[Title] Agreement on Mutual Recognition of Results of Conformity Assessment Procedures Between Japan and the United States of America
JAPAN and the UNITED STATES OF AMERICA (hereinafter referred to as "the Parties");
CONSIDERING the traditional friendly relations that exist between the Parties;
RECOGNIZING that mutual recognition of the results of conformity assessment procedures is an important means of enhancing market access between and economic activity in the respective territories of the Parties;
RECOGNIZING that such mutual recognition requires each Party to have confidence in reliability of conformity assessment procedures of the other Party;
BEARING IN MIND the obligations of the Parties as Members of the World Trade Organization (hereinafter referred to as the "WTO"), and being conscious, inter alia, of their obligations under the Agreement on Technical Barriers to Trade included in Annex 1A (hereinafter referred to as the "Agreement on Technical Barriers to Trade"), and the Agreement on Trade-Related Aspects of Intellectual Property Rights included in Annex 1C (hereinafter referred to as the "Agreement on Trade-Related Aspects of Intellectual Property Rights"), of the Marrakesh Agreement Establishing the World Trade Organization (hereinafter referred to as the "WTO Agreement"); and
RECOGNIZING that an agreement providing for mutual recognition of the results of conformity assessment procedures is of particular interest to suppliers of equipment;
HAVE AGREED AS FOLLOWS:
ARTICLE 1 - PURPOSE OF THE AGREEMENT
This Agreement establishes procedures for the acceptance by a Party of the results of conformity assessment procedures conducted by conformity assessment bodies located in the territory of the other Party for equipment within the scope of this Agreement, with the objective of facilitating economic activity related to such equipment in and between the territories of the Parties.
ARTICLE 2 - DEFINITIONS
1. For the purposes of this Agreement:
(a) the term "conformity assessment procedure" means a procedure to determine whether equipment or a process complies with the Technical Regulations of a Party;
(b) the term "conformity assessment body" means a body that conducts conformity assessment procedures;
(c) the term "Technical Regulations" means relevant laws, regulations, and administrative provisions of a Party set out in Section I of the Annex pertaining to technical requirements for equipment, conformity assessment procedures, and the criteria for designation;
(d) the term "Designating Authority" means an authority of a Party identified in Section II of the Annex with the power to designate, monitor, withdraw the designation of, suspend the designation of, and remove the suspension of the designation of conformity assessment bodies located in the territory of that Party;
(e) the term "designation" means the designation of a conformity assessment body in accordance with Article 5 and the procedures set out in Section III of the Annex;
(f) the term "criteria for designation" means the criteria with which conformity assessment bodies located in the territory of a Party must comply in order to obtain and maintain designation by the Designating Authority of that Party, and that are set out in the Technical Regulations of the other Party and the relevant ISO/IEC Guide and Standard set out in Section III of the Annex;
(g) the term "designated conformity assessment body" means a conformity assessment body located in the territory of a Party designated by the Designating Authority of that Party in accordance with Article 5 and the procedures set out in Section III of the Annex;
(h) the term "Regulatory Authority" means an authority of a Party identified in Section IV of the Annex with the power to regulate the equipment within the scope of this Agreement with respect to compliance with the Technical Regulations of that Party;
(i) the term "registration" means the registration of a conformity assessment body in accordance with the procedures set out in Article 6;
(j) the term "registered conformity assessment body" means a conformity assessment body registered in accordance with the procedures set out in Article 6;
(k) the term "results of conformity assessment procedures" means a determination, reached through conducting conformity assessment procedures, of whether equipment or a process complies with the Technical Regulations of a Party and includes certificates and marks of conformity reflecting an affirmative determination; and
(1) the term "days" means calendar days.
2. All terms used in this Agreement that are not defined in paragraph 1 have the meaning assigned to them in the ISO/IEC Standard set out in Section V of the Annex.
ARTICLE 3 - GENERAL PROVISIONS
1. This Agreement applies to conformity assessment procedures for the telecommunications terminal equipment and radio equipment covered by Section VI of the Annex and for processes associated with that equipment. This Agreement applies regardless of the location of the supplier or the country of origin of the equipment, including where the country of origin of the equipment is other than Japan or the United States.
2. Each Party shall accept, in accordance with this Agreement, the results of conformity assessment procedures that a registered conformity assessment body located in the territory of the other Party conducts for equipment within the scope of this Agreement that determine that the equipment or a process associated with that equipment complies with the Technical Regulations of the Party.
3. The results of conformity assessment procedures referred to in paragraph 1 may be based on tests conducted by a laboratory regardless of its location, including where the laboratory is located in a country other than Japan or the United States.
