. MITA stands ready to assist NIST in this important effort.

If you have any questions, please contact me directly at (703) 841 — 3279 or by e-mail at

dfisher@medicalimaging.org.

Sincerely,
David Fisher

Executive Director
Medical Imaging & Technology Alliance (MITA)

3


Representing Electrical and Medical
Imaging Equipment Manufacturers
www.nema.org

Fe

National Electrical Manufacturers Association

March 7, 2011

The Honorable Patrick Gallagher

Director

National Institute of Standards and Technology
U.S. Department of Commerce

RE: Standardization feedback for Sub-Committee on Standards
Dear Dr. Gallagher:

The National Electrical Manufacturers Association (NEMA) is pleased to have this opportunity to
provide comments in response to the Request for Information (RFI) initiated by the National Standards
of Institute and Technology (NIST), on behalf of the National Science and Technology Council’s Sub-
Committee on Standards, on the “Effectiveness of Federal Agency Participation in Standardization in
Select Technology Sectors” (Docket No. 0909100442-0563-02).

NEMA is the association of electrical and medical imaging equipment manufacturers. Founded in 1926
and headquartered near Washington, D.C., its approximately 450 member companies manufacture
products used in the generation, transmission and distribution, control, and end use of electricity. These
products are used in utility, industrial, commercial, institutional, and residential applications. The
association’s Medical Imaging & Technology Alliance (MITA) Division represents manufacturers of
cutting-edge medical diagnostic imaging equipment including MRI, CT, x-ray, and ultrasound products.
Worldwide sales of NEMA-scope products exceed $120 billion annually.

In order to assist the Sub-Committee on Standards to “develop case studies that Federal agencies can
consider in their future engagement in standards development and conformity assessment,” NEMA will
provide some general comments on federal agency participation in standardization activities as well as
specific examples demonstrating the federal role in smart grid, health information technology,
nanotechnology, Digital Imaging and Communications in Security (DICOS), and Intelligent
Transportation Systems (ITS) standards.

Executive Summary

NEMA is offering general comments on the issue of federal agency participation in standardization
activities, followed by responses to specific questions posed in the RFI as reflected in several technology
areas. In summary, NEMA expresses the following views:

e In general, the effectiveness of federal agency participation depends on the level of involvement
and commitment of resources and manpower to the process.

1300 North 17th Street, Suite 1752 — Rosslyn, VA 22209 — 703.841.3200 - 703.841.5900 fax



NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 12

How has the process worked so far?

DICOS: NEMA’s standards development process worked well in the development, balloting and
publication of DICOS v01. The publication was provided to agency sponsors on schedule, and
was accepted as a deliverable under the NEMA/DHS/TSA contract. The 17 NEMA member
companies who participated in DICOS v01 development, along with DHS and TSA
representatives, collaborated effectively, respecting others’ submissions and opinions.

ITS: The U.S. DOT RITA-sponsored development has worked very well to: (1) bring the public
and private sector stakeholders to the same standards-drafting table and facilitate the exchange of
user needs and requirements; (2) expand the number of devices for which standards could be
written; (3) reduce the time for drafting standards by providing private expert consulting
resources; (4) allow increased public agency participation through travel reimbursement; (5)
improve the scope and content of the standards by imposing System Engineer process steps; and
(6) improve the content quality by requiring internal traceability within the standard.

Nanotechnology: To date, the process has worked very well, although more stakeholders need
to be consulted as part of the consensus-building process.

When developing standards, how are the standards-setting processes managed and coordinated?

DICOS: NEMA, an ANSI-accredited standards developer, complied with its existing standards
procedures for the development of DICOS vo1.!

ITS: Standards-setting remains under the control of the standards development organizations
(SDOs), and is agreed to by the MOU terms and conditions among NEMA, AASHTO, and ITE.

Nanotechnology: The standards-setting processes for nanotechnology are managed and
coordinated through the International Electrotechnical Commission (IEC) approval process.

Is there a strategic plan that identifies the standards needs and defines the standards development life

cycle?

