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Issues: Food SafetyPMA Comments to FDA on Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds September 8, 2008 To: U.S. Food and Drug Administration/Center for Food Safety and Applied Nutrition, http://www.regulations.gov Subject: Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds Request for Comments, Docket Number – FDA-2008-D-0381 The Produce Marketing Association (PMA) is pleased to submit these comments to U.S. Food and Drug Administration (FDA) regarding the agency’s request for comments on third-party certification programs for foods and feeds. PMA is the largest global not-for-profit trade association representing companies that market fresh fruits and vegetables. We represent 3,000 companies from grower-shippers and supermarket retailers, to hotel and restaurant chains and overseas importers. Within the United States, PMA members handle more than 90 percent of fresh produce sold to consumers. PMA and our members are committed to improving food safety practices for produce, domestic and imported, to further enhance the safety of our food supply. We have been actively engaged in produce industry development and implementation of food safety practices and have worked closely with FDA, USDA, and other state and local agencies as a source of industry information, as a source of technical inputs, and as a supporter of the agencies in assuring public health. In developing our response on this issue, we incorporated comments and thoughts from our Chief Science Officer, Dr. Robert Whitaker. Dr. Whitaker has been in the produce industry working in food safety for many years and has used third-party services domestically and internationally. He has extensive experience working for a produce company that exported produce to Europe and possesses keen familiarity with the practices of the certified third parties identified in the agency’s notice. Third-party certification programs to validate food safety practices is among the most important and complex issues facing the industry. PMA has played a catalytic role in working with its membership, related trade associations, FDA, USDA, state and local agencies to develop and implement improvements in food safety practices. PMA historically has provided technical expertise, input on industry practices and logistics, and constructive feedback to FDA on food safety issues ranging from traceback investigations to technical developments and agency guidance documents. Earlier this year, PMA provided comments on FDA’s initial request concerning third-party certification programs. Those comments strongly urged FDA to move to establish, or partner to create, a globally recognized food safety standard that could be built around existing FDA guidance documents and industry developed commodity specific enhancements, be based on our best current science and be grounded on the principles of risk assessment and management. Additionally, PMA unequivocally supported FDA in its proposal to develop certification programs for third parties to perform food safety audits against a globally recognized standard for the produce industry. As we pointed out, the produce industry has a long history of using third parties to perform food safety audits nationally and internationally. PMA believes a globally recognized food safety standard for produce and a certification program for third parties would ease FDA’s resource burden by permitting the agency to allocate resources to higher-risk products. It would also provide effective verification of food safety programs from the myriad of produce growers, harvesters, distributors, processors, and brokers around the world that supply the U.S. market. Simultaneously, an FDA-developed global standard and certified audit program would address industry’s critical need for uniformity, reliability, and consistency in addressing suppliers’ and buyers’ food safety requirements. A documented, transparent certification program for third parties would also create opportunities for third parties to participate and compete for business, thereby incentivizing auditors to continually improve their performance and deliver their services on a cost-competitive basis. This commentary focuses on the program attributes FDA identified for its third-party certification program in the draft guidance and compares and contrasts the guidance draft attributes with existing third-party practices. For purposes of organization, we will provide comments on attributes as they appear in the FDA guidance draft using the section designations provided by FDA. We will pass through sections of the draft guidance when we have no constructive comment or corollary current industry practice on which to base input. IV. Certification Process Just a note on the requirement for “the establishment to notify the certification body promptly of any intended significant changes to the safety or security systems it has in place”: This is an extremely important requirement in the produce industry. The produce industry is a fast-paced, innovative industry that is evolving, meaning that new product development is at a premium and new technologies and processes are commonplace. It is critical as new products are introduced and new processes are put in place that the food safety risk management practices are reviewed and validated. This needs to be a supply chain approach so that supplier and buyer are aware of the attributes of the process or product and its food safety performance is properly vetted. A. Application Process There is a requirement for listing a unique identification code for the establishment to be audited in the FDA guidance. Many third-party auditing firms currently ask for the FDA registration number (as required by the Bioterrorism Act of 2002) for a processing plant, packinghouse or cooling/distribution facility. Certainly the intention is to verify that the party being audited is in compliance