The Food Safety Modernization Act (FSMA) of 2011 brought sweeping reform to the food industry, affecting not only domestic but international suppliers. Three years ago, the U.S. Department of Agriculture (USDA) estimated nearly a fifth of the nation’s food supply was imported, including over half of all fresh fruit and almost a quarter of fresh vegetables. As food imports continue to rise, so do concerns about safety and the prevention of foodborne illnesses.
For this reason, FSMA requires food suppliers to be proactive in preventing illness by mandating the implementation of specific steps, including the Hazard Analysis and Risk-Based Preventive Controls (HARPC) program. November 2015 brought further final rules tied to the Foreign Supplier Verification Programs (FSVP), Produce Safety, and Third-Party Accreditation delineations. This article covers FSVP and its ramifications for importers.
Importers: The Ball Is In Your Court
The FSVP puts the onus on importers to ensure food brought into the United States is safe; the program also holds them accountable if safety issues do arise. The rule applies to any U.S. owner or consignee of food being offered for import, as well as any foreign owner’s U.S. agent, representative, or consignee at the time of entry.
Importers must establish written FSVP paperwork for every product and foreign supplier to ensure they meet the safety level required of U.S. farms and food facilities as mandated by the Standards for Produce Safety or HARPC. Companies generally must comply by May 28, 2017, but very small businesses have additional time, until July 27, 2020.
“Historically, many importers have facilitated business transactions between overseas suppliers and U.S.-based customers—they haven’t always been this involved in food safety—at least probably not the way FSVP says they need to be,” explains Jennifer McEntire, Ph.D., vice president of Food Safety and Technology for the United Fresh Produce Association.
While the new requirements will affect suppliers on both sides of the border, they may be particularly difficult for brokers. “They’re the ones who will have to get up to speed,” comments Ken Gilliland, director of International Trade and Transportation at Western Growers Association. Grower-shippers who already import produce counter-seasonally are familiar with good agricultural practices, he noted.
FSVP Requirements
Components of the program include analyzing risk, evaluating each foreign supplier’s safety performance, verifying supplier activities, taking corrective action when appropriate, and proper recordkeeping. In addition, FSVP effectiveness must be reassessed every three years, or if new information emerges about a risk for a particular product or supplier.
Hazard analysis
A hazard analysis is required for each food imported. The analysis—based on experience, illness data, scientific reports, and other information—must cover the biological, chemical, and physical hazards known or reasonably likely to cause illness or injury if no controls are in place (regardless of whether naturally occurring or intentionally or unintentionally introduced).
The Food Safety Modernization Act (FSMA) of 2011 brought sweeping reform to the food industry, affecting not only domestic but international suppliers. Three years ago, the U.S. Department of Agriculture (USDA) estimated nearly a fifth of the nation’s food supply was imported, including over half of all fresh fruit and almost a quarter of fresh vegetables. As food imports continue to rise, so do concerns about safety and the prevention of foodborne illnesses.
For this reason, FSMA requires food suppliers to be proactive in preventing illness by mandating the implementation of specific steps, including the Hazard Analysis and Risk-Based Preventive Controls (HARPC) program. November 2015 brought further final rules tied to the Foreign Supplier Verification Programs (FSVP), Produce Safety, and Third-Party Accreditation delineations. This article covers FSVP and its ramifications for importers.
Importers: The Ball Is In Your Court
The FSVP puts the onus on importers to ensure food brought into the United States is safe; the program also holds them accountable if safety issues do arise. The rule applies to any U.S. owner or consignee of food being offered for import, as well as any foreign owner’s U.S. agent, representative, or consignee at the time of entry.
Importers must establish written FSVP paperwork for every product and foreign supplier to ensure they meet the safety level required of U.S. farms and food facilities as mandated by the Standards for Produce Safety or HARPC. Companies generally must comply by May 28, 2017, but very small businesses have additional time, until July 27, 2020.
“Historically, many importers have facilitated business transactions between overseas suppliers and U.S.-based customers—they haven’t always been this involved in food safety—at least probably not the way FSVP says they need to be,” explains Jennifer McEntire, Ph.D., vice president of Food Safety and Technology for the United Fresh Produce Association.
While the new requirements will affect suppliers on both sides of the border, they may be particularly difficult for brokers. “They’re the ones who will have to get up to speed,” comments Ken Gilliland, director of International Trade and Transportation at Western Growers Association. Grower-shippers who already import produce counter-seasonally are familiar with good agricultural practices, he noted.
