Part 3 of FPAA to FDA: More service needed at the border

Part 3 of comments from Lance Jungmeyer and the Fresh Produce Association of the Americas comments to the FDA.


FDA Resources Targeting Towards Risk

 FPAA agrees that FDA should inspect, examine, test, and investigate a larger percentage of domestic and imported shipments of foods, cosmetics, drugs, and medical devices than it currently does. Further, FPAA agrees that the agency requires additional resources to increase its foreign and domestic inspection cadre and its analytical capacity.

Because of age and a lack of integration of FDA’s information technology (IT) systems, there are only a handful of solutions that FDA could implement without needing to fully enhance and integrate a new IT system. Many of the border delays that occur in Nogales, AZ, affecting the fresh produce industry crossing product at Mariposa POE are a direct  result of insufficient FDA resources.

The local FDA office opens at 8 a.m. (local time) and used to close at 4:00 pm, Monday through Friday. After requests from the industry, the local office opens at 8:00 and closes at 6:00 p.m. Monday through Friday and for 2 to 3 hours on Saturday during the peak produce season.

However, trucks carrying fresh produce from Mexico bound for the U.S. arrive at all hours of the day until well past 7:00 pm and on Saturdays and Sundays. Those trucks that arrive after the FDA office closes, and which have been  recommended by OASIS for FDA sampling, must stay at or near the port of entry until the next business day.

This delay increases the risk that the food will be of lower quality when it reaches its destination and the U.S. consumer but does not bring measurable results to enhancing food safety. The most common business practices in the Mexican fresh produce industry all incorporate harvesting early in the morning followed by packing and/or cooling the early afternoon prior to shipment.

The vast majority of fresh produce crossing at Mariposa POE originates within 18 hours (drive time) from the Mexican/U.S. border. In many cases, trucks arrive at Mariposa POE in the evening bearing fresh produce picked earlier that day. However, if FDA’s electronic screening system has targeted the truck (or one particular  commodity on a truck containing several  commodities) the entire load is unable to proceed to its destination. In far too many cases, the FDA inspectors release the load without even sampling it when they arrive the next business morning. For products having shelf lives of several days, the loss of 12 hours is significant.

Moreover, the congestion at the port area caused by the delays increases the security risks to the port infrastructure as many more trucks are required to  wait at the border area solely because the government officials are not present to make release or sampling decisions. FPAA believes that FDA should receive additional resources that are specifically intended to permit the Agency to maintain operational hours that are consistent with the operating hours of the POE.

FPAA advocates for more FDA resources because of the significant food safety and food  security risks that the Agency’s restricted hours pose to imported fresh produce. However, only increasing FDA resources, even for the purpose of expanding the Agency’s operational hours at ports of entry such as Mariposa, is not a panacea. There is a significant need for FDA’s targeting of its imported food inspections and samples towards those shipments of product that are more likely to be contaminated or at risk – irrespective of the particular commodity.

Even  shipments of foods that are among FDA’s presumed “high risk” food categories can be low risk if the parties responsible for the food along the supply chain have taken verifiable steps that mitigate the risks. FDA must receive additional resources that are directed at developing a dynamic risk-based food inspection regime that takes into account those factors that indicate that a food shipment's low risk and should not be inspected.

However, these two principles still rely on other important solutions, such as the integration of the Agency’s IT systems. For even if FDA were to adopt a more dynamic risk-based model to determine what it should (or should not) inspect or sample, the Agency must be able to communicate the results of that risk-based review to Customs & Border Protection and customs brokers in real time so that the low risk shipments can proceed rapidly through the border.

The FDA has been working on a PREDICT system that, to the FPAA’s understanding, has been delayed significantly. Even with the development of PREDICT, the FDA would still operate under separate IT systems, including the Prior Notice system, which was not slated to be integrated into one master system, whether PREDICT or something else. Additionally, the FPAA is unaware of the development of a dynamic, powerful, risk-selection database geared to domestic products.

FDA will never receive sufficient resources to inspect all known and unconfirmed highrisk shipments. Therefore, FDA’s inspection resources must primarily be focused on shipments where it is more likely to find violations that relate to food safety risks.

Once FDA’s inspectional and analytical programs identify and document the relevant food safety risks, the agency should turn to programs that are designed to distinguish manufacturers, processors, packers, and growers within those higher-risk food industries which are demonstrably implementing sound, science-based food safety and security programs to mitigate the risks from those  companies which are not mitigating the risks – or those which cannot adequately demonstrate that they are mitigating the risks.

It is this fundamental element of distinguishing good suppliers and products from those that are unsafe or those with an unknown safety risk profile that FDA’s current and historical model is incapable of achieving.


