At long last, the final part of the Fresh Produce Association of the America's long comment to the FDA on preventive food safety controls for fresh produce. The comment continues its theme of a critical look at FDA's current procedures.

Communication of Procedures, Policies, and Expectations

The FDA has historically operated its import operations on the back of antiquated agency policies and procedures, which were created in the 1970s. Chapter 9 of FDA’s Regulatory Procedures Manual, a few regulations promulgated in the last century, and the more recent Bioterrorism Act regulations (relating to prior notice of imported foods and registration of food facilities) together represent the total sum of FDA policies and procedures for managing as much as half of all of  FDA’s regulated commodities in interstate commerce.

Although there are many unpublished internal procedures under which FDA districts operate, and some districts have promulgated local policies and procedures to address certain isolated problems in the importation process, the vast majority of what FDA does or expects from foreign shippers and exporters and U.S. importers remains shrouded – and therefore malleable.

Many of FDA’s published procedures (the RPM, the Investigation Operations Manual, Compliance Policy Guides and Compliance Program Manual Guides) have no legal effect whatsoever; however, they are implemented as if they are regulations  promulgated under the Food Drug and Cosmetic Act. FPAA acknowledges the need for reasonable flexibility given that FDA is confronted with so many potential concerns related to imported shipments. However, the lack of uniform practices, procedures and policies across  districts and the agency’s failure to publish its expectations in a venue that promotes  dialogue with the regulated industry often leaves similarly situated importers and shippers in different positions; legally and with regard to the ensuing administrative process.

For instance, FPAA understands FDA has no “50-mile  radius” rule, however, it is common for importers and customs brokers to believe  that if FDA targets a shipment for sampling, that shipment must remain within 50 miles  of the POE, unless FDA expressly permits it to be transported to a more remote location. In addition, FDA districts and regional labs have different “requirements” for private laboratory packages, submitted in order to obtain release of automatically detained shipments.

Some districts require  “certifications” be signed by third party samplers or private laboratories respecting whether any other analyses have been conducted on the same shipment for the same importer. Other districts permit importers to collect their own samples, rather than requiring a third party conduct the sampling.

When FDA’s OASIS targets a shipment for FDA review on a weekend or on a holiday, it is unclear whether the importer is required to keep the shipment in the port area or if the shipment may be delivered to a warehouse or to its final destination.

At times districts will inquire whether the shipment is still in the port area, and if not, the district will obtain a demand for redelivery just to determine whether the shipment is still “intact”. No sampling will occur even though the importer is required under the Customs bond to redeliver the load.  These and other incongruities could be resolved if  FDA would operate with a level of transparency similar to Customs and Border Protection. Customs’ local port offices also issue local procedures, but they do so after entering into open and public dialogue with the affected industry.

FDA’s unpublished procedures are often learned only by experience, and if they happen to be implemented in any given instance, resulting in amaging, unnecessary delays and unpredictability. The fresh produce industry is operating production and supply chains that are measured in hours, if not minutes. FDA’s lack of management over the irregularity of its own procedural house produces uncertainty in the industry and increases costs unnecessarily. FPAA recommends FDA enter into a public dialogue with the fresh produce industry to revise its procedures and policies relevant to the agency’s import operations.

FPAA believes FDA should conduct an open dialogue specifically with the Mexican fresh produce processing and exporting industries, the Mexican government, and U.S. importers to develop clear and flexible procedures that protect the public while still reducing the unpredictable nature of interacting with local FDA districts. FPAA believes FDA should consider establishing a Federal Advisory Committee under the Federal  Advisory Committee Act (FACA) to obtain recommendations from industry on how to ensure the safety of imported fresh produce and target true food safety risks at the border.

This Advisory Committee should be similar to the USDA Agricultural Marketing Services Fruit & Vegetable Advisory Committee.  Further, FDA should begin the process of promulgating, through the notice and comment review process, clear procedural regulations governing import alerts and mtigation guidelines for Customs liquidated damages actions for failing to redeliver perishable product subject to short shelf lives. The new regulations should clearly articulate the kind of evidence and information FDA may rely upon in order to issue Import Alerts, or may request demands for redelivery, or may mitigate Customs penalty cases and, similarly, the kind of evidence or information FDA would expect to see to overcome the appearance of a violation, obtain removal or exemption from an Import Alert, or obtain mitigation or cancellation of a Customs penalty case.

