(a) a proposed technical regulation or conformity assessment procedure; or
(b) a significant amendment to an existing technical regulation or conformity assessment procedure;
TBT Agreement means the Agreement on Technical Barriers to Trade, set out in Annex 1A to the WTO Agreement; and
TBT Committee Decision on International Standards means Annex 2 to Part 1 (Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5 and Annex 3 of the Agreement) in the Decisions and Recommendations adopted by the WTO Committee on Technical Barriers to Trade Since 1 January 1995 (G/TBT/1/Rev. 13), as may be revised, issued by the WTO Committee on Technical Barriers to Trade.
Article 11.2. Scope
1. This Chapter applies to the preparation, adoption and application of standards, technical regulations, and conformity assessment procedures, including any amendments, of central level of government bodies, which may affect trade in goods between the Parties.
2. Notwithstanding paragraph 1, this Chapter does not apply to:
(a) technical specifications prepared by a governmental body for production or consumption requirements of a governmental body; or
(b) sanitary or phytosanitary measures.
Article 11.3. Incorporation of the TBT Agreement
1. The following provisions of the TBT Agreement are incorporated into and made part of this Agreement, mutatis mutandis:
(a) Articles 2.1, 2.2, 2.3, 2.4, 2.5, 2.9, 2.10, 2.11, and 2.12;
(b) Articles 3.1, 4.1, and 7.1;
(c) Articles 5.1, 5.2, 5.3, 5.4, 5.6, 5.7, 5.8, and 5.9; and
(d) Paragraphs D, E, F, and J of Annex 3.
2. No Party shall have recourse to dispute settlement under Chapter 31 (Dispute Settlement) for a matter arising under this Chapter if the dispute concerns:
(a) exclusively claims made under the provisions of the TBT Agreement incorporated under paragraph 1; or
(b) a measure that a Party alleges to be inconsistent with this Chapter that:
(i) was referred or is subsequently referred to a WTO dispute settlement panel,
(ii) was taken to comply in response to the recommendations or rulings from the WTO Dispute Settlement Body, or
(ii) bears a close nexus, such as in terms of nature, effects, and timing, with respect to a measure described in subparagraph (ii).
Article 11.4. International Standards, Guides and Recommendations
1. The Parties recognize the important role that international standards, guides, and recommendations can play in supporting greater regulatory alignment and good regulatory practices, and in reducing unnecessary barriers to trade.
2. To determine whether there is an international standard, guide, or recommendation within the meaning of Articles 2 and 5 and Annex 3 of the TBT Agreement, each Party shall apply the TBT Committee Decision on International Standards.
3. Each Party shall apply no additional principles or criteria other than those in the TBT Committee Decision on International Standards in order to recognize a standard as an international standard. For greater certainty, criteria that are not relevant to determining whether a standard is an international standard include:
(a) the domicile of the standards body;
(b) whether the standards body is non-governmental or inter-governmental; and
(c) whether the standards body limits participation to delegations.
4. The Parties shall cooperate with each other in appropriate circumstances to ensure that international standards, guides, and recommendations that are likely to become a basis for technical regulations and conformity assessment procedures do not create unnecessary obstacles to international trade.
5. No Party shall accord any preference to the consideration or use of standards that are developed through processes that:
(a) are inconsistent with the TBT Committee Decision on International Standards; or
(b) treat persons of any of the Parties less favorably than persons whose domicile is the same as the standardization body.
6. With respect to any agreement or understanding establishing a customs union or free-trade area or providing trade-related technical assistance, each Party shall encourage the adoption, and use as the basis for standards, technical regulations, and conformity assessment procedures, of any relevant standards, guides, or recommendations developed in accordance with the TBT Committee Decision on International Standards.
7. Recognizing the importance of maintaining North American commercial integration and maintaining market access for producers in North America, each Party shall ensure that any obligation or understanding it has with a non-Party does not facilitate or require the withdrawal or limitation on the use or acceptance of any relevant standard, guide, or recommendation developed in accordance with the TBT Committee Decision on International Standards or the relevant provisions of this Chapter.