Without it, the agency will be left with continuing to make educated guesses as to where it might find contaminated or high risk food shipments – resulting in unnecessary and costly delays of safe and secure fresh produce shipments and improper agency release of unsafe imported food.

FDA Laboratory Analytical Delays

In those situations where FDA decides to sample and analyze fresh produce, it currently takes anywhere from 72 hours to 5 days or more to obtain the analytical results and a release from FDA. Nearly 24 hours of that delay is consumed by the sampling and shipping process alone – delivering the sample to the FDA laboratory. However, another 18 hours of delay occurs when FDA laboratory analysts, with flexi-time schedules, arrive for work in the lab at 6:00 a.m., and leave by 2:00 p.m.

When a sample of fresh product arrives at the laboratory for analysis at 11:00 a.m. or noon (or later), the analyst will wait until the next day to set up and run the sample. This additional delay compounds the damage to produce caused by increased time and  less-than-optimum storage conditions. In too many cases, by the time clean laboratory results are received and reported, the fresh produce has already passed a quality point requiring it to be discarded.

In this regard, FDA’s testing processes, which are intended  to ensure that an imported shipment is safe, ironically contributes substantially to the tested food being of such a lower level of quality that it is no longer marketable – and  yet  FDA releases the shipment because of the clean analytical results. This is not as uncommon an event as one might suspect.

Even if the FDA delay is not that dramatic, the impact on a product with a short shelf life may still be significant. Obtaining information about the status of sampled shipments can also be difficult because the local offices lack the communication systems to keep shippers, importers, and customs brokers updated as to the progress of a sample analysis.

For example, Nogales, Arizona, no longer has a Compliance Officer that is responsible for working directly with the trade and releasing shipments once test results are reported from the lab. Companies must now deal with Compliance Officers located in Dallas, which is in a time zone two hours ahead of Nogales during a portion of the shipping season.

Additionally, Compliance Officers typically work from Monday  through Friday, but lab results are often available on the weekend. Unfortunately, those results are not communicated directly back to the importer until the Compliance Officer returns to work, often costing several days of shelf life for a perishable commodity. FPAA believes that FDA should apply additional resources it receives to:

• Hire additional laboratory analysts to expand laboratory services and cover imported perishable products on a more rapid timetable; and

• Establish more laboratories which use reliable rapid screening analytical methods in order to decrease the time necessary to  obtain analytical results while maintaining testing reliability.

• Continue to invest in strategically deploying the mobile lab to Nogales, Arizona,  and other areas across the country when needed.

• Develop clearer, more risk-based sampling assignments for mobile labs when they are deployed.

• Establish weekend hours for Compliance Officers or allow lab staff to release shipments in the electronic system following completion of lab results.

FPAA will continue to advocate for additional  resources for the FDA. However, FPAA submits that it makes far greater sense to avoid shipping produce to the U.S. border that contains a contaminant in the first place. Therefore, many Mexican fresh produce growers and packers already conduct routine tests of product prior to shipment to ensure an FDA inspection and test will not reveal a problem with the product. In contrast, FDA’s current import paradigm attempts to catch  problems as they cross the border.

This is wildly inefficient and ineffective. Far too many trucks cross our borders each day to entertain the suggestion that FDA could sample and test its way to any cognizable level of safety that U.S. consumers and congressional committees expect and deserve. FPAA urges that FDA begin recognizing and incorporating into its own import risk screening process the routine, scientifically sound, and reliable Mexican government or approved third-party laboratory testing being conducted at the point of origin.

FPAA believes this will assist the Agency in focusing its limited import inspection resources on those shipments that have not been tested or that pose some additional and  identifiable risk factor. As mentioned above, many growers and packers in the Mexican fresh produce industry already conduct point of origin testing. But they also implement routine and rigorous water analyses and Good Agricultural Practices (GAP) to ensure their products are safe for consumption.

Although each of these  components should eventually be considered in developing a dynamic risk-based imported food safety program, point of origin sampling and analysis – whether the analysis is conducted in Mexico or in the U.S. – can quickly be incorporated into FDA’s current decision making process when product arrives at the port of entry. FDA’s continued failure to take the industry’s dedication to food safety into consideration in its risk matrix is counterproductive and wasteful.

The Agency’s current program essentially acts as a Quality Assurance check on produce already confirmed to be safe and wholesome. If FDA were to incorporate already conducted testing into risk analysis, the producers, growers, and packers who fail to implement verifiable and auditable point of origin testing would face an increased likelihood that their products would be inspected and tested by FDA; the FDA would be able to better target its resources where the food safety risks are truly greater; and the Agency’s border sampling programs would not add risk to supply chains carrying low risk foods.