United States - Mexico

RegulatoryCooperationCouncil

Progress Report to Leaders

August 15, 2013

Table of Contents

Highlights

Implementing the Work Plans3

Early Deliverables4

Stakeholder Engagement4

Executive Order 136095

Pact for Mexico5

Establishing the Regulatory Cooperation Council5

Key HLRCC Milestones6

Work Plan Progress to Date7

  1. Food
  2. Food Safety Modernization8
  3. E-Certification for Plants and Plant Products10
  4. Transportation: Commercial Motor Vehicle Safety Standards and Procedures11
  5. Nanotechnology11
  6. E-Health13
  7. Offshore Oil and Gas Standards14
  8. Cross-Sectorial Issue: Accreditation of Conformity Assessment Bodies15

Benefits of Regulatory Cooperation16

Continuing Work16

Appendix

Guidelines on regulations for nanotechnologies to foster competitiveness and protect the environment, the human health and the safety of the consumers. A

Highlights

The United States-Mexico High-Level Regulatory Cooperation Council (HLRCC), comprised of senior-level regulatory, trade, and foreign affairs officials from both governments, was created on May 19, 2010,[1] to promote economic growth and job creation through increased regulatory transparency and coordination.

The inaugural HLRCC meeting was held in Washington, D.C. on September 13, 2010, during which both governments agreed that regulatory cooperation can increase economic growth in each country; lower costs for consumers, businesses, producers, and governments; increase trade in goods and services across our borders; and improve our ability to protect the environment, health and safety of our citizens. On March 3, 2011, the United States and Mexico agreed to Terms of Reference for the HLRCC,[2]which called for a Work Plan that outlined cooperative activities for a period of two years.

The HLRCC Work Planwas released on February 28, 2012, identifying areas of mutual interest for cooperation. The Work Plan outlined sectorial initiativesin seven key areas: food safety, E-certification for plants and plant products, trucking safety, nanomaterials, E-health, oil and gas, and conformity assessment.

This report describes the efforts to implement the Work Plan, and summarizes the progress to date in the seven areas. Both Mexico and U.S. hope that the report will help lay the foundation for continued regulatory cooperation between our two countries.

Implementing the Work Plan:Following agreement on the HLRCC Terms of Reference, working groups comprised of regulatory agencies from each country developed detailed implementation plans and set deliverables for each of the seven initiatives. The lists of deliverables wererepresented in the Work Plan released in February 2012. As working groups continue to meet and move ahead, the Department of Commerce will post on while Mexico’s Ministry of Economy will do the same on postings will contain informationabout the Work Plan, including deliverables and status updates.

Early Deliverables:Early deliverables were achieved in advance of the final February 28, 2012, Work Plan since both countries have been working on regulatory cooperation since the HLRCC was created in May 2010. Over the past year,highlights of regulatory cooperation progress include:

  • Harmonized commercial vehicle inspection regulations to improve the safety of citizens by ensuring all vehicles are inspected to a consistently high standard, regardless of the vehicle’s country of origin. Mexico’s Ministry of Communication and Transportation updated and published for review its regulation for commercial vehicles: NOM-068-SCT-2-2000 which included system specifications and mechanical components such as Anti Brake-Lock Systems (ABS) and Pneumatic Disc Brakes which will improve the safety conditions of motor vehicles in circulation between the U.S. and Mexico.This regulation also updates the “out of service” criteria currently used by the Commercial Vehicle Safety Alliance, CVSA.
  • A Food Safety Cooperative Agreement was signed by Health and Human Services (HHS) Secretary Kathleen Sebelius, Mexico Secretary of Health SalomónChertorivski, Secretary of U. S. Department of Agriculture Thomas Vilsak, and Mexico Secretary of Agriculture FranciscoMayorga,on May 22, 2012,that strengthens existing scientific and public health activities related to the regulation of food safety, including products and feed for food-producing animals.
  • The U.S. Department of the Interior and Mexico’s National Hydrocarbons Commissionmade progresstowards harmonizing common health safety and environmental standards and requirements for the entire Gulf of Mexico through collaboration activities.

