6. Each Party, through its Designated Representative, should provide a means for interested persons to provide input to expert groups or bodies, including by allowing interested persons to:
(a) attend or appear before meetings of an expert group or body; or
(b) submit written comments to an expert group or body.
Article 3.11. Regulatory Analysis
1. The Parties, through their Designated Representatives, recognize that a regulatory authority may analyze a proposed regulation to anticipate and evaluate its likely consequences.
2. Each Party, through its Designated Representative, shall consider procedures that encourage a regulatory authority to examine the following when developing regulations that have anticipated costs or impacts exceeding certain levels established by each Party, through its Designated Representative:
(a) the need for a proposed regulation, including a description of the nature and significance of the problem the regulation is intended to address;
(b) feasible and appropriate regulatory and non-regulatory alternatives that would address the need identified in subparagraph (a), including alternatives to direct regulation;
(c) anticipated impacts of the selected and other feasible alternatives (such as economic costs and benefits, social, equity, environmental, public health, and safety effects), as well as risks and distributional effects over time, recognizing that some costs and benefits are difficult to quantify or monetize due to inadequate information. The analysis of these impacts by the regulatory authority may vary according to the complexity of the issue as well as the available data and information; and
(d) the grounds for concluding that the selected alternative is preferable.
3. Each Party, through its Designated Representative, should consider whether a proposed regulation may have significant adverse economic effects on a substantial number of small enterprises. If so, the Party, through its Designated Representative, should consider potential steps to minimize those adverse economic impacts, while allowing fulfillment of the objectives.
Article 3.12. Final Publication
When a regulatory authority finalizes its work on a regulation, the Party, through its Designated Representative, shall, without undue delay, publish in the text of the regulation, in the final regulatory impact assessment, or in another document:
(a) the date by which compliance is required;
(b) an explanation of how the regulation achieves the stated objectives, the rationale for the material features of the regulation (to the extent different than the explanation provided for in Article 3.9), and the nature of and reasons for any significant revisions made since making the regulation available for public comment;
(c) the regulatory authority's views on any substantive issues raised in timely submitted comments;
(d) major alternatives, ifany, that the regulatory authority considered in developing the regulation and reasons supporting the alternative that it selected;
(e) the relationship between the regulation and the key evidence, data, and other information the regulatory authority considered in finalizing its work on the regulation;
(f) any forms or documents required to comply with the regulation and indication of their expected availability, which should be, to the extent possible, made publicly available online; and
(g) a point of contact for a knowledgeable individual in the regulatory authority responsible for implementing the regulation who may be contacted concerning questions regarding the regulation.
Article 3.13. Review of Regulations Currently In Effect
1. The Parties, through their designated representatives, recognize that adopting or maintaining procedures or mechanisms to carry out review of regulations can ensure that a regulation remains relevant and meets its intended policy objective.
2. If a regulation currently in effect is reviewed, the Party, through its Designated Representative, should consider, as appropriate:
(a) the effectiveness of the regulation in meeting its initial stated objectives;
(b) any circumstances that have changed since the development of the regulation, including availability of new information;
(c) impacts on small enterprises;
(d) ways to address regulatory differences between the authorities of the territories represented by the Parties with a view to avoiding unnecessary disruptions to international trade and investment; and
(e) relevant suggestions from any interested persons submitted pursuant to Article 3.14.
3. Each Party, through its Designated Representative, should make publicly available online, to the extent available and appropriate, any official plans or results of a review.
4. Each Party, through its Designated Representative, should consider how to make regulatory review procedures and mechanisms more agile, especially when facing shared transboundary and global challenges.
Article 3.14. Suggestions for Improvement
Each Party, through its Designated Representative, shall provide the opportunity for any interested person to submit for consideration to a regulatory authority written suggestions for the issuance, modification, or repeal of a regulation. The basis for those suggestions may include, for example, that in the view of the interested person, the regulation has become ineffective at protecting health, safety, welfare, or the environment, has become more burdensome than necessary to achieve its objective (for example, with respect to its impact on international trade and investment), fails to take into account changed circumstances (such as fundamental changes in technology, or relevant scientific and technical developments, or relevant international standards), or relies on incorrect or outdated information.
Article 3.15. Information About Regulatory Processes and Authorities
1. Each Party, through its Designated Representative, shall publish online a description of the processes and mechanisms employed by the regulatory authorities to prepare, evaluate, or review regulations. The description shall identify the applicable guidelines, rules, or procedures, including those regarding opportunities for the public to provide input.
