U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection
FDA - Coop Arrang. Between FDA and New Zealand Covering Seafood
Cooperative Arrangement Between the Food and Drug Administration
and New Zealand Covering Seafood
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing
notice of a Cooperative Arrangement between FDA and the Ministry of
Health and the Ministry of Agriculture of New Zealand. The purpose of
the Cooperative Arrangement is the recognition of each as competent
authorities, having systems to ensure safe, wholesome, and truthfully
labeled fish and fishery products.
DATES: The agreement became effective December 20, 1995.
FOR FURTHER INFORMATION CONTACT: Janet J. Walraven, Office
of Seafood (HFS-416), Food and Drug Administration, 200 C. St., SW.,
Washington DC 20204, 202-418-3160.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR
20.108(c), which states that all written agreements and memoranda of
understanding between FDA and others shall be published in the Federal
Register, the agency is publishing notice of this cooperative arrangement.
Because this arrangement only encourages each party to achieve
compliance with the other's regulatory requirements, it does not contain a
determination of equivalency subject to the Uruguay Round Agreements
Act (see 19 U.S.C. 2578a).
Dated: February 16, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
225-96-2004
Cooperative Arrangement Between Department of Health and Human
Services, The Food and Drug Administration, United States of America
and The Ministry of Agriculture and The Ministry of Health, New
Zealand, to Ensure The Safety of Imported Fish and Fishery Products
The Department of Health and Human Services, Food and Drug
Administration of the United States of America on the one part, and
The Ministry of Agriculture, and The Ministry of Health of New
Zealand on the other part, Desiring to safeguard public health and to
ensure wholesomeness and properly labeled fish and fishery products;
Recognizing that the United States, represented by the Department of
Health and Human Services, Food and Drug Administration (FDA), and
New Zealand represented by the Ministry of Agriculture (MAF) and the
Ministry of Health (MH), as competent authorities, each have systems to
ensure safe, wholesome and properly labeled fish and fishery products;
Noting that these control measures arise from authorities that are the
United States Federal Food, Drug, and Cosmetic Act (FFD&C Act),
Public Health Service Act (PHS Act), and Fair Packaging and Labeling
Act; and the New Zealand Meat Act 1981 and Food Act 1981; Noting that
these control measures are implemented by regulations under the
aforementioned authorities that are the New Zealand Fish Export
Processing Regulations 1995 and Title 21 of the United States Code of
Federal Regulations; Reaffirming that training programs and audits are in
place in both countries that provide trained and qualified inspection forces
which are the New Zealand Circuit Inspector Training program, supported
by an inspector audit program, and FDA investigator and laboratory
analyst education and training requirements with ongoing performance
evaluation; Noting that the organizations, FDA and MAF and MH, have
resources to carry out the compliance programs, policies and laboratory
support activities that are funded in New Zealand by government
appropriation and fee-for-service arrangements and funded in the United
States by government appropriation at the Federal and State level; Noting
that the United States FDA has carried out extensive comparative reviews
of the New Zealand control system and has verified the performance of
that system, and New Zealand has issued a finding of acceptability of the
United States FDA control system; Noting that New Zealand fish and
fishery products have met U.S. FDA standards in the past based on FDA
import inspections; Noting that this arrangement offers benefits for both
consumer protection and trade in that it is an effective and efficient tool
for enhancing the safety of imports while reducing the resources that need
to be expended to monitor imports from the countries involved. Have
reached an understanding that the NZ export controls enhance the
likelihood of compliance by NZ seafood with FDA's safety, quality, and
labeling requirements; that the FDA processor controls for seafood
enhance the likelihood of compliance by US seafood with NZ MH safety,
quality, and labeling requirements; and that the FDA, MAF and MH plan
to take this understanding into account in determining frequency of border
checks when fish and fishery products are offered for entry into their
respective countries.
I. Substance of Arrangement
A. Definitions
1. Fish means fresh or saltwater finfish, crustaceans, mollusks, and
other forms of aquatic animal life (including, but not limited to,
jellyfish, sea cucumber, sea urchin, frog, alligator, aquatic turtle),
but excluding birds and mammals, where such animals are intended
for human consumption.
2. Fishery products means any edible human food product consisting
in whole of fish or a product containing a portion of fish,
including fish that has been processed in any manner, in which the
characterizing ingredient is fish.
3. Fresh means or implies that the food is unprocessed, that the food
is in its raw state, and that it has not been frozen or subjected to
any form of thermal processing or any other form of preservation.
4. Fresh frozen means that the food was quickly frozen while still
fresh.
5. Participants means the United States Food and Drug Administration
(FDA) and New Zealand's Ministry of Agriculture (MAF) and
New Zealand Ministry of Health (MH).
6. Transparency refers to the ability to have access to relevant
information about regulatory and technical measures so that their
meanings, applications, and requirements are clear. It can be
accomplished through the mutual exchange of information and
assistance between trading partners, whereby each provides the
other with the texts of legal, regulatory (except in-process legal and
regulatory actions), and technical measures, guidance documents,
and other information that apply to the commodities subject to the
arrangement.