with the 2002 Act and has a registration number. Some in the produce industry have taken the position that these registration numbers are proprietary. Thus many third parties just ask to see the documentation for the number and may either check off that a facility is properly registered or some will blank out all but the last four digits of the registration number on the cover page of the audit to verify proper registration. It is not clear whether FDA ever intended these registration numbers to be a unique identifier for an operation within the industry itself, but de facto they have become just that. There is no current equivalent of the FDA registration number at the farm level. Most produce companies do use internal codes for various growers that supply their operations down to the ranch and lot level. Growers typically have ranch and lot designations to track crop activities and these are transferred to the buyers of the crop in part via lot codes. These ranch/lot designations are often the basis for payment in the financial transaction between growers and buyers. Currently, third-party auditors list ranch names and grower’s names on the cover pages (sometimes along with addresses and GPS coordinates) of food safety or GAP audits so that it is clear which entities are being inspected. C. Recertification The section under Recertification is clear but there may be an alternate approach. In essence, FDA is saying that the frequency of recertification should be based upon the risk that the enterprise represents, which in turn emanates from the establishment itself, its compliance history, and the inherent risks associated with the products it produces. Clearly, if a company has production facilities that warrant increased scrutiny or a history of noncompliance then the frequency of recertification audits needs to be increased to ensure the company operates properly within the food safety standard. However, in terms of products and the risk they represent, it is important to note that in the produce environment, FDA’s list of high-risk crops may change depending on the latest foodborne illness outbreak data. It is clear that some products have a longer history of contamination issues, and though problems may still exist, those sectors of the industry have moved quickly to develop commodity-specific practices to improve food safety performance. Companies in those sectors strive to improve their food safety performance and should not be penalized solely on the basis of historical data generated before food safety awareness was improved, before new commodity-specific GAP programs were instituted, and before individual companies recognized their collective responsibility when foodborne illness arises in their product sector. However, it may be ill-advised to automatically increase the frequency of inspections for a company just because they produce products from crops that fall into a category where issues have arisen historically. Many companies have worked diligently to improve their food safety programs and those that have a track record of producing safe foods with these crops should not be automatically pushed into a group of higher inspection frequencies. Rather they should be rewarded and recognized for their investment in food safety and their safety records. Although the produce industry is proud of its strong efforts to improve food safety, we also recognize that there is more to be done. Some companies may not have prioritized food safety and risk management with the same emphasis. Therefore all companies growing the same products should not be treated the same in terms of inspection frequency. FDA should take into account a company’s commitment to and history with food safety. Perhaps it might be more prudent for FDA to require yearly or seasonal certification audits (many produce companies change production locations seasonally) for all participants in the produce supply chain from growers, to harvesters, coolers, distributors, brokers, terminal markets, distribution centers and processors and increase the frequency of audits only for those companies or facilities that have a history of food safety noncompliance in previous audits regardless of the crop they produce. Also bear in mind that frequency is quite different from who actually inspects a facility. One of the benefits of the FDA’s Third Party Audit guidance is that FDA can prioritize its resources such that the agency may choose to perform seasonal inspections on crop sectors it feels have a higher risk profile and could increase the frequency of those inspections based on their findings while the preponderance of inspections for other crops or entities might indeed be carried out by certified third parties. D. Decertification Again, this section is very clear and logical. We would only add that it is common produce industry practice following a food safety audit for the audited entity to submit written corrective action plans and supporting documentation to the third-party auditor within a specified time limit (generally 10 working days). Some third-party auditors have electronic corrective action format issued as part of their formal audit report and the corrective actions are submitted electronically as part of the data file. Others require paper corrective action write-ups and verification documentation (photographs, data logs, etc.) be sent in and approved prior to issuing certification. At least one scheme requires formal corrective action plans be submitted following an audit, and the auditors have the option to perform follow-up inspections to verify those corrective actions have indeed been implemented properly. V. Attributes for Third Party Certification Programs PMA supports the FDA concept of the agency “developing sufficient confidence in the credibility of the certification program in order to recognize such a program,” specifically relating to FDA confidence in the inspections and assessments