Food Safety Systems Recognition Arrangement Between The Australian Department Of Agriculture and Water Resources and The FDA of The United States of America

The Australian Department of Agriculture and Water Resources and the Food and Drug Administration of the United States of America (FDA) (hereinafter collectively referred to as "the Participants"):

Recognizing existing arrangements between the Australian Department of Agriculture and Water Resources and FDA;

Desiring to safeguard public health as it relates to the safety and integrity of food traded between Australia and the United States (hereinafter referred to as "the two countries");

Noting that reciprocal food safety Systems Recognition Assessments have been carried out regarding the operation and oversight of the food safety system of Australia, as implemented by the Australian Department of Agriculture and Water Resources, and the food safety system of the United States, as implemented by FDA, through the application of the following standards, as identified in the Participants’ respective international comparability assessment tools: Regulatory Foundation; Training Program; Inspection Program; Program Assessment and Inspection Audit Program; Food-related Illness and Outbreaks; Compliance and Enforcement Program; Industry and Community Relations; Program Resources; International Communication and Harmonization; and Laboratory Support;

Desiring greater regulatory cooperation, collaboration, partnership and information exchange between the Australian Department of Agriculture and Water Resources, on the one hand, and FDA, on the other hand, relating to these standards;

Having determined, based on the successful outcome of the food safety Systems Recognition Assessment and on existing knowledge, confidence and experience, that Australia and the United States have comparable control measures and systems as they relate to the safety of food; and

Noting that this Food Safety Systems Recognition Arrangement ("Arrangement") offers benefits for public health, consumer protection and trade, including the use of Systems Recognition as an important tool for enhancing the safety of imported food,

Have reached the following understandings:

Section I
Purpose and Scope

• 1.1 This Arrangement sets out the areas of cooperation between FDA and the Australian Department of Agriculture and Water Resources with respect to public health and consumer protection relating to food traded between the two countries, and to food safety-related areas of mutual interest.
• 1.2 This Arrangement covers articles regulated as food by the Participants, but does not include the articles listed in the Annex.

Section II
Definitions

• 2.1 For the purpose of this Arrangement:
  • "Food" includes (1) any article used as food or drink for humans, (2) chewing gum, and (3) any article used for components of any such article;
  • "Food Safety Concern" refers to a situation where there is a reasonable probability that the use of, or exposure to, a Food will cause acute or chronic deleterious health consequences or death;
  • "Systems Recognition" means that, following successful completion of a Systems Recognition Assessment, a determination has been made that (1) a country’s food safety system provides a similar, though not identical, system of food safety protection as does that of the other country, and (2) the Participants provide similar oversight and monitoring activities for Food that they regulate; and
  • "Systems Recognition Assessment" means an evaluation of the overall food safety system to determine whether the system provides a comparable degree of food safety control.

Section III
General Provisions

• 3.1 Systems Recognition allows for: more efficient and effective use of resources; collaboration on risk-informed decision-making about activities that may be carried out in each country; and enhanced regulatory cooperation, improved coordination and greater reliance on the other country’s Participant for follow-up and coordination when a Food Safety Concern arises. It may also result in reductions in the type and frequency of verification activities.
• 3.2 The Participants intend that exchanges of non-public information be done on a confidential basis under suitable arrangements to be completed by the Participants under applicable law.
• 3.3 If the level of food safety control required under the domestic law administered and enforced by, or if the level of food safety control achieved by, FDA or the Australian Department of Agriculture and Water Resources significantly changes, the Participants may carry out a follow-up Systems Recognition Assessment of the affected standards of the food safety systems. Systems Recognition continues while any such assessment is carried out.
• 3.4 This Arrangement does not create legally binding obligations under domestic or international law. The Participants intend that activities under this Arrangement be in accordance with applicable domestic laws, regulations and policies, and subject to the availability of personnel and resources.
• 3.5 The Participants may mutually determine to invite other U.S. or Australian national and sub-national government organizations to participate in activities under this Arrangement, as appropriate.

Section IV
Intentions of the Participants

• 4.1 To the extent reasonably possible, FDA and the Australian Department of Agriculture and Water Resources intend to:
  • (a) Continue to cooperate on food safety and to facilitate regular communications related to their countries’ respective food safety systems;
  • (b) Promote the management of food safety risks prior to export;
  • (c) Consistent with any applicable domestic laws and regulations, consult and collaborate on the development of changes to their food safety policies and regulatory approaches as they impact the standards that have been assessed under this Arrangement in order to optimize the prospects for continued comparability of degree of food safety control;
  • (d) Encourage early discussion of respective policy approaches when faced with similar food safety issues and challenges, which allows for the exchange of best practices and approaches and enhances the likelihood for similar or complementary approaches to be considered, where applicable;
  • (e) Work cooperatively to ensure prompt notification of a Food Safety Concern regarding Food traded between the two countries, and, as may be mutually determined, Food originating from a third country that may have been shipped to either of the two countries;
  • (f) Work cooperatively when responding to a Food Safety Concern associated with Food that is traded between the two countries to facilitate appropriate risk management interventions; and
  • (g) Collaborate, as appropriate, on foreign inspections and foreign audits and, as mutually determined, share results to support the effective use of the Participants’ resources.
• 4.2 The Participants may consider modifying this Arrangement by broadening its scope based on additional assessments at a future date.

