[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Notices]
[Pages 563-570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34827]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-98-4956, Notice 1]
RIN 2127-AH29
Agency Priorities and Public Participation in the Implementation
of the 1998 Agreement on Global Technical Regulations; Statement of
Policy
AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.
ACTION: Request for comments; notice of public workshop.
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SUMMARY: NHTSA is holding a public workshop and soliciting written
public comments on a draft statement of policy concerning (1) agency's
priorities in the implementation of the United Nations/Economic
Commission for Europe 1998 Agreement on Global Technical Regulations
for Wheeled Vehicles, Equipment and Parts, and (2) this agency's
activities and practices for facilitating public participation in the
implementation of the 1998 Agreement. The policy statement would go
into effect when the 1998 Agreement enters into force. The notice also
explores other methods for promoting public participation, e.g., the
possibility of including members of the public as advisers in the NHTSA
delegation.
The U.S. Environmental Protection Agency (EPA) which, together with
NHTSA, negotiated the Agreement for the U.S., will participate in the
public workshop. EPA plans to issue a similar statement of policy.
DATES: Public workshop: The public workshop will be held on February 3,
1999, from 9:00 a.m. to 5:00 p.m.
Those wishing to participate in the workshop should contact Ms.
Julie Abraham by February 1, 1999.
Written comments: Written comments may be submitted to this agency
and must be received by February 18, 1999.
ADDRESSES: Public workshop: The public workshop will be held in rooms
6200-6204 of the Nassif Building, 400 Seventh St. SW, Washington DC
20590.
Written comments: All written comments must refer to the docket and
notice number of this notice and be submitted (preferably 2 copies) to
the Docket Management, Room PL-401, 400 Seventh Street, SW, Washington,
DC 20590. (Docket Room is open 10:00 a.m. to 5:00 p.m., Monday through
Friday.)
FOR FURTHER INFORMATION CONTACT:
Ms. Julie Abraham, Director, Office of International Harmonization,
National Highway Traffic Safety Administration, 400 Seventh Street, SW,
Washington, DC. Telephone: (202) 366-2114. Fax: (202) 366-2106.
Ms. Rebecca MacPherson, National Highway Traffic Safety
Administration, 400 Seventh Street, S.W., Washington, DC 20590.
Telephone: (202) 366-2992. Fax: (202) 366-3820.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
A. Opening of 1998 Agreement for signature
B. Purpose of and need for 1998 Agreement
C. Issue of public participation
D. Purpose of this notice
II. Background
A. May 1998 final rule on process for assessing safety
performance and functional equivalence of U.S. and foreign standards
B. June 1998 public meeting on initial plans for promoting
public participation in the implementation of the 1998 Agreement
III. Highlights of 1998 Agreement
IV. Discussion of policy statement
V. Other methods for promoting public participation
VI. Public workshop
A. Purpose
B. Procedures
C. Agenda
VII. Regulatory analyses and notices
VIII. Written comments
Draft policy statement
I. Introduction
A. Opening of the 1998 Agreement for Signature
On June 25, 1998, the U.S. became the first signatory to the United
Nations/Economic Commission for Europe (UN/ECE) 1 Agreement
Concerning the Establishing of Global Technical Regulations for Wheeled
Vehicles, Equipment and Parts Which Can Be Fitted And/or Be Used on
Wheeled Vehicles (the ``1998 Agreement''). This agreement was
negotiated under the
[[Page 564]]
auspices of the UN/ECE under the leadership of the U.S., European
Community and Japan.2 The 1998 Agreement provides for the
establishment of global technical regulations regarding the safety,
emissions, energy conservation and theft prevention of wheeled
vehicles, equipment and parts. The covered equipment and parts include,
but are not limited to, exhaust systems, tires, engines, acoustic
shields, anti-theft alarms, warning devices, and child restraint
systems.
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\1\ The Economic Commission for Europe was established by the
United Nations in 1947 to help rebuild post-war Europe, develop
economic activity and strengthen economic relations between European
countries and between them and the other countries of the world.
\2\ At the opening of the 1998 agreement for signature,
representatives of the European Community and Japan indicated
interest in becoming signatories. The representative of the European
Community said that the Community is ``committed to completing its
internal procedures at the earliest opportunity in order to sign the
Agreement without delay.'' Although the representative of Japan did
not refer to any specific time frame for Japan's accession to the
Agreement, he did state that Japan believes that ``it is very
important that many countries join this process and cooperate in
this forum towards the global harmonization of technical
regulations.''
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B. Purpose of and Need for 1998 Agreement
The decision of the U.S. to sign the 1998 Agreement and participate
in a global standards development process is a critical step toward a
cooperative worldwide search for best safety and environmental
practices. The U.S. does not have a vote under an existing earlier UN/
ECE agreement regarding wheeled vehicles, equipment and parts, known as
the 1958 Agreement, since the U.S. is not a signatory to that
agreement.3 This has limited the ability of the U.S. to
influence the substance of the standards adopted under the 1958
Agreement.
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\3\ In 1955, the United Nations Economic Commission for Europe
established, under the Inland Transport Committee, the Working Party
on the Construction of Vehicles (commonly known as WP 29). In 1958,
WP 29 created procedures for establishing uniform regulations
regarding motor vehicles, equipment and parts, including those
affecting road safety. These procedures were codified in 1958 by UN/
ECE Agreement Concerning the Adoption of Uniform Conditions of
Approval and Reciprocal Recognition of Approval for Motor Vehicle
Equipment and Parts, (commonly referred to as the 1958 Agreement).