Article 11.5. Technical Regulations Preparation and Review of Technical Regulations
1. Each Party shall conduct an appropriate assessment concerning any major technical regulations it proposes to adopt. An assessment can include:
(a) a regulatory impact analysis of the technical regulation's potential impacts; or
(b) an analysis that requires evaluation of alternative measures, if any, including voluntary actions that are brought to the Party's attention in a timely manner.
Each Party shall maintain discretion in deciding if a proposed technical regulation is major under this paragraph.
2. Each Party shall:
(a) periodically review technical regulations and conformity assessment procedures in order to:
(i) examine increasing alignment with relevant international standards, including by reviewing any new developments in the relevant international standards and whether the circumstances that have given rise to divergences from any relevant international standard continue to exist, and
(ii) consider the existence of any less trade-restrictive approaches; or
(b) maintain a process whereby a person of another Party may directly petition the Party's regulatory authorities to review a technical regulation or conformity assessment procedure on the grounds that:
(i) circumstances that were relevant to the content of the technical regulation have changed, or
(ii) a less trade-restrictive method to fulfil the technical regulation's objective exists, such as a technical regulation based on the international standard.
Use of Standards in Technical Regulations
3. If there are multiple international standards that would be effective and appropriate to fulfil the Party's legitimate objectives of a technical regulation or conformity assessment procedure, the Party shall:
(a) consider using as a basis for the technical regulation or conformity assessment procedure each of the international standards that fulfill the legitimate objectives of the technical regulation or conformity assessment procedure; and
(b) if the Party has rejected an international standard that was brought to its attention, issue a written explanation wherever practicable.
The written explanation provided for in subparagraph (b) must include the reasons for the Party's decision to reject an international standard and shall be provided directly to the person that proposed a particular international standard or in a document that is published at the same time that the Party publishes the final technical regulation or conformity assessment procedure.
4. If no international standard is available that fulfils the legitimate objectives of the technical regulation or conformity assessment procedure, each Party shall consider whether a standard developed by a standardizing body domiciled in any of the Parties can fulfill its legitimate objectives. To that end, each Party shall:
(a) consider and decide whether to accept the standard developed by a standardizing body domiciled in any of the Parties fulfils its legitimate objectives; and
(b) if the Party has rejected a standard that was brought to its attention, issue a written explanation wherever practicable.
The written explanation provided for in subparagraph (b) must include the reasons for the Partyâs decision to reject an international standard and shall be provided directly to the person that proposed a particular standard or in a document that is published at the same time the Party publishes the final technical regulation or conformity assessment procedure.
5. In order for a Party to consider accepting or using a standard as provided for in paragraphs 4 and 5, the Parties recognize that a standard must be brought to the attention of a Party, in a language the Party utilizes for the publication of technical regulations and conformity assessment procedures. This must be done during the Party's planning stage or when the proposed technical regulation or conformity assessment procedure is published for comment as provided for in Article 11.7 (Transparency).
Information Exchange
6. Ifa Party has not used an international standard as a basis for a technical regulation, a Party shall, on request from another Party, explain why it has not used a relevant international standard or has substantially deviated from an international standard. The explanation shall address why the standard has been judged inappropriate or ineffective for the objective pursued, and identify the scientific or technical evidence on which this assessment is based. To facilitate an appropriate explanation, the requesting Party shall in its request:
(a) identify a relevant international standard that the technical regulation has purportedly not used as its basis; and
(b) describe how the technical regulation is constraining or has the potential to constraint its exports.
The requesting Party shall also endeavour to indicate whether the international standard was brought to the responding Party's attention when it was developing the technical regulation.
7. In addition to Article 2.7 of the TBT Agreement, a Party shall, on request of another Party, (2) provide the reasons why it has not or cannot accept a technical regulation of that Party as equivalent to its own. The Party to which the request is made should provide its response within a reasonable period of time.