performed and the validity of the decisions made by the certification bodies and their inspectors. It is expected that FDA should and would perform periodic inspections on the accreditation bodies and would either use those bodies or take the responsibility itself to further audit the certification entities to be sure they are performing as prescribed. The concept of accreditation of a certification body as it relates to produce industry food safety audits is still relatively new in the United States. As an issue, it has caused a great deal of frustration for both suppliers and buyers. This model of accreditation bodies germinated outside the United States in countries where central regulatory authority over food safety does not exist. Absent clear direction from FDA and with either real or perceived concerns regarding the consistency and credibility of current food safety auditing practices in the United States, many in the buying side of the produce industry are requiring suppliers to schedule food safety audits from accredited certification bodies, supplanting programs many suppliers have been using successfully for years. Having first-hand experience in the execution of both U.S.-based third-party auditors (that audit largely to the FDA’s guidance documents on GAPs and vegetable processing supplemented with commodity specific GAP standards) and European-based certifying bodies (with audits based on accredited standards), there really is very little difference in subject matter, auditor competency, process and integrity between the two options. Rather, the critical factor seems to be more one of perception where the European-based system very carefully lays out and markets the accreditation/certification aspects of their programs in comparison to U.S.-based third-party auditors that have focused on customer service and data management tools. It is important for FDA to identify those accreditation bodies that are operating in accordance with ISO/IEC 17011. Many U.S.-based third parties have begun the process of gaining certification under specific accredited standards and still others are working to have existing standards accredited. FDA can and should take a leadership role in identifying those accreditation bodies they can support and make these well-known to the industry in a timely manner. This would provide valuable direction to third parties wishing to pursue accreditation/certification and would help the buying community recognize the full pallet of certification and auditing options they could recognize for their suppliers. A transparent approach with clear definition of requirements and attributes for accreditors and certification bodies benefits the entire produce industry and opens up the process for all approved bodies to compete fairly based on merit. PMA strongly supports any FDA initiative that permits a diversity of certification and auditing options for its membership as it will permit companies who have invested heavily in food safety infrastructure to continue those business relationships with their chosen third-party partners (providing they meet FDA requirements as outlined in the guidance document), control costs via competition and create a comfort level in the buying community regarding technical competence and credibility of auditors. A. Authority of the certification Body 1. Authority to Perform Inspection Activities – The guidance document currently states “there should be no requirement that a certification body provide advanced notice of an inspection to the establishment.” Currently, in produce processing inspections, the FDA does not provide advanced warning of an inspection but does limit itself to performing inspections during normal business hours of operation. This is a very practical consideration for the produce industry even though the industry is essentially a 24/7 collection of activities. Often the personnel that could best assist FDA or third-party inspectors in accessing the information they need to perform an adequate inspection of the food safety status of an operation do work specified hours and might not be available to FDA or third-party inspectors if, for example, the inspectors were to audit a company during the sanitation shift. This issue of notification is even more important if FDA were to want to inspect a growing or packinghouse operation. Ranches go in and out of production over the course of a growing season and without proper interaction between the agency or a designated third party with the grower or packer, it is quite likely that an inspector might travel to perform an inspection only to find a ranch or packinghouse devoid of activity. While clearly recognizing the need for unannounced access to the facilities or operations to be inspected, PMA strongly urges FDA to adopt a policy of performing audits during regular or normal business hours. From this practical standpoint, the produce industry has addressed this issue in many cases by providing third parties with lists of ranches, processors, coolers, harvest companies and packinghouses they will use during a season, the approximate timeframe when they will be active and the contacts at those operations. It is important to remember that the produce industry is really a collection of industries so that a single salad processor might employ several different growers to provide raw product who in turn might use several hundred different ranches to grow that raw product. Similarly, depending on the processor’s size, a number of different harvest companies might be employed to harvest the crop and still others may be engaged to cool the crop prior to processing. At the commodity crop level, often several growers supply any one grower-shipper or repacker who in turn may use several harvesters and coolers to handle products. Often, even at the family farm level, a number of different farms may be used to grow products for any one customer. Existing third-party auditors