COOPERATIVE ARRANGEMENT AMONG THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND THE DEPARTMENT OF AGRICULTURE OF THE UNITED STATES OF AMERICA AND THE SECRETARIAT OF HEALTH OF THE UNITED MEXICAN STATES AND THE SECRETARIAT OF AGRICULTURE, LIVESTOCK, RURAL DEVELOPMENT, FISHERIES, AND FOOD OF THE UNITED MEXICAN STATES REGARDING COOPERATION TO ENHANCE ACTIVITIES OF MUTUAL INTEREST IN THE AREA OF THE SAFETY OF FOODS FOR HUMAN CONSUMPTION
This is an Arrangement between the Department of Health and Human Services (DHHS) and the Department of Agriculture (USDA) of the United States of America and the Secretariat of Health (SS) and the Secretariat of Agriculture, Livestock, Rural Development, Fisheries, and Food (SAGARPA) of the United Mexican States, hereinafter referred to as the "Participants," seek to enhance cooperative activities of mutual interest in the area of safety of food for human consumption, including animal feeds and animal drugs used by food-producing animals.
The special relationship between the Participants and their mutual commitment to achieve a significant reduction in the incidence of food-borne illnesses in both countries as evidenced by the United Mexican States and the United States of America Joint Statement on Food Safety signed on June 10, 1998;
The recent food safety modernization initiatives in both Mexico and the United States, which provide additional regulatory authorities for both countries;
Food safety officials and competent authorities of the participants can better achieve this goal by sharing information and experience concerning the regulation of food products;
The trade links between the United States and Mexico under the North American Free Trade Agreement, the common border, and the high degree of trade in food products between our two countries;
In particular, that close bilateral cooperation with regard to those food products that are traded, or may be traded, between the United States and Mexico has the potential to significantly increase public health protection in both countries;
That effective food safety programs, both in the United States and in Mexico, require close cooperative efforts of public health and regulatory officials and agencies at the federal, state, and local levels. Such programs require the active participation by other non-government entities such as consumers, industry, and academia that are responsible for and concerned about food safety and reducing the incidence of food-borne health hazards. This Arrangement does not diminish any of the existing and ongoing cooperative efforts of these government and non-government agencies, groups, and individuals working to enhance and affect food safety; and
The importance of reducing potential hazards related to situations involving processed and unprocessed food products in both countries through enhanced regulatory and scientific collaboration and through the implementation of specific cooperative activities.
Have reached the following understanding:
This Arrangement is intended to strengthen existing structures and develop new opportunities for cooperative activities in scientific matter and public health protection that are related to the regulation of safety of foods for human consumption, including veterinary drugs and animal feed products that are used for food-producing animals.
This Arrangement intends to seek new strategic opportunities to leverage the fulfillment of common goals.
In order to achieve the goal of this Arrangement, the cooperative activities may include the following products, as appropriate:
- foods and food products for human consumption, both processed and unprocessed;
- feeds intended for use in food-producing animals;
- foods derived from biotechnology;
- additives with intended use in foods;
- pesticide residues and other contaminants in agricultural food commodities;
- Veterinary drugs intended for use in food-producing animals; and
- emerging technologies (e.g. nanotechnology)
Cooperative activities may also include, the following activities related to the above-mentioned products, as appropriate:
- antimicrobial resistance;
- good agricultural practices;
- good aquaculture practices;
- good manufacturing practices;
- good laboratory practices;
- labeling requirements;
- incidents or outbreaks of disease, health hazard, contamination, injury, adverse events, or adverse results that may arise in routine or emergency situations;
- product traceability;
- food defense (i.e., protection against intentional contamination);
- consumer education and outreach;
- economic adulteration;
- capacity building, as appropriate; and
- technical collaboration/information exchange (i.e. laboratory collaboration on regulatory protocols and research projects; exchange of information and collaboration on food firm inspections).
The Participants, in accordance with their legal authority, intend to:
Develop joint efforts for the effective and appropriate exchange of information, and to strengthen and develop programs, and to coordinate, when appropriate, with other organizations, groups and individuals relevant to food safety within their countries.
