More and more fresh fruits and vegetables are being cut, sliced, bagged, packaged, and sold fresh to you and me. When outbreaks of illness last year were associated with packaged fresh spinach and lettuce, the Food and Drug Administration figured it would tighten controls on the industry.
So FDA issued a listing of new ways packagers can safely process and package fresh fruits and vegetables. Except they’re not rules as such, but guidelines. The significance of that distinction is the topic of this month’s column.
But first, why are fresh fruits and vegetables, the healthy stuff we’re supposed to be eating more often, a safety threat? Because the process of preparing fresh-cut produce can make it susceptible to contamination. Consider, for example, the removal of skins and rinds that traditionally protect fresh fruit as it moves through distribution. This exposes the edible part of the fruit to a factory environment, and that’s where contamination can enter the picture.
Confronted with a perceived need to tighten controls on an industry, an agency like FDA has at least two choices: Make mandatory regulations requiring industry to change its practices in specified ways, or issue guidelines that list all sorts of good ideas for how to improve safety without actually requiring industry to follow them.
Here, FDA took the non-required route. This brings to mind, oddly enough, the recent “Pirates of the Caribbean” films, in which there’s a running joke about the revered and respected “Pirate’s Code.” Whenever a character wants to evade the Code’s strict requirements, they say something like, “The code is more of what you’d call guidelines than actual rules.” Imagine how rare and satisfying for a lawyer with an interest in regulatory issues to find such a relevant film.
I don’t think packagers will act like pirates and try to get around the new requirements, by the way. But I do think it’s interesting to think about the rules vs. guidelines choice from FDA’s
perspective. They might never admit it, but if FDA makes regulations (also known as “rules”) on a topic, suddenly they buy themselves some headaches. On the one hand, having specified procedures, or spelled-out performance standards, gives you something to check for when you inspect factories and a clear basis on which to cite them for violations.
On the other hand, it also means you sort of have to check for those things, and Congress will ask you how often you did it, and you have to keep data on how often you did it and what you found, and then people can holler at you about whether you did enough or too much and if gosh darn it there is still an outbreak of food borne illness anyway then someone will holler that you were wasting your time. And then you could argue, Hey! I’m just doing what you told me I was supposed to do to get a handle on food safety, but by that time you already look bad.
Ah, but guidelines, they’re cool. If most affected companies choose to follow the voluntary guidelines, you get the benefits of a rule without the hassles. You take a public relations hit at first, sure, as people tease you about making them only voluntary. “If safety is so important, why not make them mandatory?” they ask. But a good guideline can get you many of the same results as a mandatory regulation, provided lots of players play along. When customers, say, big grocers, demand
that their suppliers who pack produce follow the guidelines, that assures that the suppliers will follow the guidelines if they were not otherwise inclined to do so.
What’s more, many in the industry are already way ahead on this topic. FDA reports that an industry group, the United Fresh Produce Assn., says many in the fresh-cut produce industry are not only practicing Good Manufacturing Practices (GMPs), they have even put in place voluntary Hazard Analysis and Critical Control Points (HACCP), programs to enhance control and reduce risks in their operations.
What you don’t get with mere guidelines is a big club with which to bash those who don’t comply. But, first, FDA doesn’t bash that many violators with the big weapons—seizures, injunctions, and criminal prosecutions—anyway. And second, remember, FDA still might be able to bash those who don’t follow the guidelines for related violations, or for failing to comply with the general standards of sanitation and against adulteration. It’s just that if any of those companies wanted to really fight and claim that they can’t be cited for violating regulations when all they did was violate guidelines—and that’s true—they would win that argument, and the last thing FDA needs is to lose that argument in court.
The recent boom in ready-to-eat foods has included enormous growth in fresh-cut fruits and vegetables, so there’s much more pre-packaged produce at the grocery store than in years past, an estimated $12 billion a year in sales, says FDA. Bagged lettuce, carrots, and fruit cups are only a few examples. They are peeled, sliced, chopped, shredded, cored, and trimmed, and sometimes but not always washed before packaging. Modified atmosphere gases are also often used.
