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Produce Guidelines Urge, Don’t Require Compliance

In the ongoing quest to improve food safety, the U.S. Food and Drug Administration is asking for comments on its proposed guidelines aimed at minimizing food-safety hazards in fresh-cut fruit and vegetables.

The call for comments, along with information about the guidelines, was published in the Federal Register on Oct. 25. Comments are due Nov. 24.

Pointing to the increased consumption of fresh-cut fruits and vegetables and the potential for foodborne illness associated with these products, the document says that the FDA recognizes the need for guidance specifically geared to the processing of fresh-cut fruits and vegetables.

As such, its “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables”  provides processors with the agency’s recommendations on how to avoid having their products contaminated with pathogens that can cause food borne illnesses.

According to the document, FDA’s recommendations are based on “the current state of science.”

But some food-safety advocates find fault with the agency’s recommendations, saying that the proposed guidelines veer away from anything smacking of mandatory requirements and instead resort to words such as “encourages” and “voluntary.”

A paragraph near the beginning of the document has this to say:  ”Accordingly, FDA encourages fresh-cut produce processors to adopt the general recommendations in the guidance and to tailor practices to their individual operations.”

And in a subsequent paragraph comes this sentence: “The recommended procedures contained in the guidance are voluntary.”

Another sentence later in the document says:  ”Following the recommendations set forth in the fresh-cut guidance is the choice of each individual fresh-cut operation, plant, or processor.”

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Nancy Donley, president of S.T.O.P., Safe Tables Our Priority, a national, nonprofit, public health organization dedicated to preventing illness and death from foodborne pathogens, told Food Safety News that just as her organization has said many times before “guidelines are just guidelines. They don’t have any teeth.”

“When it comes to food safety, FDA needs something stronger,” she said. “We need everyone to implement and abide by one set of rules, with no free pass for anyone.”

Pointing to the many foodborne illness outbreaks and recalls during the past several years, Donley said it’s clear that guidance documents don’t do enough.

“We need mandatory requirements to protect people,” she said. “FDA has been operating under guidance documents for years, and it hasn’t worked.  Nothing has changed.”

Attorney and food safety advocate Bill Marler, publisher of Food Safety News, said,  ”After dozens of outbreaks linked to leafy greens that have sickened hundreds if not thousands in the last decade–some reported and some not–the time has long passed for voluntary guidance, no matter how well-meaning.” 

Greg Komar, food-safety director at California-based Growers Express, told Food Safety News that FDA has been seeking comments on how it can update its guidance materials for some time, and he listed some challenges that need to be addressed:

Categorizing risks. “Guides are useful,” Komar said, “but we are at a point where we need more concrete measures.”

He pointed out that commodities such as peanuts, which were once thought to be “safe,” could be subjected to practices that ultimately make them unsafe to eat.

He said that because there are so many different industry practices and so many different kinds of produce, FDA needs to figure out what’s risky and then focus its resources on proper levels of oversight.  All through the chain.

Komar said that while it’s important to enact standards for food safety, the reality is that grocery chains also need to enact food-safety purchasing standards that are universal.

If they do not, he said, then FDA’s produce guidelines are meaningless, because food safety is only as strong as the weakest link in the chain — even if the link is at the end of the chain.

Small vs large.  Komar believes that it’s crucial that all entities that deal with food production and handling abide by the same food-safety “rules.”

And while the argument is that large entities have the resources to adopt FDA’s recommendations and that smaller ones do not, Komar said that enacting GAPs (good agricultural practices) and good food-safety practices does not have to be at a cost — monetarily or time wise — that will put companies or farmers out of business.

“But ultimately, whether you buy food from a co-op, a farmers market, a grocery store, or online, it really is in the consumer’s best interest if everyone plays by the same rules,” said Komar.

Foreign and domestic.  Similar to the “small vs large” arguments, Komar said that domestic and foreign entities need to follow the same rules.

“The FDA needs to release a guide that takes into consideration world-wide commerce, and it needs to develop a system to assure that foreign producers are only exporting produce that meets the requirements and guidelines set forth by the FDA,” he said.

When FDA asks for help. Komar said he has participated in many food-safety meetings where representatives from the FDA are present to discuss the new guidelines.

“The reps listen to feedback from the industry and listen to this person or that person say that the FDA should do this or do that,” he said. “But then the FDA rep ultimately replies with ‘How?  How is the FDA going to do this? What should the metric be? How can this be measured?’  And, unfortunately, the answer usually comes in a tidbit that does not solve the question at hand.”

Komar said he thinks many of the industry experts give nothing more than “tidbits” because they are just as perplexed with the answers because the answers are very difficult.

