1. The Importation and Exportation of Foods Food Law FSC-421

2. Importation FDA and US Customs share jurisdiction over imported food products FDA and US Customs share jurisdiction over imported food products Foods may be imported into the US so long as they meet the same standards as foods produced in US. Foods may be imported into the US so long as they meet the same standards as foods produced in US. USDA – Jurisdiction over imported meat products USDA – Jurisdiction over imported meat products Pursuant to 1906 Meat Inspection Act Pursuant to 1906 Meat Inspection Act

3. US Customs Service Sub unit of the US Department of the Treasury Sub unit of the US Department of the Treasury Charged with assessing duties, fees, etc Charged with assessing duties, fees, etc Required to notify the FDA of the entry of any food products into the US Required to notify the FDA of the entry of any food products into the US Non-conforming food shipments will be seized by Customs and released only after written approval from FDA. Non-conforming food shipments will be seized by Customs and released only after written approval from FDA.

4. Registration Food products which are imported into the United States are require to meet all applicable requirements at the time of importation Food products which are imported into the United States are require to meet all applicable requirements at the time of importation Must be conforming at the time they are offered for entry into the US Must be conforming at the time they are offered for entry into the US Not adulterated or misbranded Not adulterated or misbranded

5. Importation Certain types of foods must comply with registration requirements: Certain types of foods must comply with registration requirements: Specified dairy products (acidified milks, yogurts, cultured products Specified dairy products (acidified milks, yogurts, cultured products Low acid foods Low acid foods Acidified foods Acidified foods Meat processing facilities Meat processing facilities Must be manufactured according to specific processes Must be manufactured according to specific processes

6. Entry and Sampling Shipment must be filed with Customs within 5 days Shipment must be filed with Customs within 5 days Customs notifies FDA if food product Customs notifies FDA if food product Notice to proceed or, Notice of Sampling Notice to proceed or, Notice of Sampling Registered foods almost certain to be sampled Registered foods almost certain to be sampled

7. Entry and Sampling Notice of Detention if nonconforming Notice of Detention if nonconforming Notice of Refusal if nonconforming after sampling Notice of Refusal if nonconforming after sampling Shipment destroyed unless exported within specified time Shipment destroyed unless exported within specified time

8. Importer’s Options if Refused Request hearing, within 10 days, to defend acceptability Request hearing, within 10 days, to defend acceptability Permission to re-label or re-condition (IBP) Permission to re-label or re-condition (IBP) Export shipment Export shipment Request judicial review of Notice of Refusal Request judicial review of Notice of Refusal

9. Enforcement FDA may order destruction of nonconforming goods if not reconditioned FDA may order destruction of nonconforming goods if not reconditioned FDA may declare a bond violation if shipment distributed without Notice of Acceptance FDA may declare a bond violation if shipment distributed without Notice of Acceptance FDA may order seizure and condemnation of nonconforming goods FDA may order seizure and condemnation of nonconforming goods

10. Export Option Shipper has option after FDA condemnation of exporting the nonconforming goods as alternative to destruction if: Shipper has option after FDA condemnation of exporting the nonconforming goods as alternative to destruction if: Adulteration (or misbranding) did not occur after importation Adulteration (or misbranding) did not occur after importation Importer had no knowledge of the nonconformity Importer had no knowledge of the nonconformity Shipment is not otherwise in violation of US law Shipment is not otherwise in violation of US law

11. Exportation Goods intended for export need not meet FDA requirements if: Goods intended for export need not meet FDA requirements if: Products meets specs of importing country Products meets specs of importing country Not in conflict with laws of importing country Not in conflict with laws of importing country Labeling of shipment clearly indicates that it is for export Labeling of shipment clearly indicates that it is for export Export Exemption Export Exemption

12. Export Exemption Is US “less concerned” with safety of products intended for export? Is US “less concerned” with safety of products intended for export? Exempts exports from jurisdiction of FDA? Exempts exports from jurisdiction of FDA? Distribution into interstate commerce, nullifies the exemption Distribution into interstate commerce, nullifies the exemption Referred to as the “commodity dumping” provision (Thalidimide, DES, Cyclamates) Referred to as the “commodity dumping” provision (Thalidimide, DES, Cyclamates)

13. Export Exemption How does exporter prove shipment complies with exemption requirements? How does exporter prove shipment complies with exemption requirements? Export Certificate issued by “Official” in importing country Export Certificate issued by “Official” in importing country

14. Examples Exporter wants to ship dried figs to Australian importer who uses them in coffee flavors. FDA seizes shipment because contaminated by worms and therefore “Adulterated”. What result? FDA alleges contaminated figs = “impure material” under Australian law. What result?

