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FDA - SENASICA (New)

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MEMORANDUM OF UNDERSTANDING
BETWEEN
THE FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
OF THE UNITED STATES OF AMERICA
AND
THE NATIONAL AGRO-ALIMENTARY HEALTH,
SAFETY AND QUALITY SERVICE,
OF THE UNITED MEXICAN STATES
CONCERNING
THE ENTRY OF MEXICAN CANTALOUPE INTO THE UNITED STATES OF AMERICA

The Food and Drug Administration (FDA), Department of Health and Human Services, United States of America, and the National Agro-Alimentary Health, Safety and Quality Service (SENASICA), United Mexican States (Mexico), hereinafter referred to as the "Participants," have reached the following Memorandum of Understanding concerning the entry of Cantaloupe from Mexico into the United States of America (U.S.).

SECTION I

Purpose

The purpose of this Memorandum of Understanding is to facilitate implementation of a system that increases the likelihood that Cantaloupe from Mexico offered for import into the U.S. complies with U.S. laws. This Memorandum of Understanding also indicates the intent to establish a risk-based system that increases the likelihood that Cantaloupe from Mexico offered for import into the U.S. is safe for consumption.

SECTION II

Definitions

For the purposes of this Memorandum of Understanding, the Participants have set out the following definitions:

  1. Cantaloupe–means melon from the genus Cucumis species melo L. subsp. melo var. Cantalupensis;
     
  2. SENASICA Official Certificate (Recognition) – means a document issued by the Secretariat of Agriculture, Livestock, Rural Development, Fisheries, and Food (SAGARPA) that accredits that Systems for the Reduction of Contamination Risks (SRRC) have been implemented by a firm during the primary production (production, harvesting and packing) of Cantaloupe. The certificate is issued after the validation of a report issued by the persons recognized by SENASICA for the purpose of issuing such a report and upon request from the interested parties or upon determination from SAGARPA;
     
  3. Green Category Firms – means firms that are recognized by SENASICA as fully implementing the SRRC and which are accepted as such by the FDA. Such firms are identified on the “Green List” of Import Alert # 22-01, Detention Without Physical Examination of Cantaloupes from Mexico (IA #22-01) and are excluded from Detention Without Physical Examination (DWPE) under IA #22-01;
     
  4. Yellow Category Firms – means firms that were in the Red Category but which have implemented corrective actions evaluated and accepted by SENASICA as having brought the firm into compliance with the SRRC and subsequently accepted as such by the FDA. Yellow Category firms are subject to DWPE by the FDA under the Yellow List of IA # 22-01, and may provide private laboratory analysis results negative for Salmonella spp. for the release of their Cantaloupe shipments into U.S. commerce. For the purpose of being classified in the Green Category, firms placed in the Yellow Category may provide to the FDA the results of five (5) consecutive shipments negative for Salmonella spp.;
     
  5. Red Category Firms – means firms whose Cantaloupe shipments have been tested and confirmed positive for Salmonella spp. or which have been directly implicated by the U.S. or Mexican governments in an outbreak of disease. Such firms are subject to DWPE by the FDA under Import Alert # 22-01. These firms are to provide corrective actions evaluated and accepted by SENASICA as having brought the firm into compliance with the SRRC and subsequently accepted as such by the FDA, in order to be moved to the Yellow Category; and
     
  6. Technical Work Group – means designated individuals from SENASICA and FDA who routinely meet to discuss issues concerning the importation of Cantaloupe under this Memorandum of Understanding.

SECTION III

Intentions of the Participants

  1. FDA intends that any Mexican Cantaloupe producing firm not previously assigned to a Category under this Memorandum of Understanding, and that is seeking to petition FDA for an exemption from DWPE by way of the process described in this Memorandum of Understanding, would follow the process for obtaining a SENASICA Official Certificate (Recognition) and FDA evaluation before being assigned the appropriate Category.
     
  2. FDA intends to accept, as evidence of the implementation of a program to minimize the risk of contamination in Cantaloupe, the SENASICA Official Certificate (Recognition) and its supporting documentation demonstrating the implementation of the SRRC during the primary production (production, harvesting, and packing) of Cantaloupe.
     
  3. FDA inspections of firms, establishments, and facilities involved in the primary production of Cantaloupe in Mexican territory are to be performed in coordination with SENASICA. FDA intends to provide SENASICA with a list of firms to be inspected in Mexican territory at least 15 days prior to the inspections. This 15-day prior notification may be shortened for outbreak related inspections of Cantaloupe firms or other emergency situations that would impact Cantaloupe export. SENASICA intends to facilitate coordination with other Mexican government agencies such as the Federal Commission for Sanitary Risk Protection (COFEPRIS) and the National Water Commission (CONAGUA), when inspectional activities involve areas under the jurisdiction of such agencies.
     
