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Science-based Or Emotion-based? As Food Safety Modernization Act Soon Goes Into Effect, Industry Looks At Extra Costs And Little Return To Public Health

Jim Prevor’s Perishable Pundit, April 11, 2013

Much attention is being paid to the new rules for food safety proffered by the FDA. The Washington Post just ran a piece titled, Proposed FDA Food Safety Rules Frustrate Tree Fruit Growers:

The Food and Drug Administration, wrestling to put in place a massive overhaul of the nation’s food safety system, drew a line this year when proposing which fruits and vegetables would be subject to strict new standards: Those usually consumed raw would be included, while those usually cooked or processed would be exempt.

Since then, few groups have expressed more frustration than tree fruit farmers, who grow apples, pears and a variety of other produce. They complain that the FDA’s approach, in some ways, defies common sense.

Those gripes offer a case study in the challenges of implementing the landmark 2010 Food Safety Modernization Act, which directed the FDA to prevent food-borne illnesses rather than simply react to outbreaks. It’s an easy idea to embrace. But when it gets down to apples and oranges, figuring out who should abide by which rules has proven anything but simple.

Growers subject to the new produce rules could face a variety of new responsibilities, including regular testing of irrigation water, sanitizing canvas fruit-picking bags and keeping animals away from crops. Many tree fruit farmers worry about the cost of such measures and say they would offer few safety benefits.

They argue that the FDA should focus more on foods that have caused deadly outbreaks, such as spinach and cantaloupes, and less on fruits that have a virtually flawless safety record, grow above the ground and, in some cases, have protective skins or rinds.

“Our product is quite safe,” said Phil Glaize, a third-generation farmer and owner of Glaize Apples in Winchester, Va. “We’re perfectly willing to look at ways to make it safer. However, what’s being proposed is very onerous and expensive. ... [The costs] would end up getting passed on to the consumer, if we didnt go out of business first.

FDA officials say that the proposals offer a starting point and that they are open to making changes to create a science-based system that is adaptable to different growing conditions, different regions and different crops.

“It’s complicated. It’s a big, transformational thing that we’re doing. ... Were creating a whole new food-safety system here, so we accept that it will take some time to get the rules right,” Michael R. Taylor, the FDA’s top food-safety official, said in a recent interview. “The point is, we want to target our standards where they will make a practical difference.”

There is little reason to doubt that Mike Taylor is being honest. Executives at the FDA really do want to target their efforts where they would have an impact. They do not want to burden farmers and businesses with unnecessary regulation to no point.

However, the difficulties of framing regulations and the institutional imperatives of the FDA will doubtless lead to much bother and expense being imposed on farmers and businesses with little, if any, return when it comes to public health.

In this case, you have several issues colliding. The FDA made a distinction between foods that are typically cooked and those that are eaten raw. This seems to make sense as cooking is generally a “kill step” that kills off dangerous bacteria — although the fact that hamburger is typically cooked has not stopped many foodborne illness outbreaks from being linked to hamburger.

In any case, the distinction is just one of many such distinctions that could be made, and the tree fruit folks are suggesting a more empirically useful standard: Distinguish between commodities that have a history of causing food borne illness and those that do not.

Unfortunately their incentive structure is to be overly regulatory. Think about the Salmonella St. Paul outbreak, which was initially thought to be tomatoes and ultimately was believed to be Jalapeño. Now Jalapeños were not a known high-risk item.

The question that is top-of-mind in making these rules is that an FDA executive is sitting there saying, “Do I want to be hauled before a congressional committee and asked why I made an exception for a particular commodity, when someone just got sick or, God forbid, died as a result of consuming that previously thought of as a safe item?”

Nobody at the FDA will ever be fired because they made a judgment to be too restrictive on food safety. There will be few sleepless nights because they ordered too many water tests for some commodity, but their careers could be ruined and they could live their lives in despair because someone gets sick — even once — because they were lax.

This is one reason why the regulatory burden grows incessantly. The regulators don‘t pay the price of their edicts. There are other reasons: The more things are regulated, the bigger their departments, the larger their staffs, the bigger their budgets, the more important and well paid they are.

With such dynamics at work, it is important to understand the law and the proposed regulations. We’ve been fortunate to have our friends at Jones Day weigh in on various legal issues, both here at the Pundit and in Pundit sister publication, PRODUCE BUSINESS. These pieces have included the following:

How To Prepare For An FDA Inspection And Recall

Beware Of Bribery Beyond Our Borders

Among the authors of these pieces is Harold Gordon, who is not only a Partner at Jones Day and a well-respected litigator based in New York, but he happens to also be the son of Myra Gordon, the Executive Administrative Director of the Hunts Point Market in the Bronx.