4. The Annex is an integral part of this Agreement and sets out the following:
(a) Technical Regulations of each Party;
(b) The Designating Authority of each Party;
(c) Procedures of each Party for designating conformity assessment bodies;
(d) The Regulatory Authority of each Party;
(e) The ISO/IEC Standard for terms not defined in this Agreement;
(f) The equipment within the scope of this Agreement for each Party;
(g) Information for registration of conformity assessment bodies; and
(h) Co-chairs of the Joint Committee.
5. Each Party shall:
(a) make publicly available its Technical Regulations and any amendments it makes thereto;
(b) make publicly available a list of registered conformity assessment bodies;
(c) notify the other Party and provide corrected information on registered conformity assessment bodies, if the information the Party has provided in a proposal to register the conformity assessment body becomes inaccurate and the inaccuracy could affect the operation of this Agreement; and
(d) notify the other Party if it names a Designating Authority or Regulatory Authority other than the authority identified in Section II and IV of the Annex, respectively.
6. Each Party shall respond to inquiries from the other Party regarding:
(a) conformity assessment procedures within the scope of this Agreement and Technical Regulations of the Party, including inquiries concerning the specific article, annex, section, or part, of the Technical Regulations of the Party that is applicable to such conformity assessment procedures;
(b) implementation of this Agreement; and
(c) any proposed change in its Technical Regulations before it takes effect.
7. Each Party recognizes that cooperation with conformity assessment bodies is essential to ensuring that conformity assessment bodies located in a territory of a Party understand and comply with the criteria for designation, including the Technical Regulations of the other Party, and to that end, should encourage training sessions and other exchanges of information with conformity assessment bodies as a means to enhance their ability to benefit from this Agreement.
8. Each Party should also encourage conformity assessment bodies located in its territory to include conformity assessment bodies located in the territory of the other Party in activities organized to promote understanding of the Technical Regulations of the Party.
ARTICLE 4 - DESIGNATING AUTHORITY
1. Each Party shall ensure that its Designating Authority identified in Section II of the Annex has the necessary power to designate, monitor, conduct verification of, withdraw the designation of, suspend the designation of, and remove the suspension of the designation of, the conformity assessment bodies in its territory.
2. If a Party appoints one or more bodies to evaluate conformity assessment bodies, such appointment shall not affect the obligations of the Designating Authority set out in this Agreement.
ARTICLE 5 - DESIGNATION
1. The Designating Authority of each Party shall apply the procedures set out in Section III of the Annex in determining whether to designate conformity assessment bodies in its territory for purposes of this Agreement.
2. Each Party shall ensure, through appropriate means such as audits, inspections, or monitoring, that registered conformity assessment bodies in its territory comply with the criteria for designation.
3. Each Party shall, on the request of the other Party, provide information to the other Party on methods the Party uses to designate conformity assessment bodies.
ARTICLE 6 - REGISTRATION
1. The following procedures shall apply to the registration of a conformity assessment body:
(a) If a Party seeks to register a designated
conformity assessment body under this Agreement, the Party shall submit a proposal to the other Party and the Joint Committee. The proposal shall be in writing and include (i) a proposed text of a Joint Committee decision to register the conformity assessment body signed by the proposing Party's co-chair of the Joint Committee and (ii) the information for registration of the conformity assessment body identified in Section VII of the Annex.
(b) The Party receiving the proposal shall evaluate whether the conformity assessment body complies with the criteria for designation. If the Regulatory Authority of the receiving Party requires additional information to evaluate the conformity assessment body's compliance with the criteria for designation, it may request the information from the proposing Party through the Designating Authority of the proposing Party. A request for additional information under this subparagraph shall suspend the 30-day period referred to in subparagraph (c) until the date on which the receiving Party receives the information.
(c) Within 30 days after the date on which it receives a proposal referred to in subparagraph (a), the receiving Party shall notify the proposing Party and the co-chairs of the Joint Committee in writing whether it accepts or rejects the proposal, in accordance with subparagraph (d) or (e), based on its evaluation of whether the conformity assessment body complies with the criteria for designation.
(d) If the receiving Party accepts the proposal, that Party's co-chair of the Joint Committee shall sign the proposed text of the Joint Committee decision, which shall then constitute a decision of the Joint Committee registering the conformity assessment body. The receiving Party shall include a copy of the decision in its notification under subparagraph (c). The registration of the conformity assessment body shall take effect on the date on which the receiving Party's co-chair of the Joint Committee signs the decision.
