SAFEGUARDS | Food NO. 179/16

SafeGuardS shellfish

Since the compliance start of the Food Safety Modernization Act (FSMA) final regulations, on September 26, 2016 the US FDA has been producing more final and draft guidance information. On that date to the US FDA updated the product categories in the food facility registration guidance. [1] More recently, on October 28, it released the draft guidance on describing a hazard that needs control, [2] and on November 10, it published the final guidance for the Voluntary Qualified Importer Program (VQIP). [3]

Updates to Food Facility Registration Product Category Guidance

  • Updated: Molluscan shellfish is now a product category

  • Removed as product categories: Acidified foods and low acid canned foods (it should be noted that these have become activity types)

  • Added to the animal food category: Botanicals and herbs, direct fed microbials, animal protein products, forage products, human food by-products (not otherwise listed) and technical additive

The US FDA also notified the industry that registration, from October 1 to December 31 2016, must be completed by all companies that are required to register.

Draft Guidance on Describing a Hazard That Needs Control in Documents Required for FSMA [4]

Using four of the seven core FSMA regulations: Preventive Control for Human and Animal Foods, Produce Safety Rule and Foreign Supplier Verification Program (FSVP), the US FDA developed guidance to producing the required documents when an entity is not controlling a hazard. This guidance provides the US FDA’s thinking on this area of the regulation.

Example, 21 Code of Federal Regulations (CFR) 117 requires this disclosure, such as, “not processed to control microbial pathogens”, must be made in “documents accompanying the food, in accordance with the practice of trade”. The US FDA states that a wide variety of documents with this statement could be used such as labels or labeling, bill of lading and certificate of analysis specific for the shipment with the disclosure statement written on them. Websites could not be used because the disclosure statement must accompany the product.

Final Guidance for Voluntary Qualified Importer Program

The US FDA’s final guidance on the Voluntary Qualified Importer program [5] was published on November 10 and was provided in a question and answer format. While there are some changes to the program, a majority of what was issued in the draft guidance remains.

For an importer to be eligible for the program, the following basic requirements must be met:

  1. Development and implementation of a Quality Assurance Program (QAP) demonstrating a high level of food safety and security for the supply chain

  2. For FSVP or HACCP importers of VQIP food, assurance of compliance with FSVP or HACCP regulations for juice or seafood

  3. A current facility certificate issued by third party according to the US FDA’s third party accreditation program

  4. At least a three year history of importing into the US

  5. No ongoing or history of significant non-compliance (import alert, injunction, recall, etc.) concerning the supply chain and food

  6. Dun & Bradstreet Data Universal Numbering System ((DUNS) number

  7. No foods being imported by the importer including or not included in the program subjected to an import alert or Class 1 Recall

  8. Has not been the subject of any US Customs and Border Protection penalties, forfeitures, or sanctions Within the past three years

Each year, the importer must apply between January 1 and March 1 of the year, and each year the fee must be paid. The estimated fee is $16,400 per participant in the program, but an official announcement will be made each year on or before August 1. Additionally, the US FDA provides guidance on how to complete the application and what basic items are required for the QAP.

What Does This Mean For The Food Industry?

The US FDA is providing those promised guidance documents and clarifying some aspects of FSMA and the regulations which will enable the industry to comply with these requirements. The industry needs to understand this information in order to implement this correct. SGS offers guidance into developing and managing programs in accordance with the FSMA finalized regulations.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information, please visit our website:

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager

t: +01 973 461 1493

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