TPM - Cool Cargoes. Supporting a Safe & Secure Global Food Supply Chain

Transcription

1 SANDLER, TRAVIS & ROSENBERG, P.A. An International Trade and Business Practice TPM - Cool Cargoes Supporting a Safe & Secure Global Food Supply Chain Presented by: Lenny Feldman, Esq. Sandler, Travis & Rosenberg, P.A. March 3, 2014

2 All materials contained in this presentation are protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, published or broadcast without the prior written approval of Sandler, Travis & Rosenberg, P.A. You may not alter or remove any trademark, copyright or other notice from copies of the content. The materials contained in this PowerPoint presentation are provided for informational use only and should not be considered legal advice. The hiring of a lawyer is an important decision that should not be based solely on advertisements or seminar/ webinar materials. Before you decide, contact us by phone to or us at messages@strtrade.com and we will send you free written information about our qualifications and experience. Sandler, Travis & Rosenberg, P.A. All Rights Reserved. Disclaimer 2

3 Relevant Agencies

4 Food & Drug Administration

5 Import Review Process 5

6 Food Drug & Cosmetic Act FDA Section 801 of the FD&CA states: If it appears from the examination of such samples or otherwise (1)such article has been manufactured, processed, or packed under insanitary conditions or (2)such article is forbidden or restricted in sale in the country in which it was produced or (3)such article is adulterated, misbranded, or in violation of section 505 (New Drugs) then such article shall be refused admission 6

7 Food Drug & Cosmetic Act FDA or otherwise allows FDA to make admissibility decisions using: Examinations Facility Inspection Laboratory examination Historical Data Lack of required processes and/or approvals Other sources, e.g., a disease outbreak involving an FDA regulated product Labeling Reports from other Governmental and State Agencies 7

8 Detention Authority BTA: grants administrative detention authority over food items if credible evidence or information indicates the food presents a threat of serious adverse health consequences or death to animals or humans. FSMA: broadens authority, allowing for administrative detention based on reason to believe that the food item has been misbranded or adulterated and violates a legal standard for the product. 8

9 FDA Review - Food Facility registration numbers under BioTerrorism Act Low acid (LACF) and Acidified (ACD) Canned Foods Food Canning Establishment Number (FCE) Approved Scheduled Process Submission ID (SID) Process for adequate acidification Prior notice Food for use, storage, or distribution in U.S. Food transshipped through U.S. to another country Food imported for future export Food for use in FTZ Time frames prior to arrival Truck 2 hours; Rail 4 hours; Air 4 hours; Water 8 hours. Compliant, sufficient labeling 9

10 FDA Review Food (2) Applicable import alerts Violative history of commodities, manufacturers/shippers, growers, geographic area, countries of origin, importers, combination of issues Detention Without Physical Exam based on evidence from field offices or foreign inspections; foreign govt, state or agency Removal from DWPE by submitting petition, reviewed by FDA with evidence usually of five nonviolative shipments (may require laboratory analysis) Assurance cause of violation corrected 10

11 Food Safety Modernization Act Significantly Expands FDA s Authority to Regulate Safety of Food Domestically Produced or Imported Key Highlights of New FSMA Requirements Include Substantially Enhanced FDA Records Inspection Authority FDA Can Unilaterally Suspend a Food Facility s Registration and Require the Manufacturer to Seek Reinstatement. FDA Required to Impose Hazard Analysis and Critical Control Points Evaluation Requirements on Covered Manufacturers. FDA Required to Mandate Use of Specific Good Agricultural Practices in Growing and Handling of Produce. FDA Required to Improve Tracking and Tracing of Food Distribution to Facilitate Investigation and Resolution of Foodborne Illness Outbreaks. FDA Now Has Explicit Legal Authority to Mandate a Recall. FDA s Evidence Burden to Embargo Food For Safety Reasons Until the Agency Can Bring an Action in Court is Substantially Eased. 11

