August 22, 2011

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

Re: Preventive Controls for Registered Human Food and Animal Feed Facilities Docket No. FDA–2011–N–0238

To Whom It May Concern:

On behalf of our members, the Produce Marketing Association (PMA) submits the following comments in response to FDA’s request for comments on preventive controls for registered human food and animal food/feed facilities, Docket Number FDA-2011-N-0238 (76 Federal Register 29767, May 23, 2011). Under the Food Safety Modernization Act, FDA must promulgate regulations with respect to hazard analysis and preventive controls and issue guidance related to those regulations. This docket seeks information that will inform the development of guidance on hazard identification and control measures associated with specific types of food or specific methods of manufacturing, processing, packing, or holding food.

PMA is the largest trade association representing companies that market fresh fruits and vegetables. With members in 45 countries, we represent 2300 companies from grower- shippers and supermarket retailers, to foodservice operators and importers. Within the United States, PMA members handle more than 90 percent of fresh produce sold to consumers. Reflecting the produce industry, PMA’s members vary in size. Larger companies, including buyers such as retail chains or foodservice operators, often buy from smaller businesses. And the trend for local produce has provided significant market opportunities for local growers and processors provided they can meet food safety requirements from their buyers.

In addition, PMA supports the Center for Produce Safety (CPS), which is focused exclusively on providing the produce industry and government with open access to the actionable information needed to continually enhance the safety of produce. Research results from CPS benefit companies of all sizes and locations. PMA’s members of every size and at every level in the supply chain are committed to food safety and share FDA’s focus on prevention.

PMA respectfully submits these responses to the following topics that FDA set forth in the notice:

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1. Conducting a hazard analysis to determine the hazards associated with specific human food or animal food/feed and processes (e.g., the procedures used to determine potential hazards and to assess whether they are reasonably likely to occur).

PMA asserts that it is the responsibility of the facility operator to conduct a hazard analysis, and Congress agreed with this approach. Under the new food safety law, owners or operators of facilities have this duty. Indeed, the law specifically directs FDA to issue rules that have sufficient flexibility so that are practicable for all types of facilities. Even though operations may produce similar categories of finished products, each will have unique aspects associated with its production practices, raw product and ingredient sourcing, sanitation approaches, worker training, management principles, etc. These differences mean that these operations may present different risk profiles. Clearly, one size does not fit all. A salad plant producing bagged iceberg lettuce salads would be expected to have much different equipment and product flows than a processing operation producing cut fruit.

Even within a single operation, if the facility produces multiple types of products, one would expect to account for product-specific operational differences in any thorough hazard analysis. For example, a processing facility producing chopped romaine salads might also produce salads containing baby leaf lettuces and spinach on adjacent production lines. Even though contained in the same facility, the equipment used for these similar products may be different owing to the nature of the commodities used. Therefore, hazard analysis really needs to be conducted on a product-by-product basis to account for these differences (e.g. product washing and water chemistries, drying operations, bagging, temperature, equipment sanitation, etc.).

The variability in operational practices dictates that each facility operator needs to conduct his or her own hazard analysis. Indeed, PMA has commented before to FDA that individual operators know their facilities and processes intimately and are therefore best-positioned to conduct these hazard analyses; however, FDA can play a critical role. Many produce companies have had HACCP programs in place for several years, have trained their employees on the principles of HACCP and undergo regular audits that verify adherence to their HACCP programs. However, others, especially those that may be smaller or relatively new to processing, may still be developing their HACCP protocols.

A wide range of resources is currently available to facility operators to help guide them in conducting a hazard analysis and prepare a HACCP program including: various universities and extension services that offer HACCP and hazard analysis training, documentation from WHO, Codex, trade associations, FDA guidance documents on HACCP in produce and FDA seafood HACCP. Many companies have found FDA’s seafood hazards and controls guide valuable because it contains all of the “answers to the test.” It has become the document with which FDA field inspectors are most familiar and therefore comfortable. Working with the produce industry, it would be valuable for FDA to develop updated guidance on how to conduct a hazard analysis or do a risk assessment from a produce perspective using “real-

2 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011 world” produce examples gleaned from FDA inspections and industry operational experiences.

This “how to” guidance would be invaluable as a refresher for those who have HACCP in place and as a practical road map for those who are developing HACCP programs. This guidance could be extended to facility operations like packing sheds where full HACCP may not be appropriate (i.e. there may not be any critical control points) but where risk assessment and development of risk management practices is vital. To be most effective, this guidance should include produce-specific examples that operators can recognize and use to guide their own hazard analyses and written programs.

2. Implementing process controls (e.g., processes employed to prevent, eliminate, or reduce to acceptable levels the occurrence of any hazards that are reasonably likely to occur).

Process control covers a broad spectrum of activities in typical produce operations. As there are no practical “kill steps” in produce, manufacturing operations employ a multi- step approach toward contamination hazards. Though process controls must be tailored to specific operations and based on the attributes of the product and the manufacturing scheme, the produce industry typically deploys several layers of controls. Risk management generally starts in the field via adherence to Good Agricultural Practices (GAPs), specific time and temperature controls for raw and finished products and within processing facilities: Sanitation Standard Operating Procedures (SSOPs), Standard Operating Practices (SOPs), Good Manufacturing Practices (GMPs), employee training, HACCP and may include microbial testing and internal and third-party audits as verification measurements.