DICOS: DHS and TSA identified a need for DICOS to serve as a common format for data
transmission and representation for airport security screening data, and a critical element on the
path to interoperability in this vital national security area. As for future revisions to DICOS,
NEMA has worked in conjunction with DHS/TSA, NEMA members, and other stakeholders to
identify which revisions are more immediate, which can be addressed later in the future, and the
timing, process and resource requirements for these revision projects.

' See NEMA Standards Procedures at: http:/www.nema.org/stds/aboutstds/upload/SPP-2008_final_updated.pdf.



NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 11

ITS: The ATC and NTCIP standards have the potential to increase buyer/seller understanding of
products and their options, increase competitiveness among sellers, and spur innovation for
economic production.

Nanotechnology: The standards will serve to improve communication between suppliers and
customers and offer a level playing field on how performance is measured.

How has the standardization spurred innovation in the technology sector(s) that is the subject of your
comment?

ITS: For the U.S. traffic management device market, there are several to many suppliers of the
different types of equipment. The structure of the ATC and NTCIP standards allow most remote
control functions and hardware features to be standardized, but vendor- and agency-unique
functions and features can be added with “extensions.” Sellers differentiate their mostly
standards-based products with innovative features—such as improved user interfaces, improved
packaging, and cross-applications in new deployment areas.

Nanotechnology: Although the standards-setting process is in its infancy, nanotechnology
standards intend to remove barriers to innovation through common measurement methods.

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

DICOS: DICOS vO01 was published in August 2010, and addresses modules specific to particular
technologies (CT and digital radiography), as well as modules that are expected to apply to these
and future technologies: Owner, Object of Inspection (OOI), General Scan, General Series, and
Threat Detection Report (TDR) modules. Each of these DICOS v01 modules is designed with
extensibility to some known and some unknown future technologies in mind.

Development of a revision of DICOS v01 was initiated in February 2011, with funding from
DHS/TSA, as well as member resources. DICOS v02 (a revision of DICOS v01)is expected to
address: (1) Advanced Imaging Technology (formerly known as whole body imaging); (2)
revision of the TDR IOD, to reflect the decision of the Transportation Security Officer (TSO);
(3) proposed revisions to DICOS v01, based on testing conducted against such standard, for
DICOS v02; (4) enhancement of the data transmission capabilities of DICOS v01; and (5)
NEMA balloting and publication of DICOS v02.

ITS: In 2011, the NTCIP standards development is 18 years old, and has produced over 50
standards publications and guidance documents. Most NTCIP standards publications are in their
second or third major version revisions. In 2011, the ATC standards development is 12 years old,
and has produced four standards publications.

Nanotechnology: The standards development process for nanotechnology is in its very early
stages.


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 8

proof” a meter will be a major competitive advantage because it provides a measure of security for
investing money in the grid today.

In a broader sense, it is important for the federal government to continue to communicate a vision for the
grid. The Energy Independence and Security Act of 2007 (EISA) provided a starting point, but
unfortunately, the legislation only represents a snapshot in time. In the years since its passage, the
private and public sectors have learned a lot about the ways we can improve the methods for electricity
delivery, and the landscape of technology will continue to change at a rate that will vastly outpace the
legislative and regulatory environment’s ability to adapt. By communicating five- and ten-year
objectives, the industry can continue to strive to develop technologies and the standards to support that
‘vision.

Other Technologies:
Who participates in standards- settings activities?

¢ DICOS: DICOS v01 was developed under the auspices of the National Electrical Manufacturers
Association (NEMA), an ANSI-accredited standards developer. Participants in the DICOS
standards-setting effort include a total of 17 companies with a software or hardware interest in
the airport security scanning arena, including large and small companies. In addition,
representatives (either employees or consultants) of the U.S. Department of Homeland Security
(DHS), its Transportation Security Administration (TSA), and NIST provided guidance in
development of the DICOS v01 standard.

e ITS: The U.S. DOT’s ITS Standards Program was started to expedite the development of
information technology standards for ITS, and to balance the participation between public and
private sectors. For the ATC and NTCIP, NEMA has executed two memorandums of
understanding (MOUs) with the American Association of State Highway Transportation
Officials (AASHTO), which are the 50 state DOTs; and the Institute of Transportation Engineers
(ITE), a professional society of international practitioners from private and public sectors, and
from public sector agencies from the federal to local level. With this partnership, NEMA,
AASHTO and ITE assure wide participation.