in the United States are well-versed in the intricacies of these production relationships and work from lists provided by clients to perform audits (albeit many are still announced audits). While announced audits are still common practice, many in the industry have changed their practices to unannounced audits and the third parties have become adept at using the supplier lists provided by their clients to perform these audits based upon the timeframes provided by the client. In California, the Leafy Greens Marketing Agreement has developed a hybrid system where they essentially work from a list of growers/ranches provided by the LGMA signatory at the onset of a season but call the signatory 24 to 48 hours in advance of an audit to schedule the audit. This ensures that the proper personnel are available at both the signatory’s operation and the grower/harvester locations to provide the documentation required for the audit. It also enables the signatory to identify the ranch(es) that will be harvested that particular day so that the California Department of Food and Agriculture auditor can efficiently visit that set of ranch or harvest operations to observe the food safety practices employed. The limited notification period is de facto an announcement of the upcoming audit, but the fact that the signatory never knows when they will be contacted means that all operations must be ready for inspection at all times. 2. Authority to Examine and Gather Records and Other Information – The guidance currently would permit the “certification body and inspectors to examine records and other information relevant to the safety and security of the products for which certification is sought. This should include access to relevant records relating to the producing, manufacturing, processing, packing and holding of products for which certification is sought, including, but not limited to receiving preventative control plans and records, laboratory results, records regarding the upkeep and use of equipment, consumer complaint files and distribution records.” These general attributes are common to all third-party audits currently used in the produce industry, but it does represent an interesting conundrum in that FDA currently does not have statutory authority to some of these categories of records when performing a routine inspection of a facility unless FDA finds clear evidence that a product is adulterated. Given this apparent conflict, does FDA have a legislative plan that specifically remedies this situation? It would also be valuable for FDA to expand upon this section to point out more specifically which types of records the agency or an approved third party would want access to and how they will be used in determining the food safety status of the operation. For instance, if a third party should find a violation in a HACCP plan, e.g. in routine hourly readings of free chlorine levels in a vegetable processing wash system where the specified level of free chlorine is documented to be 3-7 parts per million (ppm), and the verification log shows the actual reading for the hour was 2 ppm, how will FDA react to that information? Currently when third-party auditors find an instance such as the example above, their focus is largely on the corrective actions taken by the producer and the verification of those actions. Will FDA work with approved third parties in the same manner, or will the agency view a single HACCP infraction as cause for regulatory action? Will FDA require certified third-party auditors to submit this type of information to the agency as a routine or only when or if that company comes under investigation? 3. Authority to Collect and Analyze Samples – “The certification body and inspectors should have the authority to collect and analyze samples.” It is not clear what kinds of samples are being discussed in this section. Vegetable and fruit growers and processors already test irrigation water and processing water as part of their GAP or HACCP programs. These data are made available to third-party inspectors as part of current food safety audits. As an example, growers are required to make their irrigation water test results available to CDFA/USDA inspectors as part of the LGMA leafy greens field audits. Other third-party GAP audits also require water testing data be made available at the time of inspection. Similarly, processing operations generally have microbial testing programs in place to verify sanitation operations (Total Plate Count for equipment sanitation, Listeria monocytogenes for drains, floors and walls) and the data are likewise made available for third-party audits. These types of microbial testing and data collection are recommended in FDA’s guidance on vegetable processing currently, and the industry has adopted these practices widely over the last 10 years. It is reasonable to hold the operator responsible for conducting this kind of testing and it is also consistent with best food safety practices to be sure that the labs performing the testing are certified (ISO 17025 or an equivalent standard) and that they are employing approved test methods appropriate for the materials being tested. It is already common practice for processors to make these data available to third parties during inspections as in during third-party food safety audits for the audited entity to provide inspectors with the laboratory certification and test methodology documentation for any tests used by the company to validate food safety practices. Indeed, many testing laboratories print the test methodology used and their certification information on the data sheets sent to the client to aid in audits and inspections. It should not be necessary for the third-party auditor or the FDA to take additional samples during an inspection unless the inspection uncovers evidence that the operation is likely producing adulterated products. It is not clear whether the agency is also including raw or