As discussed in the previous section, the underlying structure for comprehensive food safety programs is risk assessment or hazard analysis. Failure to recognize risks and properly define hazards can lead to the development of ineffective controls and a false sense of security that the resultant food safety program is sufficient. FDA can play an important role by defining a framework of general expectations around how to conduct proper hazard analyses and the types of preventive controls or metrics that might be valuable.

For example, FDA might specify that processors must develop HACCP-based programs for their processing operations. For many processors, wash water sanitation is often identified as a critical control point so therefore would be a critical component of their hazard analysis. Owing to the unique nature of individual processor wash systems, FDA cannot get more specific than to require HACCP and perhaps indicate that wash water sanitation should be considered as a potential hazard or cross-contamination risk to be managed. It then becomes the responsibility of the operator to conduct a hazard analysis that includes wash water sanitation.

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Further in partnership with industry, FDA should provide basic guidance to ensure operators of all sizes and levels of sophistication understand the basic elements of conducting a hazard analysis. It is interesting to note that while there are several resources available on HACCP development and the seven principles of HACCP, surprisingly little is available to instruct those unfamiliar with risk assessment on the basics of conducting such an exercise. Most instructional materials clearly indicate a hazard analysis must be done, but do not go into any detail as to how that should be accomplished. For many growers and operators not familiar with hazard analysis or risk assessment, lack of familiarity can become a hurdle in performing this critical element of food safety plan development. As mentioned in the previous section, this guidance needs to be produce-specific with actual examples or appendices that describe scenarios generally faced by fruit and vegetable processors. This guidance could become a basic element of operator training as executed through the Produce Safety Alliance.

3. Validating food/feed safety controls (e.g., information on procedures used to determine that control measures are capable of controlling the identified hazards).

It is important that preventive controls developed to address or manage specific hazards or risks be validated. Typically, in produce processing, operators validate the efficacy of their facility and equipment sanitation systems, wash water sanitation, metal detection, temperature control and package integrity (if appropriate). For example, equipment sanitation validation is often established by repeated testing of processing equipment over a period of time prior to sanitation and then post sanitation to measure reduction of microbial load. Often this testing is performed using a Total Plate Count method (TPC) and a well-defined swabbing protocol that includes a listing of all equipment that is to be tested and locations on that equipment where swabbing is to occur.

As TPC is time consuming (results can take 24-48 hours) and costly, TPC is often tested in parallel with a cheaper, faster test that can be easily carried out in a process environment. Often the measure of choice is ATP bioluminescence. Once sufficient data is developed to permit validation that ATP swabbing reflects the results obtained with the more direct measure of TPC testing, ATP swabbing becomes the daily test or verification method for measuring sanitation efficacy and TPC may only be conducted weekly or monthly as ongoing validation of this approach.

An important piece of any discussion on preventive control validation has to include the availability of research data to support preventive controls. For example, for several years many processors have correctly identified wash water sanitation as a critical control point in their processes. The management practices employed to mitigate cross-contamination risks from wash water have typically been to control wash water pH and addition of chlorine or sodium hypochlorite. Many operators, seeking to “do the right thing,” measure pH and chlorine in their wash water every hour throughout the day and log this data as verification for their HACCP program.

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However, recent research developments indicate that every wash system is unique (i.e. water temperature, water flow rates, duration/exposure times, sanitizer application points, water mixing cycles, product turn rates, make-up water rates, etc.). And wash water sanitation is also very much dependant on the product being washed, its condition upon receipt and the microorganisms one wishes to control. Organic materials brought in with the product like leaves or stems, accumulated organic load and pathogen targets like E. coli O157:H7 or Salmonella react very differently to specific sanitizers. Indirect measures of sanitizer, such as oxidation reduction potential, while convenient and continuous, do not accurately reflect actual sanitizer levels, especially when organic loads accumulate during the production run. In other words, recent research highlights the importance of validating that the practices used for wash water sanitation actually achieve microbial control or reduced the risk of cross-contamination under the conditions typically encountered in the production environment and that generalizations or “one size fits all” approaches are simply not appropriate. Because of the variability in systems and approaches, the operator and not FDA must take responsibility for validating that the preventive control is effective. At the same time, as the science changes around specific preventive control practices, industry, the scientific community, and FDA must be prepared to modify preventive controls to improve efficacy.

FDA can impact the practice of validation by specifying the validation of preventive controls. As indicated earlier, it may be that some operations have presumed preventive controls that are rigorously verified daily or hourly, but are largely ineffective in achieving control. Many audit programs focus only on the verification of the controls and remain silent on whether that control has actually been validated as effective. In effect, FDA and the produce industry have an opportunity to educate operators on the role of validation and the difference between validation and verification. Any rule that suggests validation of preventive controls should be accompanied by guidance to assist operators in this area. The guidance must contain produce-specific examples and outline how to validate specific types of preventive controls. It is important to define general experimental protocols for conducting validation exercises and specify the types of data needed to support. This will bring uniformity to validation activities and ease interpretation of results. As already suggested in previous sections, FDA should partner with industry to help develop guidance so that it reflects actual produce operations and practices.