The 1958 Agreement also established a system for mutual recognition
of each party's approvals of motor vehicle equipment and parts, as
long as these approvals were granted in accordance with the 1958
Agreement's conditions. While the original 1958 Agreement dealt
primarily with safety issues, in the late 1960s, the Working Group
on Pollution and Energy and the Working Group on Noise were
instituted as subgroups of WP 29 for the purpose of developing
emission and noise regulations respectively, and in 1995, the
agreement was revised to include the development of regulations
concerning pollution and energy. There are now six Working Groups:
the Working Group on Noise; the Working Group on Lighting and Light-
Signalling; the Working Group on Pollution and Energy; the Working
Group on Brakes and Running Gear; the Working Group on General
Safety Provision; and the Working Group on Passive Safety.
Fifty-five countries, including the United States, participate
in WP 29. However, only 28 European countries are party to the 1958
Agreement. The WP 29, through its administration of the 1958
Agreement, is the only multinational governmental forum currently
coordinating the development of motor vehicle safety and
environmental regulations. The 1958 Agreement has provided the
European countries with a U.N.-based forum to promulgate their
automotive regulations within Europe. More recently, this regulation
development forum has become a reference source for motor vehicle
regulations for many other parts of the world, which has expanded
the adoption of European regulations rather than those of the United
States.
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Becoming a Contracting Party to the 1998 Agreement accomplishes
several purposes for the U.S. It gives the U.S. a vote in the
establishment of global technical regulations for wheeled vehicles,
equipment and parts under the UN/ECE and enables the U.S. to take a
leading role in effectively influencing the selection of the level of
vehicle safety regulations worldwide. This is appropriate since the
U.S. has been at the forefront in collecting and analyzing crash data,
conducting vehicle safety research, analyzing the impacts of regulatory
alternatives, and requiring high levels of safety. The Agreement
ensures that U.S. standards and their benefits will be properly
considered in any effort to adopt a harmonized global technical
regulation.
C. Issue of Public Participation
Various public interest groups have expressed concerns about the
opportunities for the public to participate in activities related to
the 1998 Agreement. Similar concerns have been expressed by other
groups about other international agreements providing for the
establishment of international standards by organizations that meet
outside the U.S. The common concern is that global technical
regulations will be established abroad without adequate involvement of
the American public. In the case of the 1998 Agreement, groups have
also expressed the view that the decisions made in Geneva could pre-
determine the outcome of subsequent rulemaking proceedings in the U.S.,
even though Federal motor vehicle safety standards (FMVSSs) cannot be
amended or established without satisfaction of the Administrative
Procedure Act and the statutory provisions governing the FMVSSs.
D. Purpose of This Notice
The purpose of this notice is to obtain oral and written comments
on a draft policy statement that has two purposes. First, it sets forth
a listing of priorities that will guide this agency during its
participation in activities under the 1998 Agreement when the Agreement
enters into force. Second, it sets forth the practices and activities
that this agency could use to ensure that the public has the
information and opportunity necessary to follow the development of
global technical regulations under the 1998 Agreement and to provide
its views, beginning at the earliest stages, regarding those
regulations.
II. Background
A. May 1998 Final Rule on Process for Assessing Safety Performance and
Functional Equivalence of U.S. and Foreign Standards
On May 13, 1998, this agency published a final rule reaffirming its
policy of focusing its international harmonization activities on
identifying those foreign vehicle safety standards that clearly reflect
best practices, i.e., that require significantly higher levels of
safety performance than the counterpart U.S. standard. (63 FR 26508)
NHTSA's policy is to upgrade its standards to the level of those
foreign standards.
NHTSA emphasized that three goals must remain of primary importance
as this agency participates in efforts to explore the possibility of
harmonizing its standards with those of other countries and regions in
appropriate circumstances. First, this agency must ensure that there is
no degradation of the safety provided by a regulation as a result of
achieving harmonization. Second, this agency must preserve the quality
and transparency of its regulatory process by inviting all interested
parties to be heard and duly considered. Third, this agency must
preserve its ability to respond, through future rulemaking, to changing
safety technology and problems and make appropriate improvements in its
safety standards.
The final rule also announced this agency's policy regarding
instances in which its comparison of standards indicates that the
safety performance required by a foreign standard is not significantly
higher, but is still better than or at least as good as that required
by the counterpart U.S. standard. In those instances, this agency said
that it will consider the possibility of amending the U.S. standard to
allow manufacturers to comply with either standard or to harmonize the
U.S. standard with the foreign standard.
Since the final rule was issued slightly more than one month before
the June 1998 UN/ECE meeting in Geneva at which the U.S. expected to
sign the 1998 Agreement, NHTSA reaffirmed in the final rule its
commitment to
[[Page 565]]
transparency and public participation in connection with international
harmonization activities. With respect to the implementation of the
1998 Agreement, this agency emphasized that it would not only keep the
public advised of the key activities and make available key documents
relating to the development of vehicle safety standards under the 1998
Agreement, but also provide appropriate, and timely, opportunities for
obtaining public input regarding the merits of these matters. This
agency said that it would elaborate more fully on its procedures
regarding transparency and public participation in the near future.
B. June 1998 Public Meeting on Initial Plans for Promoting Public
Participation in the Implementation of the 1998 Agreement
In a June 17, 1998 public meeting in Washington, D.C., NHTSA took
the next step. It laid out its initial plans for promoting effective
public participation at the earliest stage in the consideration of
global technical regulations concerning motor vehicle safety. The
centerpiece of the plans was a set of activities and practices in the
U.S. that would parallel the global technical regulation development
process in Geneva. NHTSA said that the activities and practices would
include the following measures:
Access to information. NHTSA will post on its Website
information such as a periodically-updated agenda of scheduled meetings
of WP 29 and its committees (called working parties of experts) related
to the 1998 Agreement; key documents, such as proposed global technical
regulations referred under the 1998 Agreement to working parties of
experts for their consideration; and working party reports recommending
establishment of specific global technical regulations. NHTSA already
has worked with the UN/ECE to ensure that the documents generated by WP
29 are accessible on the internet to the public. NHTSA also has worked
with the UN/ECE to ensure that the meetings of WP 29 are open to the
public.
