IMPLEMENTING ARRANGEMENT 


BETWEEN THE 


FOOD AND DRUG ADMINISTRATION 


OF THE 


DEPARTMENT OF HEALTH AND HUMAN SERVICES 


OF THE 


UNITED STATES OF AMERICA 


AND THE 


GENERAL ADMINISTRATION 


OF QUALITY SUPERVISION, INSPECTION AND QUARANTINE 


OF THE PEOPLE'S REPUBLIC OF CIDNA 


REGARDING THE COOPERATIVE MECHANISM OF FOOD SAFETY 


REGULATORY STAFF 


The Food and Drug Administration (FDA) of the Department of Health and Human Services 

(HHS) of the United States of America and the General Administration of Quality 

Supervision, Inspection and Quarantine (AQSIQ) of the People's Republic of China 

(hereinafter referre-d to together as "the Participants"), recalling the Agreement between the 

Department of Health and Human Services ofthe United States of America and the General 

Administration of Quality Supervision, Inspection and Quarantine ofthe People's Republic of 

China onthe Safety of Food and Feed, signed December 11, 2007, ("2007 Agreement"), 

intend to clarify their understanding ofthe scope of activities of food safety regulatory staff 

posted in diplomatic posts in this Implementing Arrangement. 

Paragraph I. Purpose 

This Implementing Arrangement (IA): 

aims to identify the scope of activities under the 2007 Agreement for FDA and AQSIQ food 

safety regulatory personnel posted in one another's country; 

desires to further set out the framework for exchange of information and docmnents under 

Article IV ofthe Agreement related to observations and results from inspections offacilities 

that manufacture, process, package, label, transport, hold, or test Food and Feed or 

ingredients for Food and Feed; 

lays out a means through which each agency can obtain information to inform its regulatory 

decision-malcing; and 

provides further implementation ofthe 2007 Agreement by which each agency can save time 

and costs in meeting its statutory requirements, without a reduction in public health and 

safety or regulatory responsibilities. 

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Paragraph II. Principles 

In addition to acting in a 1nanner consistent with the terms ofthe 2007 Agreement, the 

Participants intend for their food safety regulatory staff to follow the below principles when 

conducting inspections in one another's country: 

1. The Pmiicipants intend to coordinate communication regarding activities through the 

competent authority or an identified point of contact posted in one another's country; 

2. FDA intends to coordinate the activities undetiaken by FDA food safety regulatory 

staff posted in China with AQSIQ. AQSIQ intends to coordinate the activities undertaken by 

AQSIQ food safety regulatory staff posted in the United States with FDA; 

3. The Pmiicipants intend for their food safety inspectors to conduct their work, 

including obligations for the protection of confidential commercial information, in a manner 

cmnpatible with their status as etnployees of their respective agencies, and to comply with the 

applicable requiretnents of both sides for protection of confidential commercial information. 

Paragraph III. INSPECTION AND COOPERATION BY U.S. FDA 


REGULATORY PERSONNEL POSTED IN CIDNA 


1. FDA intends to conduct inspections ofFood and Feed establishments in China that 

export products to the United States consistent with the 2007 Agreement. FDA's inspections 

are conducted to assess the compliance with applicable FDA requirements of facilities that 

manufacture, process, package, label, transport, hold, or test Food or Feed to be exported to 

the United States or its tenitories. 

2. For routine inspections conducted by FDA regulatory personnel posted in China, 

FDA intends to provide AQSIQ a generalized work plan early in each U.S. Government 

Fiscal Year. When FDA makes significant changes and additions to the submitted work plan, 

FDA intends to provide advance notice regarding these activities through an identified 

prilnm·y point of contact. FDA intends to provide advance notice regarding urgent or 

itmnediate activities, such as for-cause inspections and handling of severe incidents through 

the primm·y point of contact. FDA intends to undertake urgent or immediate activities to the 

extent required to protect public health. For all inspections conducted by FDA regulatory 

personnel in China, FDA intends to provide AQSIQ advance notice about the inspection 

dates through the primary point of contact. 

3. The purpose of inspections conducted by FDA regulatory personnel in China is to 

determine whether firms comply with applicable FDA requiretnents. For each inspection, 

FDA intends to send an appropriate number of staff or government authorized qualified 

professional staff and AQSIQ intends to send the number of staff it feels is appropriate. After 

each inspection that both FDA ~nd AQSIQ participate in, both Participants intend to share the 

observations fonnd during the inspection on site. For establisli.L111ents that have been listed in 

the linport Alerts, if FDA inspections identify that adequate conective actions have been 

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1nade to address the basis for the hnport Alert, FDA intends to remove the establishments 

from the relevant Import Alert in a timely manner, following normal FDA procedures. 

4. FDA intends to provide AQSIQ with timely notification regarding manufacturing 

conditions or products that may constitute potential hazards to health or violations of 

applicable U.S. reg1;1lations. This notification may include, as deemed appropriate by FDA, 

and in compliance with laws and regulations relating to confidentiality of information, the 

exchange of redacted recall information, adverse product trends, warning letters, and copies 

of FDA's Form 483. 

5. Upon request from AQSIQ, FDA intends to provide, in a tilnely manner, and in 

compliance with laws and regulations relating to confidentiality of information, redacted 

copies of establismnent inspection reports from inspections of Chinese firms and product 

sample results that FDA deems appropriate. 