4. Implementing sanitation controls (e.g., procedures and practices utilized to minimize the risk of contamination) for human food and animal food/feed.

Sanitation has been viewed by the industry as a foundation food safety program. Equipment and facility sanitation programs are essential to any comprehensive food safety program. There are clearly variations in sanitation practices throughout the industry based on commodities and operators. Typically, operators either employ separate sanitation crews or contract with outside sanitation companies to accomplish sanitation. Many larger processors have sanitarians attached to each production shift to accomplish any sanitation requirements as they arise during production, e.g. wash and sanitize a production line

5 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011 between production runs. Most companies, regardless of size, wash and sanitize equipment and facilities at the conclusion of a production day.

Sanitation programs and practices generally evolve within companies based on their layout and specific equipment. Input from equipment manufacturers, technical expertise from sanitation chemical suppliers, observations from third-party food safety partners, data from microbial verification and the collective experience of the operator and its employees form the basis for most sanitation programs. Many processors have written Standard Sanitation Operating Procedures (SSOPs), and sanitation employees are trained at the beginning of each season on these procedures and verification record keeping. Ongoing training occurs as needed. Prior to start up of a production shift or after a wash and sanitation event on equipment, some form of verification (usually an ATP bioluminescent test) is conducted to measure sanitation efficacy. Most third-party food safety audits cover these sanitation activities and require inspection of records, employee training records, availability of sanitation chemical use and content labels, records of chemical mixing and preparation, water quality data for water used to mix chemicals and inspection of chemical storage areas. In recent years we have seen equipment design and construction evolve to accommodate rapid disassembly and cleaning. Many operators use microbial verification data to assess sanitation crew performance and to identify problem areas to design engineers for equipment or facility improvement.

The produce industry has observed the priority FDA places on sanitation, particularly in those instances when FDA is conducting inspections. With all the advances in sanitation science and practices within the industry and the priority both the industry and the agency place on sanitation, there are clearly operators who still require guidance and education to emphasize the role of sanitation in making their food products safer. Indeed, it is important to help the industry level the playing field in this arena so that all operators understand the importance of proper sanitation. There is no pattern here; large or small, packing shed to processing facility and across all commodities, there will always be room to improve sanitation practices.

As has already been stated in these comments, FDA can provide leadership byspecifically identifying sanitation as a point of focus in the food safety rules and guidance under development. However, FDA can only offer a framework around sanitation (e.g. suggest written sanitation procedures, formats for SSOP development, validation of sanitation methods, provision of verification of sanitation, suggest training be provided to employees, etc.) as the specifics for the actual processes need to be the responsibility of the operator. Equipment, process design, equipment construction, commodity, temperatures of operation, the nature of the work force, facility design and construction are best known by the facility operator. Therefore, the responsibility for SSOP development and methods of sanitation needs to rest with the operator.

5. Implementing supplier controls (e.g., procedures and practices used to ensure raw materials and ingredients are safe for their intended use).

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It is important that suppliers be able to demonstrate their adherence to their food safety programs. Processors that rely on growers to provide raw agricultural commodities need to be sure that these growers employ GAPs based on sound risk assessments that are specific to the crops they provide. Similarly, processors that use custom processed ingredients, such as ingredients in salads, need to account for the safe production, shipment and storage of those products prior to use. This philosophy also extends to other materials that contact the food. For example, sanitizers should be verified for content and strength. Film manufacturers, carton producers and other packaging suppliers where the materials contact food also need to follow risk-based food safety programs to ensure these materials do not provide a cross-contamination risk.

Food safety is a supply chain-wide responsibility and that supply chain includes all of the components of the food product. The level of control required needs to be risk-based and take into consideration the intended use of the product. For example, sterile packing cartons should not be required for produce that is field packed as that product will likely be washed by consumers prior to consumption. However, it is reasonable that the carton be expected to be manufactured and stored prior to use so that it does not become an unexpected risk to the safety of the produce. On the other end of the spectrum, it should be expected that a custom sliced carrot ingredient in a bagged salad should be produced and packaged according to the provider’s HACCP-based food safety program and shipped and stored prior to use to maintain its food safety integrity.

Many processors have written suppliers’ programs that include their expectations for food safety and verification for adherence to supplier food safety programs. Some conduct audits and may also require third-party audits. Often processors will provide food safety training to valued suppliers to help them comply with food safety requirements. It is important to note that supplier food safety programs should extend to being able to demonstrate where any specific food ingredient came from. Being able to trace the source and identify specific lots of ingredients can be vital to limiting the scope of finished product recalls when safety problems are discovered. Many firms have an internal supplier approval program and lot tracking system with clearly defined coding. Indeed, “supplier approval” programs are commonly part of any good food safety auditing scheme today. These supplier approval programs should extend beyond simple “letters of guarantee.” There should be a comprehensive, risk-based supplier sourcing program that can be verified and documented via on-site visits and/or third-party audits.