2. Each Party, through its Designated Representative, shall also make publicly available online:
(a) a description of the functions and organization of each regulatory authority, including the appropriate offices through which persons can obtain information, make submissions or requests, or obtain decisions;
(b) any procedural requirements or forms promulgated or utilized by any regulatory authority;
(c) the legal authority for verification, inspection, and compliance activities by the regulatory authorities;
(d) information concerning the judicial or administrative procedures available to challenge regulations; and
(e) any fees charged by a regulatory authority to a person of the territory represented by a Party for services rendered in connection with the implementation of a regulation, including for licensing, inspections, audits, and other administrative actions required under the law of the territory represented by the Party, to import, export, sell, buy, market, or use, as appropriate, either a good or a service.
Each Party, through its Designated Representative, shall, without undue delay, publish online any material changes to this information as well as any changes, or any proposals to make changes, to the regulatory system of the authorities of the territory it represents.
Article 3.16. Encouragement of Regulatory Compatibility and Cooperation
1. The Parties, through their Designated Representatives, recognize that regulatory compatibility and cooperation can contribute to achieving shared regulatory objectives and assisting the authorities of the territories represented by the Parties in meeting shared transboundary and global challenges. Accordingly, where appropriate, each Party, through its Designated Representative, should encourage the regulatory authorities to engage in mutually beneficial regulatory cooperation activities with the relevant counterparts of the authorities of the territory represented by the other Party in appropriate circumstances to achieve these objectives.
2. The Parties, through their Designated Representatives, recognize that effective regulatory cooperation requires the participation of regulatory authorities that possess the authority and technical expertise to develop, adopt, and implement regulations. Each Party, through its Designated Representative, should encourage input from members of the public to identify promising avenues for cooperation activities.
3. The Parties, through their Designated Representatives, recognize that a broad range of mechanisms, including those set forth in the WTO Agreement, exists to help minimize unnecessary regulatory differences and to avoid unnecessary disruptions to international trade and investment, while contributing to meeting the public policy objectives of the authorities of the territories represented by the Parties.
Article 3.17. Committee on Good Regulatory Practices
1. The Parties, through their Designated Representatives as appropriate, hereby establish a Committee on Good Regulatory Practices (the GRP Committee) composed of representatives of the Parties and relevant representatives of the authorities of the territories represented by the Parties, including relevant regulatory authorities and any coordinating bodies.
2. Through the GRP Committee, the Parties, through their Designated Representatives, shall enhance their communication and collaboration in matters relating to this Chapter.
3. The GRP Committee's functions include:
(a) monitoring the implementation and operation of this Chapter, including through updates on regulatory practices and processes of the authorities of the territories represented by the Parties;
(b) exchanging information on effective methods for implementing this Chapter, including with respect to relevant work in international forums;
(c) consulting on matters and positions in advance of meetings in international forums that are related to the work of this Chapter, including opportunities for workshops, seminars, and other relevant activities to support strengthening of good regulatory practices;
(d) considering suggestions from a diverse array of stakeholders regarding opportunities to strengthen the application of good regulatory practices;
(e) considering developments in good regulatory practices with a view to identifying future work for the GRP Committee and improving the operation and implementation of this Chapter;
(f) exploring opportunities to cooperate to advance the application of good regulatory practices; and
(g) taking any other steps that the Parties, through their Designated Representatives, consider will assist them in implementing this Chapter.
4. Each Party, through its Designated Representative, shall provide opportunities for persons of the territory represented by the Party to provide views on the implementation of this Chapter.
5. In carrying out its work, the GRP Committee shall take into account the activities of other committees, working groups, and other subsidiary bodies established under this Agreement in order to avoid duplication of activities.
6. Unless the Parties, in consultation with their Designated Representatives, decide otherwise, the GRP Committee shall meet at least once a year. The Parties, in consultation with their Designated Representatives, shall endeavor to schedule meetings to permit participation of representatives engaged in the work of other relevant chapters in this Agreement. The GRP Committee may also invite persons that may have an interest to contribute to its work.
Article 3.18. Contact Points
Each Party, in consultation with its designated representative, shall designate and notify a contact point for matters arising under this Chapter, in accordance with Article 7.7 (Contact Points), and without undue delay notify the other Party ofany material changes to its contact point.
Annex 3-A. ADDITIONAL PROVISIONS CONCERNING THE SCOPE OF "REGULATIONS" AND "REGULATORY AUTHORITIES"
ANNEX 3-A 1. The following measures are not regulations for the purposes of this Chapter:
(a) general statements of policy or guidance that do not prescribe legally enforceable requirements;
(b) for TECRO: a measure concerning:
(i) a military or foreign affairs function of the authorities of the territory represented by TECRO;
(ii) the management, personnel, public property, loans, grants, benefits, or contracts of an agency of the authorities of the territory represented by TECRO;
(iii) the organization, procedure, or practice of an agency of the authorities of the territory represented by TECRO; or
(iv) financial services or anti-money laundering measures.