We asked Harold if he and some his colleagues could weigh in on the Food Safety Modernization Act, and what follows is the first of two pieces related to this subject:

The FDA is moving forward on major new “FSMA” regulations

In January 2011, President Obama signed the Food Safety Modernization Act. This Act, known as FSMA, directs the FDA to make sweeping changes to how America’s food supply is regulated. For the following two years, not much happened. Although inspections and enforcement actions are now more frequent, the most anticipated new regulations remained under wraps.

On January 4, 2013 — the second anniversary of FSMA’s enactment — the FDA published drafts of two of the most important new regulations: the Produce Standards rule and the Preventive Controls rule. These rules are not in their final form and won’t be enforced for several years, but when they are, they will have a big impact on the industry.

For at least another two months, affected businesses can voice their opinions on the proposed rules. One mechanism for doing so is to submit written comments, and our next article will discuss how to take advantage of this important opportunity to shape the proposed regulations. In addition, the FDA has scheduled three public meetings at which members of the public can provide informal, face-to-face feedback. The FDA held the first of these meetings on February 28 and March 1 in Washington, and a report of this meeting can be found below.

The FDA’s Perspective on FSMA and the Two New Rules

The FDA views FSMA as the most important change to food regulation since the Food, Drug, and Cosmetic Act was passed in 1938. These changes will result in compliance costs to industry that the FDA estimates at well over $1 billion each year. Although the FDA is attempting to balance increased safety against the compliance costs, safety is its chief concern.

Accordingly, the FDA intends its new rules to be preventive, risk-based, and science-based. In English, this means, first, that the purpose of the additional regulations is preventing foodborne illnesses, rather than merely reacting to outbreaks.

Second, the nature of a firm’s responsibilities for preventing contamination will depend on the risks posed by that firm’s operations. This is both good and bad. It is helpful that the FDA recognizes that one-size-fits-all solutions are cumbersome and often inappropriate. But the flexibility of this approach also makes it harder to determine exactly what must be done to comply.

Third, the regulations are supposed to reflect real-world risks, as proven by scientific evidence, and mandate efforts that are scientifically proven to be effective in reducing these risks.

The Proposed Produce Standards Rule

At present, the FDA does not directly regulate farming methods. This will change when the FDA finalizes the Produce Standards rule, known formally as the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” This proposed rule identifies five vectors that can lead to microbial food contamination on farms:

  • agricultural water,

  • “biological soil amendments” (essentially manure or wastewater used as fertilizer),

  • worker hygiene,

  • equipment, tools, and facilities, and

  • animals (both domesticated and wild)

The rule imposes requirements addressed to each of these possible vectors, as well as requiring worker training and the maintenance of specified records. The rule exempts produce that is seldom eaten raw and produce that will be shipped to a processor that employs a “kill step” to eliminate pathogens. Sprouts, which the FDA views as particularly high risk, are subject to additional controls.

Farms with less than $500,000 in annual sales are exempt from most provisions.

The Proposed Preventive Controls Rule

The second major rule announced in January updates current good manufacturing practice (“cGMP”) requirements and establishes new “Hazard Analysis and Risk-Based Preventive Controls” requirements. The latter requirements reflect the biggest change from current regulations. In short, the Preventive Controls regulations require covered firms to create a food safety plan that identifies the hazards reasonably likely to occur in their operations. The firms must then implement, verify, monitor, and document effective control measures to prevent those hazards. Firms must also plan how they will implement corrective action and recalls if the control measures do not work, and must periodically re-evaluate their plans.

The Preventive Controls requirements are less of a sea change than the Produce Standards. Unlike farms, registered facilities such as manufacturers and processors are already subject to cGMP requirements, and should already have compliance programs in place. The new Preventive Controls requirements are modeled after the existing “HACCP” (Hazard Analysis and Critical Control Points) regulations. HACCP regulations are already mandatory for facilities that produce seafood, juices, meats, and poultry products, and voluntary compliance with HACCP standards is increasingly common among dairy firms and many of the largest food manufacturers of all descriptions.

The changes are nonetheless significant. Most growing operations currently do not follow HACCP guidelines, and they will need to retrain their personnel, and often will want to hire outside auditors to monitor compliance.