FDA says that between 1996 and 2006, there were 72 foodborne illness outbreaks “associated with the consumption of fresh produce,” and 18 of those “implicated fresh-cut produce.”
This new draft Guidance document enumerates a number of considerations to those already familiar with GMPs for food processing, but adapts them specifically to the processing of fresh produce.
A good deal of the Guidance’s advice is directed specifically to packaging operations. The draft Guidance identifies containers, films, lids, and trays as possible packaging material sources of microbiological contamination. It provides specific recommendations to prevent contamination from packaging, including: establishing a system to prevent the use of, or promote the rejection of, contaminated, damaged, or defective packaging materials; review of incoming materials and packaging gases and determination of proper gas mixtures for each product; using packaging only for its intended purpose, and storing packaging materials so that they are protected from potential contaminants; identification and correction of potential situations where packaging could become damaged; and labeling finished produce products with proper handling and temperature instructions.
The document also discusses control measures for microbiological hazards and also some physical and chemical hazards of fresh-cut fruits and vegetables. It contains concepts similar to those found in the FDA’s 1998 Guidance on fresh fruits and vegetables and the 1999 Guidance for those producing fresh sprouts (“Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” and “Reducing Microbial Food Safety Hazards for Sprouted Seeds,” respectively.)
In order to reduce microbial contamination during primary production and harvesting, FDA recommends being aware of, evaluating, and verifying your supplier’s Good Manufacturing Practices.
The Agency’s recommendations regarding personnel include awareness and promotion of worker health and hygiene practices and training personnel in processing and packaging areas on GMPs and other preventive controls. Processing facilities, other physical structures, and processing equipment should be designed for ease of cleaning and maintenance, and tools such as metal detectors and removers can be put into place during packaging operations to prevent contamination by metal objects.
Facilities should also be designed to promote cleanliness and prevent contamination. For example, air filtration systems should move airflow in a direction that is counter to the flow of product, in other words, filtered air should move from packaging and finished product storage, the cleanest areas, to less-clean areas such as receiving. Restricting the movement of physical items (lift trucks, bins, totes, maintenance tools, cleaning implements, clothing) and people from receiving and storage areas to areas where processing and packaging takes place can also prevent microbiological contamination.
FDA also suggests a comprehensive sanitation program with sanitation standard operating procedures (SSOPs) should be developed and implemented, making sure not to contaminate packaging materials with substances such as cleaning solutions or pest control products.
FDA provides an example of an environmental sanitation master schedule that recommends using a Chlorine-Quaternary ammonium (“quat”)-based cleaner daily on floors and also walls adjacent to the processing equipment, once a week on doors and plastic curtains, and once a month on other walls, ceilings, and overhead pipes, electrical conduits, and structural beams. Other surfaces are cleaned on specific schedules with other types of cleaning substances such as chlorine-alkaline detergent, quat- or iodine-based sanitizer, chlorine-based soap or quat, acid cleaner, degreasing agent, or water with light detergent.
Where equipment such as hoses that touch the floor and other contaminated areas are used, care should be taken that the contaminated equipment does not touch processing equipment, surfaces, or packaging materials. FDA recommends against using high-pressure water hoses to clean production and packaging facilities during production or after production equipment has been cleaned because equipment, product, and packaging materials could become contaminated. Finally, FDA recommends production and process controls such as development of product specifications, procedures for receipt and inspection of ingredients, and other controls in the preparation, processing, packaging, and storage of the product.
Processors using modified atmosphere packaging should adhere to temperature and storage controls and shelf-life parameters; they should put controls into place to prevent temperature increases or they should consider time/temperature indicators (TTIs) that will tell consumers when product may not be safe; and they should establish controls to prevent contamination of the gases, equipment and packaging materials. Additionally, processors could provide handling guidelines highlighting temperature controls and washing instructions. Shelf-life recommendations include 1) validation of “use by” dates with microbiological safety studies and 2) using product labeling to communicate that refrigeration of the product is necessary to help prevent spoilage and growth of pathogens.
These tightened controls, if adopted by packagers not already using them, hold promise to reduce contamination and outbreaks. If they don’t, you can bet you will hear calls for FDA to convert these guidelines to requirements and to tighten their substance as well.