Labeling
8. In order to avoid disrupting North American trade, and consistent with the obligations contained in Article 11.3 (Incorporation of the TBT Agreement), each Party shall ensure that its technical regulations concerning labels:
(a) accord treatment no less favorable than that accorded to like goods of national origin; and
(b) do not create unnecessary obstacles to trade between the Parties.
Article 11.6. Conformity Assessment
National Treatment
1. In addition to Article 6.4 of the TBT Agreement, each Party shall accord to conformity assessment bodies located in the territory of another Party treatment no less favorable than that it accords to conformity assessment bodies located in its own territory or in the territory of the other Party. Treatment under this paragraph includes procedures, criteria, fees, and other conditions relating to accrediting, approving, licensing, or otherwise recognizing conformity assessment bodies.
2. In addition to Article 6.4 of the TBT Agreement, if a Party maintains procedures, criteria or other conditions as set out in paragraph 1 and requires conformity assessment results, including test results, certifications, technical reports or inspections as positive assurance that a product conforms to a technical regulation or standard, it shall:
(a) not require the conformity assessment body to be located within its territory;
(b) not effectively require the conformity assessment body to operate an office within its territory; and
(c) permit conformity assessment bodies in other Parties' territories to apply to the Party, or any body that it has recognized or approved for this purpose, for a determination that they comply with any procedures, criteria and other conditions the Party requires to deem them competent or to otherwise approve them to test or certify the product or conduct an inspection.
Explanations and Information
3. If a Party undertakes conformity assessment procedures in relation to specific products by specified government bodies located in its own territory or in another Party's territory, the Party shall, on the request of another Party or if practicable, an applicant of another Party, explain:
(a) how the information it requires is necessary to assess conformity;
(b) the sequence in which a conformity assessment procedure is undertaken and completed;
(c) how the Party ensures that confidential business information is protected; and
(d) the procedure to review complaints concerning the operation of the conformity assessment procedure and to take corrective action when a complaint is justified.
4. Each Party shall explain, on the request of another Party, the reasons for its decision, whenever it declines to:
(a) accredit, approve, license, or otherwise recognize a conformity assessment body;
(b) recognize the results from a conformity assessment body that is a signatory to a mutual recognition arrangement;
(c) accept the results of a conformity assessment procedure conducted in the territory of another Party; or
(d) continue negotiations for a mutual recognition agreement.
Subcontracting
5. If a Party requires conformity assessment as a positive assurance that a product conforms with a technical regulation or standard, it shall not prohibit a conformity assessment body from using subcontractors, or refuse to accept the results of conformity assessment on account of the conformity assessment body using subcontractors, to perform testing or inspections in relation to the conformity assessment, including subcontractors located in the territory of another Party, (3) provided that the subcontractors are accredited and approved in the Party's territory, when required.
Accreditation
6. In addition to Article 9.2 of the TBT Agreement, no Party shall refuse to accept, or take actions that have the effect of, directly or indirectly, requiring or encouraging the refusal of acceptance of conformity assessment results performed by a conformity assessment body located in the territory of another Party because the accreditation body that accredited the conformity assessment body:
(a) operates in the territory of a Party where there is more than one accreditation body;
(b) is a non-governmental body;
(c) is domiciled in the territory of a Party that does not maintain a procedure for recognizing accreditation bodies, provided that the accreditation body is recognized internationally, consistent with paragraph 7;
(d) does not operate an office in the Party's territory; or
(e) is a for-profit entity.
7. In addition to Article 9.1 of the TBT Agreement, each Party shall:
(a) adopt or maintain measures to facilitate and encourage its authorities to rely on mutual or multilateral recognition arrangements to accredit, approve, license or otherwise recognize conformity assessment bodies where effective and appropriate to fulfill the Party's legitimate objectives; and
(b) consider approving or recognizing accredited conformity assessment bodies for its technical regulations or standards, by an accreditation body that is a signatory to a mutual or multilateral recognition arrangement, for example, the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF).