Section 5206 of the Transportation Equity Act for the 21 Century (TEA-21) mandated that the
US. DOT “develop, implement, and maintain a National Architecture and supporting standards
and protocols to promote the widespread use of ITS technology, ensuring interoperability and
efficiency to the maximum extent practicable.”

e Nanotechnology: The National Institute of Standards and Technology (NIST) and National
Institute of Occupational Safety and Health (NIOSH) offer a federal agency perspective in
nanotechnology standards. Other participants include nano-material suppliers and end product
customers.


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 22

¢ Nanotechnology: Standards development for nanotechnology remains in its early stages; there
are no lessons to glean from at this point in time.

How have these lessons learned been implemented?

e ITS: Progress is driven largely by the agreed budget and schedule necessary to secure funding
for the standardization activity.

Have there been any impediments to implementing these lessons?

e ITS: As would be generally true with any process based on human interaction and consensus-
building, impediments can sometimes include hidden agendas, egos, and unwillingness to
compromise.

What kinds of performance metrics are appropriate to measure the effectiveness of the standards-setting
process?

e ITS: One particular performance metric used is an evaluation of broken threats in traceability
testing. The schedule and budget for the standardization activity also serves as a key measure of
progress and performance.

e Nanotechnology: Projects are given target completion dates at the outset, and the IEC and ISO
ensure that committee meet these target dates or have adequate justification for any resulting
delays.

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

e ITS: Standards drafting is mostly a “one-off” activity, and each standard is, for the most part,
different. Results vary based on the particular standard.

NEMA appreciates the opportunity to provide these case studies to the NSTC Sub-Committee. If you
have any further questions or require additional information regarding the experiences of NEMA and its
member companies with federal agencies in standardization activities, please do not hesitate to contact
us.

Respectfully, Pon.

Kyle Pitsor
Vice President, Government Relations

Enclosure


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 4

e

U.S. Department of Commerce (DOC)/International Trade Administration —- Market
Development Cooperator Program (MDCP): Standards have been at the heart of several
MDCP awards to NEMA during the past decade. This program has been exceptionally
supportive of standards development efforts in the Americas and in China for our industry sector.

Office of the U.S. Trade Representative (USTR): NEMA has worked closely with USTR staff
over the past 15 years on many standards and conformity assessment policy issues within the
context of the World Trade Organization (WTO), with many of the nations having free trade
agreements with the U.S., with the APEC economies, particularly the Sub-Committee on
Standards & Conformity, and many of the individual countries in Asia, including China, Japan,
Korea, and Thailand, among others.

U.S. Trade and Development Agency (USTDA): NEMA has worked closely with USTDA
developing and operating the U.S.-China Standards & Conformity Assessment Cooperation
Program, a robust program of capacity building and information exchange covering numerous
industry sectors, addressing safety, energy efficiency and environment. Experts of NEMA
members’ Smart Grid products have steadily increased over the past six years, to hundreds of
millions of dollars, as an example of the benefits to such trade development activities centered
around standards.

U.S. Consumer Product Safety Commission (CPSC):

CPSC has played a key role in the development of standards for ground fault circuit interrupter
(GFCI) technology. In the 1990s, CPSC focused the manufacturers’ and installers’ attention on
issues relating to occasional reverse wiring during installation, leading manufacturers to
incorporate additional installation instructions to the existing markings to eliminate reverse
wiring. CPSC staff participated in NEMA-sponsored meetings to discuss these issues, and their
influence assisted the industry in aligning patented technologies and safety standards to achieve
desired safety goals.

U.S. Occupational Safety and Health Administration (OSHA):

NEMA has experienced both success and frustration with respect to OSHA’s involvement in
standardization activities. For example, the participation of OSHA representatives on National
Fire Protection Association (NFPA) 70E, Standard for Electrical Safety in the Workplace, has
been quite beneficial to the NFPA 70E Committee. While OSHA representatives do not vote on
proposals or comments, they still provide valuable input on the technical aspects of such
proposals. OSHA is represented on the Committee by experts in electrical safety, and when they
speak, the Committee listens.