Eric can be reached at [email protected], and visit his firm’s Web site at www.ericfgreenbergpc.com.
So FDA issued a listing of new ways packagers can safely process and package fresh fruits and vegetables. Except they’re not rules as such, but guidelines. The significance of that distinction is the topic of this month’s column.
But first, why are fresh fruits and vegetables, the healthy stuff we’re supposed to be eating more often, a safety threat? Because the process of preparing fresh-cut produce can make it susceptible to contamination. Consider, for example, the removal of skins and rinds that traditionally protect fresh fruit as it moves through distribution. This exposes the edible part of the fruit to a factory environment, and that’s where contamination can enter the picture.
Confronted with a perceived need to tighten controls on an industry, an agency like FDA has at least two choices: Make mandatory regulations requiring industry to change its practices in specified ways, or issue guidelines that list all sorts of good ideas for how to improve safety without actually requiring industry to follow them.
Here, FDA took the non-required route. This brings to mind, oddly enough, the recent “Pirates of the Caribbean” films, in which there’s a running joke about the revered and respected “Pirate’s Code.” Whenever a character wants to evade the Code’s strict requirements, they say something like, “The code is more of what you’d call guidelines than actual rules.” Imagine how rare and satisfying for a lawyer with an interest in regulatory issues to find such a relevant film.
I don’t think packagers will act like pirates and try to get around the new requirements, by the way. But I do think it’s interesting to think about the rules vs. guidelines choice from FDA’s
perspective. They might never admit it, but if FDA makes regulations (also known as “rules”) on a topic, suddenly they buy themselves some headaches. On the one hand, having specified procedures, or spelled-out performance standards, gives you something to check for when you inspect factories and a clear basis on which to cite them for violations.
On the other hand, it also means you sort of have to check for those things, and Congress will ask you how often you did it, and you have to keep data on how often you did it and what you found, and then people can holler at you about whether you did enough or too much and if gosh darn it there is still an outbreak of food borne illness anyway then someone will holler that you were wasting your time. And then you could argue, Hey! I’m just doing what you told me I was supposed to do to get a handle on food safety, but by that time you already look bad.
Ah, but guidelines, they’re cool. If most affected companies choose to follow the voluntary guidelines, you get the benefits of a rule without the hassles. You take a public relations hit at first, sure, as people tease you about making them only voluntary. “If safety is so important, why not make them mandatory?” they ask. But a good guideline can get you many of the same results as a mandatory regulation, provided lots of players play along. When customers, say, big grocers, demand
that their suppliers who pack produce follow the guidelines, that assures that the suppliers will follow the guidelines if they were not otherwise inclined to do so.
What’s more, many in the industry are already way ahead on this topic. FDA reports that an industry group, the United Fresh Produce Assn., says many in the fresh-cut produce industry are not only practicing Good Manufacturing Practices (GMPs), they have even put in place voluntary Hazard Analysis and Critical Control Points (HACCP), programs to enhance control and reduce risks in their operations.
What you don’t get with mere guidelines is a big club with which to bash those who don’t comply. But, first, FDA doesn’t bash that many violators with the big weapons—seizures, injunctions, and criminal prosecutions—anyway. And second, remember, FDA still might be able to bash those who don’t follow the guidelines for related violations, or for failing to comply with the general standards of sanitation and against adulteration. It’s just that if any of those companies wanted to really fight and claim that they can’t be cited for violating regulations when all they did was violate guidelines—and that’s true—they would win that argument, and the last thing FDA needs is to lose that argument in court.
The recent boom in ready-to-eat foods has included enormous growth in fresh-cut fruits and vegetables, so there’s much more pre-packaged produce at the grocery store than in years past, an estimated $12 billion a year in sales, says FDA. Bagged lettuce, carrots, and fruit cups are only a few examples. They are peeled, sliced, chopped, shredded, cored, and trimmed, and sometimes but not always washed before packaging. Modified atmosphere gases are also often used.
FDA says that between 1996 and 2006, there were 72 foodborne illness outbreaks “associated with the consumption of fresh produce,” and 18 of those “implicated fresh-cut produce.”