(e) If the receiving Party does not accept the proposal,
(i) the receiving Party shall include in its notification under subparagraph (c) the reasons therefor, and
(ii) at the request of either Party, the Joint Committee shall discuss the matter within 60 days after it receives notification under subparagraph (c). The Joint Committee may request the proposing Party to verify whether the conformity assessment body complies with the criteria for designation. Paragraphs 2 and 3 of Article 9 shall apply mutatis mutandis to a verification requested pursuant to this paragraph.
2. The receiving Party shall accept the results of conformity assessment procedures conducted by a registered conformity assessment body located in the territory of the other Party from the date of a decision of the Joint Committee registering the conformity assessment body under paragraph 1(d).
ARTICLE 7 - WITHDRAWAL AND SUSPENSION OF DESIGNATION AND TERMINATION AND SUSPENSION OF REGISTRATION
1. Each Party shall ensure that its Designating Authority withdraws its designation of a registered conformity assessment body when the Designating Authority determines that the conformity assessment body no longer complies with the criteria for designation.
2. If a Designating Authority of a Party withdraws its designation of a registered conformity assessment body, the Party shall immediately notify the other Party and the co-chairs of the Joint Committee. A notification under this paragraph shall be considered to be a decision of the Joint Committee to terminate the registration of the conformity assessment body, unless the Joint Committee decides otherwise. The termination shall take effect on the date on which the other Party's co-chair of the Joint Committee receives the notification. The other Party shall accept the results of conformity assessment procedures conducted by the conformity assessment body before the date on which the Designating Authority of the Party withdrew the designation of the conformity assessment body.
3. If a Designating Authority of a Party suspends its designation of a registered conformity assessment body, the Party shall immediately notify the other Party and the co-chairs of the Joint Committee. A notification under this paragraph shall be considered to be a decision of the Joint Committee to suspend the registration of the conformity assessment body. The suspension of registration shall take effect on the date on which the other Party's co-chair of the Joint Committee receives the notification under this paragraph. The other Party shall accept the results of conformity assessment procedures conducted by the conformity assessment body before the date on which the Designating Authority of the Party suspended the designation of the conformity assessment body.
4. If a Designating Authority of a Party removes its suspension of the designation of a registered conformity assessment body, the Party shall immediately notify the other Party and the co-chairs of the Joint Committee. A notification under this paragraph shall be considered to be a decision of the Joint Committee to remove the suspension of registration of the conformity assessment body. The removal of the suspension of registration shall take effect on the date on which the other Party's co-chair of the Joint Committee receives notification under this paragraph. The other Party shall accept the results of conformity assessment procedures conducted by the conformity assessment body from the date of the removal of the suspension of registration.
ARTICLE 8 - CONTESTATION
1. If a Party considers that a registered conformity assessment body located in the territory of the other Party does not comply with the criteria for designation, the Party may notify the other Party and the co-chairs of the Joint Committee that it contests the conformity assessment body's compliance with the criteria for designation. The notification shall be in writing and include the reasons for the contestation. The Joint Committee shall discuss the matter within 60 days after the date on which the Party makes the notification.
2. Thirty days after the date on which the Joint Committee receives a notification under paragraph 1, the notification shall be considered to be a decision of the Joint Committee to suspend the registration of the conformity assessment body, unless the Joint Committee decides otherwise within the 30 days. The contesting Party shall accept the results of conformity assessment procedures conducted by the conformity assessment body before the date of the suspension.
3. The registration of the conformity assessment body shall remain suspended until the contesting Party withdraws the contest or the Joint Committee decides to remove the suspension of the registration of the conformity assessment body, whichever occurs first. The contesting Party may withdraw the contest by notifying the other Party and the co-chairs of the Joint Committee. A notification under this paragraph shall be considered to be a decision of the Joint Committee to remove the suspension. The contesting Party shall accept the results of conformity assessment procedures conducted by the conformity assessment body from the date of the removal of the suspension.
ARTICLE 9 - VERIFICATION
1. The Joint Committee may request a Party to verify whether a registered conformity assessment body located in the territory of that Party complies with the criteria for designation. The request shall be in writing and include the reasons for the request.
2. The requested Party shall conduct the verification in a timely manner. One or more representatives of the Regulatory Authority of the other Party may, as appropriate, participate as an observer in the verification, provided that, prior to the start of the verification, the conformity assessment body agrees to such participation.
3. The requested Party shall promptly notify the other Party and the co-chairs of the Joint Committee of the results of the verification.