This exchange of information and programs may include the following activities:
A. Development of specific procedures for the exchange of regulatory and public health information, both for routine and emergency purposes. This information includes: laws, regulations, proposed amendments, guidelines, procedures, and technical documents (such as evaluation of foreign suppliers of regulated products and enforcement decisions, including inspection reports, injury reports related to processed or unprocessed food products, "adverse events” and other injury reports, recalls or rejected shipments of products, and training material from regulatory agencies corresponding to the regulated products);
B. Development of specific procedures for exchanging information in the early stages of an investigation, whenever possible, rather than in the last stages or at the conclusion of the investigation, during emergency situations;
C. Determining the information that should be exchanged among the Participants prior to making information related to emergency situations public;
D. Communication intended to achieve, when appropriate, common positions on emerging international standards or practices in meetings of international organizations such as the Codex Alimentarius Commission and the Organization International des Epizooties (OIE);
E. Identification of research projects and studies to support the scientific basis for regulatory requirements and actions that are of mutual interest, such as those related to epidemiology, exposure estimation, risk identification, and other information that would form the bases for pre- and post-market risk assessments, risk analysis, and safety evaluations;
F. Identification of regulatory and scientific standards, procedures, and other requirements where there is potential for immediate and future coordination;
G. Identification and implementation of joint training with the purpose of mutual understanding and harmonization of surveillance and compliance activities (such as, short term secondment of food safety experts);
H. Exchange of information and data resulting from an investigation, in process or concluded, conducted by the Participants when these investigations are related to food-borne illnesses; and
I. Exchange of information on the enhancement of food safety systems including third party certification and establishment approval programs, electronic certification and database-driven certification, innovations in preventive controls, and importer verification programs.
The Participants expect that most of the information exchanged under this Arrangement may be provided in a form appropriate for public dissemination under the laws governing the transmitting Participants. Non-public information exempt from public disclosure should be shared according to the procedures and policies of the Participants as permitted by the laws governing the Participants.
With regard to any non-public information that may be provided the participants of both parties, the exchange of such information must be made in conformity with any specific signed confidentiality commitments and other requirements of these participants.
Each Participant shall fund their own activities, subject to the availability of funds, personnel, and other resources.
Plan of Work
The United States Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) will be the lead agencies for the United States of America, and will coordinate with other agencies as appropriate. The National Agro-Alimentary Health, Safety and Quality Service (SENASICA), and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) will be the lead agencies for the United Mexican States, and will coordinate with other agencies as appropriate.
The Participants intend to continue reviewing ongoing activities carried out in accordance with this Arrangement and report on their progress. Liaison Officers and/or technical working groups intend to address issues and work with their counterparts as necessary which would include, among others, the exchanges of letters and other documents, meetings, conference calls, or electronic communications through appropriate forums.
Liaison Officers are the following:
A. For HHS/FDA
Associate Commissioner and Director for International Programs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Deputy Commissioner for Foods
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
B. For USDA
Office of Policy and Program Development
Food Safety and Inspection Service
Department of Agriculture
1400 Independence Avenue, SW
Room 4866 South Building
Washington, D.C. 2500-3700
C. For SS
Federal Commission for the Protection Against Sanitary Risks
Direction General of Sanitary Control of Products and Services
Donceles 39, 1er Piso
Col.Centro. 06010 México, D.F.
Telephone: 525-512-3050 or 525-521-9134
D. For SAGARPA
Director in Chief
Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria (SENASICA)
Amores 321, 1er Piso
Col. Del Valle, C.P. 03100, México, D.F.
Telephone: 525-536-6626 or 525-687-7954
Cooperation under this Arrangement commences upon signature of all Participants for five (5) years. It may be extended for a ten-year period, following an evaluation by the Participants.
The Participants may amend this Arrangement, by mutual written consent, specifying the date in which the amended Arrangement is intended to initiate.
This Arrangement may be terminated by any Participant upon notice to the other participants.
Termination of this Arrangement does not affect the completion of cooperation activities that may have been formalized prior to termination.
SIGNED in quadruplicate, in the Spanish and English languages.
Signed on behalf of HHS: ---/s/--- Date: 05-22-2012
Signed on behalf of USDA: ---/s/--- Date: 6-13-2012
Signed on behalf of SS: ---/s/--- Date: 05-22-2012
Signed on behalf of SAGARPA: ---/s/--- Date: 05-16-2012