This new draft Guidance document enumerates a number of considerations to those already familiar with GMPs for food processing, but adapts them specifically to the processing of fresh produce.
A good deal of the Guidance’s advice is directed specifically to packaging operations. The draft Guidance identifies containers, films, lids, and trays as possible packaging material sources of microbiological contamination. It provides specific recommendations to prevent contamination from packaging, including: establishing a system to prevent the use of, or promote the rejection of, contaminated, damaged, or defective packaging materials; review of incoming materials and packaging gases and determination of proper gas mixtures for each product; using packaging only for its intended purpose, and storing packaging materials so that they are protected from potential contaminants; identification and correction of potential situations where packaging could become damaged; and labeling finished produce products with proper handling and temperature instructions.
The document also discusses control measures for microbiological hazards and also some physical and chemical hazards of fresh-cut fruits and vegetables. It contains concepts similar to those found in the FDA’s 1998 Guidance on fresh fruits and vegetables and the 1999 Guidance for those producing fresh sprouts (“Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” and “Reducing Microbial Food Safety Hazards for Sprouted Seeds,” respectively.)
In order to reduce microbial contamination during primary production and harvesting, FDA recommends being aware of, evaluating, and verifying your supplier’s Good Manufacturing Practices.
The Agency’s recommendations regarding personnel include awareness and promotion of worker health and hygiene practices and training personnel in processing and packaging areas on GMPs and other preventive controls. Processing facilities, other physical structures, and processing equipment should be designed for ease of cleaning and maintenance, and tools such as metal detectors and removers can be put into place during packaging operations to prevent contamination by metal objects.
Facilities should also be designed to promote cleanliness and prevent contamination. For example, air filtration systems should move airflow in a direction that is counter to the flow of product, in other words, filtered air should move from packaging and finished product storage, the cleanest areas, to less-clean areas such as receiving. Restricting the movement of physical items (lift trucks, bins, totes, maintenance tools, cleaning implements, clothing) and people from receiving and storage areas to areas where processing and packaging takes place can also prevent microbiological contamination.
FDA also suggests a comprehensive sanitation program with sanitation standard operating procedures (SSOPs) should be developed and implemented, making sure not to contaminate packaging materials with substances such as cleaning solutions or pest control products.
FDA provides an example of an environmental sanitation master schedule that recommends using a Chlorine-Quaternary ammonium (“quat”)-based cleaner daily on floors and also walls adjacent to the processing equipment, once a week on doors and plastic curtains, and once a month on other walls, ceilings, and overhead pipes, electrical conduits, and structural beams. Other surfaces are cleaned on specific schedules with other types of cleaning substances such as chlorine-alkaline detergent, quat- or iodine-based sanitizer, chlorine-based soap or quat, acid cleaner, degreasing agent, or water with light detergent.
Where equipment such as hoses that touch the floor and other contaminated areas are used, care should be taken that the contaminated equipment does not touch processing equipment, surfaces, or packaging materials. FDA recommends against using high-pressure water hoses to clean production and packaging facilities during production or after production equipment has been cleaned because equipment, product, and packaging materials could become contaminated. Finally, FDA recommends production and process controls such as development of product specifications, procedures for receipt and inspection of ingredients, and other controls in the preparation, processing, packaging, and storage of the product.
Processors using modified atmosphere packaging should adhere to temperature and storage controls and shelf-life parameters; they should put controls into place to prevent temperature increases or they should consider time/temperature indicators (TTIs) that will tell consumers when product may not be safe; and they should establish controls to prevent contamination of the gases, equipment and packaging materials. Additionally, processors could provide handling guidelines highlighting temperature controls and washing instructions. Shelf-life recommendations include 1) validation of “use by” dates with microbiological safety studies and 2) using product labeling to communicate that refrigeration of the product is necessary to help prevent spoilage and growth of pathogens.
These tightened controls, if adopted by packagers not already using them, hold promise to reduce contamination and outbreaks. If they don’t, you can bet you will hear calls for FDA to convert these guidelines to requirements and to tighten their substance as well.
Eric can be reached at [email protected], and visit his firm’s Web site at www.ericfgreenbergpc.com.
