Seafood HACCP and the FDA Food Safety Modernization Act Boston Seafood Show 2018 Tuesday, March 13, 2018

Transcription

1 Seafood HACCP and the FDA Food Safety Modernization Act Boston Seafood Show 2018 Tuesday, March 13, 2018

2 Agenda Discussion by FDA and CBP senior professionals on status of FSMA implementation, seafood importer and processor compliance, enforcement priorities and strategies for compliance Overview of the relationship of Seafood HACCP and FSMA, including compliance dates, exemptions, and VQIP Customs Brokerage perspectives on seafood imports, entry processes, helpful tips to smooth product clearance, and new developments in regulation affecting the seafood industry (NOAA) Sandler, Travis & Rosenberg, P.A. All rights reserved.

3 Panelists Moderated By: Shelly Garg, Attorney, Sandler, Travis & Rosenberg, PA Ted Poplawski, Special Assistant to Director of Division of Import Operations, FDA William Scopa, Chief of the Partner Government Agency Branch, Interagency Collaboration Division, Office of Trade, CBP Domenic Veneziano, Independent FDA Regulatory Consultant, Sandler, Travis & Rosenberg, PA and former Director of DIO at FDA Sergio Lozano Jr., Vice-President and Licensed Customs Broker, Alpha Brokers Corp Sandler, Travis & Rosenberg, P.A. All rights reserved. 3

4 Panel Discussion: Seafood HACCP And The FDA Food Safety Modernization Act Seafood Expo North America March 13, 2018 Presentation by: Ted Poplawski, Special Assistant Division of Import Operations

5 Changing FDA Landscape FDA s mission is the same Promote & protect the public health FDA s world has changed Dramatic increases in import volume No commensurate resource increase FDA s approach has to change too 5

6 Changing FDA Landscape Prevention Promote supply systems to build in safety Intervention Cannot regulate line-by-line any more Focus efforts where systems are lacking and on the unknown Response Protect through enforcement 6

7 Changing FDA Landscape Foreign Supplier Verification Program Promote industry systems to build in safety Importer responsibility to ensure foreign suppliers have adequate preventive controls in place Requires food from abroad to be as safe as domestic 7

8 Changing FDA Landscape Foreign Supplier Verification Program Exemption based on foreign supplier size Most go away in March 2018 Exemptions for foods with other requirements HACCP Dietary Supplements 8

9 Changing FDA Landscape Automated Commercial Environment ACE rule went into effect earlier this year Requires submission of certain data Compliant products with accurate data get more system releases More than doubled System May Proceed rate Incomplete/inaccurate data = manual review Focus efforts where systems are lacking and on the unknown 9

10 Changing FDA Landscape Voluntary Qualified Importer Program Qualified importers receive expedited entry processing Achieve & maintain high level of control over supply chain safety and security Promote industry systems to build in safety Focus efforts where systems are lacking and on the unknown 10

11 Changing FDA Landscape ORA Reorganization 1 Managing Office & 5 Import Divisions Dedicated management & operations structure Focused solely on the import process Entry admissibility Investigations, refusal verification, enforcement Operations for FSVP & VQIP 11

12 Thank you Questions? 12

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14 Boston Seafood Show 2018 William Scopa, Branch Chief Partner Government Agencies, Interagency Collaboration Division, Office Of Trade

15 Today s Topics One Government at The Border (1USG) Food Safety Seafood Risks

16 1USG AT THE BORDER 6-16

17 The Border Interagency Executive Council Executive Order 13659: The BIEC shall develop policies and processes to enhance coordination across customs, transport security, health and safety, sanitary, conservation, trade, and phytosanitary agencies with border management authorities and responsibilities to measurably improve supply chain processes and improve identification of illicit shipments. engage with and consider the advice of industry and other relevant stakeholders regarding opportunities to improve supply chain management processes, with the goal of promoting economic competitiveness through enhanced trade facilitation and enforcement. BIEC Projects: Foreign Identity Verification - Develop and implement a strategy for establishing a systemic method to accurately record foreign entities, their supply chain roles, and their foreign addresses, enabling the U.S. Government to use a common language employed by the trade community and make them better positioned to focus on high-risk shipments. REPLACE THE MID- (LEI/GLN ) Harmonization of Sub-Descriptors - Develop and implement a method to uniquely identify products (i.e., product data elements included in the entry filing and message set). (GS1-GTIN) Trade Engagement; CBP s COAC, and the BIEC External Engagement Committee