  4. If an exporting firm deviates from or does not comply with the SRRC, SENASICA intends to evaluate corrective actions implemented by the exporting firm and issue a determination of compliance with the SRRC as soon as possible. The corrective actions implemented are to contain the following elements:
    1. Summary of firm activities;
    2. Report of the detection of the aforementioned contamination;
    3. Results of internal evaluation performed by the firm;
    4. Flow charts showing hazards detected (photographs, results of water and/or microbiological analyses);
    5. Implementation of corrective actions (preventive controls); and
    6. Verification of corrective actions implemented (photographs, results of water and/or microbiological analyses).
    The FDA intends to use the results of SENASICA's evaluation of the corrective actions when deciding to assign as soon as possible the exporting firm to the appropriate Category identified in Section II, Definitions, of this Memorandum of Understanding and its corresponding List in IA #22-01.
     
  5. FDA intends to report to SENASICA any change in the Category into which a Cantaloupe exporting firm is assigned within five (5) business days after the change is made.
     
  6. FDA intends to share with SENASICA the results of violative FDA microbiological tests obtained in the sampling of Cantaloupe, and the methodology used in the analysis of Salmonella spp. in Cantaloupe.
     
  7. SENASICA intends to share information that is useful to FDA in making its determination on categorization of Cantaloupe exporting firms.
     
  8. Because of the perishable nature of the products, FDA intends to quickly perform inspection and sampling at the entry point, generate sample results, and make an admissibility decision as quickly as possible.
     
  9. Any unforeseen situation relating to Cantaloupe should be discussed by the Technical Work Group. The Technical Work Group would determine the appropriate mechanism of communication.

SECTION IV

Administrative Procedures

  1. All activities conducted under this Memorandum of Understanding are to be conducted consistent with the laws, and regulations of the U.S. and Mexico, and are subject to the availability of personnel, resources, and appropriated funds. Each Participant intends to pay its own expenses of implementing this Memorandum of Understanding unless the Participants decide otherwise.
     
  2. Communications under this Memorandum of Understanding may be transmitted either electronically or in hard-copy unless otherwise decided by the Participants.
     
  3. Procedures relating to the assignment of firms into categories and the exchange of information are contained in the attached Appendix to this Memorandum of Understanding.
     
  4. The Participants intend to jointly review this Memorandum of Understanding once per year. Such review may include, but are not limited to, in-person meetings, conference calls, or communications via e-mail.
     
  5. The Participants intend to publish this Memorandum of Understanding in both the English and Spanish languages on their respective websites. All activities, including procedures, documentation, and petitions, related to this Memorandum of Understanding are to be conducted through the Participants.

SECTION V

Duration, Modification, and Nonbinding Intent

  1. Activities under this Memorandum of Understanding take effect upon signature by both Participants and will continue indefinitely.
     
  2. The Participants may modify this Memorandum of Understanding by mutual written decision, specifying the date the modifications are to take effect.
     
  3. This Memorandum of Understanding may be terminated by either Participant. The solicitant Participant should provide sixty (60) calendar days’ written notice of its intention to terminate to the other Participant.
     
  4. This Memorandum of Understanding does not create binding obligations under international or domestic laws.
     
  5. Nothing in this Memorandum of Understanding affects either of the Participants' responsibility or ability to ensure that Cantaloupe firms comply with all applicable requirements of their respective laws and regulations.

SIGNED in duplicate in the English and Spanish languages.
 

Signed on behalf of FDA:

________/s/___________
 
  Signed on behalf of FDA:

________/s/___________
 

Date: November 16, 2012
 
 Date: November 16, 2012
 
Deborah M. Autor, Esq.
Deputy Commissioner

Global Regulatory Operations and Policy
U. S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel. +1 301-796-4600
Fax. +1 301-595-7937

UNITED STATES OF AMERICA
 MVZ Enrique Sánchez Cruz
Director in Chief

National Agro-Alimentary Public Health,
Safety and Quality Service / Secretariat of
Agriculture, Livestock, Rural
Development, Fisheries and Food



UNITED MEXICAN STATES
   
 

__________________________________________________________________________

APPENDIX

TO MEMORANDUM OF UNDERSTANDING
BETWEEN
THE FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
OF THE UNITED STATES OF AMERICA
AND
THE NATIONAL AGRO-ALIMENTARY HEALTH,
SAFETY AND QUALITY SERVICE,
OF THE UNITED MEXICAN STATES
CONCERNING
THE ENTRY OF MEXICAN CANTALOUPE INTO
THE UNITED STATES OF AMERICA

A. Procedures and Criteria for Assignment of Firms:

  1. SENASICA intends to send a petition to FDA on behalf of a Mexican Cantaloupe producing firm for FDA to place the firm in the Green Category or Yellow Category under the Memorandum of Understanding.
     