12 Additional Background Effective January 4, 2011 Most significant change to U.S. food supply regulations since 1938 Creates a comprehensive risk-based preventive approach to food safety Over 50 guidances and/or regulations to be published over a 3-year period Increased inspections over the next 5-7 years of foreign facilities 12

13 Implemented: Food Facility Registration 102 BIOTERRORISM ACT (2002) Registration required for all foreign food facilities with FDA Designation of US Agent for every facility No penalty for not updating information Essentially a one-time registration FSMA 102 Re-registration of ALL foreign & domestic food facilities on or before January 31, 2013 Re-registration every 2-years Consent to expanded records and facility inspection Expanded requirement for classification of food categories U.S. Agent liable for payment of facility reinspection fees to FDA 13

14 Proposed Rules: Timeline/Overview January 2013 Hazard Analysis and Risk-Based Preventive Controls for Human Food amending Current Good Manufacturing Practice, Jan. 4, 2013 ( Preventive Controls Rule 103) Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption, Jan. 4, 2013 ( Produce Safety Rule 105) February 2013 Final Rule on Administrative Detention of Food July 2013 Foreign Supplier Verification Program Third-Party Auditor Accreditation December 2013 Intentional Adulteration of Food January 2014 Sanitary Transportation of Food 14

15 Important Points for Supply Chain Partners FDA Required to Mandate Food Transportation Safety Standards. Requires Food Transporters to Use Sanitary Transportation Practices to Ensure Food Safety Applies to Shippers, Receivers, and Carriers Who Transport Food in U.S. by Motor or Rail Applies ex-u.s. also, e.g. Exporter Who Ships Food to the U.S. in International Freight Container By Sea or in Air Freight Container and Arranges for Transfer of Intact, Container Onto Motor Vehicle or Rail Carrier in the U.S. Such an ex-u.s. Exporter Is Considered a Shipper Under Proposed Rule Because Exporter Effectively Initiates Shipment of Food, Even if Doing So From Abroad FDA s Authority Over Foreign Food Imports Greatly Expanded. Importers Required to Perform Supplier Verification Activities FDA Can Refuse Admission of Imported Food if Foreign Facility or Foreign Government Refuses to Permit Inspection FDA Now Has Authority to require certification, based on risk criteria, that imported food in compliance with U.S. food safety requirements FDA to Develop a Voluntary Qualified Importer Program That Permits Qualified Importers Who Take Certain Measures to Receive Expedited Review of Imported Shipments 15

16 Proposed Sanitary Transport Rule (Jan. 2014) PROPOSED RULE ON SANITARY TRANSPORTATION OF FOOD Establishes Numerous Requirements Covering Following Areas Vehicles and Transportation Equipment Covers design and maintenance of vehicles and transportation Equipment Transportation Operations Covers measures, e.g. Adequate Temperature Controls and Separation of Food and Non-Food Items to Prevent Contamination Information Exchange Cover Procedures for Information Exchange Between Shipper, Carrier, and Receiver About, e.g. Prior Cargoes, Cleaning of Transport Equipment, Temperature Control. Example: Information About Possible Cross Contamination Due to Prior Carriage of Liquid Products Containing Allergen and Methods Use to Prevent Contamination of Product Now Being Shipped Training Training of Carrier Personnel in Sanitary Transportation Practices and Documentation of Training Records Maintain Written Procedures and Records By Carriers and Shippers Related to Transportation Equipment Cleaning, Prior Cargos, and Temperature Control Waivers FDA Can Waive Certain Requirements If It Makes Determination That Waiver Will Not Result in Unsafe Food Transportation Practices 16

17 Proposed FSVP FDA Proposed Rule on Foreign Supplier Verification FSVP includes the following: Compliance Status Review Hazard Analysis Verification Activities Corrective Actions Periodic Reassessment of the FSVP Importer Identification Recordkeeping 17