Opportunity to be heard. NHTSA will solicit comments from
the public at key intervals during the development of global technical
regulations. NHTSA will place those comments in the U.S. Department of
Transportation's internet-accessible public docket.
Opportunity to discuss. NHTSA will hold periodic public
meetings to discuss developments at recent meetings of WP 29 and its
working parties of experts related to the 1998 Agreement.
In addition, this agency invited representatives of the industry
and consumer groups and other members of the public to participate as
advisers in the U.S. delegation that will attend the meetings of the
full membership in Geneva. This agency announced that a public workshop
for discussion of the plan will be scheduled and a statement of policy
will be published in the Federal Register so that the public can review
and comment on it.
A broad spectrum of interests were represented at the June public
meeting. Among the attendees were representatives of the European
Commission, the Japan Automobile Standards Internationalization Center,
domestic and foreign motor vehicle manufacturers, and various public
interest groups.
Representatives of four public interest groups spoke briefly at the
meeting. All four generally supported this agency's planned activities
and practices, but urged that even more efforts be made to promote
public participation.
Advocates for Highway and Auto Safety (Advocates) said that this
agency must do more than offer a chance for the public to comment on
technical regulations being developed under the 1998 Agreement.
Advocates submitted a paper listing the specific steps that it believed
this agency and EPA must take at each of the following three phases of
negotiation: before any negotiations begin, during any negotiations,
and after negotiations have produced a text of a tentative global
technical regulation. For example, it said that this agency must accept
public comments before developing its negotiating positions and then
must declare those positions before going to Geneva to begin
negotiations. If negotiations in Geneva cause this agency to conclude
that it is desirable to change a previously declared U.S. negotiating
position, this agency's negotiators must first return to the U.S. and
seek public comments before actually changing the U.S. position. Before
voting on a recommended global technical regulation, this agency must
first seek public comment. In addition to providing copies of all key
documents, this agency should provide the stated positions of other
Contracting Parties to the 1998 Agreement.
The Alliance of Insurance Associations (AIA) endorsed the
procedural suggestions made by Advocates. AIA asked that this agency
incorporate its public participation measures in a legally binding
regulation. That organization also expressed concern about issues
related to the World Trade Organization Technical Barriers to Trade
Agreement (TBT Agreement).4 AIA was particularly concerned
that a case could be made under the TBT Agreement against U.S.
standards that are higher than the technical regulations adopted under
the 1998 Agreement. That organization suggested that objecting
countries could argue that the U.S. could have and should have adopted
a less trade restrictive approach for achieving the safety benefits in
question.
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\4\ One of the agreements of the Uruguay Round administered by
the World Trade Organization (WTO) is the TBT agreement. (http://
www.wto.org) The purpose of the TBT agreement is to ensure that
product standards, technical regulations, and related procedures do
not create unnecessary obstacles to trade. At the same time, the TBT
agreement clearly recognizes that each country has the right to
establish and maintain technical regulations for the protection of
human, animal, and plant life and health and the environment, and
for prevention against deceptive practices.
In the TBT agreement, the term ``standard'' is defined as:
[A] document approved by a recognized body, that provides, for
common and repeated use, rules, guidelines or characteristics for
products or related symbols, packaging, marking or labelling
requirements as they apply to a product, process or production
method.
Also, ``technical regulation'' is defined as:
[A] document which lays down product characteristics or their
related processes and production methods, including applicable
administrative provisions, with which compliance is mandatory
[emphasis added]. It may also include or deal exclusively with
terminology, symbols, packaging, marking, or labelling requirements
as they apply to a product, process or production method.
Thus, in the language of the TBT agreement, when a government
acts to accept a voluntary standard to make it mandatory, the
resulting document is a technical regulation. A measure used to
ascertain compliance with a standard or technical regulation is a
conformity assessment procedure.
The TBT agreement states that, where technical regulations are
required and relevant international standards exist or their
completion is imminent, WTO-member countries shall use them, or the
relevant parts of them, as a basis for their processes and
production methods, with which compliance is not mandatory. It may
also include or deal exclusively with terminology, technical
regulations, except when such international standards or relevant
parts would be an ineffective or inappropriate means for the
fulfillment of the legitimate objectives pursued. Further, the
agreement states that, with a view towards harmonizing technical
regulations on as wide a basis as possible, WTO-member countries
shall play a full part within the limits of their resources in the
preparation by appropriate international standards bodies of
international standards for products for which they either have
adopted or expect to adopt technical regulations.
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Consumers Union (CU) endorsed the statements by Advocates and AIA.
CU urged the establishment of a continuing public forum regarding the
implementation of the 1998 Agreement. That organization said that this
agency's negotiators 5 should, before going to Geneva,
discuss options and alternative
[[Page 566]]
U.S. negotiating positions, how negotiations might go, and where and
how far U.S. can or should go in negotiations. CU said that the
negotiators should also conduct post-negotiation debriefings. CU
mentioned two models that NHTSA could follow in promoting public
participation in the implementing of the 1998 Agreement: the U.S. Codex
6 delegation and the U.S. Department of Agriculture's Food
Safety Inspection Service. CU urged NHTSA to choose the U.S. Codex
delegation, calling it the better of the two models.