One way in which federal agencies implicitly engage in standardization activities is through the
incorporation of references to national consensus standards into agency rules and regulations.
While federal adoption of these standards streamlines the rulemaking process and represents a


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 15

Other Technologies:

What methods of engagement are used by Federal agencies to participate in private sector-led
standards development?

DICOS: The standard methods of engagement are: (1) Actively participating in ongoing
standards development efforts (versus “commenting at the end”); (2) providing stable funding;
and (2) providing baseline test environments (for example, product compliance independently
determined by objective government agency).

ITS: Several methods of engagement are used by federal agencies to participate in private
sector-led standards development, including U.S. DOT funding support of SDO project
management staff; participant travel; expert consultant engagement; support of standard-family
websites; review of proposals for standard work items; government employees’ or contractors’
participation at committee meetings; and membership in email listserves.

Nanotechnology: Federal agencies participate in nanotechnology standards development
through membership on the U.S. Technical Advisory Groups (TAGs) to IEC TC 113 and ISO
TC 229.

How transparent is each method?

DICOS: Each method is transparent in that they are easily understood and published to all
parties.

ITS: For the ITS standards SDOs, the process is open and transparent.

Nanotechnology: For nanotechnology, the TAGs are well structured and utilize established
consensus processes.

How effective is each method?

DICOS: Similar methods have been effective in the past, such as the Joint Photographic Experts
Group (JPEG) standard (2000 edition). For each method: (a) as stakeholders, it is common for
representatives of federal, state, and local government to participate actively in the development
of private sector-led standards. Effectiveness increases as government representatives become
more active, providing immediate feedback, for group consideration; (b) government funding
permits those companies who might not have resources available for standards development to
participate, and effectively focuses participants on speed and deliverables; and (c) as a provider
of test environments, or test criteria, again, it is common for government agencies to evaluate
equipment as part of an agency procurement process.


NEMA Comments on Standardization Feedback for Sub-Committee on Standards

March 7, 2011
Page 17

The U.S. DOT RITA funding of the ITS standards program also has created some conflicts:
o The U.S. DOT staff may have the expectation that standards are like any other

government-funded deliverable, and should be provided on-schedule and on-budget,
regardless of volunteer availability or SOD approval delays;

Other U.S. DOT-funded support contractors may try to influence the standards-setting
process, or the standards publication scope and content;

Other U.S. DOT-funded support contracts, with experience in the systems engineering
process for large aerospace and defense systems, have introduced some confusion and
delay when trying to adapt those process methodologies to SDO-based standards-setting;
and

The U.S. DOT-funded support contracts have to exercise caution on their conflicts of
interest, between advising RITA on standards publication work items worth of funding
and then contributing to or steering the development and direction of those same
standards work items. In fact, the U.S. DOT’s Office of the Inspector General reviewed
RITA, finding that “the JPO needs to address conflicts of interest among its support
contractors. These conflicts raise questions about the support contractors’ abilities to
render impartial advice and services to the ITS program.”*

Nanotechnology: Involvement from NIST has had a very positive impact in nanotechnology
standards-setting, where expertise has been very helpful, particularly at the working group levels.

How well do Federal agencies coordinate their roles in standards activities in the sector of interest?

DICOS: Early in the process, DHS and TSA clarified their respective roles, agreed to
coordinate, and made this known to participants.

ITS: There is good coordination for ITS standards among the sponsoring Research and
Innovation Technology Administration (RITA) ITS Joint Program Office, the Federal Highway
Administration (FHWA), and the Federal Transit Administration.

Nanotechnology: With some exceptions, outside of NIST, activity on and the importance of
nanotechnology standards is not widely communicated, even though multiple federal agencies
stand to benefit from the objectives of the National Nanotechnology Initiative.

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?

“U.S. DOT Office of Inspector General Report No. AV-2009-040, “The Joint Program Office’s Management of the
Intelligent Transportation Systems Program Needs to Be Improved,” March 11, 2009


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 3

Safety and Health Administration (OSHA). These employees contribute actively and readily accept
assignments to enable development of standards that will be suitable for the protection of the public.