PMA supports guidance that includes supplier verification programs to help ensure the safety of produce. As always, the guidance must be based on science and account for the factors raised in this section. As a recurring theme, any recommendations regarding supplier verification should be supplemented with produce-specific guidance to aid producers and suppliers. Though many processors and packers have documented supplier verification programs, this is another area where FDA has an opportunity to shine a light on the importance of this food safety tool and work with the industry to develop produce- specific guidance to help producers with such programs.

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6. Allergen control (human food), including procedures to ensure that ingredients are accurately declared on the label, procedures to ensure the proper label is applied to the food, and procedures and practices to prevent the unintentional incorporation of a major food allergen into a food by cross contact during manufacturing, processing, and holding food.

As products were developed that contained multiple ingredients, the produce industry recognized the need to develop allergen control programs as part of their basic food safety programs. A documented allergen control program is a requirement in most third-party audit schemes. Any processing operation should consider allergens in its hazard or risk analysis and have standard operating procedures (SOPs) for handling ingredients that are known to be allergenic and training modules for employees on allergenic materials. PMA would expect any produce food safety guidance put forward by FDA to contain a requirement for allergens to be included in hazard analysis, and that SOPs be developed and trained on to ensure proper handling.

It may also be important to consider how many allergen-related recalls are related to failures to adhere to written food safety programs versus companies not understanding labeling rules or breakdowns in communication when developing packaging artwork. Labeling requirement guidelines currently exist, but FDA may want to reference these guides when promulgating its food safety guidance. It may also be worth considering guidance that companies specifically provide verification/documentation that labels for products be specifically reviewed by appropriate managers to be sure appropriate labeling is included that accurately addresses allergen issues.

7. Environmental monitoring for Salmonella and for Listeria monocytogenes for specific types of food facilities (e.g., ready-to-eat food facilities, pet food facilities).

Many produce processors and distribution center operators have been conducting environmental sampling for Listeria spp. for several years. This requirement is standard in many current food safety audits and reflects the unique physiology of Listeria that permits growth under the cold conditions associated with produce processing and storage. The objective of these Listeria sampling programs is to verify facility sanitation protocols and prevent buildup of Listeria populations that might cross-contaminate products. The test for Listeria spp. is used by many in the industry as an indicator; if a positive Listeria spp. test is obtained, it suggests conditions in the facility exist that support the growth of Listeria and corrective actions need to be taken.

Current protocols for sampling for Listeria spp. can vary by operation, but in general, operators divide their facilities into zones and take composite samples from each zone on a regularly scheduled basis. The focus for sampling is generally on floors and drains, locations where Listeria might be expected to accumulate. Positive samples generally result in a concentrated re-sampling within the zone that yielded the positive test result for Listeria species and the use of protocols designed to specifically identify the human

8 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011 pathogen Listeria monocytogenes. Using PCR-based testing, the industry can get Listeria spp. results in 24-48 hours. If the PCR test is positive, BAM confirmation testing takes another three to four days to verify the sample as L. monocytogenes. A finding of a positive sample for Listeria spp. regardless of whether it turns out to be the pathogenic L. monocytogenes or not is generally followed by a complete wash-down and sanitation process and then another sampling to verify the process was successful in eliminating the bacterium.

Many operators work with their third-party testing laboratories to develop sampling protocols and test procedures. Sampling may be done by the operator, but in most cases it is performed by the laboratory. Risk-based sampling is employed by some operators based on their history with the facility and locations that may have been problematic in the past.

It is important to note that sampling is performed on surfaces that do not contact food, given the timeframe for sampling, shipping samples to a testing lab, conducting the initial PCR test for Listeria, confirming positive test results and then communicating results to the operator. Because of the perishable nature of produce, “test and hold” procedures for environmental testing are not practical. Operators have instead chosen to sample accumulation points where Listeria, if present, would be likely to accumulate, e.g. drains and run-off flumes where the by-products of processing flow. If food contact surfaces were sampled, finished products would need to be held prior to obtaining results. Because many processed products are shipped within 24 hours of production to ensure freshness and proper shelf life, holding product for a minimum of two days and perhaps longer, would result in product loss and supply chain disruptions.

As FDA prepares the guidance, it is important to consider the scope of various operations involved in production. As indicated here, many large processors already have environmental testing programs focused on Listeria. Packinghouses and smaller processing operations may or may not have Listeria environmental testing programs or have them to the same level of sophistication as larger companies. As discussed above, an environmental testing program calling for periodic sampling and testing for Listeria is a measurable and reasonable preventive control to verify facility sanitation efficacy. Identifying this as such will in effect level the playing field and highlight the importance of facility sanitation verification.

However, it is also important to consider environmental testing for Listeria in the context of the entire food safety program. A risk/reward argument should be considered here. In produce where the finished products are highly perishable and speed to market is always of the essence, direct pathogen testing of food contact surfaces would directly invoke test and hold protocols and cause unwarranted supply chain delays. FDA should consider leveraging current industry practices that involve testing for indicator Listeria spp. and sampling non-contact surfaces.