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\5\ NHTSA negotiators include both its representative to WP 29
as well as its representatives on the working parties of experts.
\6\ The U.S. Codex delegation consists of officials from the
U.S. Department of Agriculture, the U.S. Food and Drug
Administration, and the U.S. Environmental Protection Agency. They
participate in the activities of the Codex Alimentarius Commission.
The Codex is the major international mechanism for promoting the
health and economic interests of consumers, while encouraging fair
international trade in food. The U.S. Codex Manager coordinates all
Codex activities within the United States. The Manager, who reports
to the Under Secretary for Food Safety in USDA, is assisted by the
U.S. Codex Office, housed in the Food Safety and Inspection Service,
USDA.
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The Insurance Institute for Highway Safety expressed support for
the views of the other groups and stated that NHTSA's policy with
respect to harmonization should always be to harmonize upward and to
identify and adopt best safety practices.
III. Highlights of 1998 Agreement
To aid persons unfamiliar with the 1998 Agreement in gaining an
understanding of its provisions, this agency has summarized the key
aspects below. The complete text of the Agreement may be found on the
Internet at the following address: http://www.itu.int/itudoc/un/
editrans/wp29/wp29wgs/wp29gen/wp29glob.html.
The Agreement establishes a global process under the
United Nations, Economic Commission for Europe (UN/ECE), for developing
and harmonizing global technical regulations ensuring high levels of
environmental protection, safety, energy efficiency and anti-theft
performance of wheeled vehicles, equipment and parts which can be
fitted and/or be used on wheeled vehicles. Motor vehicle engines are
included. (Preamble, Art. 1)
Members of the ECE, as well as members of the United
Nations that participate in ECE activities, are eligible to become
Contracting Parties to the 1998 Agreement. Specialized agencies and
organizations that have been granted consultative status may
participate in that capacity. (Art. 2)
The Agreement will enter into force by September 26, 1999,
if a minimum of five (5) countries or regional economic integration
organizations (e.g., the European Community (EC)) have become
Contracting Parties. The five must include the EC, Japan, and U.S.
(Art. 11)
If the Agreement does not enter into force by that date, it will
enter into force thereafter when a minimum of eight (8) countries or
regional economic integration organizations become Contracting Parties.
At least one of the eight must be either the EC, Japan, or the U.S.
(Art. 11)
The Agreement explicitly recognizes the importance of
continuously improving and seeking high levels of safety and
environmental protection and the right of national and subnational
authorities, e.g., California, to adopt and maintain technical
regulations that are more stringently protective of health and the
environment than those established at the global level. (Preamble)
The Agreement explicitly states that one of its purposes
is to ensure that actions under the Agreement do not promote, or result
in, a lowering of safety and environmental protection within the
jurisdiction of the Contracting Parties, including the subnational
level. (Art. 1)
To the extent consistent with achieving high levels of
environmental protection and vehicle safety, the Agreement also seeks
to promote global harmonization of motor vehicle and engine
regulations. (Preamble)
The Agreement emphasizes that the development of global
technical regulations will be transparent. (Art. 1)
Annex A provides that the term ``transparent procedures'' includes
the opportunity to have views and arguments represented at:
(1) meetings of Working Parties through organizations granted
consultative status; and
(2) meetings of Working Parties and of the Executive Committee
through pre-meeting consulting with representatives of Contracting
Parties.
The Agreement provides two different paths to the
establishment of global technical regulations. The first is the
harmonization of existing standards. The second is the establishment of
a new global technical regulation where there are no existing
standards. (Article 6.2 and 6.3)
The process for developing a harmonized global technical
regulation includes a technical review of existing regulations of the
Contracting Parties and of the UN/ECE regulations, as well as relevant
international voluntary standards (e.g., standards of the International
Standards Organization 7). If available, comparative
assessments of the benefits of these regulations (also known as
functional equivalence assessments) are also reviewed. (Art. 1.1.2,
Article 6.2)
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\7\ The International Standards Organization (ISO) is a non-
governmental, worldwide federation of national standards bodies from
approximately 130 countries. (http://www.iso.ch) It was established
in 1947. Its mission is to promote the development of
standardization and related activities in the world with a view to
facilitating the international exchange of goods and services, and
to developing cooperation in the spheres of intellectual,
scientific, technological and economic activity. Its work is carried
out through a hierarchy of technical committees, subcommittees, and
working groups.
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The process for developing a new global technical
regulation includes the assessment of technical and economic
feasibility and a comparative evaluation of the potential benefits and
cost effectiveness of alternative regulatory requirements and the test
method(s) by which compliance is to be demonstrated. (Article 6.3)
To establish any global technical regulation, there must
be a consensus vote. Thus, if any Contracting Party votes against a
recommended global technical regulation, it would not be established.
(Annex B, Article 7.2)
The establishment of a global technical regulation does
not obligate Contracting Parties to adopt that regulation into its own
laws and regulations. Contracting Parties retain the right to choose
whether or not to adopt any technical regulation established as a
global technical regulation under the Agreement. (Preamble, Article 7)
Consistent with the recognition of that right, Contracting
Parties have only a limited obligation when a global technical
regulation is established under the Agreement. If a Contracting Party
voted to establish the regulation, that Contracting Party must initiate
the procedures used by the Party to adopt such a regulation as a
domestic regulation. (Article 7)
For the U.S., this would likely entail initiating the rulemaking
process by issuing an Advanced Notice of Proposed Rulemaking (ANPRM) or
a Notice of Proposed Rulemaking (NPRM). If the U.S. were to adopt a
global technical regulation into national law, it would do so in
accordance with all applicable procedural and substantive statutory
provisions, including the Administrative Procedure Act, 5 U.S.C.