FSVP Requirements
Components of the program include analyzing risk, evaluating each foreign supplier’s safety performance, verifying supplier activities, taking corrective action when appropriate, and proper recordkeeping. In addition, FSVP effectiveness must be reassessed every three years, or if new information emerges about a risk for a particular product or supplier.
Hazard analysis
A hazard analysis is required for each food imported. The analysis—based on experience, illness data, scientific reports, and other information—must cover the biological, chemical, and physical hazards known or reasonably likely to cause illness or injury if no controls are in place (regardless of whether naturally occurring or intentionally or unintentionally introduced).
Factors covered include growing, harvesting, processing, packing, labeling, storing, transporting, and employee hygiene. The analysis also must assess how severe an illness or injury would be as a result.
Evaluation
Based on the hazard analysis results, each importer must then evaluate the risk posed by the food, and how well its foreign supplier can control the hazard. This is where the program can get rather complicated.
“In some cases, it may be difficult to determine who the supplier actually is,” Dr. McEntire notes, “because if the importer’s trading partner is a broker, distributor, aggregator, etc. and is not the entity controlling hazards, that’s not the supplier according to FDA. Importers may need to look further back in their supply chains to determine where to even start.”
All suppliers must have a prevention plan in place that complies with U.S. safety standards. The plan should follow good agricultural practices, standard operating procedures covering the cleaning and sanitation of equipment, as well as employee hygiene. All aspects of production, processing, storage, and transportation should be included to prevent hazards. The food supplier’s safety history also must be documented; e.g., if the supplier has received an FDA warning letter, what happened? How did the supplier respond?
Supplier verification
In addition to all the plans and protocols, there must be verification that a foreign supplier is, in fact, complying with required U.S. food safety practices—even if the foreign source is an affiliated company. Importers have several options based on the specific food risk or supplier, though they must be able to justify the type of verification undertaken.
Sonia Salas, Western Grower Association’s director of Science and Technology, noted that the FDA is providing some flexibility with respect to verification. Testing the produce or reviewing a supplier’s safety record may be sufficient if the hazard risk is low.
However, a poor safety record for the product or supplier itself should prompt importers to document other verification activity. An onsite audit is required if the hazard can result in a serious adverse health consequence or death to humans or animals. Further, all onsite audits must be done by a qualified auditor, which can be a government employee. Salas says many importers “will have to rely on third-party auditors.”
If it turns out a foreign supplier is not in compliance with U.S. food safety regulations, the importer is required to take immediate action. Appropriate action depends on the circumstances, but can include suspending the supplier until compliance is met.
Qualified Individuals and Managing Compliance
In regional U.S. Food and Drug Administration (FDA) meetings on FSMA readiness last year, a number of importers expressed confusion and uncertainty about the required hazard analysis evaluations, the scope of the evaluation, and who could perform such an evaluation.
All FSVP activities must be conducted by a ‘qualified’ individual. Any person handling a hazard analysis and evaluation must have training or experience, a requirement of FSMA’s Preventive Controls rule published in September 2015. Specifically, this would be “training in the development and application of risk-based preventive controls” from an FDA-recognized curriculum course or through adequate job experience in developing and implementing a food safety system.
Many importers and suppliers do not have such a person on staff, but with the advent of FSMA, there are a number of companies and individuals in the fresh produce industry offering these services. Dr. McEntire notes the abundance of technical experts who can help, but recommends importers talk to their trading partners, and look into their hazard evaluations as a starting point.
And if a third-party auditor is hired to perform the required evaluation and activities, importers are still legally obligated to review and assess the relevant documentation—therefore, importers will still need either sufficient knowledge, a qualified staff member, or a consultant to review the documentation of the third party.
For help, importers can turn to the FDA-funded Food Safety Preventive Controls Alliance, which has developed FSVP training to serve as a benchmark for other groups developing equivalent training programs. Additionally, although importers are not subject to FSMA’s Preventive Controls Rule unless they manufacture, process, pack, or hold food, the Alliance is encouraging all importers to take a Preventive Controls training course.
Modifications and Exemptions
For very small importers, or companies importing from small suppliers, there are far less stringent FSVP requirements. The same is true for companies importing produce from countries with which the United States has a preferential trade agreement, called a ‘systems recognition arrangement’ (see below).
