Understanding FDA’s Food Supplier Verification Program (FSVP) MODERATOR: Mike Lahar A.N. Deringer NCBFAA RAC Co-Chair PANELISTS: Stuart Schmidt Kristen Spotz Domenic Veneziano UPS GMA Veneziano Consulting

FDA- Food Safety Verification Program March 2017 What U.S. Importers Need to Know

FDA Food Safety Verification Program (FSVP): What U. S FDA Food Safety Verification Program (FSVP): What U.S. Importers Need to Know Background What’s Not Changing What’s Changing What food is not covered When does reporting begin What do Broker’s need to submit to FDA? Helpful Resources

Background The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system in which the focus is on preventing contamination rather than primarily reacting to problems after they occur. The FSMA rules include those that create preventive controls for the production of human and animal foods, and establish science-based standards for produce grown on farms. These rules apply to domestic food producers and those in other countries who export to the United States. FDA States: The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling. Effective May 27, 2017 ACE will enforce new data elements related to the enforcement of FSVP for imported food products.

FSVP – What Is Not Changing Prior Notice for importations of food Definitions of food or food products Registration - Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined 21 CFR 1.227, for human or animal consumption in the U.S. must register with FDA effective December 12, 2003. No fee to register or update Registration required to be renewed every two years beginning on Oct 1 and ending Dec 31 each even numbered year Facilities exempt from registration Who may register a facility, information required and the methods of registration FDA Refusal of imported food manufactured by a non-registered facility

What food is not covered? Certain categories of imported food are not covered by FSVP. These include: Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations. Food for research or evaluation Food for personal consumption Alcoholic beverages and certain ingredients for use in alcoholic beverages Food that is imported for processing and future export Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards). Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation

FSVP - What’s Changing A flexible, risk-based approach to foreign supplier verification Importers must meet the requirements of the final FSVP rule1 Verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations Importers are responsible for actions that include2 Establish and follow written procedures to comply Develop, maintain and follow an FSVP for each imported food Perform re-evaluation activities every three years Conduct hazard analysis For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry Determining known or reasonably foreseeable hazards with each food Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities Conducting supplier verification activities Conducting corrective actions 3. Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements. Importers must also disclose in documents accompanying the food that the food is not processed to control the identified hazard

When do I need to begin reporting? FSVP importer whose foreign supplier is not subject to the PC or produce safety rules: May 30, 2017 FSVP importer whose foreign supplier is required to comply with the PC rule for human food or FSVP importer of animal food whose foreign supplier is subject to the current good manufacturing practices (“CGMP”) requirements in subpart B of 21 CFR part 507 in the PC rule for animal food. Compliance dates when foreign suppliers are in these categories: Small businesses as defined in 21 CFR 117.3: March 19, 2018 Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3: March 18, 2019 Suppliers subject to the Pasteurized Milk Ordinance: March 18, 2019 (Human Food) “All Other” Businesses Suppliers: May 30, 2017

When do I need to begin reporting? FSVP importer whose foreign supplier is required to comply with the animal food preventive controls requirements in subpart C of part 507 of the PC rule for animal food, but that is not required to comply with the CGMP requirements in subpart B of 21 CFR part 507. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in 21 CFR 507: March 18, 2019 Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3: March 17, 2020 “All Other” Businesses: March 19, 2018 FSVP importer whose foreign supplier is required to comply with the produce safety rule, except for the requirements applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in 21 CFR 112.3: July 29, 2019 Very Small Businesses as defined in as defined in 21 CFR 112.3: July 27, 2020 “All Other” Businesses: July 26, 2018

FSVP importer whose foreign supplier is required to comply with the requirements in the produce safety rule applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in 21 CFR 112.3: July 26, 2018 Very Small Businesses as defined in 21 CFR 112.3: July 29, 2019 “All Other” Businesses: July 26, 2017 FSVP importer whose foreign supplier is subject to the produce safety rule and eligible for a qualified exemption (other than when the foreign supplier is a farm producing sprouts). Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in21 CFR 112.3: July 29, 2019 Very Small Businesses as defined in 21 CFR 112.3: July 27, 2020 FSVP importer whose foreign supplier is a farm producing sprouts that is eligible for a qualified exemption under the produce safety rule. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in21 CFR 112.3: July 26, 2018