finished product testing in this sampling authority. Raw and finished product testing is an important issue for the produce industry. Some buyers are requiring raw product testing, still others want finished product testing and some want both. Some are only interested in E. coli O157:H7 and Salmonella species while others add in EHEC, Listeria, total coliforms, generic E. coli and even total plate count. The initial focus of this requirement was with the leafy greens industry following the September 2006 spinach/E. coli O157:H7 outbreak but it is rapidly spreading across other commodities, such as tomatoes, green onions and melons. There are a myriad of testing protocols being employed throughout the industry, which have caused a great deal of confusion and frustration concerning the meaning of test results, confirmation practices and impacts on logistics and operations. Due to the perishable nature of most produce items, test-and-hold programs that would permit the producer to test the finished products, acquire the results and release the product for shipment are very often not logistically feasible as the time lost does not permit sufficient time in depots and retail stores. Raw product testing is somewhat more reasonable to accomplish in that raw products may generally be sampled some specified period of time prior to harvest, tested, cleared for harvest and then harvested thereby not impacting finished product shipment or shelf life. In either instance, it is important for FDA to recognize that if a third-party inspector or an FDA auditor were to take raw or finished product samples during a routine inspection at a processing facility, packinghouse or farm, the operator would most likely have to put the entire lot from which that product was produced on hold pending the laboratory test results. The hold would only be removed once a negative result was obtained. For most processors of vegetable products, buyers have imposed product specifications delineating the age (time from harvest to process) of raw products that can be processed into finished products to ensure quality. The same is true for the age of finished products (post-process) that can be shipped to ensure sufficient shelf life remains when the product reaches destination to permit its use or sale. For perspective, with perishable products, e.g. leafy greens, generally raw product can be no more than two days old and finished products cannot be shipped if they are more than two days old. These time limitations pose a very tight fit regarding most molecular-based testing methodologies and, in practice, given product shipping time requirements, lab working hours, quality assurance and data entry, and the timing simply does not work consistently. “Molecular positives” or “cannot rule outs” simply elongate the time lines. The end result is that any kind of product testing during a routine inspection (without evidence of adulteration) would result in raw and/or finished products “aging out” and requiring their disposal often at a cost of tens of thousands of dollars per product type or lot sampled. Equally important from a technical point of view apart from test methodologies is the sampling methodology. Current practice in the industry, where testing is required by specific customers, is to sample at the field level in a specified pattern (many use a 60-point “Z” pattern following pesticide residue sampling procedures) over a specified block of land, e.g. per acre or 10 acres, etc. If finished product testing is specified, bags or units of product are removed from the line periodically throughout a production run and converted to composite samples and tested. One can make an argument that using a standard sampling pattern for raw product testing can be an effective measure of gross contamination events at the field level, i.e. contaminated irrigation water or a contaminated foliar application would be expected to have an even distribution pattern and if recently applied could be discovered by standard pattern raw product testing. The problem is, these contamination events do not appear to be large, catastrophic events but rather isolated, low-frequency or spot contaminations that can easily be missed with standard sampling protocols; i.e. we are looking for the proverbial needle in a haystack. If that is true, then we need a statistically significant model to guide sampling to ensure we have some confidence that our sampling program will identify contamination with some degree of confidence. Currently sampling protocols are destructive (testing eliminates the product). And the sheer volume of raw product from any given acre of produce or finished bags produced from any single line is so massive that current product testing is statistically insignificant. The issue of sampling methodology for the produce industry is clearly an area where research is needed, but absent that research, renders most current programs somewhat meaningless. Given these concerns, PMA strongly urges FDA to more clearly define what types of testing are appropriate for produce, leverage current industry microbiology testing programs for environment and equipment sanitation and avoid any type of product testing in conjunction with routine facility inspections by third parties or FDA. It is understood that FDA has statutory authority to sample products and facilities if sufficient evidence of contamination is observed by an FDA inspector or an inspection is conducted as part of an illness outbreak investigation. 