[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