18 International Trade Data System Executive Order (EO) 13659: Streamlining the Export/Import Process for America s Businesses Signed February 19, 2014 with a deadline of December 2016 Single Window Government-to-Government (49 agencies) PGA Message Set provides the electronic submission of specific PGA data Document Image System (DIS) enables submission of electronic images by the trade

19 Unfinished Message Sets Office of Marine Conservation (OMC) Fish & Wildlife Service For Official Use Only 6-19

20 FSIS SILURIFORMES Imports of Siluriformes (catfish) fish transferred from the Food and Drug Administration (FDA) to United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) as a final rule effective March 1, 2016 (76 FR 10433). ACE filing capabilities in ACE ITDS for Siluriformes began on September 1, 2017 FSIS Form and the Official Inspection Certificate is uploaded to DIS What is required? Official inspection certificate issued by the Central Competent Authority from the foreign government Import application FSIS Form for re-inspection at FSIS facilities directly after entry. Hold Intact message How to apply for a FSIS Form ? Importers/brokers can submit the import documents directly to FSIS using the paper FSIS Form

21 Food Safety Cooperation On September 10, 2007, the Interagency Working Group on Import Safety presented, to the President, the Action Plan for Import Safety The Food Safety Modernization Act (FSMA) was signed into law on January 4, Section 309 of the FSMA directs that the Secretary of Health and Human Services (DHHS) shall, in coordination with the Secretary of Homeland Security (DHS), develop and implement a strategy to better identify smuggled food and prevent entry of such food into the United States. Import Safety Coordination between CBP and FDA Prior Notice Center at CBP s National Targeting Center PGA Message Set Commercial Targeting and Analysis center (CTAC) CBP remedies available for food safety violations FDA refusals Prior Notice non-compliance CBP s Cooperation with USDA (APHIS and FSIS): meat, poultry and egg products

22 Commercial Targeting and Analysis Center Mission: To facilitate information sharing and leverage the collective resources of participating government agencies to prevent, preempt, deter and investigate violations of importation laws that affect U.S. interest in the import safety environment Provides a means to analyze shipment information prior to U.S arrival Provides necessary tools to stop high-risk cargo for inspection APHIS CPSC EPA FDA FSIS FWS NMFS NHTSA PHMSA

23 C-TPAT- Supply Chain Who is Eligible to Participate? U.S. Importers of Record Carriers (Highway, Rail, Sea, Air) U.S. Marine Port Authority/Terminal Operators Consolidators (Mexican and Canadian Manufacturers) Mexican and Canadian Highway Carriers Licensed U.S. Customs Brokers U.S. Exporters

24 Risks for Seafood Industry Mislabeling Seafood species Mislabeling Seafood Species Aquaculture commodities with US prohibited animal antibiotics and harmful chemicals Consumers demanding accuracy in what they are eating, what chemicals and additives are in the seafood and if the commodity is GMO Source of the seafood, (ADCVD) Fraudulent Foreign Government documents (Shrimp Form) Public demand for safely harvested seafood from harming dolphins, whales, endangered species 24 24

25 Other Seafood Concerns Human Labor Issues Seafood produced by North Korean laborers Shrimp peeling factories Forced labor on vessels Illegal Unreported and Unregulated Fishery Fishing without a license or quota for certain species. Unauthorized transshipments to cargo vessels. Failing to report catches or making false reports. Keeping undersized fish or fish that are otherwise protected by regulations. Fishing in closed areas or during closed seasons. Using prohibited fishing gear.