7. Wholesomeness means the food is not filthy, putrid, decomposed,
or otherwise unfit for food.
B. Scope
This arrangement covers:
1. Fish and fishery products intended for human consumption
except fresh and fresh frozen (molluscan) shellfish.
2. Food safety, wholesomeness, and labeling requirements for the fish
and fishery products covered.
C. General Principles
1. The participants understand that each one of their country's
systems to ensure safe, wholesome and properly labeled fish and
fishery products enhances the likelihood that exported fish and
fishery products will comply with the other country's safety,
quality and labeling requirements. The participants intend to take
this understanding into account in determining the frequency of
border checks when fish and fishery products are offered for entry
into their respective countries.
2. The participants intend to exchange information to ensure
transparency as described in Annex A.
3. The participants intend to establish procedures for cooperation as
described below.
a. The participants plan to meet regularly, at least every
two years, to ensure that the basis for the arrangement
continues to exist.
b. In cases of serious and immediate concern with respect
to public health or safety, the participants intend to notify
the designated Liaison Officers immediately, and written
confirmation of the concerns to the Liaison Officers should
follow within 48 hours.
c. Where a Participant has concerns regarding a potential
risk to public health, consultations regarding the situation
should, upon request of that Participant, take place as
soon as possible, and in any case within 14 days, of such
a request. Each Participant will endeavor in such situations
to provide all the information necessary to reach a mutually
acceptable solution.
4. Nothing in this arrangement will in any way abrogate the
responsibility or authority of the U.S. Food and Drug
Administration under section 801 of the Federal Food, Drug and
Cosmetic Act to examine any food product being offered for entry
into the United States or under any other law administered by
FDA. Neither will it abrogate the responsibility or authority of the
New Zealand Government Minister of Agriculture pursuant to The
Meat Act 1981 or the Minister of Health pursuant to the Food Act
1981.
5. Nothing in this arrangement precludes either the U.S. FDA,
MAF or MH of New Zealand from exercising responsibility to
ensure the safety, wholesomeness, or properly labeled seafood
and seafood products being allowed to enter that country's
commercial marketing channels.
6. All activities undertaken pursuant to this arrangement are to be
conducted in accordance with the laws and regulations of the
United States and of New Zealand and are subject to the
availability of personnel, resources and appropriated funds.
D. Specific Responsibilities
1. MAF intends to provide FDA with:
a. a list of premises licensed by MAF to process fish and
fishery products for export. MAF intends to update this
list as needed for the FDA Liaison, Office of Seafood.
b. a government health certificate for each consignment of
fish and fishery products exported to the United States.
c. an annual summary showing results of compliance audits
conducted by the MAF Compliance Group for fish and
fishery products, to the attention of the FDA Liaison,
Office of Seafood.
d. in the event that the U.S. establishes a mandatory U.S.
seafood Hazard Analysis Critical Control Points (HACCP)
program, N.Z. MAF intends to demonstrate to the FDA
Liaison, Office of Seafood, how their system implements
and ensures that fish and fishery products are produced
under a HACCP-based program in compliance or equivalent
with the U.S. seafood HACCP program.
2. FDA intends to provide MAF with:
a. a list of U.S. seafood processing firms found to require
official U.S. Government regulatory action and further
details upon request. FDA intends to update this list as
needed.
b. an annual report of FDA Field Seafood Accomplishments.
c. in the event that the U.S. establishes a mandatory U.S.
seafood HACCP program, a copy of the requirements of
that program.
E. Audits
It is understood that each participant will strive to facilitate the
other participant's reasonable access to any sites in the exporting
country that are involved in the export of fish and fishery products
for the purpose of auditing the exporting country's seafood
regulatory system, of verifying that applicable elements of the
arrangement are being met, and of carrying out checks on the
continued compliance with the arrangement and system by
producers and exporters of fish and fishery products to the
importing country. The cost of on-site visits will be the
responsibility of the visiting participant.
Some factors to be considered in auditing both countries' seafood
regulatory systems are presented in Annex A.
F. Cooperation procedures
The Participants undertake to resolve differences by:
1. Use of professional judgment as well as objective criteria,
with attempts made to resolve differences by technical
discussions at the appropriate level; and
2. Where issues remain unsolved after technical discussions
as stipulated above, the participants intend to schedule
discussions between the Director, Office of Seafood of the
U.S. FDA and either the Chief Meat Veterinary Officer of
the New Zealand Ministry of Agriculture, or the Manager
of Food Administration, New Zealand Ministry of Health,
or their designees. The nature of the issue will determine
the competent New Zealand authority.
G. Application
1. The Participants plan to maintain communications so that
the terms of this arrangement are fulfilled.
2. The Participants intend to document communications and
decisions. Those matters that need to be referred to a higher
level will be identified and referred to that level.
