Agency Priorities and Public Participation in the Implementation of the 1998 Agreement on Global Technical Regulations; Statement of Policy

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