The US Food and Drug Administration (FDA) has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance). The changes address comments the Agency received on the drafts that were made available in 2016; and provide additional context and information on hazards in food categories of current interest to ensure that the available draft documents adequately reflect the Agency’s current thinking on the most relevant food safety hazards.

The revised introduction includes additional information to better explain the purpose of the guidance and provide general information applicable to all chapters. This includes an expanded glossary of terms that are used and defined in later chapters, and the addition of three new sections on training, references, and resources. The training section provides general information on training relevant to the PCHF rule. The references section includes a comprehensive bibliography of references that have been used in certain chapters of the guidance, along with references we expect to include in future chapters that will be released. The new resources section features a compilation of resources that may be useful to someone using the guidance.

The second document released today is a revised draft of Appendix 1 “Known or reasonably foreseeable hazards (“potential hazards”).” As informed by stakeholder concerns over specific hazard-commodity associations and the Agency’s use of the Appendix during inspections, the FDA has made significant changes that include:

• The addition of new sections and descriptions meant to better explain the purpose of the Appendix, how it was developed and how it should be used;
• Revisions to the product categories identified within the Appendix to better reflect food ingredients rather than finished products;
• Replacement of a series of process-related hazard tables with a discussion of those hazards;
• An updated discussion on food allergen hazards; and
• Citations to scientific, technical and regulatory information references, particularly for less-commonly known hazards identified for different food categories.

Both the draft Introduction and Appendix 1 are available for public comment. The FDA encourages comments to be submitted to regulations.gov under Docket No. FDA-2016-D-2343 within 120 days of publication in the Federal Register.

News from AAFC’s Market Access Secretariat

The European Union (EU) has notified the World Trade Organization (WTO) of a Draft Commission Regulation G/SPS/N/EU/708 amending Regulation (EU)2023/915 with regards to maximum levels of deoxynivalenol in food.

You are invited to review the WTO notification to determine whether your industry could be impacted by these changes. Please refer to the following link for more information: G/SPS/N/EU/708

To ensure we understand the total impact this regulation may have on Canadian exports to the EU, we are asking you to please provide any comments (on a commercial confidential basis) on the implementation of this new regulation and how it will impact your business practices and/or decisions. You are invited to send comments and/or concerns to the Market Access Secretariat at aafc.mas-sam.aac@agr.gc.ca by Friday, 5:00 EST on January 19, 2024.

News from AAFC’s Market Access Secretariat

Vietnam’s Plant Protection Department (PPD) has agreed to CFIA’s alternative risk mitigation measures for seed potatoes from PEI in lieu of potato wart pest-free area requirements. Effective January 15, 2024, exports of PEI seed potatoes can resume to Vietnam.

Vietnam’s import requirements for PEI seed potatoes include:

1. Soil testing of unrestricted fields producing seed potatoes for potential export to Vietnam to ensure freedom from Potato wart.
2. Seed potatoes that are to be exported to Vietnam must have been produced in fields that are not restricted for potato wart, S. endobioticum, under the current Potato Wart Domestic Long Term Management Plan (PWDLTMP). Restricted fields include index, adjacent, primary contact, and other contact fields.
3. Seed potatoes are to be dry brushed to remove soil. Vietnam has zero tolerance for soil and this applies to all of Canada. This is not a new requirement.
4. Pre-export shipment inspections will be completed by CFIA inspection staff to verify potato tubers are free from visual symptoms of potato wart.
5. Seed potatoes are produced under the certification program outlined in the Canadian Seeds Regulations Part II.
6. A list of the unique identifying codes for the PEI fields that are free from potato wart and eligible for export to Vietnam must be provided to the Plant Protection Department (PPD), Vietnam at least one month prior to beginning to export. This list has been shared with PPD and will be published on the PPD website for their importers.

For other potato-exporting provinces from Canada, Vietnam agrees that the certification is based on Pest Free Area status for potato wart.

A valid import permit and phytosanitary certificate is required. Canadian exporters who have an import permit which is still valid, do not need to apply for a new import permit.

Please also note that exporters and importers are ultimately responsible to ensure products meet the requirements of the importing country, it is therefore recommended that exporters work closely with their importers and their local Canadian Food Inspection Agency (CFIA) office to confirm that their market access information is accurate and up to date prior to shipping. Contact information for local CFIA offices can be located at the following link: Contact a Canadian Food Inspection Agency office by telephone – Canadian Food Inspection Agency (canada.ca).

For any questions related to this notification please contact the Market Access Secretariat at: aafc.mas-sam.aac@agr.gc.ca.

The US Food and Drug Administration (FDA) has issued a supplemental response to the citizen petition dated April 18, 2018, from Bonumose, Inc., regarding the percent Daily Value (%DV) declaration for added sugars for products containing D-tagatose. D-tagatose must be declared as an added sugar on the Nutrition Facts label, but it contains fewer calories than sucrose, or table sugar.

The FDA’s original response, issued May 18, 2022, indicated that the agency would not object to the use of 1.5 calories per gram (kcal/g) for D-tagatose when determining “Calories” on the Nutrition Facts label.

The FDA’s supplemental response states that it intends to exercise enforcement discretion if the added sugars %DV declaration on the Nutrition Facts label for products containing D-tagatose is adjusted based on a calorie contribution of 1.5 kcal (calories) per gram of the sweetener, rather than the 4 kcal/g that is the basis for the value in the regulations, pending future rulemaking.

The FDA has determined that it is premature to finalize an overarching strategy for calculating the %DV on the Nutrition Facts label for all sugars such as D-tagatose because many sugars metabolized differently than traditional sugars are in the early stages of development, and the agency has limited information at this time regarding the range or uniformity of the caloric values for these other sugars.

For More Information

Federal Register Notice for Sugars that Are Metabolized Differently Than Traditional Sugars

Sugars That Are Metabolized Differently Than Traditional Sugars

Docket Regarding D-tagatose and the Nutrition Facts Label

On November 30, 2023, the agency rolled out new tools and FAQs that will continue to inform stakeholders about the Food Traceability Rule and help covered entities come into compliance.

The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to the final rule’s requirements appear on the Food Traceability List (FTL).

Featured in this update are the following:

• New webpage about traceability lot codes, including examples of how Key Data Elements (KDEs) could appear on invoices and bills of lading
• Video highlighting some technological components of product tracing systems
• Examples of a traceability plan
• New Frequently Asked Questions (FAQs)
• New supply chain examples for deli salads
• Information on how to apply for a waiver or exemption, if eligible

These featured tools are accessible from the FDA’s traceability webpage, along with:

• Supply chain examples for different commodities
• Fact sheets
• Guide to Getting Started with the Food Traceability Rule
• Translations of the codified portion of the rule as well as many of the supporting materials and tools
• Interactive tool that explains Critical Tracking Events and Key Data Elements
• Interactive tool that identifies partial and full exemptions to the rule
• FAQs

The compliance date for all persons subject to the Food Traceability Rule is January 20, 2026. In September, FDA announced that routine inspections under the Food Traceability Rule will not begin until 2027, to give covered entities additional time to work together and ensure that traceability information is being maintained and shared within supply chains per the requirements of the rule.

The rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).