And while food-safety principles can generally be considered as “common sense,” Komar said that when you are dealing with global supply, even washing your hands after using the bathroom seems to get difficult.

“No one wants to be wrong,” he said. “No one wants to paint with too broad of a brush. No one wants his or her commodity put under a microscope.  And execution is challenging.”

He’d like to see the formation of small working groups that focus on one subject at a time.

“GAPs and field food safety really do boil down to just a few things,” he said. “So if the working groups can have participants from different sections of the produce community, I do feel that some of the answers that are needed will surface even if they are not 100 percent accepted by all.”

  

When contacted by Food Safety News, officials from Western Growers and the National Sustainable Agriculture Coalition said their organizations had not yet looked through the proposed guidance document and therefore could not offer any comments.

In the document, FDA describes fresh-cut fruits and vegetables as produce that has been processed by peeling, slicing, chopping, shredding, coring, trimming, or
mashing — with or without washing or other treatment prior to being packaged for sale to consumers in a ready-to-eat form.

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It also points out that the way produce is grown, harvested, and processed may contribute to its chance of being contaminated with pathogens and therefore capable of transmitting foodborne illnesses.

It lists possible causes for this:  the high degree of handling and mixing of the product; the release of cellular fluids (which can attract pathogens) during cutting or mashing; the high moisture content of the product; the absence of a step (such as subjecting the produce to high temperatures to kill pathogens) during production; and the potential for temperature abuse (not keeping the product at a low enough temperature) in the processing, storage, transport, and retail display. (Information in parentheses supplied by Food Safety News.)

According to the document, all of these can increase the potential for pathogens to survive and grow in fresh-cut products.

Recalls and tracebacks. The agency recommends that fresh-cut processors establish and maintain written traceback procedures so they can respond to food-safety problems when they arise. As part of that, they should establish and maintain a written contingency plan they can use to initiate a recall and put it into place.

The agency also recommends that processors establish a program that documents and tracks fresh-cut products back to the source of their raw ingredients and keep records of product identity and specifications, the products in inventory, and where, when, and to whom, and how much of the product is shipped.

Many food processors say that being able to trace a contaminated product back to its source is key to being able to identify a product and quickly recall it.

Prevention. The agency says that a preventive control program is valuable for managing the safety of food products. It refers specifically to HACCP (Hazard Analysis & Control Points) as one used commonly in the fresh-cut industry. A HACCP plan identifies inherent risks and where they can occur, which allows a processor to take the necessary steps at critical points in production to control potential risks.

Paperwork. The agency recommends that operators develop and implement both a written Standard Operating Procedures plan and a Sanitary Standard Operation Procedures plan, both of which are important ways to implement and monitor good handling practices required for processed food operations.  

For many fresh-cut produce companies, the agency’s recommendations are nothing new.  In fact, according to FDA, more than 50 percent of the companies already have HACCP plans and the recommended paperwork procedures in place.

When it comes to traceback and recalls, the document says that the agency “previously estimated that firms in the industry would choose a traceback program after the guidance was made available. . . . “

The document also provides information about how much time and how much money it would cost to put its recommended guidelines into place.  According to FDA, there are 280 fresh-cut plants operating in the United States, with approximately 10 new firms expected to enter the industry each year over the next 3 years.   

© Food Safety News
  • Doc Mudd

    Great article! All good common sense recommendations that logically should be enforced across the breadth of the fresh-cut produce industry in the 21st Century.
    But, hell, even as voluntary recommendations these will evoke a hideous, disingenuous howling from the self-described “small farmer/farm market” cult. There’s no pleasing the hobby farm lobby anyway – we’ve certainly come to “know our farmer” on this issue!
    Might as well get it over with; legislate and enforce for the consumer’s sake. Someone should advocate for consumer safety – our heroic hobby farmers and their handlers have shown no concern whatsoever, except for their own grubby profits.