Sec. 553 et seq., the Vehicle Safety Act, and comparable provisions of
other relevant statutes, such as the Clean Air Act.
The Agreement allows for global technical regulations to
contain a ``global'' level of stringency for most
[[Page 567]]
parties and `alternative' levels of stringency for developing
countries. In this way, all countries, including the least developed
ones, can participate in the development, establishment and adoption of
global technical regulations. It is anticipated that a developing
country may wish to begin by adopting one of the lower levels of
stringency and later successively adopt higher levels of stringency.
(Article 4)
IV. Discussion of the Draft Policy Statement and Response to Public
Comments at the June 17 Public Meeting
Publication of a policy statement. In this notice, this agency sets
forth a draft policy statement that generally describes its priorities
and its planned activities and practices for promoting public
participation. NHTSA will revise the statement as appropriate in
response to public comment and publish it in the Federal Register.
NHTSA has tentatively chosen this approach, instead of a binding
regulation as suggested by AIA, in recognition of the newness both of
the Agreement and of NHTSA's involvement in activities under an
international agreement to which the U.S. is a contracting party.
Particularly at the beginning, there must be a sufficient degree of
flexibility so that the activities and procedures can evolve easily and
quickly as the U.S. and other Contracting Parties gain experience in
using limited resources to implement the Agreement in a manner that
advances safety and environmental protection and involves the public in
that effort.
While the need for flexibility must be met, NHTSA recognizes that
there is also an equal need for identifying this agency's specific
activities and practices that will provide the three basic elements
outlined at the June public meeting. Those elements are: access to
information, opportunity to be heard, and opportunity to discuss.
Activities and practices relating to each of those elements are clearly
set out in the draft policy statement.
Access to information. This agency will publish an annual calendar
of meetings and listing of global technical regulations under
consideration. To promote the availability of documents as they are
generated under the 1998 Agreement and become available in English,
this agency will provide the addresses to the Websites of the UN/ECE
and the International Telecommunication Union (ITU):
United Nations Economic Commission for Europe (UN/ECE)
http://www.unece.org/Welcome.html
Inland Transport Committee (ITC) of the UN/ECE
http://www.unicc.org/unece/trans/
Working Party on the Construction of Vehicles (WP 29) of the ITC
http://www.unicc.org/unece/trans/main/unecewp.htm
Working parties of experts of WP 29
http://www.itu.ch/itudoc/un/editrans/wp29/wp29wgs.html
The ITU maintains a Website that covers, among other subjects, the
activities of the Inland Transport Committee of the UN/ECE and its
various working parties. (http://www.itu.ch/itudoc/un/editrans.html)
Within the limits of its resources, and primarily with respect to the
development of particularly important global technical regulations,
this agency will also place the documents in the internet-accessible
DOT docket and place key documents on a word-searchable location in its
Website.
Opportunity to be heard. This agency plans to seek public comment
at two points during the development of global technical regulations.
In the case of a proposal to be submitted by the U.S. for a global
technical regulation, the first point would be before the proposal is
submitted.8 In the case of a proposed global technical
regulation submitted by a Contracting Party other than the U.S., the
first point at which the agency would solicit public comment would be
when the proposal is referred under the 1998 Agreement to a working
party of experts for consideration. In all cases, the second point
would be when and if a working party of experts issues a report
recommending the adoption of a global technical regulation.
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\8\ If the proposal concerns issues on which this agency has
recently obtained public comment as part of a rulemaking proceeding,
it would not seek further comment before submitting the proposal.
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NHTSA will seek comments by publishing a request for comments. In
the case of a proposal that the U.S. contemplates offering, the notice
would describe the contemplated proposal and assess its impacts. This
agency would fully consider those comments and make any appropriate
changes to its proposal for a global technical regulation, if
commenters submit sufficient supporting technical data and analysis. In
the case of a proposal submitted by another Contracting Party, the U.S.
would likely issue a short notice summarizing the proposal and seeking
comments.
Opportunity to discuss. This agency plans to hold informal meetings
to brief the public about recent and anticipated deliberations and
standards development work under the 1998 Agreement at those meetings.
In addition, interested parties may raise questions related to those
subjects. The public meetings would be scheduled so that one would
precede each of the three annual WP 29 meetings (i.e., in March, June
and November).
NHTSA solicits comments on where it should hold its public meetings
on activities related to the 1998 Agreement. It also solicits comments
on whether these 1998 Agreement meetings should be combined with this
agency's existing quarterly public meetings at which it discusses its
vehicle rulemaking. Three of those quarterly rulemaking meetings are
held in Detroit, Michigan. The fourth is held in Washington, D.C.
Discussion of U.S. negotiating positions. To the extent consistent
with retaining the ability to negotiate effectively with other
Contracting Parties, NHTSA would use the quarterly meetings to keep
interested parties generally informed about the U.S. negotiating
positions on issues under the 1998 Agreement. However, this agency
tentatively concludes that it would be impracticable to adopt the
suggestion by Advocates at the June 17 public meeting that the NHTSA
negotiators should return to the U.S. and justify any departure from a
previously announced negotiating position under that Agreement. Having
to return to the U.S., as suggested by Advocates, would make
negotiations very lengthy and unwieldy.
Post-negotiation debriefings. NHTSA believes that this need can be
met at the public meetings to be held on activities related to the 1998
Agreement.
Establishment of a continuing forum. This agency believes that the
periodic meetings will provide the public not only with an opportunity
to discuss recent and future developments under the 1998 Agreement, but
also general procedural issues involved in the implementation of that
Agreement.
Following the model of the U.S. Codex delegation or FDA in
providing for public participation.