  2. FDA intends to inform SENASICA of any petitions received directly from a Mexican Cantaloupe producing firm, and to request SENASICA to verify that the information provided by the petitioner is consistent with information provided to SENASICA and that the firm has a valid SENASICA Official Certificate (Recognition).
     
  3. The SENASICA petitions should include the following documentation, as applicable:
    1. Copy of SENASICA Official Certificate (Recognition) issued by SAGARPA to the Mexican Cantaloupe producing firm.
    2. Basic firm information on the Mexican Cantaloupe producing firm such as firm name, address, name of owner/most responsible person or legal representative, location of fields, etc.
    3. Name and credentials of the SENASICA employee (or officially authorized third party) that inspected the firm.
    4. Date of the most recent inspection.
    5. Copy of inspectional observations.
    6. Copy of the firm’s proposed corrective actions to the inspectional findings.
    7. Copy of pertinent analytical results for samples collected under the Systems for the Reduction of Contamination Risks (SRRC) program.
    8. Documentation in support of activities related to the Memorandum of Understanding, Section III, paragraph 4, for any deviations by an exporting firm from the SRRC program.
    Additional information may be requested by a Participant for the purpose of evaluating a firm’s implementation of the SRRC; such as other data elements from SENASICA’s SRRC registration database necessary for the evaluation of the petition.
     
  4. SENASICA and FDA intend to share any pertinent additional information on Mexican Cantaloupe producing firms that participate in the SRRC program.
     
  5. FDA, via its Office of International Programs in Mexico City, intends to communicate to SENASICA the results of FDA’s evaluation of the petition and the categorization of a Mexican Cantaloupe producing firm. A copy of the communication sent to SENASICA should be sent to the Mexican Cantaloupe producing firm directly.
     
  6. Mexican Cantaloupe producing firms that have a positive test for Salmonella spp. in a laboratory sample of Cantaloupe offered for importation may be subject to DWPE and assigned as a Red Category firm under the Memorandum of Understanding.
     
  7. In the normal course of entry into the U.S., there are two instances in which samples of Mexican Cantaloupe may be collected:
    1. FDA samples and analyzes Cantaloupe offered for entry under its routine surveillance activities at the border/port of entry. Importing firms may obtain information regarding these analyses by contacting the collecting FDA District Office directly.
    2. Yellow Category firms can arrange for a sample to be taken and analyzed by a private laboratory from a shipment offered for entry into the U.S. The results of such an analysis are provided to FDA as evidence for the release of shipments of the Cantaloupe into commerce in the U.S.

B. Methodology Used and Procedures for Information Exchange:

  1. FDA’s current methodology for the analysis of Cantaloupe follows the “Soak Method for Salmonella Analysis in Cantaloupe,” which is Attachment C under FDA’s Import Produce Assignment and publicly available on FDA’s website at the following link. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/ucm118884.htm#attc. FDA may change this methodology as necessary, but intends to notify SENASICA prior to a change in the methodology used for Salmonella spp. analysis in Cantaloupe.

    When a firm requests sample analysis from a private laboratory for use as evidence for the release of Cantaloupe shipments into U.S. commerce, FDA recommends that a firm request that the private laboratory follow the methodology used by FDA for the analysis of Cantaloupe. The information in Section 7 of the ORA Laboratory Procedures Manual (LPM) has been created to establish a uniform, systematic, and effective approach to ensuring that private laboratories performing analyses on FDA-regulated imported commodities submit scientifically sound data. Refer to ORA Laboratory Procedures Manual (LPM), Volume III, Section 7 for information regarding private laboratories. http://www.fda.gov/ScienceResearch/FieldScience/LaboratoryManual/ucm173340.htm  

    While this guidance is written in reference to private laboratories, it is the importer who is ultimately responsible for the imported product’s compliance with applicable laws and regulations. If a private laboratory does not provide acceptable evidence and documentation to support the credibility of its analysis, the importer bears the responsibility and consequences of the inadequacy.
     
  2. The FDA intends to inform SENASICA when the results of a sample of Mexican Cantaloupe are positive for Salmonella spp. so that SENASICA can begin working with the Mexican Cantaloupe producing firm to investigate the cause of the contamination.
     
  3. Admissibility decisions regarding individual Cantaloupe shipments are made under established FDA procedures at the point of entry. Notice of such decisions occurs through established communication channels between the FDA’s District Office and the Importer.
     
  4. All non-public information exchanged by the Participants is to be shared under the existing confidentiality commitment between FDA and SAGARPA. The non-public information is intended to be used by the Participants for the purposes established under the Memorandum of Understanding.