Stakeholder Engagement:Both countries engaged in extensive consultation with stakeholders and the public in the course of development of the HLRCC Work Plan. The U.S. Department of Commerce published a request for public comment in the Federal Register on March 3, 2011, inviting comment on possible areas of regulatory cooperation in North America.[3]The United States received 48 comments from the stakeholder community. Mexico also published a request for public comment on April 14, 2011. Mexico received 252 comments from the stakeholder community. These comments served as a basis for a bilateral discussion within the HLRCC to identify potential sectors and actions for collaboration.

On April 24, 2012, the Chamber of Commerce hosted a stakeholder engagement session with the HLRCC in Washington, D.C., in which both countries participated. Moving forward, the HLRCC will continue to engage with interested stakeholders to explain what the Council is doing and to solicit input on the implementation of the Work Plan. The HLRCC also developed a mechanism for stakeholders to provide feedback on the High-Level Regulatory Cooperation Council process and Work Plan implementation. In the U.S., comments can be sent to , and inMexico .

Executive Order 13609: In May 2012, President Obama issued Executive Order13609, “Promoting International Regulatory Cooperation,” which strengthened institutional mechanisms for facilitating international regulatory cooperation andreflecting a commitment to regulatory cooperation going forward.[4] The Executive Order recognized the increasingly global nature of the regulatory playing field, and is meant to provide a general framework for promoting U.S. efforts to eliminate unnecessary regulatory differences and related costs, burdens and delays to market. These efforts include the work underway in the HLRCC.

The Order also recognizes that engaging in international regulatory cooperation not only helps to eliminate or prevent the creation of unnecessary regulatory differences that might impair the ability of American businesses to export and compete internationally, but it helps improve regulatory outcomes. It also notes that while engaging in international regulatory cooperation, we will seek out joint regulatory approaches that are at least as protective as those that would be chosen without such cooperation.

Pact for Mexico: In November 2012, elected President Peña Nieto signedan agreement with the Presidents of the principal political forces of the Congress, the Democratic Revolution Party (PRD), the Institutional Revolution Party (PRI) and the National Action Party (PAN). This document agrees on 95 common compromises that the Government will carry on during the present administration. The Pact emphasizes the importance of regulatory improvement processes in Mexico’s development by including actions such as strengthening the Federal Commission for Competition (CFC), as well as improving regulatory conditions in strategic areas such as the telecommunications and oil sectors.

Establishing the High-Level Regulatory Cooperation Council

On May 19, 2010, the Presidents of the United States and Mexico gave the newly created United States-Mexico High Level Regulatory Cooperation Councila mandate toincrease economic growth in both nations; lower costs for citizens, businesses, producers, governments, and consumers; increased trade in goods and services across borders; and greater protection of health, safety, and the environment through increased regulatory transparency and coordination.

Mexico and the United States rely on regulation to maintain a high level of health, safety, and environmental standards, while acknowledging that regulation can sometimes impose significant burdens and costs. The Terms of Reference tasked the HLRCC to create a Work Plan that identified areas of mutual interest for cooperation, taking appropriate account of the goals of the Council, both to facilitate intra-North American commerce and to enhance the competitiveness of North American producers in key export markets, with a special (but not exclusive) emphasis on small and medium-sized enterprises, while enhancing our collective ability to achieve regulatory ends.

The Terms of Referenceinstruct the HLRCC to identify sectors for cooperation in line with the following key principles:

1)Making regulations more compatible, increasing simplification, and reducing burdens without compromising public health, public safety, environmental protection, or national security;

2)Increasing regulatory transparency to build national regulatory frameworks designed to achieve higher levels of competitiveness and to promote development;

3)Simplifying regulatory requirements through public involvement;

4)Improving and simplifying regulation by strengthening the analytic basis of regulations;

5)Linking harmonization and regulatory simplification to improvements in border-crossing and custom procedures; and

6)Increasing technical cooperation.

