DOING BUSINESS WITH USA

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1 DOING BUSINESS WITH USA Jay Parikh CEO Nijay International, Inc. P. O. Box Anaheim, CA USA August 13, 2018

2 Upgrading the production facility INTENT TO EXPORT manufacturing process efficient & cost effective hygiene and good sanitation wholesome ingredients export worthy packaging shelf life of the products product pricing developing a competitive edge

3 US IMPORT STATISTICS

4 Food imports regulatory bodies US Customs Export only allowable products by US Customs & Border Protection Agency. United States Food and Drug Administration (USFDA) UNDERSTANDING USA FOOD LAWS USFDA regulates all food products both from abroad & produced domestically. All manufacturing facilities need to register with USFDA and obtain FDA #s to commence exports. This registration needs to be renewed every 2 years. Hazard Analysis and Critical Control Points (HACCP) accreditation. Compliance with Food Safety Modernization Act (FSMA) instituted in 2011 accounts for easy clearance. Food labeling this is required for most prepared foods. Details can be obtained from USFDA website: Allergen information about the manufacturing facility that processes wheat, wheat based products, peanuts, and tree nuts is a requirement on every pack. United States Department of Agriculture (USDA) USDA has an agency Animal and Plant Health Inspection Service (APHIS) to regulate imports in to USA. APHIS makes sure that all imported agricultural products shipped to USA from abroad meet the agency s entry requirements to exclude pests & diseases. All dairy products, products containing eggs etc. are regulated. Importer needs a valid USDA permit & the exporter needs to obtain original Veterinary & Animal Husbandry Certificate from the appropriate Ministry in India and submit with every export shipment.

5 INSPECTIONS It is advisable for the manufacturing facility to undergo periodic inspection by a US approved Inspection Agency to avoid holds and rejections of the exported products Such inspections will also help upgrading the technology in use It will also help avoid contamination issues

6 QUALITY CONTROL SOP (Standard Operating Procedure) must be well defined and QC (Quality Control) systems should be in place Process Control is equally important to ensure manufacturing of wholesome foods with the same and approved recipes Control on final products packaging to avoid spillage & leakage is very essential

7 CERTIFICATIONS AND PERMITS Required certifications for specific product lines are a must to accompany every export shipment. E.g. ETO (Ethylene Oxide) sterilization for Red Chili Powders Gamma Radiation Certification for Indian mangoes and fruits etc. Exporter must ensure that the US importer has required Import Permits to ensure smooth passage of the cargo into USA FCE (Food Canning Establishment) registration and obtaining of Process Filing SID (Submission Identifier) number for all low acid and acidified canned foods is a must

8 IMPORT ALERT / AUTOMATIC DETENTION AND PROHIBITED ITEMS Manufacturer should have complete knowledge of food products from India, which are on Import Alert / Automatic Detention e.g. basmati rice, tamarind, poppadum/ farfar wafers etc. USFDA has 61 Food products lines, which are on Import Alert (Detention without physical examination) from India. This can be seen on the FDA web site. Manufacturer must not try to export any of the restricted and prohibited food products/ ingredients to USA e.g. restricted food colors

9 EXPORT REGULATION & TAX LAWS It is very important for manufacturers to abide by the export regulations in India. All banned for export products should be avoided Manufacturer should have a proper knowledge of the Indian Tax laws related to exports to avail permissible benefits in order to be more competitive in the export market

10 BANKING & FINANCE Proper knowledge of various export documents and negotiation instruments is required such as exports against DA; DP at sight; direct documents to importers or documents through bank; against Irrevocable LCs, Bank Guarantees etc. Obtaining ECGC (Export Credit Guarantee Corporation) cover on importers for discounting documents drawn on these importers Complete knowledge of currency exchange rates from time to time to remain profitable and competitive at the same time

11 IDENTIFYING DISTRIBUTION PARTNERS This is one of the most important & vital elements of success for exports into USA. The manufacturer must decide and ensure: A proper Distribution model in USA e.g. master distributor controlling regional distributors (this is by far the most successful model) or multiple distributors model Importer/ Distributor's Knowledge and Experience in the US markets Market Reach Sales and Marketing Capabilities Competitive Products Portfolio Financial Capability Brand building abilities

12 HISTORICAL POPULATION OF ASIAN INDIANS IN USA Historical population Year Pop. ±% , , % , % , % , % , % ,678, % ,843, % 2020 population of Asian Indians is likely to exceed 4.0 million over 40 lakhs

13 SALES & MARKETING STRATEGY Manufacturer must have very well defined Sales and Marketing Strategies. These include: Product pricing Promotional Strategy in-store display racks POS (Point of Sale) material samples BTL (Below the Line activities) such as Demos, Wet Sampling, Freebees/ Discount Offers etc. Advertising Strategy ATL (Above the Line activities) media selection based on available budgets and its effectiveness Trade shows/ exhibitions

14 SHIPPING Appointing CFA (Clearing and Forwarding Agent) Choosing the right shipping line in conjunction with the importer based on prices and transit times for each US port Container stuffing Shipping conditions such as fumigated containers with certification, wherever required; checking the containers for any damage/holes etc. before stuffing

15 KEY POINTERS ON QUALITY / REGULATORY COMPLIANCE Establish a strong and sustainable Quality Management System. Focus on end-to-end quality of the product supply chain e.g. from resources, material quality, production, storage, shipping, and distribution. Implement strong management and leadership to enforce quality and compliance standards. Establish organizational structure or roles to meet regulatory and quality system elements of the business. This will mean establishing forms, processes, management notification, documenting and tracking issues and followthrough. Be aware of the latest trade and financial regulations. Consider a formalized quality system certification e.g. ISO that will ensure implementation and audits. Ensure production sites are well designed and in good state of repair.

16 KEY POINTERS ON QUALITY / REGULATORY COMPLIANCE Ensure prevention of cross-contamination during the entire product realization life cycle. Be vigilant and responsive about customer feedback. Implement Corrective and preventive action programs to address quality and compliance issues. Be vigilant about responding to the FDA alerts, and queries. Be aware of food allergies and accurate product labeling. Create easy to use packaging with tamper evident features. Establish a knowledge management program. Ignorance of laws and rules will not exempt you. Develop strong relationship with distributors and suppliers.

17 QUESTIONS

18 THANK YOU Jay Parikh CEO Nijay International, Inc. phone: +1 (714) For USA Compliances: