FDA - New Zealand MPI, Food Safety Systems Recognition Arrangement

Food Safety Systems Recognition Arrangement between The Ministry for Primary Industries of New Zealand and The Food and Drug Administration of the United States

The New Zealand Ministry for Primary Industries (MPI) and the United States Food and Drug Administration (FDA) (hereafter referred to as “the Participants”):

Recognizing the Participants’ Cooperative Arrangement between the Food and Drug Administration, Department of Health and Human Services of the United States of America and the New Zealand Ministry of 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;

Desiring to safeguard public health and to ensure the safety and integrity of foods traded between the United States and New Zealand;

Noting that a systems recognition assessment has been undertaken with respect to the operation of the food control systems in effect in each country as well as more in-depth reviews of the regulatory systems in place for commodities of higher regulatory interest such as dairy products, and seafood (including shellfish).

Recognizing that the Participants have decided that each has comparable control measures and systems to help ensure the safety, integrity and proper labeling of foods;

Noting that this Arrangement between the Participants offers benefits for public health, consumer protection and trade as an effective and efficient tool for enhancing the safety of imports, including the usage of preventative approaches as provided for in the United States’ Food Safety Modernization Act of 2011;

Have hereby reached the following mutual understandings and intentions.

Paragraph I
Purpose and Scope

This Arrangement describes the principles and areas of cooperation between the Participants that they intend to relate to the safety of foods traded between the United States and New Zealand with respect to public health and consumer protection.

Paragraph II
Definitions

For the purpose of this Arrangement the Participants intend that the following terms have the following meanings:

“Systems Recognition Assessment” means an evaluation of each country’s overall food safety system , or sub-components of it to assess whether the countries’ respective systems provide for a comparable degree of food safety assurance. Systems recognition is acknowledged when (1) a country’s food safety system provides a similar, though not identical, system of protections as another, and (2) the country’s food safety authority (or authorities) provides similar oversight and monitoring activities for food produced under its jurisdiction. Existing knowledge, confidence and experience may form a substantive component of an assessment.

“Food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. Under this Arrangement, “Food” refers only to those articles that fall under the jurisdiction of both the FDA and the MPI and does not refer to articles that fall under the jurisdiction of one Participant, but not the other.

“Regulatory Good Standing” refers to an establishment for which FDA, or its delegate, or MPI or its delegate, has performed an inspection, where required, and for which the establishment has no pending judicial enforcement or regulatory action such as seizure, injunction, or prosecution.

A “Food Safety Problem” means a situation in which there is a reasonable probability that the use of, or exposure to, a food will cause serious adverse health consequences or death.

Paragraph III
General Principles

1. Based on the mutual systems recognition assessment the Participants have decided that their respective food safety regulatory systems provide for a comparable degree of food safety assurance.
    
2. This systems recognition decision allows for a more efficient and effective use of resources. This includes reductions in the type and frequency of further reviews of each other’s regulatory systems, the type and frequency of border checks when foods are offered for entry into their respective countries, and the level and type of verification activities expected by the Participant’s importers and exporters of food and feed products from either country.
    
3. The Participants intend that all activities conducted under this Arrangement be conducted in accordance with the laws and regulations of the United States and New Zealand and are subject to the availability of personnel, resources, and appropriated funds.
    
4. The Participants intend that exchanges of non-public information should be done on a confidential basis under suitable arrangements completed by the Participants under applicable law.
    
5. Where the level of food safety assurance required under domestic law or achieved by one of the Participants significantly changes, the Participants may conduct a further system recognition assessment of the sub-components of the food safety system affected. Systems Recognition continues while any assessment needed as a result of the change is carried out.
   
   This Arrangement does not create binding legally obligations between the Participants.

Paragraph IV
Intentions of the Participants

Each Participant intends to:

1. Continue to cooperate and make available summary information on the performance of their respective food control systems;
    
2. Take appropriate actions to prevent the export to the territory of the other Participant Food from an establishment subject to food safety related sale restrictions within their territory and to notify the other should such an export be identified as having occurred, and to the extent possible, promote the management of risks prior to export rather than border inspection;
    
3. To the extent possible, make available for review and discussion any proposed changes to the laws, regulations or performance measures required to be met or underpinning their respective regulatory systems prior to their implementation;
    
4. Promptly notify the other Participant of Food Safety Problems identified with Food traded between the two countries, including any associated additional measures required by the importing Participant, or where a Food Safety Problem is identified with Food traded between the Participants or from a third country and subsequently shipped to one of the Participants;
    
5. Work cooperatively where Food Safety Problems associated with Food shipped by one of the Participants to the other are identified to facilitate appropriate tracing and disposition decisions necessary concerning the identified affected product in a timely manner. Thereafter to work cooperatively to facilitate any appropriate risk management interventions needed to ensure food safety while minimizing any disruptions to trade; and,
    
6. Collaborate as appropriate on foreign establishment inspection/system audit planning in third countries and in the sharing of results to help reduce duplication of foreign activities.