The Terms of Reference reflect the fact that the HLRCC was not established to create a single regulatory system for both countries, or to allow one country to make regulatory decisions on behalf of the other. Accordingly, the HLRCC Work Plan reflects the goal of strengthening the regulatory relationship between Mexico and the United States, while fully respecting each country’s domestic law and policy priorities and prerogatives.

Key HLRCC Milestones

Steady progress has been achieved to date with respect to fostering U.S.-Mexico regulatory cooperation via the HLRCC, as indicated by the following list of key HLRCC milestones and events.

  • May 19, 2010 - President Calderón and President Barack Obama announced the creation of the United States-Mexico High-Level Regulatory Cooperation Council (HLRCC)
  • September 13, 2010 - The inaugural HLRCC meeting was held in Washington, D.C.
  • March 3, 2011 - The United States and Mexico issued the Terms of Reference outlining the mandate, principles, and organization of the work to be performed by the HLRCC.
  • February 28, 2012 - The U.S. and Mexico published the HLRCC Work Plan, which identifies seven areas of mutual interest for cooperation and outlines activities to be carried out by the two countries over a period of two years.
  • May 1, 2012 - President Obama issued an Executive Order entitled Promoting International Regulatory Cooperation.
  • August 22-24, 2012 -The HLRCC organized a series ofregulator-to-regulator conference calls to discuss implementation of the Work Plan.
  • April 24, 2012 - The U.S. Chamber of Commerce hosted a stakeholder engagement session to coincide with the visit of President Calderón to Washington, D.C., in which both countries participated.
  • October 15, 2012 - The 2nd HLRCC government-to-government meeting was held in Washington, D.C.
  • December 2, 2012 - Mexican President Enrique Pena Nieto signed the Pact for Mexico, which described his administration’s priorities forstructural economic reform and competiveness.

Work Plan Progress to Date

On February 28, 2012, the HLRCC Work Plan was launched to target existing or emerging misalignments, and focuses on creating systemic mechanisms to secure regulatory alignment into the future in the areas of food, transportation, nanotechnology, e-health, oil and gas, and conformity assessment. The Work Plan deliverables and timelines touch upon a wide array of regulatory cooperation activities and practices, including technical/scientific collaboration, pilot programs, information sharing, mutual recognition, joint standards, and collaborating on common approaches to regulations.

Each section of the Work Plan contains a description of the issue, the objective / desired outcome, a list of specific deliverables and timeline, and an explanation of the benefits. In certain cases, deliverables were described as “accomplished” if they were completed in advance of the final publication of the Work Plan.

The Work Plan includes a balanced set of actions oriented to reduce administrative burdens, align regulations, and create new opportunities for businesses. These actions are ultimately focused on improving the overall economy of our countries, and improving regional competitiveness. Nothing in the Work Plan is intended to give rise to rights or obligations under domestic or international law.

Since the HLRCC Work Plan release on February 28, 2012 much has been accomplished towards meeting the specific deliverables and timelines outlined. To date, all of the areas for regulatory cooperation have been worked on by both governments.

In August 2012, regulator to regulator conference calls were held to implement the Work Plan which was followed by a stakeholder engagement meeting as the deliverables in the work plans were discussed and further input was provided. Government-to-government meetings were also held in Washington D.C. in October 2012 to discuss implementation of the outlined deliverables.

The following updates provide, for each area of cooperationin the Work Plan, a brief summary of the goal and the progress madeto date.

  1. Food and Agriculture
  2. Food Safety Modernization.The goal is to develop common approaches to food safety in ways that will benefit consumers and the food industry in Mexico and the United States.

Increased Regulatory Collaboration on food safety requirements. The Food Safety Cooperative Agreement (FSCA) signed by Health and Human Services (HHS) Secretary Kathleen Sebelius,Mexico Secretary of Health SalomónChertorivski, Secretary of U.S. Department of Agriculture Thomas Vilsak, and Mexico Secretary of Agriculture Francisco Mayorga,on May 22, 2012,recommits the two countries to communicate on food safety and to identify areas for coordination and collaboration between several U.S. and Mexican agencies—HHS, through its Food and Drug Administration (FDA), and the U.S. Department of Agriculture; and the Secretariat of Health, through the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA) in Mexico through its National Service of Health, Food Safety and Agro Food Quality (SENASICA). U.S. and Mexican regulators met to consider Mexican views on the U.S. Food Safety Modernization Act (FSMA) by June 2011. Mexico has also had the opportunity to comment on U.S. FDA’s proposed rules pursuant to timelines set forth in the relevant U.S. Federal Register entries and WTO notifications so that Mexico can learn about and offer its perspectives on the proposed requirements. It is in the best interest of both countries to improve the process of application of FSMA regulations in the areas of production, processing and handling of food that is exported or imported.

