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Fix Suggested For FDA’s Vigilante System Of Banning Product
Through Import Alerts

Jim Prevor’s Perishable Pundit, April 16, 2008

The story of Agropecuaria Montelibano and the “import alert” the FDA imposed against its cantaloupes grown in Honduras still remains an issue of great concern — partly because the “import alert” is ongoing, partly because there are continuing issues with cantaloupes and partly because the conduct of the FDA poses troubling issues for the produce industry and for America.

FDA Fumbles Again On Cantaloupe ‘Alert’ was our first piece addressing the issue, and we ran a special 14-article edition devoted solely to the controversy. This piece was entitled, We Are All Affected By Cantaloupe Issue.

Then we ran Positive Test On Cantaloupe Causes More Confusion, dealing with an alleged positive test result on a serotype of salmonella different from that implicated in the food safety outbreak.

We proceeded to deal with some of the letters we have received on the subject, including one from Tom Church of Church Brothers in a piece we called, FDA Status Quo Cannot Stand. Most recently we ran an article entitled, Despite Flawed FDA, Cantaloupes Are Challenged, which pointed out that whatever the problems of the FDA, the industry still has to deal with issues related to the nature of cantaloupe.

We also owe a hat tip to Steven L. Varnis, an attorney specializing in Customs Law as well as doing work in international trade and logistics. Steven has done many things in the food industry, from evaluating emergency food distribution in Ethiopia to coordinating food inspections with FDA in Detroit, to name just a couple. We appreciate that Steven took the time to send us a letter that has led us to a most important interview:

With respect to the (rhetorical?) question you posed in your piece entitled, FDA Fumbles Again On Cantaloupe ‘Alert’:

The “import alert” was peculiar in several ways. First of all, what in the world is an “import alert”? Do we have something called a “domestic product alert”? What does this term mean?

You may find the attached, written by a former FDA Investigator/Compliance Officer, to be instructive. It highlights one of the (many) shortcomings in the FDA import program.

— Steven L. Varnis, Ph.D., LL.M.
Houston Center for Food System
Research and Development

You bet we found it instructive! The attachment Steve sent along, a Law Review article entitled The Food and Drug Administration’s Import Alerts Appear to Be “Misbranded”, which was published in the Food and Drug Law Journal, was written by Christine M. Humphrey.

At first we thought Ms. Humphrey was a prodigy of some sort, as she wrote the article while in law school. Then we realized that by the time she wrote the piece in 2003, she had already been working as an Investigator and Compliance Officer for the Food and Drug Administration since 1994.

The article is a fascinating analysis of the way the FDA has subverted procedural safeguards through the use of “import alerts”:

This article suggests, however, that Alerts — labeled as “guidance” — do not provide fair notice. The aggregate effect is an administrative scheme that undermines principles of uniform enforcement, and moreover, fundamental fairness and procedural due process, which are the hallmarks of the Administrative Procedure Act’s (APA’s) notice-and-comment procedures.

Since the article was written in 2003, we wanted to get an update and discuss the applicability of the thesis to the “import alert” associated with the cantaloupes from Honduras. We asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

Christine M. Humphrey, Esq.
Mitchell Fuerst, Esq
Fuerst, Humphrey, Ittleman
Miami, Florida

Q: In the context of how FDA has handled the cantaloupe outbreak, there is much confusion throughout the industry as to FDA’s legal authority and procedures in issuing and upholding import alerts, and concurrently, the responsibilities and rights of produce companies it implicates.

A: HUMPHREY: It’s interesting that under the Bioterrorism Act, FDA has new enforcement authority it hasn’t used and has reverted to issuing arbitrary import alerts, basically banning product from entering the country. [Editor’s note: issues regarding the Bioterrorism Act are discussed later in the interview.]

Q: Does the import alert legally mandate a ban? What is the scope of the ban and how is it lifted?

A: FUERST: When FDA issued an import alert on cantaloupes from this Honduran grower, the effect was to ban product from this grower. The ban was specific to cantaloupes, although the reality is no one wants any of [the company’s] product. And it is also likely that anything that comes in under [the company’s] name will be flagged by a compliance officer and easily go under requirement for inspection.

Once the import alert is in place, the burden is on the importer to demonstrate product is not adulterated, so testing is mandated before product can ever be released. When the alert is issued, FDA compliance officers will automatically detain product. The concept has arisen over the years that just before product is about to enter the U.S., it will be detained and either released or refused based on adjudication, an informal administrative process.

