MEMORANDUM OF UNDERSTANDING 


BETWEEN 


THE EXPORT INSPECTION COUNCIL OF INDIA, 


MINISTRY OF COMMERCE AND INDUSTRY 


AND 


THE UNITED STATES FOOD AND DRUG ADMINISTRATION OF 


THE DEPARTMENT OF HEALTH AND HUMAN SERVICES 


The Export Inspection Council (EIQ, Ministry of Commerce and Industry (MoO) and the United 

States Food and Drug Administration (FDA), Department of Health and Human Services (HHS), EIC 

aryd FDA, hereinafter collectively referred to as the "Participants" and individually referred to as a 

"Participant," recognize the importance of timely and effective collaboration, communication, and 

information exchange in the promotion of food safety and food defense to faciJjtare trade. The 

Participants share a mutual high regard for the crucial role that their respective regulatory sys tems 

perform to ensure the food and food ingredients that each Participant regulates are safe. The Participants 

intend to strengthen existing cooperation in scientific and regulatory areas. 

I. PURPOSE 

This Memorandum of Understanding is intended to develop opportunities for cooperative engagement 

in regulatory, scientific, and technical matters and public health protection that are related to the food 

products the Participants regulate. Further, this Memorandum of Understanding may serve as a 

precursor for product specific memoranda of understanding between the Participants aher the 

Participants develop further confidence in each other's regulatory capability and abilities to assess the risk 

of certain food products. 

The Participants share a common interest in advancing food safety, and in sharing expertise in support of 

mutually beneficial public health outcomes. Activities of mutual interest may be developed consistent 

with the Participants' missions and strategic plans . 

The Participants, in accordance with the ir respective laVJS and regulations, intend to work together as 

appropriate to implement the intent of this Memorandum of Understanding. This work is intended to 

facilitate the effective exchange of information, develop new or strengthen existing cooperative 

efforcs/initiatives, and coordinate, when appropriate, with other countries and stakeholder groups 

relevant to product regulation within their respective countries or in a broader global context 

II. SCOPE 

This Memorandum of Understanding covers food products regulated by both Participants. 

The Participants intend to explore mechanism(s) for regular meetings and other types of engagements 

for the development of plans for exchanging information, capacity building, and strengthening regulatory 

cooperatiOn. 

The activities intended to be planned and performed under this Memorandum of Understanding may 

include, but are not limited to, the following activities. 

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A Exploring the development of procedures for the timely exchange of regulatory and public health 

information for routine and/or emergency purposes . 

B. 	 Collaborating tO increase knowledge and understanding of the Participants' respective regulatory 

systems, and, whenever possible, exploring opportunities for leveraging the Participants' resources in 

ways that help to expand the safety net for the products the Participants regulate. Activities may 

include: 

Sharing information on product refusals, recalls, emergency notification procedures to be 

followed in case of contaminated food and their ingredients, or other situations that 

could potentially affect the public health; 

Exchanging information resulting from investigations, in progress or completed, that are 

conducted by the Participants when their investigations are related to product-associated 

risks; 

Engagi ng co!Jaboratively as observers tn food mspections conducted by one of the 

Participants , i.e., FDA may observe EIC-led inspections and EIC may observe FDA-led 

inspections to gain further understanding of both Participants' inspectional systems; 

Sharing lnformation on the lack of adherence to current good manufacturmg practices as 

prescribed by the Participants' respective laws by manufacturers of food in one another's 

country; and 

Sharing applicable information on regulatOry findings and science-based decision making. 

C 	 FDA may request EIC tO share the results of its internal or othe r entities' assessments of its food 

safety or regulatory system, if EIC chooses to do so. 

D. Collaborating in appropriate knowledge- and capacity-building activities including: 

Participating m relevant scientific meetings, symposia, seminars, and other appropriate 

venues that may be organized by either Participant; 

Exploring development of co!Jaborative activities to strengthen food safety through 

preventive control mechanisms and regulatory science; 

Promoting and facilitatmg exchanges of technical experts, relevant technical m:1.terials and 

appropriate training programs (e.g., food mspections, good aquaculture practices, seafood 

Hazard Analysis and Critical Control Points (HAco:>) protOcols, spice & botanical food 

safety practices, good agricultural practices, food safety plan design and implementation, 

etc.), as murua!Jy arranged; 

Increasing the understanding of regulatory standards, guidelmes and best practices 

through participation in various appropriate mtemational venues and activities and using 

these venues to encourage harmonized practices more routinely, 

Collaborating and sharing technical lnformation on the application of current good 

laboratory practices and current good regulatOry practices; and 

Explormg opportunities for the exchange of information relating to such areas as risk 

management measures, nutrition and product labeling, and the mtemational 

harmonization of food safety standards. 