Very small importers are defined as those with less than $1 million a year in human food sales. Facilities that qualify as very small suppliers include farms with three-year average annual produce sales of $25,000 or less, or growers exempt under the Produce Safety rule, and facilities that qualify for modified requirements under the Preventive Controls rule.
“Importers in these categories do not have to conduct hazard analyses,” confirms Salas. Nevertheless, she stresses, importers must still “get written assurance the supplier is in compliance.” In addition, small suppliers eligible for the exemption must have their status verified annually, and importers must still evaluate each small supplier’s compliance history.
The other exempt category is for suppliers of fresh produce from Canada and New Zealand. The U.S. has signed a ‘systems recognition arrangement’ with these countries, acknowledging that their food safety systems are comparable to the United States. Importers must, however, document not only that the imported food meets FSVP-modified requirements, but that the foreign supplier is covered by and in good standing with their country’s food safety program.
Maintaining Records
Although some may not view it as a critical factor in the FSVP process, records maintenance is a key component to compliance. Importers are required to maintain all FSVP records, in English, for each imported product and supplier, covering all of the aforementioned stages and activities. The difficulty, relates Dr. McEntire, is “keeping track of all the information, especially if the importer sources many different products from many trading partners.”
All records related to FSVP must be maintained for at least two years. Offsite storage of records is permissible, if the documentation can be provided onsite within 24 hours of an FDA request for official review. One plus is that it’s not necessary for importers to duplicate existing records complying with other federal, state, or local regulations—as long as the records contain the information required by the final rule.
Some Good News: VQIP
Importers with a history of at least three years can apply for the forthcoming Voluntary Qualified Importer Program (VQIP) beginning in January 2018 for the October 1, 2018 to September 30, 2019 period.
This voluntary, fee-based program is designed to expedite the review and importation of foods—a process of particular benefit to fresh produce importers. It will ensure faster entry into the United States, including limited FDA sampling and expedited analysis of audit samples.
To qualify, importers must develop and maintain a Quality Assurance Program that demonstrates “a high level of control over the safety and security of their supply chains.” Fresh produce must come from farms certified as safe under the FDA’s accredited third-party audit program, and VQIP applications can be renewed annually.
Critics say VQIP is too costly for smaller importers and places additional burdensome requirements and paperwork onto those already mandated by FSVP. Houston attorney Steven L. Varnis agrees, finding “VQIP will be a benefit only to large entities.” Further, he says the program requires a great deal of advanced planning to meet its requirements.
Some Bad News
In September 2016, the FDA reported that only 45 percent of small and mid-sized importers and 48 percent of large importers who participated in a self-assessment were ready for FSVP and its documentation.
According to the FDA, identified program challenges included “educating foreign suppliers, combating misinformation, working with documents in different languages [and] having to overcome language barriers.” For smaller companies, being “under-resourced and unable to dedicate complete resources to fulfilling the requirements of FSVP” loomed larger.
As a result, Gilliland believes importers “are going to take a good look at who they’re buying from” and could end up switching business partners to deal with “more established companies to supply their product.”
Varnis suggests FSVP requirements could have a negative impact on the industry’s smaller businesses. “If you only import avocados from Mexico and the value is well below the threshold or the producer is a very small entity, it’s not a big issue,” he reports, because importers can get written assurances from suppliers attesting to compliance. But for others, with numbers just above the threshold, FSVP training and verification activities can greatly increase costs and affect already slim margins.
The final component of FSVP compliance is enforcement. As the program moves forward, the FDA is likely to target products that pose a greater risk to public health. For fiscal 2017, the agency requested $14 million to perform FSVP inspections and provide educational activities.
The agency also plans to increase foreign facility inspections and is working with state authorities to develop their role in implementation and enforcement. Importers not in compliance with FSVP requirements will be subject to regulatory action, with warning letters and inclusion on an ‘Import Alert’ list among the penalties.
Conclusion
The FSVP rollout certainly presents challenges to some importers, particularly those that have had limited involvement in food safety issues. It will force receivers to take a close look at their suppliers, to not only determine who in the supply chain is controlling hazards, but to understand what is expected of them by the FDA. Business leaders involved in cross-border trade should begin now to put the pieces in place, to ensure they can meet upcoming FSVP requirements.