There is a general consensus among NEMA members that federal agency participation in
standardization activities can have one of two effects. Federal agencies can contribute positively to the
standardization activities, resulting in an overall improvement in product reliability and cost
containment, or federal involvement can limit or hinder the advancement of technology, resulting in
mandates that detract from legitimate research and development efforts drive in response to realistic
market-driven forces. NEMA’s experience has varied among federal agencies and even within the
agencies themselves. Several general examples of NEMA’s experiences are provided below for the Sub-
Committee’s review.

¢ National Institute of Standards and Technology (NIST): NEMA has collaborated with NIST
numerous times developing and conducting standards capacity building workshops as part of its
Standards-in-Trade Program with U.S. trading partners, including many countries from the
Americas and Asia. For example, NEMA collaborated on workshops in China and Brazil on
Intelligent Transportation Systems, resulting in standing room-only attendance that has since led
to the adoption of U.S. private sector transportation standards in Brazil. This program is a prime
example of the important supporting role NIST plays in the U.S. voluntary consensus standards
system. NEMA also has worked closely with and advised NIST as it developed the Smart Grid
Interoperability Panel (SGIP), which will be explored in subsequent sections of these comments
as a specific case study.

In addition, NEMA managed the development of the Requirements for Smart Meter
Upgradeability standard (NEMA SG-AMI]1). This standard was developed and approved in
record time—less than 90 days from start to final approval. The team that developed the standard
was comprised of all five major U.S. meter manufacturers, five US electric utilities, a
representative from NIST, a contractor to NIST, and a NEMA project manager/facilitator.
NEMA, which is an American National Standards Institute (ANSI) accredited standards
development organization (SDO), managed this project at the request of NIST.

The Smart Meter Upgradeability standard was critical for the expansion of Advanced Meter
Infrastructure (AMI) and Smart Meters in the US. At the time the standard was developed (fall
2009) many state commissions were considering adopting AMI systems. However, the
commissions were concerned whether the technologies would be forward interoperable and
whether they would comply with soon to be established national smart grid standards. The Smart
Meter Upgradeability standard closed those gaps by providing technical and security
requirements for smart meters so that the firmware used in the meters could be upgraded to
support future requirements and future smart meter standards. This standard helped to educate
and support state commissions in approving the installation of roughly 50 million smart meters
over five years.


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 2

e Federal agency participation in standardization activities ensures that the needs and requirements
of the various agencies, particularly as needed for the development of regulations or for
government procurement, is taken into consideration and incorporated into the standards.

¢ There appears to be general consensus that federal agency participation in standardization
activities can have one of two effects. Federal agencies can contribute positively to the
standardization activities, resulting in an overall improvement in product reliability and cost
containment, or federal involvement can limit or hinder the advancement of technology, resulting
in mandates that detract from legitimate research and development efforts in response to realistic
market-driven forces.

e Federal agencies participate implicitly in standardization by incorporating references to
consensus standards in rules, regulations, and guidance documents. However, keeping these up-
to-date is a significant challenge for some federal agencies.

¢ Participation in standards-writing generally is a voluntary activity, with the expense borne by the
individual participants. The costs associated with standards development can impede the
timeliness with which work on standards is conducted. The federal government should find ways
to creatively incentivize participation in standards development activities. Federal investment in
standards development leverages increased participation by other stakeholders.

General

NEMA reviewed several technology areas in which federal agencies participate in standardization
activities. In general, the effectiveness of federal agency participation depends on the level of
involvement and commitment of resources and manpower to the process. The case studies provided in
response to the questions posed in the RFI will provide specific examples of varying levels of agency
participation and effectiveness.

Federal agency participation is the exception rather than the rule for many of the International
Electrotechnical Commission (IEC) committees with which NEMA is most familiar. This does not seem
to negatively impact IEC standards development activity since public policy issues rarely arise in this
context. As a result, the federal government generally is content to allow private industry to take the lead
on standards development. On occasion, federal agencies have communicated specific needs that have
been addressed by the standards development activities of IEC.

