Archive for the ‘Categories: Food Policy & Law, Government Agencies, Nutrition & Public Health Tags: FDA, HACCP, HARPC, preventive controls, processing, produce safety, small farm food safety’ Category

HACCP Have We Lost Our Way With HACCP?

By Greg Scher, A Senior Food Protection Warrant Officer, U.S. Army

As food safety becomes an increasingly important issue, it might be a good idea to take a step back and reexamine your food safety plans. Asking a few key questions, such as “who are my customers?” and “how do my HACCP plans help them?” are a good place to start.

HACCP principles were pioneered by the Department of Defense as a way to assure things that can’t be tested are safe. When you look at things such as bombs and artillery shells, it is obvious that they can’t be tested. To test something like that is to destroy it and anything else in the area. I remember Bugs Bunny in the animated Looney Tunes cartoon Forward March Hare, released in 1953. At the end, Bugs is hitting each artillery shell as it came off an assembly line to see if it was a dud. It was the punchline because it’s a really bad idea to test ammunition that way. The thing with testing food is, much like artillery shells, when you test it, you destroy it.

Then we started putting people in space.

NASA could not have astronauts getting sick from the food they eat. To prevent illness from food in space, the agency asked Pillsbury and the U.S. Army Laboratories to find a way to ensure, to a very-high degree, that any hazards to food are removed during packaging and processing. This collaboration resulted in HACCP. A great timeline for the development of HACCP can be found here.

The USDA’s Food Safety and Inspection Service (FSIS) has made HACCP regulatory since 1996. Yet, we still have contamination and recalls with products the agency regulates. The agency will tell you exactly how your HACCP should be implemented and take no ownership if it fails to reduce a hazard to a safe level. You have to take your HACCP plan back; assume your customers are astronauts and you can’t allow a hazard to reach their food.

Having been in Food Safety and Defense for 25 years, I have seen HACCP go through many cycles; first by the requirement of regulators and then by third-party audit standards, such as GFSI. While most food safety professionals would argue this was a good thing, I would argue that, like most well-intended programs, it turned a producer-led process into a process being pulled by benchmarks and regulators to fit their ideas. I believe this stifles initiative, new ideas, and in many of the plants I have visited, seen it becomes a “check-the-box” mentality where there is no HACCP culture developed. There is a good “dog-and-pony” show for regulators and auditors, but when you peel back that first layer, you can often find that the programs are driven by the requirements of customers and regulators, and not specifically by the hazards.

Avoiding HACCP Pitfalls                                                                                             The most common snare to HACCP plans I see is companies not owning them. “Corporate wrote this plan not us.” If your corporation is so directive-based that you have no say in your facilities HACCP plan, then you need to take ownership and take a stand. Most of these types of violations can be found in prerequisite programs. An example would be a program that requires chlorine bleach spray used on a food contact surface to be tested to be at least 200ppm. When you look at the test strip it is obviously stronger than 200ppm. Federal rules state that if you go over 200ppm you are required to do a fresh water rinse of the surface. If you are just using paper that gets darker with the presence of chlorine why not back off to 150ppm? How can you assure that each time you mix the spray you have not exceeded 200ppm? More is not always better or more effective. By backing chorine to 150 you cut chlorine use by 25% and remove the hazard of going over the 200ppm threshold and avoiding violating 21CFR 178. Here is a link to a good paper on use of bleach.http://ucfoodsafety.ucdavis.edu/files/26437.pdf 

Another mistake I see is a lack of HACCP prerequisite programs that make sense. People are smart; when you want a program taken seriously, you need to make sure you are not wasting people’s time, money, or effort.

For instance, we are taught that “hair restraint” is a requirement and hairnets need to be worn. In comes the bald guy. Why is he made to wear a hairnet? Are you making people that are clean shaven wear a restraint for their beards? Programs have to make sense if you want them to be taken seriously and embraced by employees to create a great food safety culture.