26 Antidumping/Countervailing Duty (ADCVD) CBP is actively enforcing 7 seafood orders, 5 of those orders cover frozen warm water shrimp Shrimp orders cover imports from Brazil, China, India, Thailand, and Vietnam. The other seafood orders cover crawfish tail meat from China and frozen fish fillets from Vietnam. CBP continues to target high-risk shipments of shrimp to enforce the AD/CVD Orders. With the enactment of the Enforce and Protect Act (EAPA) in February 2016, Congress vested authority to conduct civil investigations into the evasion of AD/CVD orders with the Trade Remedy Law Enforcement Directorate in the Office of Trade. EAPA investigations came online in August 2016 when the Interim Final Rule was published. In its first year, the interim measures CBP has taken in EAPA investigations to protect the revenue has prevented the evasion of approximately $45 million dollars in unpaid antidumping and countervailing duties annually. EAPA allegations are led by a TRLED case investigator and consists of an expert from a Center of Excellence and Expertise (such as the Agriculture & Prepared Products Center), Regulatory Audit, and a National Targeting Analysis Center. For Official Use Only 6-26

27 TIPS TO SEAFOOD IMPORTERS Keep all violations in trade to a zero. Educate your broker, ensure they know what government regulations apply to you. Provide all data elements in ACE (data, permits, Certificate of Origin, Captains Statement..) Verify that the commodity requirements with FSIS, FWS, FDA, NMFS, USDA. Provide correct information: tariffs match commodity description, data matches program requirements, e.g. 370 data is for Tuna. 27

28 Centers of Excellence and Expertise (CEE) CEEs at CBP.gov\ Both facilitation and targeting Consolidated CBP actions and expertise Agricultural and Prepared Products CEE in Miami 28

29 How can you help? We accept allegations via CBP Trade EALLEGATIONS BE-ALERT 29

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31 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Seafood Expo North America Seafood HACCP and the Food Safety Modernization Act March 13, 2018 Domenic J. Veneziano CAPT USPHS (Retired) Independent FDA Regulatory & Strategic Consultant

32 Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level Disclaimer 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 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 presentation materials. Please contact us and we will send you free written information about our qualifications and experience. 32

33 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Third level Fourth level Fifth level Agenda Seafood and the FDA Food safety Modernization Act: Voluntary Qualified Importer Program: (VQIP) 33

34 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Seafood and the FDA Food safety Modernization Act Third level Fourth level Fifth level Regulations impacting Seafood processors and Importers 21 CFR part 123 Fish and Fishery Products 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods (cgmp & PC Regulations) 21 CFR 1, Subpart L, Foreign Supplier Verification Program for Importers of Food for Human and Animals (the FSVP Regulations) 21 CFR 1, Subpart M, Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certificates (Accredited Third-Party Certification) 21 CFR part 121, Mitigation Strategies To Protect Food Against Intentional Adulteration (The IA Regulation) 21 CFR 1, Subpart O, Sanitary Transportation of Human and Animal Food (the ST Regulations) 34

35 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Third level 21 CFR Part 117 cgmp & PC Regulations Fourth level Fifth level Except as provided by 21 CFR 117.5(b), a seafood processor must comply with cgmps & PC Regulations. cgmps & PC regulations contain 7 subparts which address key areas associated with a comprehensive food safety program. They are: Subpart A: General Provisions Subpart B: Current Good Manufacturing Practice Subpart C: Hazard Analysis and Risk-Based Preventive Controls Subpart D: Modified Requirements Subpart E: Withdrawal of a Qualified Facility Exemption Subpart F: Requirements Applying to Records that must be Established and Maintained Subpart G: Supply-Chain Program 117.5(b) Subparts C & G do not apply with respect to activities that are subject to part 123 at a facility if you are required to comply with AND are in compliance with part 123 of this chapter with respect to such activities. 35

36 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level 21 CFR 1, Subpart L, The FSVP Regulations Third level Fourth level Fifth level 21CFR 1.501(b)(1) & (2) exempts fish and fishery products and raw materials or ingredients that are imported from a foreign supplier that is subject to and in compliance with 21 CFR Part 123, Fish and Fishery Products HOWEVER: 21 CFR requires that for any food being imported into the US, an FSVP Importer be identified at the time of entry, unless it is exempt. To let the agency know that the FSVP importer is not required for this food, due to its exemption, an Affirmation of Compliance Code FSX needs to be submitted during the entry process. Failure to submit this code will result in the entry being rejected by U.S. Customs and Border Protection. An incorrect code could also result in the importer being listed in FDA s FSVP inventory to conduct an FSVP inspection. 36