E. 	 Exploring the development of an understanding tO structure FDA's evaluation of whether tO accept 

or leverage the export inspection and certification system of EIC 

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F. 	 Encouraging sustainabilityof this Memorandum of Understanding in food safety by building linkages 

with various ministries and agencies, state and local govemmenrs, industry and trade groups, 

universities and other educational institutions, professional societies, and other relevant stakeholders. 

G. 	 Facilitating senior leadership and staff of the ParticipantS in holding (in person or by teleconference) 

periodic discussions to repon and assess progress on current coUaborations and implementation, 

address concerns and resolve issues leading to strengthening and improving the bilateral relationship 

and transparency and, as appropriate, identify new areas for collaboration. 

III. CONFIDENTIALITY 

A 	 The ParticipantS intend most of the information exchanged under this Memorandum of 

Understanding to be provided in a form appropriate for public dissemination under the law of 

the transmitting Panicipant. 

B. 	 With regard to any non-public information that may be provided, the exchange of such 

informacion is intended to be consistent with signed confidentiality commitmentS and other legal 

requirementS of the PanicipantS. ' 

IV. SOURCE OF FUNDING 

Each Participant recognizes that it intends to fund and implement itS own acuvmes under this 

Memorandum of Understanding, subject to, and only to the extent made possible by, the availability of 

appropriated funds, personnel, and other resources.. 

V. NON-BINDING 

This Memorandum of Understanding does not create any binding obligations. Nothing in this 

Memorandum of Understanding negatively affectS the ParticipantS' responsibilities or abilities to carry 

out their regulatory activities and programs in accordance with their respective laws and regulations. 

VI. DISPUTES 

The Panicipancs intend that any dispute arising under this Memorandum of Understanding be solved 

amicably through consultations, discussions and negotiations between the ParticipantS. 

VII. DURATION AND PROCESS 

The ParticipantS intend for this Memorandum of Understanding to commence upon the Partictpams' 

signatures thereof and to continue for a period of five (5) years. The Panicipants also intend that this 

Memorandum of Understanding may be modified by mutual decision in writing, specifying the date the 

modifications are intended to commence. 

The Panicipancs intend that the duration of this Memorandum of Understanding may be extended as 

mutually decided by the ParticipantS. 

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The Panicipants intend that this Memorandum of Understanding may be discontinued by either 

Participant. A Participant should endeavor to give sixty (60) calendar da~' advance written notice to the 

other Participant of its intent to discontinue this Memorandum of Understanding. 

VIII. POINT OF CONTACT 

Both the Participants designate the below-mentioned contact points to ensure smooth cooperation under 

this Memorandum of Understanding and intend that all future communication relating to this 

Memorandum of Understanding be addressed to: 

Associate Commissioner for International Director (I&Q/Q 

Programs Export Inspection Council of India (EIQ 

Office of International Programs 3'd Floor, NDYMCA Cultural Centre Building, 

United States Food and Drug 1, Jai Singh Road 

Administration New Delhi-11 0001 

10903 New Hampshire Avenue India 

Silver Spring, MD 20993 Tel. +91.11.2374.8025 

United States of America Facsimile: +91.11.2374.8186 

Tel. +1.301.796.4600 ' 

Facsimile: + 1.301. 595.7937 

{ \-. )o , / 

Signed at N~ 11\Lt~ on thisdJ .,:.:;:...,__ _ _ day of f\6fcA., in duplicate in the English and Hindi languages. 

DEPUTY COMMISSIONERS EXPORT INSPECTION COUNOL, 

1HE UNITED STATES MINISTRY OF COMMERCE AND INDUSTRY, 

FOOD AND DRUG ADMINISTRATION 

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Michael R Taylor S.K. Saxena 

Deputy Conunissioner for Foods Director, Inspection & Q!C 

and Veterinary Medicine 

Howard R Sklamberg, J.D. 

Deputy Conunisstoner for Global 

Regulatory Operations and Policy 

---/S/---

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