Section V
Reassessment, Review and Audit

• 5.1 FDA and the Australian Department of Agriculture and Water Resources may periodically reassess, review or audit the operation of the other country’s regulatory systems as they relate to food safety for the purpose of maintaining knowledge of and confidence in the other country’s systems. It is intended that the content and extent of any such reassessment, review or audit be based on discussions and mutually determined and coordinated through the Contact Points.
• 5.2 It is intended that any such reassessment, review or audit focus on significant changes in food safety systems. Each Participant intends to fund its own expenses relating to such reassessment, review or audit.
• 5.3 To support continued confidence in the countries’ food safety systems, the Participants intend to discuss Systems Recognition reassessments, reviews or audits, at least once every five years.
• 5.4 It is intended that determinations regarding the type and frequency of reassessments, reviews or audits reflect the high level of knowledge, experience and confidence that each Participant has in the other country’s food safety systems.
• 5.5 The Participants intend to cooperate so that responses to any issues that arise during such reassessments, reviews or audits are risk-based, outcome-focused and reflect the high level of knowledge, confidence and experience each has in the other country’s food safety systems.

Section VI
Cooperation and Technical Information Exchange

• 6.1 FDA and the Australian Department of Agriculture and Water Resources 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:
  • (a) The scheduling of meetings, including annual meetings as well as urgent meetings, to resolve in a mutually acceptable manner issues of significance to the Participants;
  • (b) Scientific exchange and collaboration on food safety hazards, including emerging hazards, such as: scientific reviews, development of surveys/monitoring, and procedures for sampling and analysis;
  • (c) Collaboration on and/or sharing of regulatory assessments, pertinent laws, regulations, policies and guidance information, where appropriate; and
  • (d) Cooperation in other food safety-related areas of interest as mutually determined.

Section VII
Contact Points and Notification

• 7.1 The Participants intend to identify Contact Points for the activities associated with this Arrangement.
• 7.2 Each Participant intends to provide written notification to the other Participant within 30 days of relevant changes in the names of its organization, the structure of its organization, or its Contact Points. The updating of such administrative aspects does not constitute a change in the terms of this Arrangement.

Section VIII
Implementation

• 8.1 Activities under this Arrangement may be carried out through existing collaboration mechanisms or new mechanisms, as considered appropriate by the Participants.
• 8.2 This Arrangement is intended to take effect on the date of the last signature of the Participants.
• 8.3 Participants may modify this Arrangement, including the Annex, by mutual consent in writing.
• 8.4 A Participant may discontinue its participation under this Arrangement or discontinue an activity under this Arrangement by giving at least 60 days’ written notice to the other Participant.
• 8.5 The Participants understand that discontinuation of participation under this Arrangement or discontinuation of an activity under this Arrangement is not intended to affect ongoing cooperative activities.

FOR THE AUSTRALIAN DEPARTMENT OF AGRICULTURE AND WATER RESOURCES:

Gregory R. Read
First Assistant Secretary
Exports Division
Place: _________________
Date: __________________

FOR THE AUSTRALIAN DEPARTMENT OF AGRICULTURE AND WATER RESOURCES:

Raelene Vivian
First Assistant Secretary
Compliance Division
Place: _________________
Date: __________________

FOR THE FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES OF AMERICA:

Erik P. Mettler, M.P.A., M.P.H.
Acting Deputy Commissioner
For Foods and Veterinary Medicine
Place: _________________
Date: __________________

FOR THE FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES OF AMERICA:

Dara A. Corrigan
Acting Deputy Commissioner
For Global Regulatory Operations and Policy
Place: _________________
Date: __________________

ANNEX - ARTICLES EXCLUDED FROM THE SCOPE OF THIS ARRANGEMENT

• Meat, except Game meat;
• Poultry;
• Processed egg products;
• Farmed catfish and catfish products;
• Specified milk and milk products: U.S. Grade A milk and Grade A milk products and raw milk cheese;
• Raw bivalve molluscan shellfish; and
• Dietary supplements and natural health products.