In the broader context as part of a comprehensive, written, risk-based, facility food safety program, Listeria spp. testing can be effective verification tests of sanitation efficiency. It is

9 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011 important that FDA give operators the flexibility to create a risk-based plan that meets food safety requirements but also permits efficient production and distribution. Given the statistical limits of sampling and the timeframe constraints for produce, a food safety program from field to finished product in conjunction with selected measures like environmental testing is likely to be more effective that an effort focused only on pathogen testing.

8. Microbiological and other testing used to help ensure the safety of specific human food and animal food/feed.

The produce industry has employed microbial testing for several years. These comments have described microbial testing procedures for verifying sanitation programs on equipment and in facilities. The industry has also routinely tested irrigation water quality using generic E. coli as an indicator for contamination. Water used for processing, pesticide mixing and field-level produce rinsing operations is also tested routinely by growers and processors for some commodities, e.g. leafy greens. Indeed, many companies also test the water quality of drinking water provided to harvest crews. Clearly, not all operators employ microbial testing as broadly as indicated here. PMA would encourage FDA to work with the industry to examine the use of microbial testing versus the risks presented and the operational impacts testing would engender. This risk-based approach is consistent with FDA philosophy and will serve to focus industry efforts on contamination risks that represent the highest priorities.

PMA has provided FDA with comments on product testing in the past (July 23, 2010, FDA Docket 2010-N-0085: Preventive Controls for Fresh Produce). The produce industry is currently discussing the value of product testing. For some of the commodities that have been historically related to illness outbreaks, producers and buyers have developed raw and/or finished product testing programs for pathogens. The industry has even seen expansion of some of these programs to include non-O157 shigatoxin-producing strains. In addition to industry-related efforts, FDA, USDA and others continue to execute market basket, border sampling and inspection-based testing programs focused on a range of commodities and targeted to various points in the supply chain.

Product testing offers several unique challenges for the produce industry and FDA. Any regulation or guidance on product testing must account for some of the following considerations:

 Can “test and hold” work with highly perishable produce? The perishable nature of processed fruits and vegetables dictates that these products must be harvested, processed and shipped within 12-48 hours so that they can be received in distribution centers around the country with approximately 10 days of shelf life remaining. This permits adequate time to distribute produce to retail outlets and foodservice operations to be purchased by consumers. Failure to deliver products within these time constraints can result in product being rejected at distribution

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centers. This timeframe makes traditional “test and hold” protocols difficult to execute in produce.

When buyers have mandated product testing (raw or finished), growers and processors have resorted to using rapid, DNA-based polymerase chain reaction (PCR) testing as a screening tool. Most results from this type of rapid screening are available within 24-36 hours. Unfortunately, although these tests can be very useful, they have proved to be less than 100 percent conclusive. It turns out that “positives” are not always positive and, in some cases, samples that are positive can be missed. As a result, positive or “can’t rule out” samples are subjected to follow-on confirmation testing using traditional FDA BAM methods. While BAM plating tools are useful as confirmation tests, they can take three to four days to complete.

 Are all pathogens tests equal? Test sensitivity and selectivity are important factors when choosing an assay method. There are a variety of tests available commercially today for E. coli O157:H7, Salmonella and other pathogens. They can cost anywhere from $8-10 to nearly $100 per test, depending on the technology employed and the testing objective desired. When evaluating the appropriateness of a specific test type or protocol, it is important to consider whether a test meets one’s particular needs in its specificity (the ability to distinguish between closely related bacteria) and/or its sensitivity (the ability to detect various bacterial species at a required level or concentration). If FDA required product testing, it would be incumbent on the agency to specify a standard test methodology for each commodity/pathogen combination. Failure to set very specific test criteria could result in producers using a test that might not have the specificity or sensitivity to achieve the intended objective.

For example, if the objective of a product testing program were to test all raw products for Salmonella, without further direction provided, a technically inexperienced producer might opt for any one of the many immunological test kits developed for Salmonella detection as they are relatively inexpensive and generally simple to use. Though these types of test kits are a reasonable choice for testing a sterilized food, they cannot be used reliably in raw produce because of the natural presence of closely related but non-pathogenic relatives of Salmonella that can cross-react with many of these tests.

 What impact does the compositional complexity of produce have on testing? Further complicating the preceding discussion is the fact that produce represents a very complex chemical, physical and biological food matrix. Most obvious is the fact that commodities vary substantially in terms of chemical composition; for example a tomato is chemically very different from iceberg lettuce, which in turn is quite different from a green onion. The produce industry has witnessed several instances in recent years where pathogen testing procedures had to be modified to account for these compositional differences. It has been shown that specific plant metabolites (most often pigments associated with product color) can interfere with

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PCR reactions and can cause “false negatives.” In effect, this means that testing procedures would need to be optimized for each pathogen/commodity combination. It is important to note that very few commercial pathogen tests have been validated on a commodity-specific basis.