A: HUMPHREY: You don’t see the word detention or detained in the statute [the Food, Drug and Cosmetic Act export provision, commonly referred to by FDA as Section 801. The correct citation under U.S. Code is 21USC381]. But practically, when an import alert is issued, the product will be automatically detained and subject to refusal. The importer will have 14 days to demonstrate what it plans to do, and to prove the product is not violative or it will be refused. The importer bares the burden of third-party lab tests so FDA is satisfied that product does not contain salmonella, or E. coli or whatever the problem in question.

Q: Is that 14 days a rule?

A: HUMPHREY: There is no general rule. OASIS (Operational and Administrative System for Information Support) automatically generates FDA notices of action, and they’re programmed to allow for 14 days for an importer of record or other party of interest to respond to the notice of action. It’s not found in regulation or statute; it’s just FDA policy.

Q: So the import alert is not a legal document? The FDA doesn’t have legal authority to ban product from entry?

A: HUMPHREY: The FDA alleges or it’s their posture that import alerts are guidance documents, not a law, just guidance that FDA officers in the field can use when making an assessment.

The reality is where import alerts are issued. Every compliance officer who comes upon product at entry will automatically detain product. There is a paper notice issued to the broker and importer that states product is subject to refusal.

Q: What is actually on the notice? Are these standard protocols? Does it give the importer instructions on what needs to be done?

A: FUERST: These import alerts are not consistent or uniform. They don’t always specify how the violation can be overcome. Some alerts have requirements, like in Chinese agricultural and seafood products. They mandate the importer conduct a battery of tests at third-party labs to make sure antibiotics are not in shrimp, for example. It’s like a rule. It’s a real problem from a legal perspective because an import alert acts as a rule. It prevents the importer from bringing any product in; it’s a ban.

Q: Has anyone ever brought the issue to court and legally challenged FDA’s authority here?

A: HUMPHREY: It’s been challenged. The courts have struck down import alerts in the past. [Editor’s note: Humphrey details related court decisions here and here]. But FDA continues to use import alerts. It’s a real problem. It does confuse importers because the requirements are not clear. Sometimes when a prescribed set of events must take place, many times FDA will add additional requirements later.

Q: In other words, FDA moves the goal posts?

A:HUMPHREY: The alert says the importer must test this product to determine x, y and z. We’ve seen several incidents where the importer does conduct these tests in compliance with what FDA has required and the FDA says that’s not good enough.

A lot of the third-party labs look to the FDA guidance in the laboratory bulletins, which are not necessarily clear or complete. The third-party labs often have to work with those FDA centers that issue the lab bulletins. What you have is third-party labs calling all these centers, with no real point person. They don’t know who to call.

One regional lab says one thing, and another regional lab says the opposite; headquarters says something else, and there’s no clear directive. It’s a real mess, and the rights and obligations on importers and even manufacturers are unclear.

Hundreds of Chinese companies are trying to get on an exemption list and only one is exempt. There is no process for a company to get an exemption. FDA keeps requiring more and more. The initial requirements are met and FDA raises the bar higher. Requirements are added to the alert but not documented on the alert. It’s a crap shoot.

How can I get product in or an exemption? No one knows the answer.

Q: The time delays in getting product released could be disastrous for produce companies. Products with short-shelf lives could be rotting away while companies await resolution, and end up in the trash regardless of the outcome.

A: FUERST: In perishable categories like produce, you don’t have the time to wait two, three days, sometimes up to a week to get those test results back. How does a foreign grower of cantaloupes demonstrate to FDA that a particular lot of product is unadulterated to satisfy FDA?

Q: How forthright does FDA need to be when documenting the reasons for import alerts? If FDA does product testing, for example, does it have any legal obligation to release test results and methods for how its labs arrived at those results?

A: FUERST: The importer would be a party to that adjudication, the informal hearing, and under due process, the importer needs to be addressed. In the case of product sampled by FDA found to obtain salmonella, the importer has the right to those results.

Many districts will refuse to supply the whole testing analysis. This is a problem. The importer needs that information to present its case; it could be challenging FDA’s own methodology, where the FDA lab has a false positive. The importer has the legal right to those tests.

A: HUMPHREY: Unfortunately many districts require the importer to submit a Freedom of Information Act, which is absurd. You might have a compliance officer in Florida willing to supply you with the full lab work so you can assess and audit, while others refuse. Getting the documents through the Freedom of Information Act could take two weeks to a year. No way is that acceptable when dealing in perishables. A lot of our clients understand these issues, and we can make these arguments so companies don’t have to wait.