ARTICLE 10 - JOINT COMMITTEE
1. The Parties hereby establish a Joint Committee composed of one or more representatives of each Party. The Joint Committee shall be co-chaired by a representative of each Party as set out in Section VIII of the Annex.
2. The Joint Committee shall have the authority to take decisions concerning:
(a) registration, suspension of registration, removal of suspension of registration, and termination of registration of conformity assessment bodies as provided in Articles 6, 7, and 8; and
(b) requests for verification as provided in Articles6 and 9.
3. The Joint Committee shall adopt rules of procedure.
4. The Joint Committee shall convene at the request of either Party.
5. The Joint Committee shall take decisions by agreement of the co-chairs of the Joint Committee or as provided in this Agreement. All decisions of the Joint Committee shall be in writing.
6. The Joint Committee may consider any matter related to the operation of this Agreement.
7. The Joint Committee shall confirm that each Party makes publicly available a list of conformity assessment bodies that are registered under this Agreement.
8. The Joint Committee shall establish appropriate means, including relevant contact points, for the Parties to exchange the information and respond to inquiries referred to in paragraphs 5 and 6 of Article 3 and paragraph 3 of Article 5.
9. A Party may bring any question or concern it may have regarding the interpretation or application of this Agreement to the Joint Committee, which shall seek to answer the question or resolve the concern in a manner that is acceptable to the Parties.
ARTICLE 11 - REGULATORY AUTHORITY
The Regulatory Authority of a Party may request a registered conformity assessment body located in the territory of the other Party to answer questions or provide information concerning the results of conformity assessment procedures the conformity assessment body has conducted. Responses by registered conformity assessment bodies to such requests shall be voluntary. The Parties recognize that responses to such requests shall not affect the power of the Designating Authority of the other Party. The Regulatory Authority of a Party shall notify the Designating Authority of the other Party regarding requests made to the conformity assessment body under this Article.
ARTICLE 12 - CONFIDENTIALITY
Each Party shall maintain, in accordance with its laws and regulations, the confidentiality of any information provided to it as confidential in connection with the operation of this Agreement and the disclosure of which would prejudice the legitimate commercial interests of particular enterprises, public or private.
ARTICLE 13 - HEADINGS
The headings of the Articles of this Agreement are included for convenience of reference only and shall not affect the interpretation of this Agreement.
ARTICLE 14 - MISCELLANEOUS PROVISIONS
1. Nothing in this Agreement shall require either Party to accept standards or technical regulations of the other Party.
2. Nothing in this Agreement shall be construed to limit the authority of a Party to:
(a) determine the level of protection it considers appropriate with regard to health or safety, including the safety and effectiveness of medical devices and radiological health, the environment, or misleading or deceptive practices;
(b) take such measures as it considers necessary to protect health or safety, including with regard to the safety and effectiveness of medical devices and radiological health, or the environment or to prevent misleading or deceptive practices; or
(c) take all other appropriate measures whenever it ascertains that particular equipment does not meet its Technical Regulations or other laws, regulations, or administrative provisions or policies governing such equipment.
3. Nothing in this Agreement shall be construed to affect the rights or obligations of either Party under the WTO Agreement, including the Agreement on Technical Barriers to Trade or the Agreement on Trade-Related Aspects of Intellectual Property Rights.
ARTICLE 15 - ENTRY INTO FORCE
This Agreement shall enter into force on the first day of the second month following the date on which the Parties exchange diplomatic notes informing each other that they have completed their respective internal procedures necessary for the entry into force of this Agreement.
ARTICLE 16 - AMENDMENTS
1. This Agreement may be amended by agreement between the Parties. The Parties may amend Section I, II, IV, V, or VIII of the Annex by agreement between the Government of Japan and the Government of the United States through an exchange of diplomatic notes.
2. If there is any change in the laws or regulations of a Party that renders any of the information set out in Section I, II, IV, or VIII of the Annex no longer accurate or complete, the Party shall initiate, in a timely manner, an exchange of diplomatic notes between the Government of Japan and the Government of the United States in accordance with paragraph 1 to revise the relevant Section.
ARTICLE 17 - TERMINATION
Either Party may notify the other Party in writing of its intention to terminate this Agreement. If a Party gives such notice, this Agreement shall terminate 180 days after the date on which the other Party receives the notice.
IN WITNESS WHEREOF, the undersigned, being duly authorized, have signed this Agreement.
Done in duplicate at Washington, this sixteenth day of February, 2007 in the Japanese and English languages, both texts being equally authentic.
For Japan:
Akitaka Saiki
For the United States of America:
Karan K.Bhatia