  • http://www.healthyfoodcoalition.org hhamil

    First, this document is a “guidance” because the FDA can issue “guidances” immediately without any input from anyone. In addition, “guidances” allow the FDA to avoid publishing the comments made to it about them. Opponents are forced to use FOIA requests to learn the details.
    Second, as shown in the document itself, this is revision of a “guidance” that began several years ago. In fact, I haven’t been able to find anything new in it except that the OMB number has expired. Thus, this may only have been published to comply with the Paperwork Reduction Act and not actually change anything.
    Third, had the FDA chosen all those years ago to establish a “regulation” rather than a “guidance,” a “regulation” could have been in force right now. This is similar to the 19 years the FDA took to publish its “Shell Egg Rule” and then “sadly” said, “If only our reg had been in force earlier, it might have prevented the need to recall 550,000,000 shell eggs and all of the illnesses.”
    Fourth, Ms. Beecher failed to mention one of the most significant parts of this “guidance.” Under “Preventive Control Program,” the “guidance” says, “FDA estimated the paperwork burden of developing and implementing a HACCP plan based on a plan with two CCPs. The number of CCPs may vary depending on how the processor chooses to identify the CCPs for a particular operation. Developing a HACCP plan is a one-time activity that is estimated to take 100 hours based on a trained HACCP team working on the plan full time.”
    That is 100 hours by a “trained HACCP team.” My research reveals that the “trained HACCP team” qualifier enabled the FDA to reduce the number of hours in its estimate and avoid having to include the time required to “train” the HACCP team.
    By the FDA’s own estimates, it is clear that the financial cost of developing and implementing the Sec. 103 HARPC plan requirement of S 510 will put almost all businesses below a certain size out of business.
    Finally, FSN has, once again, allowed “Doc Mudd” to make a personal attack on the producers of local, healthy food without any substantiation of his charges NOR, most importantly, even having to reveal who he or she or it is.
    As always, I will happily discuss, defend and/or provide additional details to anyone who writes to me at healthyfoodcoalition@gmail.com, particularly, “Doc Mudd.”

  • http://www.healthyfoodcoalition.org Harry Hamil

    First, this document is a “guidance” because the FDA can issue “guidances” immediately without any input from anyone. In addition, “guidances” allow the FDA to avoid publishing the comments made to it about them. Opponents are forced to use FOIA requests to learn the details.
    Second, as shown in the document itself, this is revision of a “guidance” that began several years ago. In fact, I haven’t been able to find anything new in it except that the OMB number has expired. Thus, this may only have been published to comply with the Paperwork Reduction Act and not actually change anything.
    Third, had the FDA chosen all those years ago to establish a “regulation” rather than a “guidance,” a “regulation” could have been in force right now. This is similar to the 19 years the FDA took to publish its “Shell Egg Rule” and then “sadly” said, “If only our reg had been in force earlier, it might have prevented the need to recall 550,000,000 shell eggs and all of the illnesses.”
    Fourth, Ms. Beecher failed to mention one of the most significant parts of this “guidance.” Under “Preventive Control Program,” the “guidance” says, “FDA estimated the paperwork burden of developing and implementing a HACCP plan based on a plan with two CCPs. The number of CCPs may vary depending on how the processor chooses to identify the CCPs for a particular operation. Developing a HACCP plan is a one-time activity that is estimated to take 100 hours based on a trained HACCP team working on the plan full time.”
    That is 100 hours by a “trained HACCP team.” My research reveals that the “trained HACCP team” qualifier enabled the FDA to reduce the number of hours in its estimate and avoid having to include the time required to “train” the HACCP team.
    By the FDA’s own estimates, it is clear that the financial cost of developing and implementing the Sec. 103 HARPC plan requirement of S 510 will put almost all businesses below a certain size out of business.
    Finally, FSN has, once again, allowed “Doc Mudd” to make a personal attack on the producers of local, healthy food without any substantiation of his charges NOR, most importantly, even having to reveal who he or she or it is.
    As always, I will happily discuss, defend and/or provide additional details to anyone who writes to me at healthyfoodcoalition@gmail.com, particularly, “Doc Mudd.”

  • Doc Mudd

    Yep. Howling, right on cue!
    Why don’t self-righteous “small producers” have a care for consumer safety? They absolutely never mention that except to howl that they can’t afford it. That tells all of us just about everything we need to know about just how safe the food they’ve been selling us really is…and always has been. Pretty dubious, at best, as they’ve been routinely cutting corners to plump their own grubby profits.
    Good gosh, every producer is “local” to some place or other; what’s so danged special about that, huh? But, claiming a food product is “safe” with nothing more than some slick salesman’s word on it, well, that’s just foolish…and potentially dangerous for customers who are taken in by the vacuous sales pitch.
    Time to advocate for the paying customer and their safety, the safety of their families – pass & enforce legislation like S.510 to bring producers of all sizes and all philosphies up to a minimum standard of food safety. Don’t let the mournful howling distract you. If these guys weren’t howling piteously about having to give a damn for their customers’ welfare, they’d be howling selfishly over some other perceived encroachment upon their quaint profiteering.
    I guess, by now we all “know our farmer” well enough through the many, many tedious objections from Mr. Hamil and his elitist hobby farm lobby, none expressing the slightest concern for the safety of paying customers and our families. No more tailgate food purchases for my family! Too damned risky. And too damned slippery with the slick salesmanship. We’re finished supporting that.