At the suggestion of CU, the NHTSA Director of International
Harmonization met with Dr. F. Edward Scarbrough, the U.S. Manager for
Codex, on August 13, 1998. Dr. Scarbrough described the efforts made by
the members of the U.S. Codex delegation to develop and publicize a
general description of the U.S. position regarding the agenda items to
be discussed at upcoming meetings of the committees of Codex
Alimentarius Commission. By way of example, he mentioned the
descriptions that would be provided and discussed the next day at a
public meeting held in preparation for the September 1998 meeting of
the
[[Page 568]]
Codex Committee on General Principles. (The notice announcing that
meeting was published at 63 Fed. Reg. 42608, on August 10, 1998.)
He also noted the notice published by the FSIS on February 12, 1998
about duties of U.S. Government delegates and delegation members
including non-government members. (63 Fed. Reg. 7118) That notice:
describes the activities of the Codex Alimentarius Commission
(Codex); describes the duties of the United States delegate and
alternate delegate to Codex committees; provides the criteria and
procedures to be used in selecting non-government members to various
United States delegations to Codex committees; describes the
appropriate role of non-government members on Codex committees;
identifies the manner in which the public will be informed of and
may participate in Codex activities; and requests comments on these
matters.
With respect to advising the public of the positions of the U.S.
Government about Codex activities, paragraph V.C. of that notice
states:
The United States delegate will notify members of the public who
have indicated an interest in a particular Codex committee's
activities of the status of each agenda item and the United States
Government's position or preliminary position on the agenda item, if
such a position has been determined. The United States delegate may
request members of the public who have indicated an interest in a
particular Codex committee's activities to submit written comments.
Public meetings may also be held to receive comments.
The content and disposition of public comments is discussed in
paragraph V.E. of the February notice:
Public comments relevant to Codex committee activities should be
supported by as much data or research as possible and such data or
research should be properly referenced to enhance the persuasive
impact of the comments. The United States delegate will consider all
comments received but will not be bound to agree with any comment.
The views expressed in these comments may or may not be presented by
the United States delegate to a Codex committee.
Dr. Scarbrough also discussed the role and responsibilities of non-
government members of U.S. delegations. For example, he noted that the
February 1998 notice stated that while the U.S. delegate will, to the
extent feasible, consult and seek recommendations for non-government
members, the U.S. delegate will not be obliged to present at any Codex
committee session any recommendation made by a non-government member.
NHTSA has attempted to reflect the results of its talk with Dr.
Scarbrough in the draft policy statement. However, this agency is open
to further suggestions and perspectives. Accordingly, this agency
invites commenters to address the following question: In establishing
the activities and practices that NHTSA will use in providing for
public participation in the implementation of the 1998 Agreement, what
specific lessons should be drawn from the experiences of the Food and
Drug Administration (FDA) and the Department of Agriculture's Food
Safety Inspection Service (FSIS) with respect to the Codex, and FDA
with respect to the International Conference of Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH) (drug safety)? 9 10
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\9\ The ICH was organized to provide an opportunity for
tripartite harmonization initiatives to be developed with input from
both regulatory and industry representatives. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union,
Japan, and the United States. The six ICH sponsors are the European
Commission, the European Federation of Pharmaceutical Industries
Associations, the Japanese Ministry of Health and Welfare, the
Japanese Pharmaceutical Manufacturers Association, the Centers for
Drug Evaluation and Research and Biologics Evaluation and Research,
FDA, and the Pharmaceutical Research and Manufacturers of America.
The ICH Secretariat, which coordinates the preparation of
documentation, is provided by the International Federation of
Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering
Committee includes representatives from each of the ICH sponsors and
the IFPMA, as well as observers from the World Health Organization,
the Canadian Health Protection Branch, and the European Free Trade
Area.
\10\ For information concerning FDA and FSIS involvement in the
Codex and ICH, see the following Federal Register notices or contact
those agencies directly:
FDA, ``International Harmonization; Policy on
Standards,'' (October 11, 1995; 60 FR 53078).
FSIS, ``Codex Strategic Planning Meeting,'' (May 1,
1997; 62 Fed. Reg. 23745).
FDA, ``Consideration of Codex Alimentarius Standards,''
(July 7, 1997; 62 FR 36243).
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Interested persons desiring information regarding these other
harmonization activities may wish to consult the following Websites:
US Codex Office
http://www.fsis.usda.gov/OA/codex/;
Codex Alimentarius Commission:
http://www.fao.org/waicent/faoinfo/economic/esn/codex/
FDA (including the ICH)
http://www.fda.gov/oia/homepage.htm
Best safety practices. This agency reaffirms its prior statements
that the identification and adoption of best safety practices is its
highest priority in its international harmonization activities.
TBT Agreement issues. The U.S. is well-positioned to defend its
vehicle safety standards against a complaint under the TBT Agreement
that the standard is higher than the technical regulations adopted
under the 1998 Agreement as well as against a complaint that the
standard is more trade restrictive than necessary to achieve the safety
benefits in question. NHTSA takes great care in establishing the safety
needs for its standards and in assessing the benefits and other impacts
of its safety standards. Both the TBT Agreement and the 1998 Agreement
expressly recognize the right of nations to adopt safety standards more
stringent than existing international standards.
V. Other Methods for Promoting Public Participation
Currently, the motor vehicle industry and consumers are represented
at meetings of WP 29 and of its working parties of experts by
international organizations that have been granted consultative status
by the Economic and Social Council of the United Nations. The industry
is represented by the Organisation Internationale Des Constructeurs
D'Automobiles (OICA) (International Organization of Motor Vehicle
Manufacturers), while consumers are represented by Consumers
International. Those organizations participate in the discussions, but
cannot vote.