Federal participation in the regulatory and public policy aspects of standardization efforts, largely within
the International Organization for Standardization (ISO), is more robust, particularly as the ISO
addresses broader issues like environmental and worker safety. NEMA also works closely with the
Institute of Electrical and Electronics Engineers (IEEE). In the area of human exposure limits to
electromagnetic fields, there are a number of federal employees working alongside industry
representatives with the IEEE, including individuals from the Federal Communications Commission
(FCC), Food and Drug Administration (FDA), Department of Defense (DOD), and the Occupational


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011

Page 13

ITS: There are several planning documents that identified and guided the ITS standards, and the
NTCIP in particular, including (1) the National ITS Architecture, version 6.1’; (2) the U.S. DOT
ITS Strategic Research Plan 2010-2014 (issued in December 2009), which defines the strategic
direction for the U.S. DOT’s ITS research program for the next five years; and (3) NTCIP 8001,
Joint Standardization Policies and Procedures.

Nanotechnology: The IEC TC 113 Strategic Plan® governs the nanotechnology standards
development process.

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

DICOS: As with any strategic plan, and particularly for those involving national security,
frequent review and, if necessary, revision is required to reflect current security needs and
requirements; the changing levels of resources available to the project; and any other factors, a
newly-identified threat, or technology (as examples) that may influence schedule, deliverable or
sequence of development. Sustainable funding is sometimes a barrier to the development of
high-level strategies for standards-setting activities. Funding from DHS and TSA mitigated this
concern, enabling smaller companies (with fewer resources) to participate in expedited standards
development.

ITS: The utility of strategic plans correlate to their specificity. However, wider agreement and
support often derives from generalized and vague terms, and plans for standards are no different.
Perhaps the greatest barrier to ITS standards strategic plans are the requirement for five-year
review and maintenance of IT-based standards as technology progresses.

Perspectives on Government’s Approach to Standards Activities

Smart Grid:

As cited by Dr. Gallagher and Mr. Chopra at the January 25, 2011 roundtable discussion held at the U.S.
Department of Commerce, the government’s role as convener is critical in accelerating the standards
development process, as is the case of the Smart Grid Interoperability Panel (SGIP). Focusing on the
interoperability aspect (the “I” in SGIP), the challenge that SDOs in the electrical industry are facing is
the need to consider the functionality of their standards in a broader context. As we strive to achieve
greater levels of interoperability in the grid, our standards are likely to come into contact with a greater
number of other standards.

TCP/IP and Wireless are two such examples. In the simplest sense, communication protocols are the
primary tool through which operational and control information is shared. A majority of the existing
electrical standards were not designed to communicate with such a vast variety of dissimilar objects. The

? National ITS Architecture, version 6.1, is available at: http: www. iteris.com/itsarch/
3 Available at: hitp://www.iec.ch/cgi-bin/getfile.pl/sbp_113.pdf?dir=sbp &format=pdf&type=&file=113.pdf


NEMA Comments on Standardization Feedback for Sub-Committee on Standards
March 7, 2011
Page 16

e ITS: The funding support provided for ITS standards activities buys a high level of input and
control of the standards format and content.

e Nanotechnology: Participation in the TAGs is very effective.
How could the methods be improved?

e DICOS: As with any other standards development efforts, improvements may include
compressed development or increased funding; however, development of a standard within
approximately one year is admirable, and increased funding is unlikely in the current economic
environment.

What other methods should the Federal agencies explore?
e ITS: Federal agencies should explore the use of Wiki-based collaborative development.

e Nanotechnology: To avoid duplicate efforts in nanotechnology standards development, no other
methods should be pursued.

What impact have Federal agencies had on standards activities?

e ITS: For the ITS sector, federal agencies have had a significant impact on standards activities.

ITS standards represent a very important way that the U.S. DOT leverages the deployment of
their programs around the United States, with deploying funding from the Title 26 Federal “gas
tax.”

The U.S. DOT RITA funding of the ITS standards program has provided several benefits, such

as:

o Compensated expert technical consultants to perform the drafting and revision of
standards, rather than volunteer contributors;

o Compensated project management staff at the SDOs, rather than SDO member-funded
staff;

© Travel reimbursement for public sector participants, to bring their end-user perspective
and comments to the standards-setting table;

o Shortened development time to achieve approved standards;

o Expansion of the number of standards publications to provide a modular library, rather
than just a selected inventory of volunteer-produced documents; and

© Assistance with outreach and education to the stakeholder community about ITS
standards.