At what stage does that foreign grower have the right to the information that the FDA is asserting is the reason behind the import alert? If FDA is dragging its feet on giving lab results to the foreign grower, it can’t mount a defense and is left stranded.

Q: Does politics complicate matters when dealing in the international arena?

A: FUERST: A foreign grower has no legal right to do business in the U.S. When FDA takes action in the form of an import alert, if it affects just a particular grower, that grower has no right to go to court and say, ‘you’ve taken away our business.’

But if FDA banned all country imports, it would create the right of that country to go to WTO and contest what FDA has done. In order to avoid that issue, FDA will put out a countrywide alert with one exemption to prove the FDA is not creating a non-tariff trade barrier; but is instead asserting its right under WTO to protect the U.S. public from unhealthy food. The FDA can contentiously say, ‘we’re not revealing what we have,’ and evade the judicial process.

Q: How should FDA procedures change? What needs to be done? What actions should the produce industry take to facilitate a better process?

A: HUMPHREY: In my import alert report, at the very end I present ideas of how the agency could better utilize its resources and provide a more just and effective system to insure a safer food supply.

Having a rule published in the Federal Register establishes clear standards and procedures that can be followed by a company, and ways the importer can establish product is not violative. Currently, each case is different, some have requirements that others don’t. It’s confusing for third-party labs in the U.S. It is unclear if the company would be allowed to do testing overseas before importing product. With perishables, that’s the only way to do it.

Since I wrote the import alert report, Mitchell and I have worked with FDA to implement a prototype where the agency would focus on risk assessments as the way to look at particular commodities.

On April 2, FDA issued stakeholder comments on its Food Protection Plan. It includes a great deal of what we presented in our prototype; the ability of foreign companies to identify critical steps in their process that will meet FDA approval.

If you have a cantaloupe grower in Honduras, the focus might be on water systems due to certain risk factors, and there would be checks and balances a company would institute and document through accredited third-party certifications. If the grower went through that process, they’d move lower on the FDA responder list. The risk level would be reduced and therefore that grower’s product should come into the country without having some arbitrary review.

Right now FDA doesn’t have its arms around products coming through or an established risk assessment to demonstrate product is controlled and audited by third parties.

Q: The implicated Honduran grower has done exactly as you suggest. It has gone beyond standard GAP procedures instituting GlobalGAP, critical control point testing, and undergoing extensive third-party auditing by Primus Labs, a reputable third party. Yet FDA maintains the same threshold in issuing and upholding an alert as it would a company with minimal standards.

A: FUERST: This Honduran grower is the perfect example of a company doing everything in its power to provide safe product and FDA has no mechanism in place but to say the food safety controls sound great but we see a problem. Because there is no implemented policy to measure risk, FDA doesn’t know what to do, so it goes back to issuing an import alert.

Q: How is the actual decision made to issue an alert?

A: HUMPHREY: Bureaucracy at the FDA is out of control. The FDA Division of Import Operations and Policy (DIOP), the division that issues import alerts, doesn’t report to anyone but the Office of Regulatory Affairs (ORA). The Center for Food Safety and Applied Nutrition (CFSAN) is consulted in some respects, but there is no synergy between the divisions. CFSAN is its own distinct body, so there are no real procedures for one entity to speak to the other. The varying offices within FDA don’t communicate and when they do, there is no systematic protocol.

Q: Having 14 years of FDA experience and working inside the FDA for 10 years, gives you additional perspective to understand the disconnect.

A: HUMPHREY: One hand doesn’t know what the other is doing. FDA’s legal section hasn’t focused on imports as much as domestic issues. In judging the lawfulness of this, the avenue is the Office of Chief Council. I actually dealt with the Office of Chief Council recently; they fumble around and don’t have an answer.

The Center for Food and Applied Nutrition says this product needs this requirement before it can be considered unadulterated. Another arm says something different. There are a lot of disconnects and at the end of day, you have ambiguity and no clear pathway for a firm to get a fair hearing. There is no pathway to adjudicate; there is no pathway for a foreign company to demonstrate product is unadulterated to the satisfaction of the FDA because it is dealing with four or five offices.