The 1998 Agreement expressly provides for participation of any
specialized agency and any organization, including intergovernmental
organizations and non-governmental organizations. Paragraph 2.3 of
Article 2 provides
Any specialized agency and any organization, including
intergovernmental organizations and non-governmental organizations,
that have been granted consultative status by the Economic and
Social Council of the United Nations, may participate in that
capacity in the deliberations of any Working Party during
consideration of any matter of particular concern to that agency or
organization.
At the June 17 public meeting, the Administrator raised the
possibility of members of the public participating as private sector
advisers on a U.S. delegation at meetings under the 1998 Agreement.
This agency notes that if a manufacturer or public interest group were
to take advantage of this opportunity, it would have to provide its own
funding. The selection of private sector advisers and protocol
governing their participation are set forth in the final guidelines
published by the Department of State concerning the participation of
representatives of affected private sector interests to serve as
advisers on U.S. delegations to international conferences, meetings and
negotiations (44 Fed. Reg. 17846; March
[[Page 569]]
23, 1979). This agency solicits comments on the extent of public
interest and ability to serve as private sector advisers.
VI. Public Workshop
All interested persons and organizations are invited to attend the
workshop. To assist interested parties to prepare for the February 3,
1999 workshop, this agency has developed a preliminary agenda, shown
below, of introductory presentations and of major topics for discussion
at the meeting. Requests for this agency to consider adding additional
topics should be addressed to Ms. Julie Abraham at the address or
numbers given above.
A. Purpose
This agency is holding a workshop to facilitate the interactive
exchange and development of ideas among all participants. The purpose
is to present and discuss the planned activities and practices for
facilitating public participation in the implementation of the 1998
Agreement. NHTSA hopes that through an interactive discussion,
opportunities to improve the draft policy statement can be identified.
NHTSA plans to consider the information and views presented at the
workshop and in the subsequent written comments in developing the
policy statement it will issue.
B. Procedures
This agency intends to conduct the workshop informally. The
Director of International Harmonization will preside at the workshop,
with the participation of the NHTSA's and EPA's representatives on WP
29's working parties of experts. The Director will first give a brief
overview of the 1998 Agreement, followed by brief presentations by
agency officials regarding the operation of WP 29 and its work plans.
Then the presiding official will discuss all of this agency's planned
activities and practices for promoting public participation. As each
activity or practice is presented, the participants will be asked for
comments and input. At any point during the workshop, and upon request,
the presiding official will allow participants to ask questions or
provide comments. When commenting, participants should approach the
microphone and state their name and affiliation for the record. All
participants are asked to be succinct. Participants may also submit
written questions to the presiding official and request that they be
directed to particular participants.
Any person planning to participate should contact Ms. Julie Abraham
at the address and telephone number given at the beginning of this
notice, no later than 10 calendar days before the workshop.
C. Agenda
i. Opening remarks
Ricardo Martinez, Administrator (NHTSA)--10 min.
ii. 1998 Agreement: opportunities for seeking higher levels of safety
and broader public participation
Julie Abraham, Director of International Harmonization (NHTSA)--15
min.
iii. WP 29 procedures for developing technical regulations under the
1958 and 1998 Agreements
Ken Feith, Policy Advisor, Office of Air and Radiation (EPA)--20
min.
iv. The U.S. role in the implementation of the 1958 Agreement
WP 29 Working Party of Experts on Lighting and Light-Signalling:
recent events and future directions
Richard Van Iderstine, U.S. Representative (NHTSA)--5 min.
WP 29 Working Party of Experts on Pollution and Energy: recent
events and future directions
Thomas Baines, U.S. Representative (EPA)--5 min.
WP 29 Working Party of Experts on Noise: recent events and future
directions
Ken Feith, U.S. Representative (EPA)--5 min.
WP 29 Working Party of Experts on Passive Safety: recent events and
future directions
Dr. William R. S. Fan, U.S. Representative (NHTSA)--5 min.
Case example illustrating the current role of NGO's in the
development of a UN/ECE technical regulation Frank Turpin, Office of
International Harmonization (NHTSA) (Retired)--10 min.
v. Interactive discussion of public participation in the implementation
of the 1998 Agreement 11
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\11\ The participants in the interactive discussion are
encouraged to discuss the issues on which the agency has solicited
comments in the preamble to this notice, i.e.:
What lessons should be drawn from the experiences of the FDA and
FSIS with respect to the Codex, and of the FDA with respect to the
International Conference of Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH) (drug
safety)?
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The policy statement
Access to information
Opportunity to comment
Opportunity to discuss
Other measures for promoting public participation
Participation in U.S. delegation
VII. Rulemaking Analyses and Notices
Since this request for comment contemplates the establishment of a
statement of policy (as opposed to a regulation or rule) that will not
have the force and effect of law, this request is not subject to the
requirements of the various Executive Orders (e.g., Executive Order
12866), statutes or DOT regulatory policies and procedures for analysis
of the impacts of rulemaking. Further, it is not subject to the notice
and comment requirements of the Administrative Procedure Act.
Nevertheless, this agency has decided to seek public comment on the
statement of policy before publishing a final version.
VIII. Comments
This agency invites all interested parties to submit written
comments. This agency notes that participation in the public workshop
is not a prerequisite for submission of written comments. Written
comments should be sent to the address and follow the same requirements
specified above in section ADDRESSES. It is requested but not required
that two copies be submitted.
All comments must not exceed 15 pages in length (49 CFR 553.21).
Necessary attachments may be appended to these submissions without
regard to the 15-page limit. This limitation is intended to encourage
commenters to detail their primary arguments in a concise fashion.