I also see poor supervision and leadership. If your company’s supervisors are not knowledgeable and do not enforce the programs, it’s time to find new supervisors. If employees are “breaking” program rules there is a reason. Supervisors need to identify the reason and find the root cause. For example, a door to the back of the building is propped open because it is hot and is held open to cool the area. Supervisors should address the temperature in a way that does not violate food defense and won’t let pests in the building. Managers often tell me the employees set them up; I would argue there is poor supervision.

Make Audits A Two-Way Street                                                                                  If you do your homework and can convince a regulator or an auditor that what you do adequately addresses specific hazards, your HACCP plan will be seen effective in their eyes. You are in the plant every day and you know the ins and outs of your facility; most auditors and regulators are only interested in you putting out a safe product. Make audits and inspections two-way conversations where both parties are made the better.

About The Author Greg Scher is a CW4 in the U.S. Army Veterinary Corps with 25 years of food safety and defense experience. He has a B.S. in Management, and as a Senior Food Protection Warrant Officer, has audited over 500 food producers in 57 countries. He is a member of the Order of Military Medical Merit and has been awarded three Bronze Stars.


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With FDA already over the original due date for FSMA rules, extending comment periods, and being subjected to lawsuits and court mandates because of that, the government shutdown certainly has not helped to move things along. However, this does not mean that the food industry should sit back and wait for the rules to be finalized or compliance to take effect. There are numerous reasons you should be working toward compliance now – many of which are, like the rules themselves, interdependent.

Following are 10 Reasons you should be working toward FSMA compliance now:

1. Prevention vs. Reaction –

Moving the industry from reaction to prevention is the foundation of FSMA. Acting now is preventive; waiting until all the rules are in place and the deadline is pending is reactive. Further, much of what is in FSMA is good for brand protection, so paying attention to these rules today will help you develop systems that have other important impacts on your business. (See #9.)

2. The Devil is in the Details –

If you’ve taken a look at the proposed rules, you know that they are quite detailed. The longer you wait to review the rules and apply them to your business, the more you can expect to be scrambling to try to meet the compliance dates – particularly if you find that you are subject to more than one rule with interdependent clauses. (See #3.) When you rush to complete a task, you are more likely to make mistakes or miss those devilish details. Think about any project you recently undertook. Did you give yourself enough time to thoroughly review the specifications, strategize and plan, take action to implement the plan, then evaluate it to ensure that it not only fits the specifications but also is effective for your business? If you waited until the last minute to start the project, you probably did not have enough time to implement each of the steps needed for success. In the same way, if you wait until the last minute to begin working on the FSMA rules, it’s unlikely you will give yourself enough to do much more than simply take action and hope for the best.

3. Multiple Rule Compliance –

The complexity and interdependence of the FSMA provisions are a primary reason that FDA has had to take extra time to develop the rules and has extended the comment periods. In much the same way, every business will have to interpret the complex details of at least one rule; and most businesses will be subject to multiple rules and have to take into consideration the interdependence of each. For example, the Preventive Controls rule will impact most businesses in one way or another; if you grow, harvest, pack, or hold produce, you will also be subject to the Produce Safety rule; and if you use any imported ingredients or supplies, you may be impacted by the Foreign Supplier Verification Program (FSVP) and the Accredited Third-Party rule – all of which are interdependent.

4. Training –

Implementing practices and standards in your operation to ensure compliance with the rules will require personnel training. If you are still in the process of developing compliant standards when the deadline looms, you will have no opportunity to educate or train your workers in your new standards.

5. ROI –

Start monitoring critical operations and save time and money by seeing that things need a correction before you have a problem on your hands. Identify corrective actions before there is an issue so that you don’t need to reinvent the wheel or waste time trying to remember what you did last time. Similarly, have a recall plan so that there isn’t mass confusion on who does what when (not if) you have a recall.