A: FUERST: When it comes to import alerts, the agency’s fragmented functions prevent adjudication from occurring. One part of the agency says thou shall not do this, another part enforces it. Those controversies have to be handled on an import by import basis. It prevents the affected party from getting a true resolution.

A: HUMPHREY: I can only imagine what the company in Honduras is going through. Having worked in the agency, I can understand how truly frustrating it is that no matter what the company has done in the past, there is no structure for the grower to gain recognition for good agricultural practices.

Q: What does the Bioterrorism Act allow FDA to do? And why wouldn’t it use its new powers to handle food safety issues rather than revert to ineffective and from what you say illegal import alerts?

A: FUERST: Through the Bioterrorism Act, the agency can detain these products, if these companies say they won’t recall product. As a health and safety issue, FDA can administratively detain, similar to a seizure, taking enforcement action to stop further distribution of product. FDA has to have enough evidence, but if there is significant evidence of a food safety problem, the Bioterrorism Act gives FDA the legal authority. Instead they use import alerts.

Q: WHY?

A: HUMPHREY: I would suspect the agency doesn’t have a system in place to execute administrative detentions. I don’t know this for certain, but I haven’t seen any signs. In some instances, you have a company that shouldn’t be subject to an import alert. How can we get that company on an exemption list? Time and time again, this happens and we are still trying to figure out how we will handle this. The FDA doesn’t have procedures in place.

Even with port shopping [going into one particular U.S. port of entry whether by air or ship and having product refused and subsequently shipped back to the country and having it re-imported via another port], one of the provisions in the Bioterrorism Act makes it unlawful for a firm that has product refused to bring that product back into the U.S.

In the case of administrative detention, I don’t believe the agency has articulated how they would handle it. FDA began promulgating regulations to effectuate the Bioterrorism Act provisions, and with respect to the port shopping provision, I haven’t seen if FDA has final regulations. I don’t believe it does. With respect to the resources and FDA’s ability to act under the codification of all the requirements under the Bioterrorism Act, it’s taking a lot of time and I think port shopping provisions are last in line.

Q: In FDA’s import alert against this Honduran grower, it also asked companies that have purchased product from this company to conduct voluntary recalls. Could you address the concept of voluntary recalls?

A: FUERST: FDA issues a warning, and unless the foreign company litigates and says, ‘forget it, you don’t have any authority to recall’, the agency will continue to put pressure on companies to voluntarily recall. Depending on who is speaking from the FDA, they’ll threaten these companies, letting them know if they do not cooperate and proceed with the recall, then FDA will issue a release that it is concerned the product is not safe.

Q: Prior to the spinach crisis, FDA asked several companies to recall packaged spinach and several refused since they believed the FDA epidemiology was flawed and they were not part of the problem. In the end FDA was persuaded. But FDA still issued a consumer advisory that no consumer should eat any spinach period. All companies wound up not being able to sell spinach anyway. Is this an attempt by FDA to assert power they don’t have?

A: FUERST: You put the hammer on the head of the nail. The agency doesn’t have authority to mandate a recall. This is the core issue. If FDA goes into mandatory recall posture and attempts to use the Bioterrorism Act, the recall could result in litigation, which is estimated to take 25 to 28 days. If the problem is with a perishable item like produce, consumer safety is not protected. Therefore, FDA has turned into the direction of voluntary recalls and putting companies in the position of being adverse to consumer interest by not cooperating.

The FDA believes its mandatory authority to cause a recall or force a seize-and-arrest presents a posture that FDA may not have adequate evidence for the volume of product it sees as dangerous to prove its case. It uses the public media and reputational concern of manufacturers and distributors and retailers to bring about the same results.

What happens in order to force a mandatory recall, the standard of evidence required in court doesn’t allow the speed necessary for potentially dangerous product to be taken off the market. The law doesn’t allow the FDA to proceed with the alacrity that FDA feels is necessary.

In the case of the spinach recall, because FDA didn’t have evidence to enforce a mandatory recall — it was too sweeping and no court would allow it to happen at that level — the FDA had to force consumers away from the product instead of forcing manufacturers to recall it.

Q: What key steps can be done at this point to effectuate change at the FDA to create a just system while insuring a safer food supply?

A: FUERST: One solution is putting into place a process where risk assessment is recognized; where foreign manufacturers have an avenue to travel down to show their compliance. If there is a particular outbreak, all these companies can be affected, but there is no process whereby they can vindicate themselves. There’s no risk assessment strategy.