The Parties recognize that the arrangements referenced in subparagraph (b) can address considerations in approving conformity assessment bodies, including technical competence, independence, and the avoidance of conflicts of interest.
Choice of Conformity Assessment
8. The Parties recognize that the choice of conformity assessment procedures in relation to a specific product covered by a technical regulation or standard should include an evaluation of the tisks involved, the need to adopt procedures to address those risks, relevant scientific and technical information, incidence of non-compliant products, and possible alternative approaches for establishing that the technical regulation or standard has been met.
Fees
9. Nothing in this Article precludes a Party from requesting that conformity assessment procedures in relation to specific products are performed by specified government authorities of the Party. In those cases, the Party conducting the conformity assessment procedures shall:
(a) limit any fees it imposes for conformity assessment procedures on products from the other Parties to the costs of services rendered;
(b) not impose fees on an applicant of another Party to deliver conformity assessment services, except to recover costs incurred from services rendered;
(c) make the amounts of any fees for conformity assessment procedures publicly available;
(d) not apply a new or modified fee for conformity assessment procedures until the fee and the method for assessing the fee are published and, if practicable, the Party has provided an opportunity for interested persons to comment on the proposed introduction or modification of a conformity assessment fee.
10. On request of a Party, or an applicant's request if practicable, a Party shall explain how:
(a) any fees it imposes for such conformity assessment are no higher than the cost of services rendered;
(b) fees for its conformity assessment procedures are calculated; and (c) any information it requires is necessary to calculate fees. Exceptions
11. For greater certainty, nothing in paragraphs 1 or 2 precludes a Party from taking actions to verify the results from a conformity assessment procedure, including requesting information from the conformity assessment or accreditation body. These actions shall not subject a product to duplicative conformity assessment procedures, except when necessary to address non-compliance. The verifying Party may share information it has requested with another Party, provided it protects confidential information.
12. Paragraphs 2(b) and 5 do not apply to any requirement a Party may have concerning the use of products, conformity assessment procedures or related services in the commercial maritime or civil aviation sectors.
Article 11.7. Transparency
1. Each Party shall allow persons of another Party to participate in the development of technical regulations, standards and conformity assessment procedures (4) by its central government bodies on terms no less favorable than those that it accords to its own persons.
2. Further to Articles 2.9 and 5.6 of the TBT Agreement, if a Party prepares or proposes to adopt a technical regulation or conformity assessment procedure that is notin response to an urgent situation as referred to in Article 2.10 and Article 5.7 of the TBT Agreement, the Party shall:
(a) publish the proposed technical regulation or conformity assessment procedure;
(b) allow persons of another Party to submit written comments during a public consultation period on no less favorable terms than it provides to its own persons;
(c) publish and allow for written comment in accordance with subparagraphs (a) and (b) at a time when the authority proposing the measure has sufficient time to review those comments and, as appropriate, to revise the measure to take them into account;
(d) consider the written comments from a person of another Party on no less favorable terms than it considers those submitted by its own persons; and
(e) if practicable, (5) accept a written request from another Party to discuss written comments that the other Party has submitted.
The Party requested under subparagraph (e) to discuss its proposed technical regulation or conformity assessment procedure shall ensure that it has appropriate personnel to participate in the discussions, such as from the competent authority that has proposed the technical regulation or conformity assessment procedure, in order to confirm that the written comments are fully taken into account.
3. Each Party shall endeavor to promptly make publicly available any written comments it receives under paragraph 2(c), except to the extent necessary to protect confidential information or withhold personal identifying information or inappropriate content. If it is impracticable to post these comments on a single website, the regulatory authority of a Party shall endeavor to make these comments available via its own website.
4. Each Party shall publish the final technical regulation or conformity assessment procedure and an explanation of how it has addressed substantive issues raised in comments submitted in a timely manner.