6. Improve Food Safety

Besides the direct standard-making practices of the first four reasons there is also a business case to be made for implementing improved practices that meet or exceed FSMA rules. If the proposed rules contain preventive controls or safety measures that you are not already implementing in your facility, you are likely at risk for a food safety violation and/or recall – and all the negative media attention and economic reprisals that entails. (See #7 and #8.) If you have any doubts along these lines, read our blog from last week: Are We in a New Era of Federal Prosecutions for Food Safety?

7. Brand Protection

While business closure and complete loss of brand is an extreme result, any food safety violation (unintended or not) or recall can, and usually does, garner undesirable media attention. And today, media is not only the local paper or national TV news, it is also the homemaker blogger, the teenage tweeter, and the cause-centric consumer activist, all of whom have open access to Internet posting of information – and misinformation. The more you protect the safety of your food through regulated or unregulated preventive-based controls, the more you protect your brand.

8. Move Toward or Maintain Certification to a GFSI-benchmarked Scheme –

There are many parallels between the FSMA Preventive Controls rule and GFSI standard. Take SQF for example – Although there are elements of SQF and other GFSI-benchmarked schemes that are not as prescriptive as FSMA, there are several areas addressed by SQF that have not been addressed in the proposed rule. Thus, as the food industry looks to protect customers and their brand as well as be in compliance with the proposed new rules, our own analysis indicates that being SQF level 2 certified to today’s SQF standards is a very strong start. If you’re already certified, keep improving (#9); if you’re not, consider if implementing preventive controls warrants the pursuit of certification to a GFSI scheme.

9. Best Practices for Continuous Improvement

Implementing best practices should be a basic practice for every food facility, and there are plenty of best practices written into the proposed rules that will enable a facility to improve. Implementing best practices gleaned from this review of the rules will not only move you toward compliance, it will help you continuously improve.

10. Just Do It –

Although the final rules are unlikely to be exactly the same as the proposed rules, getting started will certainly give you a leg up. And if you work toward complying with the strictest of the proposed rule, you will be closer to being ready if the final rule is even stricter. And if the final rule is less strict? Worst case, you will be over safe; certainly not a bad thing! The bar of FSMA is not that high – do you really want to be only as good as the lowest common denominator?

By David Acheson
The Acheson Group


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I stopped being a fan of Alex Rodriquez years ago when he left the Mariners, so I was not that particularly bothered when he was banned from baseball for steroid use.

A-Rod’s banning, along with the past steroid-induced sins of Mark McGwire, Barry Bonds and others, show that player punishment or embarrassment does not always stop the crime.

No serious person can believe that players have an incentive to play “clean.” More homers and strikeouts mean more fans in the stands, or glued to TV commercials, and even more revenue for the owners. More revenue for owners translates into bonuses for players, incentivizing players to cheat. Owners talk all season about the evils of steroid use as they stuff great gobs of money into their pockets that they make from players advantaged by steroids.

Money talks and ethics walk.

Players are the well-paid chattel of owners who want to win at any cost. Owners may well feign ignorance of steroid-induced homers or strikes, but they covet them nonetheless. Banning A-Rod changes nothing.

Want to change the direction of baseball overnight? Change the incentives. If the Yankees had been banned from Baseball for a year and a half — not A-Rod — you can bet that no player in baseball would touch the stuff again.

So, what does cantaloupe have to do with Baseball? Much, in addition to both being round. Like players and the baseball industry, incentives are wrong with cantaloupe growers — actually all food — and the retail industry.

In 2011, Listeria-tainted cantaloupes grown in Eastern Colorado sickened 147 in two dozen states, killing at least 33. It was the largest foodborne outbreak death toll in the United States in 100 years. That is saying a lot given that the Centers for Disease Control and prevention estimate that food sickens 48,000,000, hospitalizes 135,000 and kills over 3,000 each year.