(c) for AIT: a measure concerning:
(i) a military or foreign affairs function of the authorities of the territory represented by AIT;
(ii) the management, personnel, public property, loans, grants, benefits, or contracts ofan agency of the authorities of the territory represented by AIT;
(iii) the organization, procedure, or practice of an agency of the authorities of the territory represented by AIT; or
(iv) financial services or anti-money laundering measures.
2. The following entities are not regulatory authorities for the purposes of this Chapter:
(a) for TECRO: the President of the territory represented by TECRO; and
(b) for AIT: the President of the territory represented by AIT.
Chapter 4. DEVELOPMENT AND ADMINISTRATION OF SERVICES AUTHORIZATION MEASURES (SERVICES DOMESTIC REGULATION)
Article 4.1. Definitions
For the purposes of this Chapter:
authorization means the permission to supply a service, resulting from a procedure to which a person must adhere in order to demonstrate compliance with licensing requirements or qualification requirements; and
public enterprise means an enterprise that is owned, or controlled through ownership interests, by the authorities of the territory represented by a Party.
Article 4.2. Scope
1. This Chapter applies to measures related to authorization and technical standards adopted or maintained by the competent authorities of the territory represented by a Party affecting trade in services by a service supplier of the territory represented by the other Party.
2. This Chapter does not apply to:
(a) procurement by the authorities of the territories represented by the Parties;
(b) any service that is supplied in the territory represented by a Party neither on a commercial basis nor in competition with one or more service suppliers; (1)
(c) a subsidy or grant provided by the authorities of the territory represented by a Party or a public enterprise, including loans, guarantees, or insurance supported by the authorities of the territory represented by the Party;
(d) air services, including domestic and international air transportation services, whether scheduled or non-scheduled, or to related services in support of air services, other than aircraft repair or maintenance services during which an aircraft is withdrawn from service, excluding so-called line maintenance; or
(e) measures concerning the entry of natural persons into the territory represented by a Party, including conditions of admission for temporary entry.
Article 4.3. Development and Administration of Measures for Supply of a Service other Than a Financial Service
1. Provisions of this Article apply in addition to the provisions of Chapter 3 (Good Regulatory Practices). This Article does not apply to measures affecting the supply of a financial service.
2. Each Party, through its Designated Representative, shall ensure that all measures of general application of the authorities of the territory represented by the Party are administered in a reasonable, objective, and impartial manner.
3. If the authorities of the territory represented by a Party adopt or maintain a measure of general application, the Party, through its Designated Representative, shall, with respect to that measure, ensure that:
(a) the measure is based on objective and transparent criteria; (2)
(b) the competent authority of the territory represented by the Party reaches and administers any decision in a manner independent from any supplier of the service for which authorization is required;
(c) the procedures in the measure are impartial, adequate for applicants to demonstrate whether they meet the requirements for authorization, and do not in themselves prevent fulfilment of a requirement;
(d) to the extent practicable, the measure does not require an applicant to approach more than one competent authority of the territory represented by the Party for each application for authorization; (3) and
(e) the measure does not discriminate on the basis of gender.(4)
4. If the authorities of the territory represented by a Party require authorization for the supply of a service, the Party, through its Designated Representative, shall ensure that each competent authority of the territory represented by the Party:
(a) to the extent practicable, permits submission of an application at any time;
(b) if a specific time period for applications exists, allows a reasonable period for the submission of an application;
(c) if an examination of the suitability of an individual for authorization is required, schedules the examination at reasonably frequent intervals and provides a reasonable period of time to enable an applicant to request to take the examination;
(d) to the extent practicable, provides an indicative timeframe for processing an application;
(e) ascertains without undue delay the completeness of an application for processing under the law of the territory represented by the Party;
(f) at the request of the applicant, provides without undue delay information concerning the status of the application;
(g) if an application is considered complete under the law of the territory represented by the Party, within a reasonable period of time after the submission of the application, ensures that the processing of the application is completed, and that the applicant is informed of the decision concerning the application, to the extent possible in writing;°
(h) if an application is considered incomplete for processing under the law of the territory represented by the Party, within a reasonable period of time, to the extent practicable:
(i) informs the applicant that the application is incomplete;
(ii) if the applicant requests, identifies the additional information required to complete the application or otherwise provides guidance on why the application is considered incomplete; and
(iii) provides the applicant with an opportunity (6) to provide the additional information that is required for the application to be considered complete,
however, if none of the actions in subparagraphs (i) through (iii) is practicable, and the application is rejected due to incompleteness, ensures that the applicant is informed of the rejection within a reasonable period of time;
(i) if an application is rejected, to the extent possible, either upon its own initiative or upon the request of the applicant, informs the applicant of the reasons for rejection and, if applicable, the timeframe for an appeal or review of the decision to reject the application and the procedures for resubmission of an application; an applicant should not be prevented from submitting another application (7) solely on the basis that an application had been previously rejected; and
(j) ensures that authorization, once granted, enters into effect without undue delay, subject to the applicable terms and conditions.