37 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. 21 CFR 1, Subpart M, Accredited Third-Party Certification Click to edit Master text styles Second level Third level Fourth level Fifth level Third Party Certification is required: if an Importer wants to participate in FDA s Voluntary Qualified Importer Program. Under Import Certification VQIP Importer: The person that brings food or causes food to be brought from a foreign country into the customs territory of the United States. 21 CFR 121, The IA Regulation Domestic and foreign seafood processors required to register with FDA must comply with the Intentional Adulteration regulations, unless the facility is exempt per Example: very small business per definition. However the facility will have to provide documentation sufficient to show that the facility qualifies for an exemption. Other exemptions most likely will not apply to seafood processors. 37

38 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Third level Fourth level Fifth level 21 CFR 1, Subpart O, The ST Regulations Seafood processors are subject to the ST regulations when they are engaged in transportation operations for food that is not excluded under 21 CFR For example: the transportation of seafood that requires temperature control for safety. 38

39 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Third level Fourth level Status of VQIP Fifth level Notice of Availability published in Federal Register June 5, 2015 Final Guidance Document Nov 2016 Informal Fee Estimate available August 2017 (DIDN T HAPPEN) A formal Fee will be published no later than August 1, 2018 Anticipate first applications January 1, 2018 (DELAYED UNTIL JAN 31.) Anticipate first benefit period to begin October 1, 2018 (?)

40 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Voluntary Qualified Importer Program (VQIP) Third level Fourth level Fifth level FDA required to establish a program to provide for the expedited review of food imported by voluntary participants. User Fee Based Program Linked to FSMA s 3 rd Party Certification Program FDA issued Final Guidance Nov Eligibility limited to importers who demonstrate a high level of control over the safety and security of their supply chains. Definition of VQIP Importer: Section 806(g) defines importer as the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States. Can include manufacturers, consignees, and importers of record for food for humans and animals. Important: a VQIP importer may be outside the US May or may not be the FSVP importer.

41 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Third level Fourth level Fifth level Benefits of VQIP Public posting on the FDA s VQIP web page of approved VQIP importers, if desired VQIP Importers Help Desk Expedited entry into the U.S. for all foods included in an approved VQIP application Examination and/or sampling generally limited to for cause situations in which there is a potential threat to public health Any sampling or examination done at destination or another location chose by the importer Expedited laboratory analysis of any samples

42 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Third level Benefits of VQIP cont. Fourth level Fifth level Expedited entry incentivizes importers to adopt a robust system of supply chain management Allows FDA to focus its resources on food entries that pose a higher risk to public health Provides predictability when product will arrive Saves money on storage charges Helps to get customers by participating in the program

43 Click to edit Master title style 2018 Sandler, Travis & Rosenberg, P.A. All rights reserved. Click to edit Master text styles Second level Third level Fourth level Fifth level Contact Information Domenic J Veneziano CAPT USPHS (Retired) Independent FDA Regulatory and Strategic Consultant Sandler Travis & Rosenberg Dveneziano@strtrade.com Office (202) Cell (240)

44 U.S. Customs Brokers & The Modern Day Customs Broker By: Sergio S. Lozano Jr., CHB

45 Brokers and ACE Brokers transmit all information through the ACE system Prior to submitting all information the Broker s responsibility is to ensure that all documents received and presented match. Brokers transmit entries to FDA and NOAA through ACE simultaneously with the transmission for CBP clearance. Primarily Brokers work as facilitators of information between the government agencies and the importers.

46 Common Issues Importers Face FDA Product Codes Valuation NOAA transmissions Matching all Documents (Invoice, Packing Lists, NOAA Docs., & AWBs/BLs) Different types of holds and information that must be transmitted The time sensitivity of seafood products Government agencies outages and update timing.