Q: But FDA says there must be clear evidence that the source of the problem behind the import alert must be found and corrected before the ban can be lifted. The catch is that the source of the problem may never definitively be determined, as was the case in the spinach E. coli crisis.

A: HUMPHREY: A true beginning is in The Food Protection Plan; having established processes in place to be sufficient to control hazards with a particular product. If those principles are adopted, at least there will be a measurable standard in which to move forward. There will always be cases of adulterated product; that is a fact of life. There is never a way to guarantee produce will be safe 100 percent of the time. If there is a strong food safety platform for these companies to operate from, that is the best we can expect.

The whole system needs to be in harmony, so corrective actions can occur when there is a breakdown.

A: FUERST: If it’s based on a HACCP model, and the company has this model in practice, it can go through all the procedures. There will always be potential for contamination in water, but the company must demonstrate [it has] taken adequate safety measures to mitigate potential problems. It’s about addressing hazards and mitigating risks, targeting where problems surface and having corrective actions in place to prevent contamination.

There will be times where it will be difficult to assess where in the chain the problem originated, but the company can demonstrate that whatever the problem was, it has taken adequate measures to contain it. The final analysis is that where they identified critical control points, they evidenced product is complying with those requirements through testing; that has to be good enough.

FDA can’t expect every processor to test every piece of fish and every cantaloupe. Typically with foodborne issues, generally it’s a problem with the water system or GAP in the field, but the problem could be related to shipping or have occurred at another point in the supply chain.

A: HUMPHREY: Last year in October or so, President Bush mandated that the agency put together a food safety plan. We worked over a year on this particular prototype with senior officials at FDA. A large percentage of the principles that we recommended were adopted in the plan.

The agency is recognizing they must do something. There were formal meetings with the agency on this prototype. We’re actively involved in working with the agency and other third-party verification agencies to make this happen. These third-party agencies exist, the HACCP programs work, so let’s operate in a risk-based universe, not through arbitrary import alerts.

There’s no incentive for these foreign companies to put these systems in place if they’re not going to get priority review or a green light when they do.

We are very proud of what we do here at the Pundit, and bringing the work of Christine M. Humphrey and Mitchell Fuerst to the attention of the broader industry is truly important work.

There is a cornucopia of information in this interview, but the situation seems to break down to five principles:

1. The FDA is currently dysfunctional:

Bureaucracy at the FDA is out of control. The FDA Division of Import Operations and Policy (DIOP), the division that issues import alerts, doesn’t report to anyone but the Office of Regulatory Affairs (ORA). The Center for Food Safety and Applied Nutrition (CFSAN) is consulted in some respects, but there is no synergy between the divisions. CFSAN is its own distinct body, so there are no real procedures for one entity to speak to the other. The varying offices within FDA don’t communicate, and when they do, there is no systematic protocol.

One hand doesn’t know what the other is doing. FDA’s legal section hasn’t focused on imports as much as domestic issues. In judging the lawfulness of this, the avenue is the Office of Chief Council. I actually dealt with the Office of Chief Council recently; they fumble around and don’t have an answer.

The Center for Food and Applied Nutrition says this product needs this requirement before it can be considered unadulterated. Another arm says something different. There are a lot of disconnects and at the end of day you have ambiguity and no clear pathway for a firm to get a fair hearing. There is no pathway to adjudicate; there is no pathway for a foreign company to demonstrate product is unadulterated to the satisfaction of the FDA because it is dealing with four or five offices.

2. The FDA acts to achieve what it wishes to achieve, regardless of whether Congress has given it that authority:

The FDA alleges or it’s their posture that import alerts are guidance documents, not a law, just guidance that FDA officers in the field can use when making an assessment. The reality is where import alerts are issued, every compliance officer who comes upon product at entry will automatically detain product. There is a paper notice issued to the broker and importer that states product is subject to refusal.

It’s been challenged. The courts have struck down import alerts in the past.

…if FDA banned all country imports, it would create the right of that country to go to WTO and contest what FDA has done. In order to avoid that issue, FDA will put out a countrywide alert with one exemption to prove the FDA is not creating a non-tariff trade barrier; but is instead asserting its right under WTO to protect the U.S. public from unhealthy food. The FDA can contentiously say, ‘we’re not revealing what we have,’ and evade the judicial process.

In the case of the spinach recall, because FDA didn’t have evidence to enforce a mandatory recall — it was too sweeping and no court would allow it to happen at that level — the FDA had to force consumers away from the product instead of forcing manufacturers to recall it.