18 FSVP Key Definitions Who is the Importer? The person in the U.S. who purchased the food If the food has not been sold to a person in the U.S., the importer is the U.S. consignee. If there is no owner or consignee, the importer is the U.S. agent or representative of the foreign supplier. Who is the foreign supplier? The farm that raised the animal or harvested the imported food or The last foreign establishment that manufactured or processed the imported food in more than a minimal matter (examples of minimally processed are adding a label, packing, or holding). 18

19 FSVP - Fundamentals Objective: Importers required to perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that provides the same level of public health protection as that required of domestic food producers Proposed regulations vary based on the following: On the type of food product (e.g. processed foods, produce, and dietary supplements) The category of importer The nature of the hazard in the food, and Who is to control the hazard Requirements All importers must establish and follow an FSVP (unless exempted) Under proposed rule, an importer is required to develop, maintain, and follow an FSVP for each food it imports. 19

20 FSVP - Control of Hazards Options for control include: The Importer: must document (at least annually) that it has established and is following procedures that adequately control the hazard The Importer s Customer: Importer must obtain written assurance, at least annually, that its customer has established and is following the procedures identified in the written assurance to adequately control the hazard The Foreign Supplier or Its Supplier: 2 Options 20

21 FSVP - Control of Hazards Option 1: if Foreign Supplier Controls the Hazard at its Establishment, AND: (1) reasonable probability that hazard will result in serious hazards (SAHCODHA), requires: annual on-site audit of the foreign supplier by the importer or by a third-party Can rely on inspection results of FDA or an FDA-sanctioned food safety authority (e.g. New Zealand) (2) Non-serious hazards (non-sahcodha) conduct 1 or more of the verification activities listed below (in determining proper verification activity, must consider risk presented by hazard/food and foreign supplier s compliance status). Option 2: For all hazards that the foreign supplier or its supplier will control, importers must choose a verification procedure from among: (a) onsite auditing, (b) sampling and testing, (c) review of supplier food safety records, or (d) some other appropriate procedure. Determining proper verification activities and frequency = evaluation of risk presented by hazard, probability that exposure to the hazard will result in serious harm, and food/foreign supplier s compliance status. 21

22 FSVP - What is Actually Sufficient? FDA s flexibility can create troubles Assessing whether a hazard could result in SAHCODHA is a subjective standard, could present practical challenge under Option 1. On-site auditing for such hazards may be difficult to perform Option 2 provides greater flexibility in obtaining supplier verification; option 2 appears more favorable to importers for verification activities if permitted: How to prepare/justify the rationale for your verification activity (onsite auditing vs. sampling/testing vs. records review) What documents should you maintain? Specific food safety protocols in any given FSVP plan will depend on several factors, including inherent risks associated with the food, country of origin of the food, and manufacturers involved in the supply chain 22

23 Proposed Preventive Controls Rule Covered facilities required to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Requirements for: A written food safety plan; Hazard analysis; Preventive controls for hazards that are reasonably likely to occur; Monitoring; Corrective actions; Verification; and Associated records. 23

24 Proposed Produce Safety Rule Objective: Science based minimum standards for safe production and harvesting of fruits and vegetables. Covers fruits and vegetables while they are in raw or natural (unprocessed) state. Proposed rule does NOT apply to fruits and vegetables destined for commercial processing that will reduce microorganisms of public health concern. Proposed rule is based on FDA s evaluation of science and risk-analysis. Focuses on specific risk areas of risk, primarily: agricultural water quality; biological soil amendments of animal origin; worker health and hygiene; contamination from domesticated and wild animals in the growing area; and standards for equipment, tools and buildings. training Requirements Proposed produce rule is intended to be flexible for different-sized farms, to complement conservation laws and rules, to not conflict with laws and rules for organic farming. 24

25 Proposed Third-Party Auditor Accreditation FDA will have comprehensive oversight of a credible and reliable program for third-party audits. Accreditation body must meet FDA standards and requirements FDA receives reports of third-party audits conducted for certification purposes (regulatory audits) FDA has monitoring and oversight over system including procedures that FDA will follow to remove an auditor/accreditation body from the program for good cause Must maintain records, provide FDA access to records, monitor its own performance, and protect against conflicts of interest 25

