[Federal Register Volume 61, Number 38 (Monday, February 26, 1996)]
[Notices]
[Pages 7112-7114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4187]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 

[[Page 7113]]
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 

[[Page 7114]]
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