4. Authority to Assess and Report on Compliance with Certification Requirements – In this section FDA addresses the issue of whether the agency expects third-party auditors to provide inspection and corrective action reports, etc. There is also mention of obtaining information to “facilitate an investigation.” As discussed earlier in these comments, what level of violation does FDA see as sufficient to trigger an investigation? Perhaps it would be appropriate for FDA to describe in more detail how it will determine when an investigation is warranted and the steps it will take to make that determination. This section also states that “certification bodies and inspectors should have authority to approve corrective action plans for conditions noted during an inspection.” This seems very reasonable and necessary. However, it would be important to develop an arbitration procedure for those instances where the audited operation and the certified inspector cannot agree as to the appropriate corrective action. A principle objective of this Third Party Guidance is to ensure appropriate competence in inspectors and uniformity in approach and technical content for food safety audits. However, there most assuredly will be variability between inspectors even within the same third-party organization just based on their knowledge and experience levels. Further, in some areas of produce food safety (e.g. water quality, buffer zones, modes of transmission, etc.), there is a void in science-based data leaving some of these areas open to interpretation or application of what some might call common sense. Even among some accredited food safety standards there is room for interpretation at the operational level as they are written for general application and not developed based on a specific risk assessment for a particular production operation. These factors lead to the very real possibility that there will be differences of opinion between third-party auditors and the audited. Some will undoubtedly be invalid, but others might have merit. Does FDA have any specific plans for addresses these probable instances? There is a model in existence today with the GAP metrics for leafy greens and the audits performed by USDA/CDFA in California that may be worth considering at the agency. If during the course of an audit, the inspector notes a deficiency, the handler must develop a corrective action. If the inspector upon a return visit does not think the corrective action sufficient or proper, the LGMA has a standing technical committee that can examine the issue based on the intent of the metrics and advise the LGMA Board of Directors on the science involved. Similarly, the USDA/CDFA inspectors can identify issues that are not clear in the metrics where more than one interpretation is possible and raise these with the technical committee to get input and clarification as to intent and the science behind the requirement. This two-way communication between the audited and the technical committee and the inspectors and the technical committee has proven to be effective in minimizing issues around metrics implementation and corrective action development. The process also allows for modifications to the metrics and the audits as we learn from their implementation or as science and technology offer improved solutions to food safety questions. B. Qualifications and Training for Inspectors – The qualifications and competency for food safety auditors or inspectors in the produce industry has been a controversial issue for some years. First-hand experience with U.S.-based third-party inspectors, inspectors representing certified food safety bodies, various state and federal regulatory inspectors and international food safety inspectors indicates that there is some validity to the concerns posed by suppliers and buyers over auditor competency. There are certainly some extremely talented and devoted auditors plying their trade in the produce industry presently across all third-party companies and government agencies, but there is definitely room to improve performance and competence; a major tenet of the proposed guidance. The qualifications listed in the proposed guidance document are impressive and if properly implemented would undoubtedly address historical issues observed in the industry. A few suggestions for FDA consideration:
C. Elements of an Effective Inspection Program – PMA supports the risk-based approach to prioritization and focus for food safety auditors described in the guidance. The section on written policies and procedures is logical and well-presented. For the most part, these attributes are common to current third-party audits in the industry. There is a bullet point regarding “using sampling techniques that prevent contamination of the product and ensure a representative sample is collected.” The issue of raw or finished product sampling and testing has been addressed earlier in these comments and will not be repeated here. 3. Verification That the Establishment Meets Certification Criteria a. FDA Regulatory Requirements – In fact, the FDA guidance documents and the commodity-specific GAP documents developed at FDA’s request by the industry are the basis for food safety audits done by the preponderance of third-party auditors in the United States. PMA would support an FDA initiative to use these documents as a basis for creating a food safety standard that the agency could certify third parties to audit against. Alternatively, and in step with current trends, the agency could elect to create a standard from these guidance documents and submit that standard to a globally recognized accrediting body for accreditation and then act as a certifier for third parties. In either instance, it would be beneficial for the agency to enlist members of the produce industry all along the supply chain in the preparation of a standard to ensure it represents the best thinking of a cross-section of regulators, scientists, industry executives and operational managers thereby creating industry wide acceptance. An open process with full transparency need not be cumbersome in this instance as the guidance documentation that would form the basis of the standard is currently employed throughout the industry and well-known. b. Specific Safety and Security Systems – the attributes listed in this section appear to be reasonable and consistent with current