Cooperative Arrangement between The Food and Drug Administration Department of Health and Human Services of the United States Of America and The Ministry for Primary Industries of New Zealand

Regarding Cooperation to Enhance Activities of Mutual Interest in the Area of the Safety and Defense of Foods for Human Consumption and Animal Feeds

The Food and Drug Administration (FDA), Department of Health and Human Services, of the United States of America and the New Zealand Ministry for Primary Industries (MPI ) (hereinafter referred to as "the Participants"):

1. Recognizing the special relationship between the Participants and their shared goal of protecting the life and health of the citizens of both countries with respect to food and feed safety and food defense associated with traded food commodities;
    
2. Acknowledging their mutual interest in a science and risk-based approach to food and feed safety and food defense;
    
3. Recalling the long-established close and cooperative relationship between the Participants on food and feed safety issues as manifested by the various existing cooperative arrangements, including the Cooperative Arrangement between the Food and Drug Administration Department of Health and Human Services of the United States of America and the New Zealand Food Safety Authority regarding cooperation to enhance activities of mutual interest in the area of the safety and defense of foods for human consumption and animal feed," signed March 18, 2005;
    
4. Desiring to further develop and coordinate existing and future cooperation in a structured and consistent manner;
    
5. Seeking to facilitate prompt and effective communication between the Participants on emerging food and feed safety and food defense issues;
    
6. Acknowledging tbe Food Safety Systems Recognition Arrangement between the U.S. Food and Drug· Administration and New Zealand's Ministry for Primary Industries, signed on December 10, 2012; and,
    
7. Acknowledging the desire to further facilitate the safety of food and animal feed products traded between the countries, including aspects relating to food defense,

have hereby reached the following understanding as to this Arrangement.

Paragraph I
Purpose

1. This Arrangement reflects the Participants' intention to further coordinate,strengthen and extend the existing scientific and public health protection cooperation activities related to the regulation of food and feed safety and food defense with the aim of better ensuring consumer protection while facilitating trade.

Paragraph II
Scope

1. This Arrangement is limited to the sanitary measures and food defense measures applied or required by either Participant, and/or cooperation in consumer protection issues, related to food and feed products for which each Participant has regulatory authority under applicable regulations. FDA and MPI are the national regulatory bodies with responsibility to ensure that their respective laws stipulated in Attachment 1 are applied with respect to the matters covered by this Arrangement. Areas of cooperation are intended to be determined by mutual decision.
    
2. The Attachments to this Arrangement constitute an integral part of this Arrangement.

Paragraph III
Definitions

1. For the purposes of this Arrangement the following definitions apply:
    
   1. "Sanitary measures" means sanitary measures, as defined in Annex A, paragraph 1, of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). A reference to sanitary measures may cover individual sanitary measures or groups of sanitary measures for product areas, sectors, or parts of sectors, as appropriate.
       
   2. "Food defense" means implementing preventive measures to provide assurance against an intentional act of contamination that may result in harm or illness to humans or animals.
       

Paragraph IV
Confidentiality

1. Information exchanged under this Arrangement may include non-public information exempt from public disclosure under the laws and regulations of the United States and New Zealand. The Participants expect that information that is not appropriate for public dissemination be shared only according to Confidentiality Commitments decided upon by the Participants (see Attachment 1).
    

Paragraph V
General Principles

1. The Participants intend to:
    
   1. work together to achieve public health and safety objectives while minizming to the extent possible any unnecessary impediments to trade;
       
   2. cooperate, as appropriate, to share information on regulatory and scientific isses concerning food and feed that adversely affect the health and safety of our consumers;
       
   3. cooperate to provide appropriate support for cross-jurisdictional food or feed safety or food defense investigations;
       
   4. utilizie a risk-based and outcome-focused approach when assessing whether a Participant's assurance system is deemed comparable. The systems recognition assessment, historical trade and associated experiences may form a substantive part of such derminations;
       
   5. take into consideration, as appropriate, international standards developed by the Codex Alimentarius Commission and the World Organization for Animal Health guidelines; and,
       
   6. maximize, where appropriate, the use of existing regulatory assurance mechanisms in the exporting country to provide assurances for the safety of imported products from the exporting country.

Paragraph VI
Process

1. This Arrangement should serve as the overarching framework of intent for developing specific activities covering areas of mutual interest as decided by the Participants. Further understandings reached including where appropriate, product-specific understandings, are listed in Attachment 1.
    