Without clearly articulated and enforceable policies and procedures governing all administrative processes associated with FDA enforcement actions at the border, the industry is unnecessarily exposed to arbitrary, unpredictable, non-uniform and disparate regulatory and  administrative actions across districts.

This encourages exporters and  importers to seek more lenient, less wary ports of entry to import products that may or may not represent safety risks. Improving the OASIS Sampling Rate Process FDA’s current OASIS screening process is based, in part, upon the Agency’s annual budgeting and work planning processes.

 Once the Agency determines the number of samples it intends to collect and analyze from a certain imported commodity group, OASIS is programmed to recommend a pool of potential shipments of that commodity to be sampled as they arrive.

Under the current  system, FDA lacks the resources to collect samples on many of the shipments recommended by  OASIS. To a certain extent, the over targeting of shipments for sampling enables the local districts to exercise discretion  regarding which specific shipments they will actually sample for testing. There is tremendous value in relying upon the local inspectors’ expertise for targeting among a pool of potential shipments those specific shipments FDA will analyze.

However, the challenge when a significant percentage of shipments are held for electronic review before release is that many of the shipments not selected for sampling are not officially released until later the following day after arrival in the U.S. This delays the shipment of that product to customers across the U.S. Because of the restricted local office hours (mentioned previously) and the failure to consider point of origin testing programs that are  already in place in many Mexican fresh produce operations, far more shipments are held and unnecessarily delayed than can ever actually be tested.

When the greater percentage of those delayed shipments are high risk, or coming from producers who are not routinely implementing food safety program to mitigate risks, the increase delay may indeed be justified and certainly can be useful to the Agency in promoting food safety programs in the industry overall. However, without providing benefits for those producers who are using established and  documented food safety programs, such as expedited clearance and facilitated importation, FDA is unable to point to a market-based reason for new shippers to implement food safety programs.

The FDA’s current program, in this way, is counterproductive to promoting food safety across the industry because it does not distinguish between those who are committed to it in their operations and those who are not. FPAA believes FDA should immediately exert substantial effort in developing -- with industry -- voluntary risk-based programs, which enable growers, packers, shippers, and importers to demonstrate their regular and reliable use of systems that mitigate food safety risks prior to shipment.

These joint industry-agency efforts should be conducted using a public Advisory Committee to ensure transparency of the process and the collection and evaluation of many new ideas for identifying, assessing, and mitigating risks associated with imported fresh produce. Such programs may incorporate independent third party reviews or inspections of growing, harvesting, packing, cooling, and shipping operations.

They may rely upon Mexican government food safety inspections or USDA inspections. As a result, FDA would be able to distinguish in OASIS between low risk and high risk shipments and populate its potential pool of FDA sampling targets with substantially greater high risk  products. The FPAA believes that OASIS should be modified to enable it to electronically may proceed far more shipments of fresh produce originating from Mexican operations which are capable of documenting their implementation of verifiable food safety and security measures.

Repeat Sampling of the Same Products Originating from the Same Shipper

Another contributing factor to the weakness and inefficiencies of FDA’s current import safety program involves OASIS recommending sample collections from shipments containing the same commodities originating from the same shippers which have been repeatedly tested by FDA before.

Irrespective of whether FDA actually tests the targeted shipment (which merely compounds this problem further), the shipper or importer must hold the shipment intact at or near the border until an FDA inspector is available to release it. In the situations where FDA actually samples a repeat shipment, the agency is, more often than not, wasting precious inspection, sampling, and testing resources and capacity.

Clearly, even if FDA is aware that a shipper is implementing a food safety system that is likely to substantially mitigate the risks associated with an imported food, some audit process is necessary to ensure the shippers systems remain effective.

This audit process must be implemented using FDA partnerships with foreign governments, the USDA, private companies, and FDA’s own inspectors to ensure that limited FDA resources are not overwhelmed by auditing demands and that the industry is not punished by the lack of government resources. In many cases, FDA samples the same product from the same shipper and not surprisingly achieves the same negative analytical results.