The year before, a third generation cantaloupe grower had been enticed by a broker-shipper preferred by Walmart and Kroger to expand its market nationwide. An auditor recommended by Walmart inspected the farm and packing shed in 2011, while the cantaloupes were actually being washed by un-chlorinated, Listeria-tainted water. The farm, as with most food audits, got a superior rating of 96%. That was the green light for the cantaloupes to ship to your local Walmart or Kroger.

Those same retailersdistance themselves from such behavior, clucking constantly about food safety from “farm to fork” and creating a “culture of food safety.” They hire auditors as middlemen in the food-safety chain to give them cover to ignore food safety risks.

The grower of the tainted cantaloupe has gone bankrupt. The grower is also facing criminal misdemeanor charges for selling food considered to be “adulterated,” which according to Federal law is food that “bears or contains any poisonous or deleterious substance, which may render it injurious to health.” These charges, unlike a felony charge, “do not require proof of fraudulent intent, or even of knowing or willful conduct.” The grower does face fines and jail nonetheless.

Countless other growers and manufacturers of food produced in the last decades have faced both civil and criminal liability — yet food poisoning continues.

Sound a bit like players facing suspension over and over again?

Retailers, like team owners, require audits, set the rules, called specifications, for how food — like cantaloupes — should be safely produced. They then ignore their own rules because living by their rules costs a cent or two more, and that seems not worth the price. Why? Because just like Baseball owners who can pass the buck to the players, it is not retailers who are on the hook if there is a problem — the growers are.

Team owners squeeze their players by demanding performance. No home runs or strike-outs — no place on the team. Retailers squeeze their suppliers on price. Not the lowest price? You are out. In fact, retailers squeeze growers for the last bit of profit, leaving little for growers to invest in producing safer food – an oddly perverse incentive.

Want to change the direction of food safety overnight? Change the incentives.

Most Americans do not realize that the retailers they buy their food from are mainly insulated from civil and criminal liability. Only their suppliers have liability. But, if we were to put the onus of compensating customers for medical bills and lost wages onto the retailers that profit the most from the sale, their incentives to buy food that will not kill you would go up a lot.

Want to change the incentive of a retailer who sells you food that can make you sick or kill you? Have them face jail time or fines if they do.

Want to make food safer from “farm to fork” in a “culture of food safety?” Pay fair wages to farm workers and fair prices to growers. Both are investments in safer food.

Like steroid use in baseball, food safety will not change until those with the most power have the incentive to change behavior. Banning players or bankrupting cantaloupe growers does nothing to change the dynamic. Banning baseball owners would stop steroid use overnight. Fining or jailing retailers who sell food that kills people – well, that will do it.


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“Coming down like a ton of bricks.”

“Complicated and interwoven.”


“The end of many small- and mid-size farms and food processors.”

“Never heard of it.”

“A work in progress.”

When asked about FDA’s new proposed rule for food processing facilities, that’s how a sustainable-agriculture advocate, a food-safety expert for a large fresh produce association, the Office of Management and Budget, a small-scale farmer who owns a processing facility, a farm commodity official and an FDA food safety expert — in that order — described it.

Referred to as HARPC (pronounced “harp sea”), the acronym stands for Hazard Analysis Risk-based Prevention Controls. Mandated by the Food Safety Modernization Act, signed into law in 2011, HARPC embraces a strategy that focuses on preventing foodborne illness and other risks make food unsafe to eat. As such, it would apply to certain unintentional hazards such as microbiological, chemical, physical and radiological hazards, as well as to allergens.

According to estimates from the U.S. Food and Drug Administration, 951,000 million cases of foodborne illnesses can be attributed each year to the pathogens that this rule is designed to eliminate or reduce. The economic cost of illnesses avoided comes to $2 billion a year.

A big player in the food safety arena, FDA regulates about 80 percent of U.S. food supply—$602 billion in domestic food and $64 billion in imported food each year. That accounts for nearly everything consumers in the United States eat except for meat, poultry and some egg products, which are regulated by the U.S. Department of Agriculture.