FSVP – ACE PGA Message Set Reporting Effective: May 30, 2017 New Entity Type: FSV – FSVP Importer May be different than FD1 Importer Party – similar to the DII importer, must be US party. If foreign IOR must be US Agent. DUN# must be reported for party – currently the only FDA approved number (FEI number?) Only email address required, name and phone number remain optional Exemption codes must be used if food is exempt

What do I need to do to Prepare? Know the Rules – Complex, full of exemptions, exceptions Review FSVP rule with importer to determine if/when it is applicable Evaluate exemptions to determine if they apply Excludes most of the standard FSVP requirements for certain types of food from a foreign supplier in a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States (Currently Canada and New Zealand) Coordinate with your Importer Determine who is the FSVP in your supply chain Provide new data elements, FSVP Importer, email address and Duns # Ensure their suppliers and manufacturers are registered with FDA and D&B D&B = Dun and Bradstreet

FSVP – Helpful Resources Am I Subject to FVSP? http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm331957.htm The CATAIR chapters and appendices can be found on CBP.gov here (pages 147 – 221): https://www.cbp.gov/sites/default/files/assets/documents/2017- Jan/FDA%20Supplemental%20Guide%20Release%202.5%20FINAL%20DEC%2028%202016%20.pdf FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm FDA Dun and Bradstreet lookup and Registration link: https://fdadunslookup.com/

Understanding FDA’s Food Supplier Verification Program (FSVP) Kristen Spotz Grocery Manufactures Association Senior Manager, Food Safety and Quality Assurance

NCBFAA Webinar May 12, 2017 foreign supplier verification program

AGENDA FSMA & FSVP compliance How FSMA could impacts on Customs House Brokers Exemptions & Modified Requirements

What is FSVP It is a PROGRAM that importers must have in place to VERIFY that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling Why is that important? 1st Warning Letter 2nd IA The ripple affect.

Prohibited act 301(zz): The importation or offering for importation of a food if the importer does not have in place a foreign supplier verification program in compliance with section 805. 801(a) If it appears from examination of such samples or otherwise that (3) …. or the importer is in violation of such section 805. then such article shall be refused admission.

Why FSMA Compliance is Important Failure to comply with FSMA can result in: Suspension of food facility registration Withdrawal of commercial contracts with major retail grocery food service customers Disruption of consumer confidence Placement on FDA Import Alerts Product recall Financial loss Will lead to FDA oversight in other areas (supplier, 3rd party, VQIP) FDA Invoke section 414, if appropriate.

FDA Inspectional Strategy - Fsvp FY16 forward: Outreach and Education Public meetings, webinars, FSMA website FSVP final rule Industry Guidance FSVP Alliance Course Regulator Training FY17 and FY18: Field Assignments Initial importer inspections include “education” Conduct inspections using Intelligent Questionnaire Classify initial inspections; enforcement may be taken Goal is 600 inspections in FY17 FY19 forward: Compliance Program In Effect Status: Industry Guidance – Currently on hold, so it might not be out for a while. FSVP Alliance Course – Currently being offered, I had heard it isn’t very good. It goes through the law. Regulator Training – The Course has been design and it went through a test session. It was determined that it needed to be reworked. Therefore, they still need to train both the investigators. FY17 & 18 The Initial Importer is one that is responsible for FSVP but doesn’t do any processing. They will plan to go there first and it will be the import staff that will be doing the work. The agency is still drafting an assignment. Approximately 8% will be conducted each year or 2960 firms. Of the 2960, 20% or 592 firms will be done electronically and 2368 firms will be actual on-site inspections. The agency has allocated 45 FTE to conduct FSVP inspections. Due to FSVP coming into effect in May that leaves only 4 months. Therefore, we are looking at 148 electronically and 592 completed on-site Discuss the difference between electronic and on-site. And that an electronic could turn into an on-site.