 How do we account for the diverse microbial ecology on produce? Another important aspect of the complexity of testing for pathogens in raw produce is the fact that the exterior surfaces of fruits and vegetables have a vibrant microbial ecology; a number of microbial species are natural inhabitants of fruits and vegetables. Many of these are beneficial bacterial species that can actually protect its host from infection by plant pathogens, and perhaps even human pathogens. As already noted, the sensitivity and selectivity of a test is a very important consideration. Since buyer-driven product testing has been introduced in the produce industry (especially in leafy greens), the industry has seen numerous instances where the rapid DNA-based screening methods like PCR have yielded “positive” results. When these samples were further tested to confirm these putative test results using standard microbial plating techniques, those initial results were not verified. Indeed, often what triggered a positive result in a rapid test for a human pathogen like Salmonella actually turned out to be a common nonpathogenic bacteria, like Citrobacter that is phylogenetically related to Salmonella but not harmful to humans.

In other words, commonly employed rapid test methods intended to minimize disruption to the supply chain and preserve product quality can actually result in false positive results if they are not selective enough to unequivocally target the desired pathogen’s unique DNA sequences. This lack of selectivity can have significant financial consequences and logistical impact if decisions regarding use of raw or finished product are based solely on these tests. For example, finished product may be destroyed based on an initial positive result, only to have confirmatory testing find that the original test was erroneous three to four days later, i.e. after the product has aged to a point where it can no longer be shipped.

 What are the optimal enrichment practices and what do they mean? Another consideration in product testing is the practice of enrichment. Most rapid DNA- based testing methods employ an enrichment step. Product samples are placed in a nutrient-rich culture medium, allowing pathogen cells to grow in ideal conditions so that enough cells can be recovered and sufficient DNA extracted to perform PCR or PFGE tests. Pathogens sampled from the surface of a fruit or vegetable that are in a slowed metabolic condition or are dying may in fact recover in such enrichment conditions and be induced to grow if sufficient time is provided. Studies of various enrichment periods indicate that optimum enrichment times can vary based on the physiological condition of the pathogen, and can run anywhere from 8-20 hours. Many commercial test protocols specify the lower end of this time range, so that products that are being held pending test results can be released sooner rather than later to meet supply chain and quality demands. Clearly, if FDA required fruit or

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vegetable product testing, further research would be needed to permit definition of this practice so that consistent enrichment periods could be established.

When weighing the question of enrichment, FDA must also consider its implications. If a pathogen has been physiologically injured by the inhospitable environment on a plant or food surface, but can essentially be “rescued” by using laboratory culture methods, would that pathogen have actually been able to cause illness if the product had been consumed? This is another area of research that needs to be initiated to understand whether injured pathogen cells are capable, under any conditions, of causing disease in humans.

 Which pathogens should the produce industry test for? If FDA required product testing, the agency would need to determine which pathogens need to be tested on a commodity-specific, and perhaps even a location-specific, basis. A number of bacterial, protozoan and viral pathogens have been associated with foodborne illness outbreaks linked to produce over the last 20 years. In some instances, patterns seem to emerge. For example, Salmonella is more consistently associated with tomatoes and melons, E. coli O157:H7 with leafy greens, Hepatitis A with green onions or berries, and Shigella in leafy herbs. However, there are also a number of examples where these relationships do not hold up. To manage the time element of produce logistics as described earlier in this document and to best utilize resources, it is important to avoid a “one size fits all approach.” Instead, a science- and risk- based approach may be more appropriate to determine a commodity-specific and/or pathogen-specific strategy.

 Are sampling methods available that permit confidence in test results? The specificity and selectivity of tests employed to identify a pathogen are only half of the equation in a product testing scheme. The other half is the sampling program. It is impractical to test every bag of salad or every tray of mixed vegetables as all the marketable product would be destroyed in the process. Instead, the number of samples collected, their distribution, the frequency of collection, the amount collected and other factors need to be carefully calculated if a sample is to be created that represents the entire production lot. This is important because the object of product testing is to create confidence that a specific production lot is not contaminated with a potentially harmful human pathogen. Though PMA has raised several important technical issues associated with actual pathogen tests, in many ways developing a sampling methodology that can achieve statistically significant confidence levels is more troublesome.

Based on the millions of pounds of produce that are harvested, packed or processed, shipped and consumed each day by millions of people throughout the country without illness, the frequency of pathogen contamination can be assumed to be quite low. To add weight to this assumption, data from buyer-mandated product testing of some commodities and FDA and USDA surveillance product testing also reveal that contamination is indeed a low-frequency event. Therefore it is

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imperative that the industry’s sampling methods be constructed so that it can detect even these low-frequency events. Further, from some of these recent product testing programs, it is known that contamination, when it does occur, is not uniform. The question becomes one of how much product needs to be sampled to give confidence that negative tests are really negative and positive tests are positive?

If FDA were to consider recommending testing finished products from processing facilities, such testing would have to be done within the context of the actual production rates of today’s operations. Automated packing machines typically run at speeds anywhere from 50-100 bags per minute (depending on bag size and the material being packed), and sampling 10, 20 or even 100 bags per line per hour only represents a fraction of the total material being processed. These standard production rates demonstrate an inherent problem with developing statistically significant sampling programs that support a conclusion that the product in question is free of contamination.