5. Each Party, through its Designated Representative, shall ensure that any authorization fee charged by each of the competent authorities of the territory represented by the Party is reasonable, transparent, based on authority set out in a measure, and does not, in itself, restrict the supply of the relevant service. (8)
6. Each Party, through its Designated Representative, shall encourage the competent authorities of the territory represented by the Party, when adopting a technical standard, to adopt technical standards developed through an open and transparent process, and shall encourage any body designated to develop a technical standard to use an open and transparent process.
7. If the authorities of the territory represented by a Party require authorization for the supply of a service, the Party, through its Designated Representative, shall provide to a service supplier the information necessary to comply with requirements or procedures for obtaining, maintaining, amending, and renewing that authorization. That information shall include:
(a) any fee;
(b) the contact information of a relevant competent authority of the territory represented by the Party;
(c) any procedure for appeal or review of a decision concerning an application;
(d) any procedure for monitoring or enforcing compliance with the terms and conditions of authorizations;
(e) any opportunities for public involvement, such as through hearings or comments;
(f) any indicative timeframe for processing of an application;
(g) any requirement or procedure; and
(h) any technical standard.
8. If the authorities of the territory represented by a Party require authorization for the supply of a service, the Party, through its Designated Representative, shall ensure that each competent authority of the territory represented by the Party:
(a) endeavors to accept applications in electronic format;
(b) endeavors to accept requests in electronic format to take any required examination of the suitability of an individual for authorization and to consider, to the extent practicable, the use of electronic means in other aspects of the examination process; and
(c) subject to any authentication requirements under the law of the territory represented by the Party, accepts copies of documents, including electronic copies, unless the competent authority of the territory represented by the Party requires original documents to protect the integrity of the authorization process.
9. Each Party, through its Designated Representative, shall endeavor to ensure that measures related to authorization do not impose disproportionate burdens on SMEs.
Article 4.4. Development and Administration of Measures for Supply of a Financial Service
1. This Article applies to measures related to authorization adopted or maintained by the authorities of the territory represented by a Party affecting trade in a financial service by a service supplier of the territory represented by the other Party. Chapter 3 (Good Regulatory Practices) does not apply to a measure covered by this Article.
2. Each Party, through its Designated Representative, shall ensure that all measures of general application are administered in a reasonable, objective, and impartial manner.
3. Each Party, through its Designated Representative, shall, to the extent practicable and in a manner consistent with the legal system of the territory represented by the Party for adopting measures:
(a) publish in advance any regulation of general application proposed for adoption and the purpose of the regulation; and
(b) provide interested persons, the authorities of the territory represented by the other Party, and the other Party with a reasonable opportunity to comment on that proposed regulation of general application.
4. At the time that the authorities of the territory represented by a Party adopt a final regulation of general application, the Party, through its Designated Representative, shall, to the extent practicable and in a manner consistent with the legal system of the territory represented by the Party for adopting measures, address in writing the substantive comments received from interested persons, the authorities of the territory represented by the other Party, and the other Party with respect to the proposed regulation. For greater certainty, a Party, through its Designated Representative, may address those comments collectively on an official website maintained by the authorities of the territory represented by the Party.
5. To the extent practicable, each Party, through its Designated Representative, shall allow a reasonable period of time between publication of a final regulation of general application and the date when it enters into effect.
6. Each Party, through its Designated Representative, shall establish or maintain appropriate mechanisms for responding to inquiries from interested persons, the authorities of the territory represented by the other Party, or the other Party regarding measures of general application covered by this Article.
7. If the authorities of the territory represented by a Party adopt or maintain a measure of general application to which this Article applies, the Party, through its Designated Representative, shall, with respect to that measure, ensure that:
(a) the measure is based on objective and transparent criteria; (9)
(b) each relevant competent authority of the territory represented by the Party reaches and administers decisions in a manner independent from any supplier of the service for which authorization is required;