5. If appropriate, each Party shall encourage non-governmental bodies including standardization bodies in its territory to act consistently with the obligations in paragraphs 1 and 7, in developing standards and voluntary conformity assessment procedures.
6. Each Party shall ensure that its central government standardizing bodyâs work program, containing the standards it is currently preparing and the standards it has adopted, is published:
(a) on the central government standardizing body's website;
(b) in its official gazette; or
(c) on the website referred to in paragraph 10.
Stakeholder Participation in Developing Technical Regulations and Mandatory Conformity Assessment Procedures
7. Each Party shall encourage consideration of methods to provide additional transparency in the development of technical regulations, standards and conformity assessment procedures, including the use of electronic tools and public outreach or consultations.
8. If a Party requests a body within its territory to develop a standard for use as a technical regulation or conformity assessment procedure, the Party shall require the body to allow persons of another Party to participate on no less favorable terms than its own persons in groups or committees of the body that is developing the standard, and apply Annex 3 of the TBT Agreement.
9. Each Party shall take such reasonable measures as may be available to it to ensure proposed and final technical regulations and conformity assessment procedures of regional governments are published. (6)
10. Each Party shall publish online and make freely accessible, preferably on a single website, all proposed and final technical regulations and mandatory conformity assessment procedures, except with respect to any standards that are:
(a) developed by non-governmental organizations; and
(b) have been incorporated by reference into a technical regulation or conformity assessment procedure.
Notification of Technical Regulations and Conformity Assessment
11. In accordance with the procedures established under Article 2.9 or Article 5.6 of the TBT Agreement, each Party shall notify proposed technical regulations and conformity assessment procedures that are in accordance with the technical content of relevant international standards, guides, or recommendations if they may have a significant effect on trade. The Party's notification shall identify the precise international standards, guides or recommendations with which the proposal is in accordance.
12. In accordance with the procedures under Article 2.10 or Article 5.7 of the TBT Agreement, and notwithstanding paragraph 11, if urgent problems of safety, health, environmental protection, or national security arise or threaten to arise for a Party, that Party shall notify a technical regulation or conformity assessment procedure that is in accordance with the technical content of relevant international standards, guides or recommendations. In its notification, the Party shall identify the precise international standards, guides, or recommendations with which the proposal is in accordance.
13. In accordance with the procedures established under Article 2.9 or Article 5.6 of the TBT Agreement, each Party shall endeavor to notify, proposed technical regulations and conformity assessment procedures of regional level of governments that may have a significant effect on trade and that are in accordance with the technical content of relevant international standards, guides, and recommendations.
14. With respect to notifications made under Articles 2.9 and 5.6 of the TBT Agreement and paragraph 11 of this Chapter, each Party shall notify proposed technical regulations and conformity assessment procedures at an early appropriate stage by:
(a) ensuring the notification is made at a time when the authority developing the measure can introduce amendments, including in response to any comments submitted as set out in subparagraph (d);
(b) including with its notification:
(i) any objective for the proposed technical regulation or conformity assessment procedure and its legal basis,
(ii) an explanation of how the proposed technical regulation or conformity assessment procedure would fulfill the identified objectives, and
(iii) a copy of the proposed technical regulation or conformity assessment procedure or an online address at which the proposed measure can be accessed;
(c) transmitting the notification electronically to the other Parties through their enquiry points established in accordance with Article 10 of the TBT Agreement, contemporaneously with the submission of the notification to the WTO Secretariat; and
(d) providing sufficient time between the end of the comment period and the adoption of the notified technical regulation or conformity assessment procedure to ensure that the responsible authority can fully consider the submitted comments and the Party can issue its responses to the comments.
Each Party shall normally allow 60 days from the date it transmits a proposal under subparagraph (b) for another Party or an interested person of a Party to provide comments in writing on the proposal. A Party shall consider any reasonable request from another Party or an interested person of a Party to extend the comment period. A Party that is able to extend a time limit beyond 60 days, for example 90 days, shall consider doing so.