There was some interesting data presented recently at a commodity board research meeting that is illustrative of the problems associated with sampling. This specific commodity has had issues with Salmonella contamination and as a result has taken the initiative to proactively sample raw products. Historically, this commodity displays a one percent contamination rate at very low levels (3 MPN/gram) in raw products prior to processing by heat. In one recent production year, 1,000 samples were taken and, true to form, 10 positive samples and 990 negative samples were identified for a consistent 1 percent frequency. Interestingly, when 40 samples were retested from the 990 negative samples that tested negative, an additional 16 positives were discovered. In other words, “negative” samples were not really negative; it is really just a matter of the sampling program. This type of observation is not unusual. In field level testing for spinach or romaine, positive test results are very rare, but when they do occur, follow-up testing from the same field with additional tissue samples in an attempt to identify the source of contamination nearly always come up negative. The low level and frequency of contamination, makes developing meaningful sampling programs nearly impossible.

 When should products be sampled? As FDA considers the proper role of product testing, it is important to understand the implications of testing based on where the product is sampled; i.e. raw or pre-harvest versus finished products. Simply put, in- field raw product testing versus finished product testing can be less disruptive. As the industry has sought to diminish the business impacts of finished product testing, some have implemented raw product or preharvest testing programs as a strategy to meet selected customer requirements without starting the biological clock ticking on product quality and shelf life. Basically, preharvest or raw product testing programs direct that products are sampled and tested prior to their scheduled harvest date.

14 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011

As an example, many leafy greens growers and processors in California and Arizona have implemented such preharvest testing programs to satisfy customer requirements. Typically, these pathogen testing programs rely on field sampling three to seven days prior to harvest. This permits enough time to sample and test the product and get the results back to the harvester so that a “negative” result can “clear” the field for the scheduled harvest date. In the event of an initial positive result requiring further confirmatory pathogen testing, harvest can be held until results from this second phase of testing is complete. Although delaying harvest can have negative impacts on quality for some fruits and vegetables, for many commodities this is a better logistical and cost alternative than trying to hold harvested or even finished processed product.

Additionally, if confirmation testing does reveal a confirmed positive for a pathogen, the affected product remains in the field, permitting follow-up studies on the cause for contamination, avoiding harvest and packaging costs, and minimizing disposal costs as well as the possibility that product is inadvertently shipped to the consuming public. Though generally less disruptive than finished product testing, field-level raw product testing can still be highly disruptive to the supply chain. Harvest windows for products can often be very narrow due to rapidly changing market opportunities. Delaying harvest to permit product testing can have significant impacts on profitability. This strategy also leaves a potential window of vulnerability, i.e. if the raw product is tested in the field three to seven days prior to harvest, any contamination that might occur after sampling but before harvest could go undetected.

Clearly, there remains a number of critical issues for FDA to consider regarding microbial testing, specifically pathogen testing on raw or finished products. Simply put, it is not possible to test one’s way to safety, and it is much more prudent to use resources that might otherwise be devoted to product testing to instead develop and manage practices that mitigate contamination in the first place.

Given the developmental status of product testing methodologies for produce and the current absence of validated sampling methods, FDA guidance on product testing would prove difficult to create. That said, FDA should be encouraged to work with the industry, testing laboratories and method certification authorities to identify research needs to improve and validate risk-based pathogen testing methods. FDA is currently conducting exciting research on new methods to more precisely and efficiently detect pathogens in foods, and private companies and academic institutions are pursuing similar objectives. The produce industry and FDA should work together to bring these innovations to bear as they are validated in production environments.

9. Specific biological, chemical, radiological, and physical hazards and controls for food types such as (but not limited to) spices, nuts, ready-to-eat food, bakery products, fresh-cut produce, milk products, and medical food.

15 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011

The produce industry has had HACCP-based food safety programs in process facilities for several years. Consistent with HACCP principles, operators conduct a hazard analysis and classify potential hazards into three categories: biological, chemical and physical. The identification of potential hazards is generally based on the commodity or raw materials to be processed and their physical characteristics, the production environment and process flow, experience obtained with that product, ingredients used in processing or in manufacture, packaging materials, human touch points, temperature and final product formats.

For example, in leafy green processing one might consider the potential for contamination of pathogenic bacteria during growth as a possible biological hazard, pesticide residues as a possible chemical hazard and stones picked up during automated harvest as a possible physical hazard. The operator would then go on to identify preventive controls, verification, responsibilities, etc. as called for by HACCP methodology. Specific hazards need to be identified for each individual operation and, within that operation, individual product categories. As discussed earlier, a single operation might produce a wide variety of different products, each representing a different portfolio of potential risks or hazards.

Typically, processing operations in the produce industry have two critical control points (CCPs); wash water sanitation and metal detection. There are a number of control points (CPs) in various operations and these can vary based on the process and product. By definition, CCPs are the final point in a process where a hazard can be controlled. As there are no “kill steps” in produce processing, the concept of a CCP has always been difficult to apply to produce. Wash water sanitation as a mechanism to control a potential pathogen cross-contamination hazard is generally controlled by addition of sanitizers and pH control. More recently, processors have begun monitoring organic load in wash water as our understanding of the relationship of organic load and sanitizer efficacy has become clearer. Often, wash water control is mistakenly viewed as a mechanism to sanitize the surface of the fruit or vegetable that is being washed.