INSPECTIONAL PRIORITIZATION For-cause (e.g., tied to an outbreak or recall, Lab Class 3 samples) Follow-up to FSVP problems (e.g., OAI, VAI, Import Alerts) VQIP (maximum of 200 inspections in first year) Include importers whose foreign suppliers have been inspected by FDA Routine (all others) INSPECTIONAL PRIORITIZATION

VQIP Guidance – Eligibility Criteria Quality Assurance Program (QAP) Assurance of compliance with the supplier verification and other importer responsibilities under the applicable FSVP or HACCP regulations Current facility certification, including farms, issued under FDA’s Accredited Third-Party Certification regulations for each foreign supplier of food in VQIP 3+ year history of importing good to the U.S. No ongoing FDA administrative or judicial action (e.g. Import Alert, injunction, recall) or other history of non-compliance with food safety regulations by the importer, other entities in the supply chain (e.g. foreign suppliers, filers/brokers, and FSVP and HACCP importers) or food Have a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.

FSVP DATA ELEMENTS: Importer Identification Use Entity Role Code Foreign Supplier Verification Program Importer (FSV) & provide: Firm Name Firm Address DUNS number Email address Individual’s name and telephone are optional If product is a food and above data elements are not submitted, the entry will be rejected by CBP, unless an Affirmation of Compliance exemption code is applied: FSVP Exempt or later compliance date (FSX) Research and Evaluation (RNE) (Optional) TBA – An Unknown Code (UNK) Soft roll out Obtain DUNS number for free at www.fda.dunslookup.com. These data elements are separate & distinct from Prior Notice requirements.

FSVP EXEMPTIONS Firms subject to juice or seafood HACCP regulations Food for research or evaluation Food for personal consumption Alcoholic beverages and ingredients (when importer uses them to make an alcoholic beverage) Food transshipped through U.S. Food imported for processing and export “U.S. goods returned” Meat, poultry, and egg products subject to USDA regulation at time of importation

Modified requirements Low Acid Canned Food (not further processed) Manufacturer/processor (1.502(c)) Dietary Supplements (21CFR-1.511) Very Small Importers & Small Foreign Suppliers (21CFR 1.512) Countries with Comparable or Equivalent Food Safety Systems (21CFR 1.513)

Low Acid Canned Food (not further processed) You do not need an FSVP with respect to microbiological hazards for that food. Instead, you must verify and document that the food was produced in accordance with 21 CFR part 113. With respect to all matters that are not controlled by part 113 such as chemical and radiological, you must have an FSVP.

Manufacturer/processor If in compliance with PC you are deemed in compliance with most aspects of FSVP requirement for importer identification at entry.

Dietary supplements Importers subject to DS cGMPs 111.73 & 111.75 You must utilize a Qualified individual and Qualified Auditor You must identify the FSVP importer at entry Importers whose customers are subject to DS cGMPs 111.73 & 111.75 Required to have an annual written assurance Maintain Records

Very small: importer/foreign supplier You must document that you meet the definition of very small importer in with respect to human food and/or animal food before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year. You must obtain written assurance that your small foreign supplier complies with PC before first approving the supplier for an applicable calendar year and thereafter on an annual basis by December 31 of each calendar year, for the following calendar year. You must utilize a Qualified individual and Qualified Auditor You must identify the FSVP importer at entry Required to have an annual written assurance Maintain Records Corrective Actions

Countries with Comparable or Equivalent Food Safety Systems Generally, FSVP requirements do not apply when importing certain food from suppliers in countries whose food safety system FDA has officially recognized as comparable or determined to be equivalent (Systems recognition initiative) Applies to food that will not be processed further (packaged food: fresh produce) Importer must document that: Foreign supplier is under oversight of comparable or equivalent food safety system Food is within scope of official recognition or determination Supplier is in good compliance standing with comparable or equivalent food safety authority.

Questions? Contact Information Domenic J Veneziano CAPT USPHS (Retired) Independent FDA Regulatory and Strategic Consultant Email: Domenic.Veneziano@Yahoo.com Telephone: (240) 400-0567

Understanding FDA’s Food Supplier Verification Program (FSVP) MODERATOR: Mike Lahar A.N. Deringer NCBFAA RAC Co-Chair PANELISTS: Stuart Schmidt Kristen Spotz Domenic Veneziano UPS GMA Veneziano Consulting