15. US v Catz American 53 F. 2d. 425 Importer has options of re-conditioning goods to make them conform to Australian law or can divert them to some permitted use. Importer has options of re-conditioning goods to make them conform to Australian law or can divert them to some permitted use. So long as it is possible for the goods to comply with importers laws, US will allow exportation So long as it is possible for the goods to comply with importers laws, US will allow exportation

16. Query: Agents Scully and Mulder tipped off Agents Scully and Mulder tipped off about Progressive Inc., who is discounting nonconforming “alien frog legs” which were refused entry into US, to salvage purchasers about Progressive Inc., who is discounting nonconforming “alien frog legs” which were refused entry into US, to salvage purchasers Salvage purchasers selling frog legs in interstate commerce at premium prices Salvage purchasers selling frog legs in interstate commerce at premium prices FDA wants to seize and condemn shipment FDA wants to seize and condemn shipment Progressive asserts export exemption as defense Progressive asserts export exemption as defense What result? What result? US v. 76,552 Pounds of Frog Legs

17. Banana Wars 1980 Bananas big business 1980 Bananas big business 1993 EU introduce preference for bananas from former colonies (404/93 Regime) 1993 EU introduce preference for bananas from former colonies (404/93 Regime) Latin America countries protested and negotiations began but not binding Latin America countries protested and negotiations began but not binding 1995 WTO established (rulings binding on members) 1995 WTO established (rulings binding on members)

18. Bananas Producers

19. Banana Wars 1996 Chiquita, Dole, Del Monte gave $5 Million in contributions to Democrats and Republicans 1996 Chiquita, Dole, Del Monte gave $5 Million in contributions to Democrats and Republicans Same year US rep challenged EU preference for bananas from former EU colonies Same year US rep challenged EU preference for bananas from former EU colonies Bananas from former EU colonies allowed into EU tariff free Bananas from former EU colonies allowed into EU tariff free Preference established as reparations for ills of European colonization of Africa and others Preference established as reparations for ills of European colonization of Africa and others

20. Banana Wars US alleged this was “barrier to free trade” US alleged this was “barrier to free trade” Costing US market $520 million/year Costing US market $520 million/year Chiquita and Dole accustom to monopoly (term “Banana Republic”) Chiquita and Dole accustom to monopoly (term “Banana Republic”) Caribbean countries started growing “pot” as opposition to US banana policies Caribbean countries started growing “pot” as opposition to US banana policies

21. Banana Wars 1997 WTO (under US pressure) ruled in favor of US 1997 WTO (under US pressure) ruled in favor of US Said EU preference was “violation of international law” Said EU preference was “violation of international law” Chiquita’s right to make a profit superseded preference for former EU colonies farms Chiquita’s right to make a profit superseded preference for former EU colonies farms WTO appellate body upheld decision against the EU WTO appellate body upheld decision against the EU

22. Banana Wars EU responded by establishing a “new scheme” which tried to get around WTO problems with preference (first come/first serve policy) EU responded by establishing a “new scheme” which tried to get around WTO problems with preference (first come/first serve policy) 1999 - US responded by imposing 100% tariff (worth 1 billion dollars to EU markets) on a list of EU exports to US 1999 - US responded by imposing 100% tariff (worth 1 billion dollars to EU markets) on a list of EU exports to US Mostly EU luxury items Mostly EU luxury items

23. Banana War Tariffs Pecorino Cheese Pecorino Cheese Sweet biscuits, waffles Sweet biscuits, waffles Bath preparations and salts Bath preparations and salts Candles Candles Handbags, and plastic coated items normally carried in handbags Handbags, and plastic coated items normally carried in handbags Greeting cards Cashmere clothes Paper boxes and cartons Cotton bed linen Metal chandeliers and other light fixtures Danish hams

24. Banana Wars April 2001 Banana Wars resolved April 2001 Banana Wars resolved US agreed to drop tariffs on EU exports US agreed to drop tariffs on EU exports EU agreed to drop preference EU agreed to drop preference Quota for bananas from former colonies decreased Quota for bananas from former colonies decreased Quota for US produced bananas increased Quota for US produced bananas increased Almost forced Chiquita into bankruptcy Almost forced Chiquita into bankruptcy Lost 40% of its share of EU market Lost 40% of its share of EU market