Paragraph V
Reviews and Border Checks

1. The Participants may periodically review the operation of each other’s regulatory systems for the purpose of maintaining knowledge and confidence in each other’s systems. Any such reviews are to be mutually decided upon and coordinated through the Liaison Officers and are to focus on how the Participant being reviewed helps ensure compliance with the requirements of its own regulatory system. Each Participant is to be responsible for its own costs relating to such reviews.
    
2. The type and frequency of reviews by one Participant of the other Participant’s system and the type and frequency of product examination and analysis at the border by one Participant of product from the other Participant’s country should reflect the high level of knowledge, experience and confidence that exists between the Participants.
    
3. The Participants intend to cooperate to ensure that responses to any issues that arise during such reviews are risk-based, outcome focused, and reflect the high level of knowledge, confidence and experience each has in the other.

Paragraph VI
Cooperation and Technical Information Exchange

The Participants intend to further cooperate and exchange information on at least an annual basis on regulatory and scientific issues related to food safety. Such cooperation may include, but is not limited to:

1. the scheduling of meetings, including urgent meetings, to attempt to resolve in a mutually acceptable fashion issues of significance to the Participants;
    
2. direct and timely notification of cases of serious and immediate concern with respect to public health associated with Food traded between the countries;
    
3. notification of changes made to their respective food safety systems and whether changes are significant enough to necessitate a review of this Arrangement;
    
4. training and participation in food safety programs including interstate cooperative meetings such as the Interstate Shellfish Sanitation Conference (ISSC) and the National Conference on Interstate Milks Shipments (NCIMS);
    
5. the sharing of methods and procedures for sampling and analysis; and,
    
6. the sharing of scientific reviews, regulatory assessments, pertinent laws, regulations, and guidance information.

Paragraph VII
Participants and Liaison Officers

1. Liaison Officers are to be the primary point of contact for activities associated with this Arrangement.
    
2. Each Participant intends to provide written notification to the other Participant within 30 days of relevant changes in the names of their organization, its structure or the Liaison Officers. The updating of such administrative aspects does not otherwise constitute a change in the terms of this Arrangement. 
    
3. The Liaison Officers for matters within the scope of this Arrangement as of the effective date are:
   
   A. Ministry for Primary Industries (MPI)
   
   Chief Assurance Strategy Officer
   Pastoral House
   25 The Terrace
   P.O. Box 2526
   Wellington
   New Zealand
   Phone: +64 29 894 2621
   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
   
   B. 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 Activities 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

Paragraph VIII
Implementation

1. Participants intend for activities under this Arrangement to commence upon Signature.
    
2. Either Participant may discontinue activities under this Arrangement though the Participants intend that in that case the relevant Participant should provide sixty (60) calendar days’ written notice to the other Participant of the intention to discontinue.
    
3. Discontinuation of the activities under this Arrangement should not affect the completion of ongoing cooperative activities that were begun prior to discontinuation.
    

Signed at Washington, D.C., on this 10th day of December 2012, in duplicate in the English language.
 

NEW ZEALAND MINISTRY FOR PRIMARY INDUSTRIES
______________/s/______________
Carol Barnao
Deputy Director General (Standards)

Address: Pastoral House,
25 The Terrace
P.O. Box 2526
Wellington
New Zealand
Telephone: +64-4-894-2652
Facsimile: +64-4-894-2501
 

UNITED STATES FOOD AND DRUG ADMINISTRATION
______________/s/______________
Michael R. Taylor, J.D.
Deputy Commissioner for Foods and Veterinary Medicine

Address: 10903 New Hampshire Avenue
Building 1, Room 3240
Silver Spring, MD 20993
United States of America
Telephone: +1-301-796-4500
Facsimile: +1-301-847-3535