There have been several notable recent developments involving FSMA implementation. Most significantly, FDA proposed to extend the compliance dates for the agricultural water provisions of the Produce Safety rule and announced it will delay the start of Produce Safety rule inspections until spring 2019.  Additionally, FDA has issued another chapter of its Preventive Controls for Human
Foods (PCHF) draft guidance, which addresses the use of heat treatment process preventive controls.

In addition to summarizing these developments, this post also provides a reminder that the next round of FSMA compliance dates for the Preventive Controls rules is September 18, 2017.  Read more.

FDA has started conducting inspections to assess compliance with its Foreign Supplier Verification Programs (FSVP) regulation. The initial FSVP compliance date was May 30, 2017, though FSVP importers may have later compliance dates for their various suppliers that are smaller sized businesses. Inspections started earlier this summer. In this post we provide a brief overview of how these inspections are progressing based on the inspections we have learned about.

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There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA) of interest to the food industry. In this post, we summarize the following topics:

  • Delayed start date for inspections for compliance with the preventive controls requirements under the Preventive Controls for Animal Food (PCAF) rule and under the Foreign Supplier Verification Programs (FSVP) rule for animal food importers;
  • Guidance for low-acid canned food (LACF), seafood, and juice manufacturers regarding compliance and exemptions under FSMA;
  • Updated domestic and foreign reinspection fee rates for fiscal year (FY) 2018;
  • Release of new Food Safety Plan Builder software to assist with development of food safety plans; and,
  • Clarification regarding the definition of “retail food establishment” for purposes of the waiver from requirements under the Sanitary Transportation of Human and Animal Food rule.

Click here to read our update.

There have been several recent developments regarding implementation by the Food and Drug Administration (FDA) of the FDA Food Safety Modernization Act (FSMA) that should be of interest to the food industry. In this post, we summarize the following topics:

  • Regarding imports:
    • FDA’s recognition of Australia’s food safety system as comparable to the United States, which allows for modified Foreign Supplier Verification Programs (FSVP) requirements of certain foods imported from Australia;
    • Information from FDA to importers about key things they need to know about compliance with the FSVP rule and what to expect during upcoming inspections;
    • Launch of a website where organizations can apply for recognition as a third-party accreditation body.
  • Information from FDA on the agency’s implementation of the Sanitary Transportation of Human and Animal Food (Sanitary Food Transportation) rule;
  • FDA’s plans to extend the compliance dates for the agricultural water requirements of the Produce Safety regulation; and
  • Inflation-adjusted values applicable to several very small business-related definitions used in the FSMA rules.

    Click here to read more.

May 15, 2017, was the “stand up” day for the Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) new organizational structure under its Program Alignment initiative. The Program Alignment initiative began in 2013 as an effort to modernize and strengthen the agency’s workforce and to improve public health response. A key aspect of the Program Alignment initiative is a shift from the current geography-based district offices to program-specific “division” offices where staff are aligned by FDA-regulated product – i.e., there will now be distinct food-based offices, inspectors and labs and distinct medical products-based offices, inspectors and labs. This means that, over time, food companies will be inspected by individuals trained in food inspections, not drug or device inspections. This increase in specialization is intended to create a more proficient workforce and increase the efficiency of FDA operations.

With the change to program-specific division offices, some of the former district offices have been merged together. Practically speaking, this means that for some food companies, the contacts in their respective division offices may have changed. Other key changes under the Program Alignment initiative include a reorganization of the import program, state cooperative programs, and FDA’s field laboratories, and the creation of a Produce Safety Network. We have provided an overview of the key organizational changes at ORA that impact the food industry.

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There will be significant changes at the U.S. border starting May 30, 2017, that will affect all imported FDA-regulated foods—even if they are exempt from the Foreign Supplier Verification Programs (FSVP) regulation under the FDA Food Safety Modernization Act (FSMA). All food imports will be rejected at entry unless certain new information is provided to FDA. We summarize these new data requirements below.

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The Food and Drug Administration (FDA) recently issued a guidance document entitled Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs [(FSVP)] Regulation, which recognizes the use of Dun & Bradstreet Data Universal Numbering System (DUNS) numbers for identifying the FSVP importer to FDA when filing entry for imported food. This recognition was anticipated, having been forecast during the rulemaking. It is notable, however, because it serves as a reminder of the importance of ensuring the appropriate entity’s DUNS number is provided at entry given the significant responsibilities placed on the FSVP importer. Therefore, in addition to providing background on and a summary of FDA’s guidance, this post also discusses the significance of DUNS numbers for identifying the FSVP importer.

This new requirement takes effect as soon as May 30, 2017 for some imports.  DUNS numbers also will be required for imported food that is verified or further processed under the either of the Preventive Controls regulations.

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Earlier this month, the Food and Drug Administration (FDA) held a two-day public hearing that addressed the agency’s plans to engage in strategic partnerships to enhance the safety of imported foods. FDA used the hearing as an opportunity to ask questions of and learn from private entities and food safety authorities in other countries. The key topics discussed were the use of third-party certification bodies in regulatory decision-making, systems recognition, international capacity building, and commodity-specific exports and programs. We summarized some of the highlights from the hearing that may be of particular interest to food manufacturers and their trade associations. FDA has opened a docket for comments on the issues discussed at the hearing, which is open through May 16, 2017.

Click here to read the summary.

The Food and Drug Administration (FDA) recently finalized its guidance regarding the Voluntary Qualified Importer Program (VQIP) for food importers. Enacted under the FDA Food Safety Modernization Act (FSMA), VQIP is a fee-based program that provides expedited entry for food from importers who have a high level of control over the safety and security of their supply chains. Participation is limited to food from foreign facilities that are certified by an accredited third-party auditor under FDA’s final rule on accreditation of third-party certification bodies.  FDA will begin accepting applications for VQIP on January 1, 2018 and the program will start operating during fiscal year 2019 (October 1, 2018 through September 30, 2019). The agency has not yet finalized the program fee.

Below we provide an overview of the VQIP requirements and benefits, as explained in FDA’s VQIP guidance, as well as next steps for implementation of the program. We summarize the benefits of VQIP, the eligibility criteria for participation, the application components, how VQIP applications will be reviewed, and VQIP inspections. The guidance also details the procedures FDA will follow in revoking or reinstating participation in VQIP, which are not summarized herein.

Click here to read more.


The Food and Drug Administration (FDA) recently issued its final rule addressing Foreign Supplier Verification Programs (FSVPs) under the FDA Food Safety Modernization Act (FSMA).  The regulation parallels the supplier verification provisions of the preventive controls regulations, requiring “importers” to develop and implement supplier verification programs for food imported to the United States. The rule takes effect for most importers in 18 months (May 2017). FSVP represents a paradigm shift, as it is the first time that FDA has regulated food importers. The requirements under the new regulation are very detailed and record-intensive, likely necessitating careful attention by all food importers—including retailers, brokers, and food companies importing finished goods. The regulation will have less impact on facilities that are subject to preventive controls, as they are deemed in compliance with FSVP because the supply-chain oversight requirements in both rules are essentially the same. Below we provide an overview of the key provisions of the FSVP final rule.


Click here to read more.