FPAA believes this is in part due to the fact that FDA’s current risk assessment program fails to adequately consider the steps that many in the fresh produce industry are taking to reduce safety risks. In addition, as long as FDA’s import program predominantly attempts to catch safety problems at the border through random selection, the likelihood that safe product will be unnecessarily delayed and FDA will consume precious laboratory resources testing products and finding nothing will continue to increase.

As the trade in fresh produce continues to grow as is anticipated, the inefficiencies in the system will also increase – particularly if FDA receives additional import resources but does not fundamentally change its approach to its imported food program. Repeated testing of the same products from the same shippers is only reasonable if FDA targets shipments for sampling based upon the shipper’s failure to implement a reliable food safety program – or its failure to distinguish itself from other high-risk shippers.

Under the current program, however, growers, packers, shippers, and importers of safe and secure fresh produce experience significant delays because the system does not account for the documented food safety programs implemented throughout the supply chain. FPAA again thanks FDA for continuing a dialogue with the industry on food safety enhancements and commodity specific food safety practices.

The FPAA urges the Agency to continue a dialogue with the industry,associations, and growers who stand ready to distinguish themselves as producers of safe and secure fresh produce for the U.S. market. Through such dialogue, the industry and the Agency can design a program thatincorporates a mix of food safety verification procedures that will enable FDA to target the greater portion of its examination and sampling efforts on the food posing the greatest threats to the U.S. consumer.

 In the interim, FPAA believes FDA should develop procedures that permit the Southwest Import District (SWID) to set local OASIS criteria reducing the sampling rate for Mexican fresh produce processors and exporters that have repeatedly demonstrated their food safety and security programs are mitigating risks.

In addition, SWID and the Southwest Region should  be granted the authority, within certain constraints, to review the food safety and security measures of Mexican fresh produce growers, exporters and importers and to determine sampling rates based upon clearly (and publicly) articulated criteria.

Taking Advantage of Existing OASIS Screening Improvements and Opportunities

 FPAA is aware that OASIS has the capacity to screen  against more data elements than it currently uses in its operations. In the absence of  a clear development timeline for PREDICT, the FPAA urges the FDA to find ways to better use the data elements submitted to the Agency.

For instance, the system is able to take in account not only the manufacturer or shipper and product associated with  an entry, but can also screen against the carrier, customs broker, importer, and port of  entry. U.S. customhouse brokers, that are traditionally the link between FDA and the exporter/importer and who submit information to FDA on each shipment, conduct regular in-house audits to verify the accuracy of information submitted to FDA.

In addition, through the new PREDICT system, which was proven as a concept using fresh  Mexican lettuce in 2004 and piloted more recently in Los Angeles District on imported seafood, the possibilities for introducing substantially more dynamic risk-based screening could be possible. Again, FDA has thus far resisted expanding PREDICT to  enhance the screening capabilities of OASIS. As a result, even when importers were ableo demonstrate that they were purchasing their products (including fresh produce) from growers and packers  implementing effective food safety systems, and consistently using the same transport companies, the Agency has not considered such facts in its routine import screening programs. As proven by the PREDICT model, the ability for FDA to know more about how food is produced, handled, transported and stored necessarily improves the agency’s ability to make more effective risk-based import examination and sampling decisions.

Moreover, OASIS is already capable of receiving and screening against supply chain data, which can be used to create a signature for low-risk and mitigated-risk fresh produce shipments. Therefore, FPAA urges FDA implement those  enhancements that are already available in OASIS to enable growers, packers, shippers and importers to distinguish themselves as implementing the necessary food  safety and security programs to mitigate risks, justifying FDA’s facilitation of their imports using the improvements to OASIS  already in place.

Further, FPAA believes that SWID should have the capability of modifying screening criteria, using published criteria, to enable that district to better target shipments that represent high or unknown risks and to target away from low- isk and mitigated-risk products and supply chains.

Extending FDA Prior Notice Screening to Render Advanced Admissibility Decisions

With the promulgation of FDA’s Prior Notice regulation, mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the BioterrorismAct), the agency repeatedly refused to use Prior Notice data for assessing admissibility of imported foods. Because the vast majority of prior  otice submissions occur simultaneously with the entry declaration, there is little basis for continuing this paradigm. unexamined products. This delay is wholly unnecessary and contributes to a loss of shelf life with no food safety or security benefit. 