3. Whenever specific issues requiring attention are identified,
the participants intend to establish a timetable to resolve
those issues.
II. Participants
a. The U.S. Food and Drug Administration, 5600 Fishers
Lane, Rockville, Maryland 20857, U.S.
b. Ministry of Agriculture, ASB Bank House, 101-103 The
Terrace, P.O. Box 2526, Wellington, New Zealand;
Ministry of Health, Food Administration, P.O Box 5013,
133 Molesworth St., Wellington, New Zealand
III. Liaison Officers
A. New Zealand Ministry of Agriculture:
The Ministry of Health, the body responsible for the safety of
domestic and imported food products, defers to the Ministry of
Agriculture to act as liaison officers with the U.S. FDA related to
matters of U.S. fish and fishery products imported to New
Zealand.
Chief Meat Veterinary Officer, Ministry of Agriculture, ASB Bank
House, 101-103 The Terrace, P.O. Box 2526, Wellington, New
Zealand, Phone: 011-64-4-4744125, FAX: 011-64-4-4744240
Counsellor (Veterinary Services), New Zealand Embassy, 37
Observatory Circle N.W., Washington, DC 20008, United States
of America, Phone: (202) 328-4861, FAX: (202) 332-4309
B. United States Food and Drug Administration:
Director, Office of Seafood, Center for Food Safety and Applied
Nutrition, 200 C Street, S.W., Washington, DC 20204, United
States of America, Phone: (202) 418-3133, FAX: (202) 418-3196
Director, International Activities Staff, Center for Food Safety and
Applied Nutrition, 200 C Street, S.W., Washington, DC 20204,
United States of America, Phone: (202) 205-5042, FAX:
(202)205-0165
IV. Period of Arrangement
Cooperation under this arrangement will begin on the last date of
signature of the participants. After the first year the participants
plan to evaluate the arrangement, thereafter, no less than once
every five years. It may be amended by mutual written consent or
terminated by either participant upon a 60 day written notice to the
other participant.
This Arrangement is not intended to create any legal obligations
under international law. In Witness Whereof the undersigned, being
duly authorized by their respective Government agencies, have
signed this Cooperative Arrangement.
FOR THE FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
UNITED STATES OF AMERICA
William B. Schultz,
Title: Deputy Commissioner for Policy.
Date: December 20, 1995
Place: Rockville, Maryland
FOR THE MINISTRY OF AGRICULTURE
NEW ZEALAND-
L. J. Wood
Title: Ambassador of New Zealand
Date: December 20, 1995
Place: Rockville, Maryland
FOR THE MINISTRY OF HEALTH
NEW ZEALAND
L. J. Wood
Title: Ambassador of New Zealand
Date: December 20, 1995
Place: Rockville, Maryland
Annex A
I. Performance Verification
The United States FDA, and the New Zealand's MAF and MH,
understand that the participants of the importing country can audit
the exporting country's seafood control system to verify that the
terms of the arrangement are being met. These system checks may
take place upon request of the participants of the importing
country. The costs of system check visits are the responsibility of
the visiting participant.
Verification may take the form of:
ongoing exchange of information toward continuing transparency;
reviewing the competent authorities' compliance/audit programs;
verifying the efficacy of the total program in meeting the
requirements of the importing country;
checks of products on importation at an appropriate frequency;
program checks.
II. Information Exchange/Transparency
A. Participants intend to cooperate and exchange information in
scientific areas.
B. The participants intend to put in place a system for the uniform and
systematic exchange of information, so as to provide assurance and
engender confidence in each other and to demonstrate the efficacy
of the programs controlled.
C. In particular the liaison officials intend to provide each other copies
of:
1. Proposed changes in requirements developed by each side
where they affect the other party before they become
effective.
2. Changes in requirements including:
a. legislation
b. rules
c. enforcement policy documents
d. guidelines
e. methods and procedures for sampling and analysis
f. inspection procedures
g. notice of surveillance programs or assignments
requiring sampling at importation of a fish or fishery
product (i.e., for data base development)
3. Documentation regarding any fish or fishery products from
the other country found to be in non-compliance with
requirements upon importation including information on:
a. product name
b. manufacturer/shipper name
c. processor name
d. reason for detention
e. product lot and certificate number (if applicable)
f. sampling procedures
g. methods of analysis and confirmation
h. port of entry
4. Documents regarding any fish or fishery product found to
be in non-compliance by the exporting country after
exportation to the other (e.g., recalls):
a. product
b. manufacturer/shipper name
c. processor name
d. reason for recall
e. product lot and certificate number (if applicable)
f. consignee(s)
g. dates
h. amount shipped
[FR Doc. 96-4187 Filed 2-23-96; 8:45 am]
BILLING CODE 4160-01-F
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The Contents entry for this article reads as follows:
Grants and cooperative agreements; availability, etc.:
New Zealand; systems to ensure safe, wholesome, and truthfully labeled
fish and fishery products, 7112
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