[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Notices]
[Pages 67035-67036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[FDA-225-96-4006]


Memorandum of Cooperation Between the Food and Drug 
Administration and the Economy, Development, and Reconstruction 
Ministry of Chile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of cooperation (MOC) between FDA and the Economy, 
Development, and Reconstruction Ministry of Chile. The purpose of the 
MOC is to facilitate the trade of safe and wholesome fish and fishery 
products.

DATES: The agreement became effective May 13, 1996.

FOR FURTHER INFORMATION CONTACT: Anthony P. Brunetti, Office of Seafood 
(HFS-400), Food and Drug Administration, 1110 Vermont Ave. NW., 
Washington, DC 20005, 202-418-3150.


[[Page 67036]]


SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and memoranda of cooperation between 
FDA and others shall be published in the Federal Register, the agency 
is publishing notice of this memorandum of cooperation.

    Dated: December 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination

Memorandum of Cooperation Between the Food and Drug Administration 
(FDA) Department of Health and Human Services of the United States of 
America and Servicio Nacional de Pesca (SERNAP) the Economy, 
Development and Reconstruction Ministry of Chile Concerning an Exchange 
of Information and Technical Cooperation With Regard to Food Control 
Practices to Protect Public Health and to Facilitate Trade in Fish and 
Fishery Products

    In keeping with a mutual desire of the Governments of the United 
States and Chile to facilitate the trade of safe and wholesome fish 
and fishery products, and
    Desiring to strengthen the bonds of cooperation between the two 
governments, and
    Recognizing that both countries wish to ensure the public health 
and the wholesomeness of foodstuffs consumed by their citizens, and
    Noting that increasing global trade of foodstuffs and the 
related global trade agreements provide an incentive for countries 
to harmonize food safety control measures and sanitary practices to 
facilitate trade without compromising food safety, sanitation and 
wholesomeness, and
    Recognizing that the existing Memorandum of Understanding 
between the United States and Chile regarding the safety and 
wholesomeness of shellfish remains in place, and that shellfish are 
separate and apart form the fish and fishery products considered in 
this Memorandum of Cooperation,
    FDA of the Department of Health and Human Services of the United 
States and SERNAP, of the Economy, Development and Reconstruction 
Ministry of Chile, have reached the following general understanding 
to guide their cooperation:

I. Objectives

The objectives of this Memorandum of Cooperation are to:
    A. Exchange information about food laws, regulations, standards, 
food inspection and the enforcement practices that comprise the fish 
and fishery products control procedures and practices of each 
country.
    B. Determine whether there exist appropriate food safety laws, 
regulations, guidelines, and an inspection infra-structure for 
exported fish and fishery products that will, at a minimum, provide 
assurances that these products meet the same level of protection as 
for the domestic fishery products of the trading partner, or meet 
other stipulated standards. Particular areas of interest include: 
Laboratories and analytical methodologies and standards, use of 
Hazard Analysis Critical Control Point (HACCP) controls, extent and 
provisions for HACCP training, permitted food and color additives, 
permitted drugs and allowable drug residues in aquacultured fishery 
products.
    C. Determine whether each country is prepared to adhere to the 
principle of ``transparency'' (the continuing open exchange of 
regulatory and compliance information or changes therein) as 
described in the World Trade Organization agreement on Sanitary and 
Phytosanitary Measures.
    D. Provide confidence in the ability of government agencies or 
government sanctioned agencies to effectively oversee the compliance 
of the fish and fishery products industry with acceptable sanitary 
and food safety practices, and thereby provide a foundation for 
future agreements on measures to facilitate the unencumbered trade 
of these products between the United States and Chile.
    E. Discuss the development of a framework for the resolution of 
issues of mutual concern related to differences in regulations or 
practices that may have an effect on the level of protection 
afforded consumers with regard to the safety, sanitary processing 
methods, identification of species, and the wholesomeness of 
exported fish and fishery products.

II. Implementation

Both sides will seek to:
    A. Establish a procedure for the exchange of information and 
documents as permitted by law, as may be deemed necessary by either 
participant, that establish, support, or explain fish and fishery 
products safety, sanitation, and enforcement procedures used by 
either country, and the level of public health protection afforded 
by them. All information and documents exchanged under this 
Memorandum may not be further disclosed by the receiving participant 
without the written consent of the other participant.
    B. Discuss, explain, and promote an understanding of how these 
legal and regulatory provisions work in practice, identify the 
government departments or authorities that are responsible for 
ensuring their effectiveness (identification of the competent 
authorities), and explain their operations, with particular regard 
for their role in the import and export of fishery products and the 
oversight of HACCP control measures.
    C. Facilitate visits by representatives of the competent 
authorities of each country, at their own expense, to an agreed-upon 
number of facilities in the other country that process fish and 
fishery products for export, to evaluate inspection methods and 
other regulatory practices in these facilities.
    D. Establish procedures to discuss emerging issues and promote 
cooperation in carrying out these objectives. The discussions should 
alternate between countries and be held on mutually agreeable dates 
and at mutually agreeable places. The host country should designate 
a Chairperson for the discussions who should develop an agenda and 
circulate appropriate information and materials to participants 
prior to the talks. Agenda topics and briefing papers should be 
identified as items for active discussion or information requests. 
In addition, the Chairperson will obtain agreement on the minutes of 
the talks.

III. Records

    A. The working language and the draft minutes of discussions 
will be in Spanish and English. The Chairperson should obtain 
interpreters for the talks, as may be necessary.
    B. Each participant to this Memorandum should name a contact 
person to implement the decisions reached during the discussions.
    Cooperation under this Memorandum will begin on the last date of 
signature of the participants. After five years the participants 
plan to evaluate the Memorandum and may mutually consent in writing 
to additional five year periods. It may be amended by mutual written 
consent of both participants and may be terminated by either 
participant upon thirty days written notice to the other 
participant.
    For the Servicio Nacional de Pesca of the Economy, Development 
and Reconstruction Ministry of Chile:
By: Juan Rusque Alcaino
Title: Director Nacional de Pesca
Date: May 13, 1996
Place: Washington, DC
    For the Food and Drug Administration, Department of Health and 
Human Services of the United States of America:
By: William B. Schultz
Title: Deputy Commissioner for Policy
Date: May 13, 1996
Place: Washington, DC
[FR Doc. 96-32187 Filed 12-18-96; 8:45 am]
BILLING CODE 4160-01-F