3. The FDA is needlessly obstructionist:

Many districts will refuse to supply the whole testing analysis. This is a problem. The importer needs that information to present its case; it could be challenging FDA’s own methodology, where the FDA lab has a false positive. The importer has the legal right to those tests.

Unfortunately many districts require the importer to submit a Freedom of Information Act, which is absurd. You might have a compliance officer in Florida willing to supply you with the full lab work so you can assess and audit, while others refuse.

4. Current FDA procedures act as a disincentive to spend money on food safety:

These third-party agencies exist, the HACCP programs work, so let’s operate in a risk-based universe, not through arbitrary import alerts. There’s no incentive for these foreign companies to put these systems in place if they’re not going to get priority review or a green light when they do.

5. The light at the end of the tunnel is a risk-assessment strategy:

One solution is putting into place a process where risk assessment is recognized; where foreign manufacturers have an avenue to travel down to show their compliance. If there is a particular outbreak, all these companies can be affected, but there is no process whereby they can vindicate themselves. There’s no risk assessment strategy.

A true beginning is in The Food Protection Plan; having established processes in place to be sufficient to control hazards with a particular product. If those principles are adopted, at least there will be a measurable standard in which to move forward. There will always be cases of adulterated product; that is a fact of life. There is never a way to guarantee produce will be safe 100 percent of the time. If there is a strong food safety platform for these companies to operate from, that is the best we can expect.

The whole system needs to be in harmony so corrective actions can occur when there is a breakdown.

There is a sense in which the import alert against Agropecuaria Montelibano is tragic… with thousands unemployed, reputations ruined, perfectly healthy food left to rot in shipping containers and unpicked in the field. There is a sense in which it is pointless… since the FDA has simply no statistically valid reason to believe that cantaloupe currently being shipped by other companies is any “safer” for human consumption than the product that would be shipped by this farm if the “import alert” were not in place.

From a business perspective, the problem with the FDA’s modus operandi is clear: The uncertainty it injects into the system reduces the incentives to invest in production, import and distribution. The costs imposed on producers, importers, retailers, etc., are ultimately passed on to consumers and raise food prices.

From a public health perspective, it fails to incentivize producers and processors to invest in food safety. How did the FDA’s action in the fall of 2006 give an advantage to the very best spinach processor that invested fully in food safety over the very worst? Answer, it did not. The FDA just told consumers not to eat spinach. Period.

Yet the broader issue, for the country, is that FDA is behaving like a law unto itself. In America, citizens are not supposed to cower before government agencies. The food industry is filled with people who want to speak out but are filled with fear. The FDA has too much discretion and can destroy businesses by simply deciding to hold product for testing. Nobody wants to get on the bad side of FDA officials.

As food safety has become more complex, depending on difficult-to-interpret epidemiology, and as food safety efforts have made expertise in this area a big ticket item in business, FDA is left with many officials, especially in regional FDA offices, who are not top-notch people. They make low salaries compared to the private sector and are not able to understand the complex epidemiology driving FDA decisions.

Sometimes this leads the FDA to make mistakes — as when they tried to get other companies to recall during the spinach crisis. Sometimes it leads to bullying — a not-uncommon human reaction to being unable to explain or defend one’s actions.

In the end, the discovery of a pathogen is an almost random event. For the same reason testing of finished product is rarely done on produce with the frequency required to be statistically valid, so the occasional pathogen on crops grown in dirt under the rain is not surprising.

Christine Humphrey and Mitchell Fuerst are working to redirect our resources from hysteria at a normal occurrence to a risk-based assessment system that can provide a stable business environment and maximize food safety.

An additional and not inconsiderable benefit of this approach is that it moves the time line back so that if there is a dispute with FDA as to how risk should be judged or how a critical control point should be addressed, those disputes could be addressed through normal judicial channels, as it would not typically involve perishable food waiting to be eaten.

This would allow businesspeople to communicate with the FDA as free people and not as supplicants begging for a break.

Freedom and the bureaucratic discretion to destroy the lives and businesses of people are simply not compatible. We must find an alternative.

Many thanks to Steven L. Varnis, Ph.D., LL.M. of the Houston Center for Food System Research and Development, for pointing us in such a productive direction and to Christine M. Humphrey and Mitchell Fuerst of Fuerst, Humphrey, Ittleman in Miami, Florida, for fighting the good fight and sharing their insights with the industry.

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