2. The Participants intend to, as appropriate, meet either in-person or by electronic means to develop and implement a work program relating to specific areas of cooperation. The Participants may also meet to plan the necessary maintenance of this Arrangement and those further arrangements recorded in Attachment 1. All arrangements reached are to be mutually determined and thereafter listed in Attachment 1.
    
3. The Participants may form Working Groups to address specific issues bearing on the successful implementation of this Arrangement.

Paragraph VII
Contact Points

1. The contact points for the application of this Arrangement are contained in Attachment 2. Each Participant intends to provide written notification to the other Participant within 30 days of any changes to its contact points. The updating of such administrative aspects does not otherwise constitute a change in the terms of this Arrangement.

Paragraph VIII
Final Provisions

1. Each Participant intends to fund and carry out its own activities subject to the availability of appropriated funds, personnel, and other resources.
    
2. Activities under this Arrangement are intended to be eligible to commence upon signature hereof by both Participants.
    
3. The Participants may modify this Arrangement in writing by mutual consent.
    
4. This Arrangement may be discontinued by either Participant by giving six (6) months notice in writing. Discontinuation of this Arrangement does not affect the completion of cooperative activities that may have been planned or commenced prior to termination.
    
5. All activities conducted under this Arrangement should be conducted in accordance with the applicable laws and regulations of the United States of America and New Zealand.
    
6. This Arrangement does not create binding legal obligations between the Participants and does not affect the rights or obligations of the United States of America or of New Zealand under any international agreement.

Signed at Silver Spring., MD, on this 30th day of September 2015, in duplicate.

______________/s/______________
Howard R. Sklamberg
Deputy Commissioner for Global Regulatory Operations and Policy

FOR THE FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES OF THE UNITED STATES OF AMERICA

______________/s/______________
Michael R. Taylor
Deputy Commissioner for Foods and Veterinary Medicine

FOR THE FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES OF THE UNITED STATES OF AMERICA

Signed at Wellington, on this 9th day of September 2015, in duplicate.

______________/s/______________
Deborah Roche
Deputy Director General, Policy and Trade Branch

FOR THE MINISTRY FOR PRIMARY INDUSTRIES OF NEW ZEALAND

ATTACHMENT 1

Legislation concerning food and animal feed sanitary and food defense measures applied by either Participant:

For the United States of America
The Federal Food, Drug, and Cosmetic Act
The Public Health Service Act
The Federal Import Milk Act
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration Modernization Act of 1997
The FDA Food Safety Modernization Act of 2011.

For New Zealand
The Food Act 1981
The Food Act 2014
The Animal Products Act 1999
The Agricultural Compounds and Veterinary Medicines Act of 1997.

List of Understandings:

Generic Understandings

1. The New Zealand Ministry for Primary Industries Confidentiality Commitment to the United States Food and Drug Administration.
    
2. United States Food and Drug Administration Confidentiality Commitment to the New Zealand Ministry for Primary Industries.

Specfic Understandings

1. Food Safety Systems Recognition Arrangement Between the Food and Drug Administration of the United States and the Ministry for Primary Industries of New Zealand.
    
2. The 1995 Exchange of Letters on: Residue Compliance Assurance programme for the export of New Zealand horticultural produce to the United States of America.

ATTACHMENT 2

Contact Points

1. The United States Food and Drug Administration
   10903 New Hampshire Avenue
   Silver Spring, MD 20993-0002
   United States of America
    
2. The Ministry for Primary Industries
   Pastoral House
   25 The Terrace
   PO Box 2526
   Wellington 6140
   New Zealand

LIAISON OFFICERS

Ministry for Primary Industries
Chief Assurance Strategy Officer
Pastoral House
25 The Terrace
P.O. Box 2526
Wellington
New Zealand
Phone: +64-4-894-2621 or
     +64-4-894-0100
FAX: +64-4-894-2625

MPI (Food Safety) Representative
New Zealand Embassy
37 Observatory Circle N.W.
Washington, DC 20008
United States of America
Phone: (202) 328-4849
FAX: (202) 332-4309

United States Food and Drug Administration:
Director
Office of Food Safety
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, Maryland 20740
United States of America
Phone: (301) 436-2300
FAX: (301) 436-2599

Director
International Affairs Staff
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, Maryland 20740
United States of America
Phone: (301) 436-2380
FAX: (301) 436-2618