If a commenter wishes to submit certain information under a claim
of confidentiality, three copies of the complete submission, including
the purportedly confidential business information, should be submitted
to the Chief Counsel, NHTSA, at the street address given above, and two
copies from which the purportedly confidential information has been
deleted should be submitted to Docket Management. A request for
confidentiality should be accompanied by a cover letter setting forth
the information specified in this agency's confidential business
information regulation. 49 CFR Part 512.
All comments received by NHTSA before the close of business on the
comment closing date indicated above for the notice will be considered,
and will be available for examination in the docket at the above
address both before and after that date. To the extent possible,
comments filed after the closing date will also be considered. Comments
received too late for consideration in regard to the policy statement
to be issued will be considered as suggestions for future action.
Comments on the notice will be
[[Page 570]]
available for inspection in the docket. NHTSA will continue to file
relevant information as it becomes available in the docket after the
closing date, and recommends that interested persons continue to
examine the docket for new material.
Those persons desiring to be notified upon receipt of their
comments in the docket should enclose a self-addressed, stamped
postcard in the envelope with their comments. Upon receiving the
comments, the docket supervisor will return the postcard by mail.
Statement of Policy: NHTSA Priorities and Public Participation in the
Implementation of the UN/ECE 1998 Agreement on Global Technical
Regulations
I. Our Priorities Under the 1998 Agreement
A. Advance vehicle safety by identifying and adopting best safety
practices from around the world or by developing new standards
reflecting technological advances and current and anticipated safety
problems.
B. Seek to harmonize our safety standards with those of other
countries, to the extent consistent with maintaining existing levels of
motor vehicle safety.
C. Notwithstanding our harmonization efforts, preserve our ability
to adopt standards that meet U.S. vehicle safety needs.
D. Ensure the opportunity for public participation, through means
such as pre-rulemaking activities and practices.
II. Procedures for Providing Public Information and Facilitating Public
Participation
A. Access to information.
1. Annual calendar of activities and list of pending work.
We will publish annually a notice providing (a) a calendar of
scheduled meetings of WP 29 and its working parties of experts; and (b)
a list of the global technical regulations relating to motor vehicle
safety, theft or energy conservation that are being considered by a
working party of experts, or that have been recommended by a working
party of experts for establishment under the 1998 Agreement.
2. Availability of documents relating to global technical
regulations proposed by Contracting Parties and global technical
regulations recommended by working parties of experts.
As we obtain English versions of key documents relating to motor
vehicle safety, theft or energy conservation that are generated under
the 1998 Agreement (e.g., proposals referred to a working party of
experts, and reports and recommendations issued by a working party), we
will place them in the internet-accessible DOT docket
(www.dms.dot.gov). Since documents in the DOT docket are imaged
documents, they cannot be word-searched. Within the limits of available
resources, we will also place the documents on an international
activities page that will be included in our Website. This additional
step will give interested persons the ability to word-search the
documents.
B. Opportunity to comment.
1. Proposals by Contracting Parties for consideration of global
technical regulations.
a. Proposals by the U.S.
Before we submit a proposal for the development of a global
technical regulation relating to motor vehicle safety, theft or energy
conservation for consideration under the 1998 Agreement, we will
publish a notice requesting public comments on our proposal. We will
consider those comments before submitting our proposal to the Executive
Committee.
(1) U.S. proposal for harmonizing existing technical regulations.
Our notice will compare the proposed harmonized standard and the
related existing U.S. standard, including the relative impacts of those
standards.
(2) U.S. proposal for establishing a new global technical
regulation.
Our notice will discuss (i) the safety, theft or energy
conservation problem addressed by the proposal, (ii) the rationale for
the proposed approach for addressing the problem, and (iii) the impacts
of the proposal.
b. Proposals by Contracting Parties other than the U.S.
After a Contracting Party other than the U.S. submits a proposal
for a global technical regulation relating to motor vehicle safety,
theft or energy conservation for consideration under the 1998
Agreement, we will place a copy of an English language version of the
proposal in the DOT docket and, within the limit of our resources, may
also post it on our Website. We will also publish a brief notice
summarizing the proposal, indicating where it may be located in the DOT
docket (and/or on the internet), and inviting public comment. We will
consider those comments in connection with our participation in future
deliberations under that Agreement.
2. Recommendations by a working party of experts for the
establishment of a global technical regulation.
When a working party of experts issues a report recommending the
establishment of any global technical regulation (including one based
on one of our proposals) relating to motor vehicle safety, theft or
energy conservation, we will place a copy of an English language
version of the report in the DOT docket and, within the limit of our
resources, may also post it on our Website. We will also publish a
brief notice summarizing the recommended regulation, indicating where
the report may be located in the DOT docket (and/or on the internet),
and inviting public comment. We will consider those comments in
connection with our participation in future deliberations under the
1998 Agreement.
(Note: If we subsequently initiate a rulemaking proceeding
concerning the subject matter of any document mentioned above in
paragraphs 1-3, we will place the comments relating to the document
in the docket for that proceeding and address them as appropriate.)
C. Opportunity to discuss.
We will hold public meetings to summarize the events under the 1998
Agreement since the last meeting held pursuant to this policy statement
and the anticipated upcoming events. We will also discuss key issues
regarding pending standards development work relating to motor vehicle
safety, theft or energy conservation under the 1998 Agreement, and
public comments regarding those issues. Our representatives on the
working parties of experts, and, as appropriate, other agency
officials, will also participate in those meetings.
Issued on December 29, 1998.
Julie Abraham,
Director, Office of International Harmonization.
[FR Doc. 98-34827 Filed 12-30-98; 2:37 pm]
BILLING CODE 4910-59-P