6. On an ongoing basis, FDA intends to provide AQSIQ infonnation on firms registered 

under the U.S. food regulatory system, including infmmation regarding products firms 

produce, through electronic databases or information platfonns, or through hard-copy records 

where no computer data exist. 

7. FDA intends to designate to AQSIQ a primary point of contact for connnunications 

under this IA. This point of contact holds primary responsibility for communication and 

coordination related to inspection notifications; requests for inspection reports; and follow-up 

regarding compliance actions, recalls, alerts, adverse event reports, and 1neetings. 

8. Beyond the coordination outlined above for inspectional activities, FDA intends to 

coordinate with AQSIQ the activities of its in-country policy and technical experts on foods 

on the following efforts: technical collaboration and policy coordination with Chinese food 

regulators, including AQSIQ; and efforts to leverage information from both Participants' 

food regulatory systems. 

Paragraph IV. INSPECTION AND COOPERATION BY AQSIQ 


REGULATYORYPERSONNELPOSTEDINTHE 


UNITED STATES OF AMERICA 


1. AQSIQ intends to conduct inspections of U.S. Food and Feed establishments that 

export to China consistent with the 2007 Agreement. AQSIQ 's above inspections intend to 

assess the compliance with relevant Chinese require1nents of facilities that manufacture, 

process, package, label, transport, hold, or test Food or Feed to be exported to China. 

2. For routine inspections conducted by AQSIQ regulatory personnel posted in the 

United States, AQSIQ intends to provide FDA a generalized work plan early in each calendar 

year. When AQSIQ makes significant changes and additions to the submitted work plan, 

AQSIQ intends to provide advance notice regarding these activities through an identified 

primary point of contact. AQSIQ intends to provide advance notice regarding urgent or 

immediate activities, such as for-cause inspections and handling of severe incidents tm·ough 

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the primary point of contact. AQSIQ intends to undertake urgent or immediate activities to 

the extent required to protect public health. For all inspections conducted by AQSIQ 

regulatory personnel posted in the United States, AQSIQ intends to provide FDA advance 

notice about the inspection dates through the primary point of contact. 

3. The purpose of the inspections conducted by AQSIQ regulatory personnel posted in 

the United States is to determine whether firms comply with applicable AQSIQ require1nents. 

For each inspection, AQSIQ intends to send appropriate number of staff or government 

authorized qualified professional staff and FDA intends to send staff it feels is appropriate. 

After each inspection, both Pruiicipants intend to share the observations found during the 

inspection on site. 

4. AQSIQ intends to provide FDA with timely notification regarding manufacturing 

conditions or products that 1nay constitute potential hazards to health or violations of 

applicable Chinese requirements. This notification may include, as deemed appropriate by 

AQSIQ, the exchange of recall information, adverse product trends, warning letters, 

appropriately formatted copies of relevant AQSIQ inspection reports, and information from 

import measures put in place by AQSIQ. 

5. Upon request from FDA, AQSIQ intends to provide, in a timely manner, 

appropriately formatted copies of inspection reports frmn inspections ofU.S. firms and 

product sample results that AQSIQ deems appropriate. 

6. On an ongoing basis, AQSIQ intends to provide FDA information on firms registered 

under China's food regulatory system, including information regarding firms' names and 

products firms produce, through electronic databases or information platforms, or through 

hard-copy records where no computer data exist. 

7. AQSIQ intends to designate to FDA a primary point of contact for cmnmunications 

under this IA. This point of contact holds primary responsibility for communication and 

coordination related to inspection notifications; requests for inspection reports; and follow-up 

regarding compliance actions, recalls, alerts, adverse event reports, and meetings. 

Paragraph V. FINAL PROVISIONS 

All activities under this IA are to be carried out in compliance with both Participants' 


applicable laws and regulations including those relating to confidentiality of information. 


This IAdoes not affect existing arrangement or agreements between the Participants, 


including the 2007 Agreement. 


Nothing in this IA diminishes or otherwise affects the authority of either Participant to carry 


out its respective statutory functions within its own territory. 


All activities undertaken pursuant to the IA are subject to the availability of appropriated 


funds, personnel, and other resources. The terms ofthe 2007 HHS-AQSIQ Agreen1ent, and 


all terms herein that are defined in the Agreement have the same meanings as in the 


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Agreement. Each Pm-ticipant is expected to fund its own activities under the IA unless the 

Pa1iicipants decide otherwise. 

Coop~rative activities under this IA may cormnence uponsignatureandremain in force for a 

period of five (5) yem·s, unless terminated by either Participant. On the last day of the fiveyear period, and of each subsequent five-year period, the IA automatically renews for another 

five-year period, unless either Participant notifies the other Participant that it wishes to 

terminate the IA upon at least sixty ( 60) calendar days prior to the last day of the relevant 

five-year period. In addition, either Participant may terminate the IA upon sixty (60) calendar 

days' written notice to the other Participant. The Participants may amend the IA at any time, 

by mutual written agreernent ofthe Participants. 

Signed on the~day of December, 2014, at Chicago in English and Chinese. 

ADMINISTRATION, 

DEPARTMENT OF HEALTH AND D QUARANTINE 

HUMAN SERVICES OF THE PEOPLE'S REPUBLIC OF CHINA 

OF THE UNITED STATES OF AMERICA 

R THE GENERA ADMINISTRATION 

OF QUALITY UPERVISION, 

INSPECTION 

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