Experimental data show that surface populations of microbes may decrease by 1-2 logs. However, the microflora on fruit or vegetable surfaces are dynamic and that hydrophobic and hydrophilic interactions, biofilms, antagonistic bacteria and the topography of the plant surface play critical roles in sanitizer efficacy. The potential hazard of metal contamination (iron, non-ferrous iron and stainless steel) that might occur from equipment failure from the process equipment is managed by passing finished goods through a calibrated metal detector.

Any given process facility may have many potential control points where a hazard or risk factor is controlled by actions taken to prevent or manage the potential for biological, chemical or physical contamination throughout the entire process of producing that product. In the case of produce, controlling risk starts before planting and continues through finished product shipment to the customer. GAPs, GMPs, SSOPs, SOPs, employee hygiene training, preventive maintenance programs, supplier qualification programs,

16 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011 temperature monitoring, inventory rotation, traceability systems all have control points built into them that can be measured via observation or direct measurement.

For example, hand washing would be considered as a preventive control to prevent cross contamination from workers to the food. Training sessions, use of gloves, mandatory use of glove-dip stations, measurement of sanitizer concentration in hand-dip stations, restroom cleanliness, use of sanitizing soaps, availability of single use hand towels and other measurable or operational controls would all be typical preventive controls employed to prevent cross contamination from hands.

FDA should clearly specify basic foundational food safety programs be used in conjunction with risk or hazard based preventive controls in developing fruit and vegetable processing food safety programs. Absent kill steps, this multi-faceted approach of sound foundational programs and risk-based preventive controls is the most effective way to manage food safety risks. However, it should remain the responsibility of the facility operator to conduct the hazard/risk analysis and design the preventive controls and specific elements of the food safety program.

10. Preventive control approaches and practices (e.g., for validation, supplier controls) that are practical for small and very small businesses to implement.

Food safety programs can and must be scalable. It is important for operations of all sizes to have risk-based food safety programs and preventive controls. Consumers expect product to be safe—every time. It makes sense that a larger processor might have to expend proportionally larger resources to manage a large, multi-production line processing plant with hundreds of employees manufacturing a half million pounds of product a day versus a small processor that has a handful of employees and processes, washes and packs a thousand pounds of cut fruit or vegetables in small operation. It follows that risk management practices and preventive controls can be designed to match the risk and the scale of the operation.

Preventive control programs can seem overwhelming to someone who has not previously prioritized food safety as part of their operations. However, the goal for FDA and the industry has to be improved food safety performance for the entire industry. PMA’s experience with smaller companies is that once processors understand the concepts of hazard analysis and management, they come to understand that very simple practices that are not expensive to implement can be effective preventive controls.

Indeed, often these controls are simply good operational or business practices. For example, a preventive control on water quality for a small processor’s wash water system that uses a single pass batch wash system might be as simple as a visual inspection of organic load through a portal in a flume tank. As the water changes color and becomes opaque, the operator knows to change out the wash water. This scale-appropriate preventive control can be just as effective as a continuous flow spectrophotometric method that might be employed by a large processor to monitor multiple production lines in an

17 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011 automated system. The key factor is identifying the need for monitoring wash water quality and the importance of organic load and permitting processors of any size the freedom to develop preventive controls to manage the risk.

At the next level of preventive control, a microbial test to verify sanitation efficacy or a food safety audit to verify adherence to a food safety program is routine for many processors, yet many smaller processors not accustomed to applying these controls might fear the costs of these services. Again, if one has not been using these types of preventive controls, they can appear daunting, but they are rapidly becoming part of doing business. While the many buying groups are looking to supply the marketplace with local or regional produce from growers of all sizes, the liabilities associated with foodborne illnesses cause them to use only producers that have risk-based food safety programs and verifiable preventive controls. Many buyers have worked with their smaller, local suppliers to explain their requirements. PMA offers training to help small growers understand how food safety programs can be incorporated into their operations, can be cost-effective, and can open or maintain market channels where buyers require effective food safety programs.

As indicated already, it would not be prudent for FDA to prescribe preventive controls regardless of the size of the operation. Instead, the company’s specific risk assessment/hazard analysis plan should become the guide as to which preventive controls should be employed. Again, FDA should strongly consider issuing guidance in this area to help all companies determine the range of preventive controls they might employ to manage identified potential risks. No matter the size, basic measures such as providing training for worker hygiene, wash water sanitation, facility and equipment sanitation and supplier qualification apply to all operations and can help assure food safety.

PMA believes guidance from FDA can help level the playing field and provide needed assistance for companies that heretofore have not incorporated robust food safety protocols in their operations. We appreciate the opportunity to provide comments on this issue and will be happy to provide additional information as needed by FDA.

Sincerely,

Dr. Robert J. Whitaker Chief Science and Technology Officer Produce Marketing Association

18 Produce Marketing Association Comments to FDA Food Safety Modernization Act: Preventive Controls for Registered Human Food and Animal Food/Feed Facilities – August 22, 2011