HARPC’s focus

While HARPC is intertwined with the FDA’s proposed produce rule, which focuses primarily on preventive controls on the farm, HARPC puts the spotlight on what’s happening in food processing facilities.

For the most part, HARPC would apply to facilities that manufacture, process, pack or hold human food. These would include manufacturers, processors, warehouses, storage tanks and grain elevators, although there are some exceptions. Bottom line – HARPC would apply to facilities that are required to register with FDA under the agency’s current food facility registration regulations, which went into effect under the 2002 Bioterrorism Act.

When looking at the numbers, the proposed rule would cover an estimated 97,600 domestic and 109,200 foreign facilities. (According to FDA, in 2011 about 50 percent of the fresh fruit consumed in the U.S. was imported.)

What triggers HARPC on a farm?

Not surprisingly, there’s a lot of confusion, and even alarm, about the activities conducted by a farm that might cause it to fall under the FDA’s definition of a processing facility.

According to detailed-but-straightforward information about who would be affected by HARPC supplied by the National Sustainable Agriculture Coalition, the key distinction between a farm and a facility “seems to be whether you are transforming a product in any way.”

Farms, as defined by FDA, won’t be subject to HARPC, said FDA’s Jenny Scott. According to FDA’s definition, a farm is an agricultural operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both. It can also include facilities that pack or hold food, as long as all of that food is grown or raised on that farm or on another farm under the same ownership.

Farms that grow and harvest their own food crops are exempt from the facility registration rule. But if the farm purchases product from another farm to sell at its own retail operation and/or through wholesale transactions, it is then considered a facility and therefore required to register with FDA as a processing facility.

If a farm doesn’t grow a crop but sells it, HARPC also kicks in. Likewise, if a farm is growing fruits and vegetables and then doing anything beyond standard practices to prepare that fruit or vegetable to sell it as a whole product, HARPC would kick in. Drying, baking, cutting, and mixing products all trigger HARPC.

Manufacturing and processing always includes these activities:

– Irradiation

– Cutting, coring, chopping, slicing

– Canning

– Coating with things other than wax, oil, or resin

– Drying that creates a distinct commodity

– Artificial ripening

– Cooking

– Pasteurizing, homogenizing

– Infusing

– Distilling

– Salting

– Smoking

– Grinding, milling

– Freezing

– Slaughtering animals or post-slaughter operations

Going beyond what’s already expected

Although HARPC is similar to HACCP, Hazard Analysis and Critical Control Points, a food-safety system already in place for juice, seafood, and some produce processing plants when commercial buyers require it, it goes a bit further than HACCP.

The main difference between the two systems, said Jenny Scott, senior advisor in FDA’s Office of Food Safety, is that under HARPC, preventive controls may be required at points other than at critical control points, and critical limits (such as temperature and time requirements) would not be required for all preventive controls.

In a recent Food Safety News article about this risk-based preventive approach to food safety, Scott said that facilities that already have HACCP plans in place may need to make some changes, but for the most part, they “will be well on their way toward complying with preventive control rules.”

Pull out a pen and paper

During a presentation about HARPC, David Gombas, food safety expert at United Fresh Produce Association, called up images of a pen and paper — in other words, a lot of paperwork — when he described the proposed provisions of HARPC:

-Written food safety plan

– Written preventive controls for identified hazards

– Written monitoring procedures and frequencies

– Written corrective actions

– Written verification procedures, including validation of most preventive controls

– Written recall plan

The specter of additional paperwork and the time and expense involved in gathering the necessary information for the paperwork always rises up to haunt small- and mid-sized businesses. And with that specter come fears that HARPC will push food processors of this size off the map.

“These businesses don’t have much, if any, room to raise food costs to cover the added expenses,” said Kristen Wilmer, program assistant at Community Involved in Sustaining Agriculture.