FPAA is of the opinion that because FDA is receiving notice of all relevant criteria through prior notice, the agency should release all fresh produce shipments it does not intend to sample by the time the product is physically released by Customs at the port of entry. The unnecessary delays in obtaining electronic releases from OASIS plays a substantial role in increasing financial risks of for the importer through the Customs bonding and liquidated damages process. Moreover, FPAA believes that the delay between the Customs release and the FDA release amounts to the  substantial equivalence of a detention without any evidence of any appearance of a violation.

For instance, FDA has in the past delayed release of cantaloupes for several days without taking a sample when it wants to “send a message” to the industry or to wait to obtain laboratory results from a sample from a previous shipment. FPAA believes such conduct is contrary to the law. In order to correct it, FPAA believes FDA should release fresh produce based on the prior notice data so that by the time Customs has released the shipment at the border the importer is safe to use or further distribute the shipment.

Connecting the release process to the prior notice disconnects shipments that are awaiting laboratory results from those have not been sampled. Where FDA holds a shipment for sampling FPAA believes FDA should conduct that sampling within 24 hours of importation at the importer’s warehouse. 

FDA’s Government to Government Negotiations Should Focus on its NAFTA Partners

Due to the widely publicized food and drug safety breaches involving products of Chinese Origin, the Department of Health and Human  Services (DHHS or department) and FDA spent months negotiating with the Chinese government to open a pathway for Chinese made foods and over-the-counter drug products into the U.S. market. DHHS entered into Memoranda of Agreement (MOAs) with Chinese government agencies that provide a blueprint for Chinese manufacturers and  processors of “high risk” foods, which are otherwise subject to a countrywide import alert and other products from China, which have historically been fraught with safety and processing problems.

Under the FDA’s and department’s food safety and imported food safety strategic plans and action plans, a high risk food is one where there has been an historical food safety or food contamination problem. The U.S. government’s  approach in the MOAs is to establish a quasi-third party inspection regime, similar to that used for managing risks associated with heavy metal-laden Chinese-made  ceramic-ware. FPAA agrees with many of the principles contained in the MOAs, however,

FPAA believes FDA’s and the department’s efforts to pave the way for Chinese-made high-risk foods using a third-party inspection program is misdirected and should only be undertaken following a similar program developed  with Mexico and Canada.

The United States’ most trusted and important food trading partners are Mexico and Canada. More than 50% of all FDA-regulated imports originate in or travel through Mexico and Canada. The United States has far more extensive access to Mexico’s foreign manufacturing, processing, and exporting   industries than it will ever have in China.

Because of the high level of cross border traffic between Mexico and the U.S. and the importance of establishing good paying and high quality jobs in Mexico, to name just a few reasons, FDA’s and the department’s efforts should first be directed at America’s NAFTA partners. FPAA believes that FDA has a far better chance of  obtaining verification of third party programs instituted in Mexico than in China because of the transparency of the Mexico-U.S. food supply chain, the scope and extent of existing relationships between the two countries’ food safety agencies and the close proximity of the Mexican source industries to the U.S. target markets.

FPAA urges FDA and the department to apply its limited resources in negotiating and implementing international agreements, to  include development of third party-riskbased imported food programs with Mexico rather than China.

U.S. importers, Mexican food safety agencies and the Mexican industry are poised and prepared to work directly and immediately with FDA to establish a verifiable third party testing and inspection program that goes to the  core of imported food safety. Again, the FPAA thanks the FDA for the opportunity to comment on these issues during the open comment period for food safety initiatives for domestic and imported foods.

The FPAA also reiterates the desire to create industry-FDA  partnerships/committees to review imported produce procedures, databases, information usage and collection, and more to better streamline the operations of both FDA and the industries that strive for enhanced cooperation and compliance with FDA.

As we mentioned at the beginning of these comments,  the members of the FPAA strongly support a risk-based approach to food safety that has equal oversight of both domestic and imported produce and equal oversight of small, medium, and large farms. We see this as the most effective approach to enhancing food safety. Sound science and proper allocation of resources based on risk must be the foundation of food safety regulations moving forward.

The industry strongly urges the FDA to continue forward with additional research that would improve testing and detection methods and that would identify new procedures in growing, packing, and harvesting that could enhance food safety. Please do not hesitate to contact us if we can provide additional information, assistance, or further feedback.