19 Jan 2018
FDA to Exercise FSMA Enforcement Discretion, Will Soon Move Forward with Expedited Food Import Programme
The Food and Drug Administration has announced its intent to not enforce certain provisions in four rules issued under the Food Safety Modernization Act concerning preventive controls for human and animal food, the foreign supplier verification programme for importers of such food, and produce for human consumption. FDA Commissioner Scott Gottlieb said this enforcement discretion is designed to allow the agency to address certain challenges with implementing FSMA requirements as it works to find long-term solutions. The FDA had previously extended the compliance dates for many of these same provisions in recognition of these challenges.
The provisions the FDA does not intend to enforce relate to the following.
- preventive controls and current good manufacturing practices requirements in the human and animal food rules for foreign and domestic facilities that conduct activities typically conducted on farms but that fall outside the current definition of farm (e.g., facilities that would qualify as farms if they did not colour raw agricultural commodities, or as secondary activities farms except for (i) the ownership of the facility or (ii) the fact that they pack, package, label and/or hold processed food that consists only of raw agricultural commodities that have been dried or dehydrated to create a distinct commodity)
- customer provisions in all four rules intended to provide written assurance to importers, manufacturers, processors or farmers that the food will be processed to control for hazards before it reaches consumers
- foreign supplier verification programmes for importers of food contact substances
- activities performed on certain human food by-products for use as animal food
The FDA has also announced that it expects to begin accepting applications early this year for the Voluntary Qualified Importer Program, which will provide for expedited review and importation of human and animal food by participating importers who achieve and maintain a high level of control over the safety and security of their supply chains. This expedited treatment will be particularly helpful, the FDA states, for those importing perishable products or using just in time processing. The FDA believes VQIP benefits will incentivise importers to adopt a robust system of supply chain management and allow the FDA to focus its resources on examining and sampling food imports that are more likely to present a potential risk to public health.
The FDA states that it will expedite entry for all foods included in an approved VQIP application. Specifically, the agency will be setting up its PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) import screening tool to recognise food shipments that are part of the VQIP programme and, in most cases, immediately release those shipments without further examination and sampling.
The FDA notes that it will generally limit its examination and sampling of approved VQIP food to “for cause” situations in which it suspects a potential risk to public health, such as possible contamination or misbranding. In such cases the sampling or examination location would be the VQIP food’s destination or another location chosen by the importer, to the extent possible, and any laboratory processing of samples would be expedited.
The VQIP application can include any FDA-regulated human and/or animal food, including seafood, processed foods, produce, dietary supplements and pet food. Foods covered by the VQIP application must be produced in a foreign facility or farm that is certified by an auditor accredited through the FDA’s accredited third-party certification programme.
Importers should have at least a three-year history of importing food into the United States and be in compliance with supplier verification and other responsibilities under the Foreign Supplier Verification Program and the juice and/or seafood Hazard Analysis and Critical Control Points regulations, if required. However, the FDA notes that VQIP recognises importers that go above and beyond the mandatory requirements of these programmes to establish additional controls over their supply chains. For example, VQIP importers should have quality assurance programmes (which include written policies and procedures regarding safety and security) that show compliance with criteria related to transportation and food defence. The FDA notes that many companies “are already doing much of what is required to participate in VQIP.”
Importers will be able to start applying for VQIP in early 2018 (the specific date has yet to be established and is dependent on how soon auditors can issue facility certifications) and will need to resubmit their notices of intent to participate each year. Participants will be charged a user fee each year; the specific amount will be published around 1 August but the FDA previously estimated it at US$16,400. One application will cover all the foods an importer intends to import under the programme and may cover multiple foreign supplier facilities or farms. The FDA intends to initially assess up to 200 applications in the first year, although that number could be higher or lower depending on the amount of resources needed to initiate the programme.