News from AAFC’s Market Access Secretariat

In follow-up to the April 2022 message which notified that sheep, goats and certain other ruminants could now be exported to the United States under applicable conditions, AAFC is pleased to inform you the Canadian Food Inspection Agency has confirmed that all of the necessary documentation related to “in-transit” of small ruminants by land through the U.S. to Mexico is now finalized and trade can resume.

The import conditions in place between Canada and Mexico are active (HRZ 098-09-863-CAN-USA), and can be found on Mexico’s regulatory agency’s (SENASICA) website, or obtained from the CFIA regional office.

They encourage you to work closely with your Mexican importer to ensure all of the necessary paperwork is completed as per Mexico’s requirements before you export.

Exporters can also contact their local CFIA inspector office for any further questions relating to the export certificates.

This update resolves a longstanding and important issue for both Canada and Mexico and they are pleased that economically feasible bilateral trade of small ruminants can now occur.

Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2022.

The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2022. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver that allows for paper submission.

All facilities must include a unique facility identifier (UFI) recognized as acceptable to the FDA with the registration submission. The UFI is used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. Currently, the FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) and can be obtained or verified by visiting D&B’s website at https://www.dnb.com/duns-number/get-a-duns.html.

Food facility registration is critical to helping the FDA identify the location and possible source of a foodborne illness outbreak or potential bioterrorism incident. Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA requires facilities to submit additional information to the FDA and to renew their registrations every other year.

The following resources are available to assist in the registration and renewal process:

• Registration of Food Facilities
• Food Facility Registration User Guide: Step-by-Step Instructions | FDA
• Food Facility Biennial Registration Renewal Fact Sheet
• Webinar on Food Facility Registration (FFR), Biennial Renewal, and Unique Facility Identifiers (UFI)
• Small Entity Compliance Guide: Registration of Food Facilities
• Questions and Answers Regarding Food Facility Registration (Seventh Edition)
• Guidance for Industry: Determination of Status as a Qualified Facility | FDA
• Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation | FDA

Food facilities with questions can contact the FURLS Helpdesk: by phone 1-800-216-7331; or by email at FURLS@fda.gov

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News from AAFC’s Market Access Secretariat

On August 3, 2022, The Food Safety and Standards Authority of India (FSSAI) released an order outlining additional health certificates required to accompany the below imported foods (one per category):

• Milk and Milk products;
• Pork and Pork Products; and
• Fish and Fish Products.

The health certificates are to be issued by the Competent Authority in the exporting country as per the FSSAI format included in the order. The order will be effective from November 1, 2022.

Please see the official notification published to the World Trade Organisation (WTO) Committee on Technical Barriers to Trade (TBT).

We are seeking your comments on India’s new requirement, as Canada intends to submit comments for India’s consideration. Please submit your comments to the Market Access Secretariat at aafc.mas-sam.aac@agr.gc.ca by September 16, 2022 at the latest.

The US Food and Drug Administration has kicked off the third phase of the Artificial Intelligence (AI) Imported Seafood Pilot program, which uses AI and machine learning (ML) to strengthen import screening and to ensure that foods entering the US are safe. The pilot focuses on imported seafood because more than 90 percent of the US seafood supply comes from other countries, and in the past, FDA has seen food safety concerns for various imported seafood products along different points in the supply chain. This pilot builds upon the two previous phases of the pilot under the New Era of Smarter Food Safety Blueprint, a program that seeks to reduce the number of foodborne illnesses by leveraging technology to create a safer, more digital, traceable food system.

ML is a type of AI that can help identify connections and patterns that people, or the FDA’s screening system, cannot see. These patterns are applied to incoming supply chains to help predict the likelihood that an import shipment is potentially harmful and not compliant with FDA regulations. The ability of ML to analyze data, already generated and used by the agency, makes it well suited for addressing complex public health challenges and helping the agency to ensure the safety of imported foods.

The third phase is designed to improve the agency’s ability to quickly identify imported seafood products that may be contaminated by illness-causing pathogens, decomposition, the presence of unapproved antibiotic residues, or other hazards.

The knowledge gained from the pilot will enable the FDA to expand the use of ML in the screening of other FDA-regulated products and will inform future risk-based surveillance in products that present the greatest risk to consumers. The ultimate goal is to better protect consumers from unsafe foods by advancing the FDA’s ability to identify potential hazards.

The third phase, begun on August 15, 2022, will help to determine the feasibility of deploying in-house AI/ML models using the intelligence that FDA extracts from the data we collect reviewing millions of import entries per year. For example, there have been enhancements made that determine how machine learning algorithms can best complement field operations and improve the agency’s ability to identify products posing a threat quickly and efficiently. We also are looking at our seafood project portfolio to expand the use of machine learning to better protect consumers. Machine learning gives the agency the ability to analyze data from various sources to help inform FDA decisions and target our resource at the borders. In a related shrimp pilot, we have begun to focus on areas of increased risk, such as shrimp contaminated by aquaculture drugs, for foreign inspections. This includes increased importer inspections, higher rates of sampling and examination, and use of non-traditional tools, such as third-party audits, specific to this commodity. We incorporated the data from this project into the Third Phase of AI Imported Seafood Pilot Program, allowing for a more robust and larger targeted sampling.

Pilot Timeline/Background

In 2019, the agency launched the first phase of the pilot, an analytical proof of concept. The analysis demonstrated potential for an ML-driven approach to expedite the review of lower-risk seafood shipments, while identifying those of higher risk for violations or refusals. The second phase, conducted in-the-field, was designed to integrate ML into existing import data systems to inform decisions about sampling by entry reviewers while gaining more experience with training of the ML model. The operational pilot was launched at all 328 US ports of entry from February 2021 through July 2021 and proved successful. The real-time model was able to analyze an import entry and return a sample recommendation within seconds.

The agency is committed to enhancing the screening of potentially hazardous products at ports of entry and facilitating access to safe seafood and other products without delay. The third phase is expected to be completed in late fiscal year 2023. For more information or questions, contact FDA’s Office of Regulatory Affairs (ORA) via email at ORAOEIOAIInquiry@fda.hhs.gov.

For Additional Information:

New Era of Smarter Food Safety

FDA Technology Modernization Action Plan

FDA Strategy for the Safety of Imported Food

Seafood