industry practices. Employee training programs are part of most third-party audits and verification documentation are generally available from the field to processing plant and cooling/distribution levels. Supplier management programs are an essential tool for produce companies. Most processors have approved supplier lists and those that do not, should, as it is crucial to the safety of their products. FDA needs to recognize that the idea of approved suppliers does become more difficult in certain sectors of the industry. Brokers often buy and sell products when grower-shippers need more than they have produced to meet a customer’s needs or have excess product they wish to move. These products are bought from a various growers and/or shippers and are sold to a wide array of customers including other growers, processors, restaurants, retail chains, terminal markets and other brokers. Often a broker never really has possession of the products in a physical sense as they are bought and sold specifically for a customer and moved from seller to the ultimate purchaser directly. When sold on the open market, it can be difficult for purchasers to verify that the product was grown according to approved GAP programs and certified by an approved third party. Some shippers and processors in the industry have developed approved vendor lists based on their own internal review of potential suppliers’ food safety criteria, developed approved supplier lists and provide these lists to their brokers and buyers requiring them to source for their company only from that approved list. The sections on preventive controls, traceability (one step forward, one step back), consumer complaints, recall and crisis management are in line with current industry practices and are audited routinely by most third parties. Once again, we would caution FDA regarding the use of product testing as a validation for food safety in produce under the verification of product safety section. D. Inspection Audit Program – The proposed guidance is well-done. It is very important that the third-party certification body perform quality control on their inspectors and constantly measure the performance of their auditors. This will help guarantee auditor competence, improve the inspection process and engender confidence from both suppliers and buyers. FDA and/or third-party company management personnel may want to consider gathering comments and performance input regarding their auditors from the client companies being audited. The professional demeanor and ability of the auditors to relate to their clients’ food safety personnel are important aspects of overall performance and the client companies would be in a good position to provide that input on performance to the third party. E. Cooperation with FDA and Other Appropriate Government Officials When Safety Problems Occur - PMA supports agency efforts to improve traceback investigations in the event of foodborne illness outbreaks and the rapid determination of the causative agents and their sources so that the industry and the agency can learn and develop better mechanisms and mitigation methods to prevent recurrences. Toward this end, PMA can support FDA in its proposal for third parties to cooperate with FDA during an investigation when required. F. Compliance and Corrective Actions – no comments. G. Industry relations – no comments. H. Resources – no comments. I. Self Assessment of the Overall Certification Program – no comments. J. Laboratories – The matter of laboratories being certified and operated in conformity with ISO 17025 requirements has been discussed earlier in these comments. However, before finalizing these guidelines, it is incumbent on the FDA to verify just how many laboratories worldwide do comply with ISO 17025 requirements. As little as five years ago, a currently available certified auditing company had a requirement that all testing be done by ISO 17025 certified laboratories. In having this audit performed, a contracting Mexican company was denied certification because it was using a U.S.-based commercial laboratory that was not ISO 17025 certified but was certified by the state of California. Upon further investigation, the audited company learned that there were no ISO certified laboratories in Mexico at that time and only a handful of U.S. firms that were certified or seeking certification. Undoubtedly, this situation has changed dramatically over the last several years, but it may be advisable to look at the concept of equivalencies to ISO 17025 to ensure companies have general access to labs that can meet this requirement. K. Notification to FDA – No additional comments other than concerns already raised earlier regarding clarification of FDA’s actions for various types of infractions that might occur during routine food safety inspections. L. Conflicts of Interest – The proposed guidelines cover this important area well. It is important that third-party auditors, accreditors and certifying groups not have any formal financial, ownership, or other conflicts of interest with buying or supplying companies, associations or other organizations representing produce buyers or suppliers. Failure to abide by these principles can erode confidence in the validity of the audit process and create imbalances between buyers and suppliers. FDA is uniquely positioned to play the role of impartial arbiter of food safety as it has statutory authority over the industry. This aspect alone points to the need, stated throughout these comments, for FDA to develop a food safety standard and become the certifier for third parties to audit against that standard. Thank you for this opportunity to present our views. We look forward to working with the agency on this important issue and welcome any questions or opportunities for dialogue. Dr. Robert J. Whitaker, Ph.D. Chief Science Officer Produce Marketing Association
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