“Very small businesses” are exempt from many of the new requirements. The scope of this exception remains uncertain; at present the FDA is considering whether this exemption should be restricted to businesses that sell less than $250,000 of food per year, or whether firms with up to $1 million in annual sales can qualify.

The Public Meeting in Washington

The FDA held the first in a series of public meetings to discuss the Produce Standards and Preventive Controls rules on February 28 and March 1. Many senior officials attended. The FDA Commissioner, Margaret Hamburg, gave the opening presentation, and the Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, stayed for the entire two-day meeting.

The public comments were consistently supportive of the regulations, albeit with varying levels of enthusiasm. The first four speakers set the tone. These speakers — and no doubt this was not a coincidence — were a girl suffering long-term health issues as a result of eating a contaminated cantaloupe, a young woman who nearly died from tainted spinach, a mother who had fed her daughters a nearly lethal spinach salad, and a man whose father died from eating cantaloupe. While many speakers voiced concern over specific issues, no one attempted a head-on assault on the rules.

The most common concern voiced by industry representatives involved imported foods. The FDA is explicit that imported foods will be required to meet the same requirements as domestic foods. The FDA promises to publish soon a series of proposed rules and initiatives designed to implement this policy. The most important anticipated rule will require importers to verify that their suppliers comply with all FDA requirements.

Despite the FDA’s assurances, there remains an undercurrent of doubt as to whether foreign producers really will be forced to comply. As a result, many speakers complained that they could not meaningfully comment on the Produce Standards and Preventive Controls rules until after the FDA publishes the importer verification rule. An FDA spokeswoman later stated informally that the FDA “will adjust the comment periods to allow the opportunity for the public to comment as a package.”

Other comments addressed the scope of the small business exemptions. The consumer advocates, and some industry representatives, argued for making the exemptions as narrow as possible. All operations, they asserted, pose the same risks of contamination. Some commentators, however, asked the FDA to keep in mind the burden that the new regulations would impose on smaller firms and farms.

*****

Even two years after FSMA became law, its implementation process is just beginning. The second public meeting took place in Chicago, Illinois, on March 11 and 12, and the third public meeting was held in Portland, Oregon, March 27 and 28. The FDA will be accepting comments on the two rules we have been discussing until May 16, and the comment period may be extended.

And more regulations are coming. Many more regulations are coming. Importers will likely be dramatically affected by the importer verification rule mentioned above. New pet food rules, perhaps comparable to the Preventive Controls rules, are also coming soon, along with rules designed to beef up foreign enforcement abilities by establishing a network of third-party inspectors. Other rules in the pipeline will address sanitary transportation of food, intentional adulteration, and increased record-keeping burdens for high-risk foods.

For more information about FSMA or food regulation, please contact the authors:

Harold K. Gordon
Partner
Jones Day
New York, New York

Jonathan Berman
Partner
Jones Day
Washington, DC

June K. Ghezzi
Partner
Jones Day
Chicago, Illinois

For more information about our law firm, please visit our website at www.JonesDay.com

To us the most telling paragraph in this thoughtful piece by Jonathan Berman, June K. Ghezzi and Harold K. Gordon is the one about who testified:

The public comments were consistently supportive of the regulations, albeit with varying levels of enthusiasm. The first four speakers set the tone. These speakers — and no doubt this was not a coincidence — were a girl suffering long-term health issues as a result of eating a contaminated cantaloupe, a young woman who nearly died from tainted spinach, a mother who had fed her daughters a nearly lethal spinach salad, and a man whose father died from eating cantaloupe. While many speakers voiced concern over specific issues, no one attempted a head-on assault on the rules.

There is a saying among lawyers and judges that “Hard cases make bad law,” and the fact that individuals have suffered from a state of affairs does not prove that the law can or should do anything about it. We always believe that it isthe responsibility of the industry to Look At The Faces and realize that real people are affected by industry decisions. But allowing small numbers of victims to add such emotional weight to a debate that nobody else is prepared to speak lest they be thought indifferent to human suffering simply will not help advance our thinking on these matters.

We have never thought that the Food Safety Modernization Act was likely to improve food safety and laid out our ideas for an alternative approach in a piece in The New Atlantis, titled How to Improve Food Safety.

Still, we are stuck with the law so, like the tree fruit people, we have little choice but to use the comment process to  try to make it less harmful. Many thanks to our friends from Jones Day for helping us to better understand the issues at stake.

 

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