According to the White House Office of Management and Budget, the proposed rule has a first-year cost to the industry of $701 million and an annualized cost of $472 million, using a 7 percent discount rate.

Trevor Suslow, food safety expert at University of California, Davis, told Food Safety News that it’s the mid-level and smaller-scale food processors consolidating product from multiple farms that will face the greatest challenges.

“Bottom line, it will take some work,” Suslow said, pointing out that most of the large food processors “are already about there,” in meeting HARPC’s requirements.

But Suslow also said that the FDA recognizes that different scales of operations need to be considered. He also warned about becoming polarized over specific sections of HARPC.

“At a reasonable, commonsense level, these smaller food processors can implement what’s expected of them,” he said. “There are ways for people to put something in place. I certainly hope this won’t push people out of business.”

Along those same lines, the FDA describes the preventive controls as science- and risk-based and points out that the proposed rule would require controls only where necessary to prevent hazards to public health and would exempt certain facilities from requirements or modify requirements for certain low-risk activities.

In addition, the requirements are flexible in that food processors could develop preventive controls that fit their products and operations, as long as they are adequate to significantly minimize all food-safety hazards that are reasonably likely to occur, according to FDA.


Size does come into play when it comes to exemptions. With certain stipulations and requirements, “small” and “very small” processors, as well as those with a previous 3-year average product value of less than $500,000, would qualify for an exemption, but they would not be exempt from following food-safety rules and good handling practices.

For more information about HARPC and exemptions from HARPC, visit FDA’s FAQ page. FDA also offers a chart showing exemptions and modified requirements for Preventive Controls for Human Food.

What about CSAs and farm stands?

FDA’s Jenny Scott said that farm stands and CSAs (Community Supported Agriculture) organizations, which are similar to subscribing for baskets or boxes of food on a regular basis from a farm or group of farms) would likely be classified as “exempt retail establishments.” That would mean they wouldn’t be subject to HARPC, although food-safety practices would need to be followed. But since this is a proposed rule, there’s no saying how the final rule, which is expected to be released late next year, will actually treat these sort of farming operations.

What about current Good Manufacturing Practices?

According to an article in Food Processing, for the past several decades, current Good Manufacturing Practices (CGMP) have provided the primary food safety framework for most foods regulated by the FDA. As such, they cover practices that need to be followed to ensure that food is manufactured, processed, packed and held under sanitary conditions and that the food is safe, clean and wholesome.

While HARPC embraces the same goals, it goes in a different direction, pointing the way to preventing food from being contaminated with harmful pathogens such as E. coli, Salmonella and Listeria, which can sicken or kill people. The goal is to make sure that specific potential threats to the food supply can be identified so that effective measures can be taken to counter them before any harm can occur.

Make sure to send in written comments

FDA’s Jenny Scott said that it’s extremely important for people to send in written comments, primarily because the agency needs to know what people are concerned about and what they would like to see changed and why.

“We really want to hear about specific situations and concerns and how people would be impacted by the proposed rule,” she said. But she emphasized that it’s only when the agency gets a written comment that it can be considered.

Comments can be submitted on the Federal Register. To read already-submitted comments about HARPC, enter docket #FDA-2011-N-0920 on the Federal Register’s site.

Due to requests from many people in the ag industry, the comment period was extended to Sept. 16, 20013.

The first year of enforcement will likely be 2016, although the dates are staggered for small facilities (3 years) and for “very small” facilities (4 years).

I need help with this

Scott said that people can ask their county extension agents for help figuring out whether their farm or processing facility needs to comply with HARPC requirements. During office hours (Eastern Standard Time), they can also call this toll-free number: 1-888-SafeFood (723-3366).

In the meantime, the Food Safety Preventive Controls Alliance is developing FDA-approved training materials for implementing HARPC. Guidance on the best way to implement the requirements is also being developed.

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