26 Requirements for Recognized Accreditation Bodies Rule sets forth eligibility requirements for recognition as an accreditation body Accreditation Body can be a foreign government/agency or private third-party Must meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance, and records procedures Requirements of accreditation bodies Asses third-party auditors for accreditation; Monitor performance of the third-party auditors it accredits and notify the FDA of any change in, or denial of, accreditation; Conduct self-assessments and correct any problems in its own performance; Submit reports and other notifications to the FDA; Protect against conflicts of interest; and Maintain and provide the FDA access to records 26

27 Use of Accredited Third-Party Auditors Third-party will be used for the following purposes: 1. Voluntary Qualified Importer Program (VQIP) 2. Condition of entry for certain foods. 3. As part of an importer s FSVP (optional) 27

28 U.S. Customs & Border Protection

29 CBP Process Compliance Measurement Investigations CEEs - Transformation ISA ENFORCEMENT AND COMPLIANCE PROCEDURES Focused Assessment Regulatory Audit Targeted Industries/Issues National/Port/Broker Account Management C-TPAT Interventions 29

30 Critical CBP Considerations Origin and trade preference programs Classification and value - duties Bonded facilities & foreign trade zones Duty drawback Clear, accurate invoices and entry information Genuine trademarks

31 Transforming Cargo Clearance 31

32 Facilitate legitimate trade through risk segmentation Centers of Excellence & Expertise Utilize account based methods Expand partnerships Comprehensive risk management Increase industrybased knowledge within CBP Advance bi-directional education to raise industry knowledge Engage industry groups and key stakeholders Bring CBP s single industry expertise to virtual environment Enhance enforcement and address industry risks Leverage industry to identify issues of mutual interest to provide CBP with targeting, enforcement, and/or intelligence information Coordinate enforcement efforts by industry to address unique risks 32

33 CEEs At a Glance 33

34 C-TPAT Certification Fast Lane Voluntary partnership to promote legitimate trade and enhance border security Businesses implement established security criteria In exchange, CBP provides reduced inspections at port of arrival and expedited processing at border C-TPAT members 3 to 8 times less likely, on average, to receive inspections or exams

35 Animal & Plant Health Inspection Service

36 Animal and Plant Health Inspection Service Objectives: Animals - monitor health of animals and regulate import and export of animals, animal products and biologicals. Plants - monitor the movement of risk material, protect against the introduction of pests and regulate the import and export of plants. Treatments are fruit and origin specific. Fruit is subject to PPQ compliance inspection upon entry. 36

37 APHIS Perishables - Checklist Consider whether PPQ Form 587, Permit to Import Plants or Plant Products is required. Valid for five years. Obtain proof that fruit underwent necessary treatment prior to entry. Consider whether PPQ Form 203, Plant Export Certificate or other governmental certificate of treatment is required to obtain release. Consider any Agricultural Marketing Service (AMS) compliance inspection upon entry. 37

38 APHIS Perishables - Checklist Consider Fruits and Vegetables Import Requirements (FAVIR). Quarantine 56 or Q56 regulations. Consider Country Summary Approved imports (provides plant part and ports of entry) Note Commodity Import Report (CIR) - Inspection requirements Be familiar with Frequently Asked Questions Database, Treatment, Permits/E-Permits, Phytosanitary Certificates Stay aware of Import Alerts Consider Fresh Fruits and Vegetables Import Manual 38

39 Cold Treatment IN TRANSIT on shipboard or AFTER ARRIVAL in approved cold storage warehouses at Ports North of 39⁰ latitude and East of 104⁰ longitude or at: Wilmington, NC Seattle, WA Seattle Tacoma International Airport Corpus Christi, TX Gulfport, MS Hartsfield International Airport Washington Dulles International Airport Chantilly, VA 39

40 Thank You! Lenny Feldman, Esq. (305)