Development of Joint Food Safety Outreach Programs.FDA has been working with Mexico’s Ministry of Economy and its Federal Delegations, Proméxico and Chambers of Commerce to help educate the food sector in Mexico on new proposed food safety standards and newly implemented requirements under FSMA, and to improve capacity in existing standards and import/export requirements. From July 24 to August 30, 2012, FDA and Economia hosted 16 workshops throughout Mexico to facilitate understanding of FDA’s existing rules and regulations on food safety and to update the audience on the latest rules developed under the FSMA. Industry associations were contacted by the FSMA Intersecretarial Working Group in Mexico to engage withstakeholders. Instructions included how to submit comments on proposed regulations during public comment periods and how to receive updated information on forthcoming rules.

Implementation of the U.S. Food Safety Modernization Act. With the leadership of Secretariat of Economy and the participation of COFEPRIS, SENASICA and Secretariat of Economy, the Mexican government introduced an initiative to assist with the effective implementation of the FSMA. The Secretariat of Economy and FDA Latin America Regional Office in Mexico have conducted outreach workshops directed to public, industry, and academic sectors related to the implementation of new FSMA requirements and to provide information on upcoming proposed regulations.

The workshops took place in four regions in Mexico from February 19, 2013, to April 2, 2013. FDA Latin America Regional Office in Mexico conducted outreach activities in March and April 2013 covering the two currently proposed rules: Produce Rule and Preventive Controls for Food for Humans. The outreach activity included guidance on providing comments on proposed rules during the public comment period and how to receive updated information on forthcoming FSMA implementing regulations.

Renewed Statement of Cooperation between FDA and SALUD/COFEPRIS. In June 2012, FDA and SALUD/COFEPRIS renewed their Statement of Cooperation to help assure molluscan shellfish exported from Mexico to the United States are safe for human consumption.

Renewed Memorandum of Understanding between FDA and SAGARPA/SENASICA.

In November 2012, FDA and SAGARPA/SENASICA renewed their Memorandum of Understanding to help assure cantaloupe melons exported from Mexico to the United States are safe for human consumption.

Strengthen the Laboratory Capacity Collaboration Program (LCCP). The Laboratory Capacity Collaboration Program (LCCP) between FDA, SENASICA and COFEPRIS, as part of the FSCA is ongoing. The key objectives of this laboratory collaboration program include improving communications and laboratory capacity, consulting with SENASICA and COFEPRIS on the development, validation and implementation of testing methods, and participation in proficiency programs as SENASICA and COFEPRIS pursue efforts for strengthening its laboratory infrastructure for food microbiological testing.

  1. E-Certification for Plants and Plant Products. The goal is to reduce burdens on U.S. and Mexican businesses, while maintaining the safety and reliability of products. The development and bi-lateral pilot of each country’scompatible electronic certification (e-certification) programs for plants and plant productswill ensure these goals(plant health/non-food stage).

Agreement on apaperless mechanism. In 2012, Mexico and the United States agreed to develop respective e-certification systems to allow the exchange of electronic certificates between governments for plants and plant products. Mexico and the United States also agreed with the E-certification panel of the North American Plant Protection Organization (NAPPO), where both countries took part in the creation of aligned systems in the standard model established by the United Nations Centre for Trade Facilitation and Electronic Business (UN/CEFACT). According to the Mexican FIEL Law, Mexican exports sent to the U.S. will be digital and certified by Electronic Signature (FIEL). Utilization ofe-certifications will accelerate confirmation and authenticity of documents and will result in less paper for documentation.