New food rules: How healthy?

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After decades of delay, feds ramping up food safety


Food poisoning was once largely blamed on meat; in recent years, veggies, leafy greens and fruits like cantaloupes (right) have caused many outbreaks of food-borne illness.

On Jan. 4, 2013, the government announced new safety rules of food production and processing.

The FDA Food Safety Modernization Act — we’ll call it FSMA — was signed into law on Jan. 4, 2011. The Food and Drug Administration then spent two years cooking up more than 1,000 pages of rules. The twin proposals just released cover safety of produce, and manufacturing and handling practices in the food industry.

After a 60-day public comment period, FDA will have a year to issue final rules, and larger operations will have two more years to comply. That schedule will be eased for smaller businesses; micro-farmers and producers will be exempt.

Core of the proposal

“The proposed rule … would apply to many domestic and foreign firms that manufacture, process, pack or hold human food. These firms would be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results and specify what actions will be taken to correct problems that arise.” (Source: (FDA)

Sprouted seeds have been one of the larger sources of pathogen contamination in the U.S. food supply.

Although meat production remains the realm of the U.S. Department of Agriculture, the FDA is responsible for most other foods.

The past 10 years have brought a cascade of food-contamination scares, affecting everything from chopped meat to spinach to peanut butter.

We grabbed this recent roll call from Food Safety News, a website published by a law firm “with a practice dedicated to representing victims of foodborne illness”:

Jan. 11, 2013: 26 cases of deadly E. coli O157:H7 infection, which can cause uncontrollable bleeding and kidney failure, are due to California lettuce.

Jan. 4: FDA warns an Indiana farm about salmonella-infected cantaloupe, which caused about 150 illnesses and three deaths last summer.

Dec. 13, 2012: More than 150 people in Wyoming have intestinal illness, apparently due to a norovirus-infested restaurant buffet.

Nov. 30: At least 42 Salmonella infections are blamed on peanut butter made in New Mexico.

Recent outbreaks

When samples reach a lab, modern gene-sequencing equipment allows public-health authorities to quickly identify the causative agent. Currently the leading disease-causing organisms are norovirus, the cause of “projectile vomiting,” and two broad groups of bacteria, Salmonella and Listeria.

Following most outbreaks, manufacturers voluntarily recall offending foods from stores and restaurants, but FDA did not have authority to order mandatory recalls. That oversight will be remedied under the new rules.

The burden of edible disease

The the Centers for Disease Control and Prevention calculates that 48 million Americans get a food-borne illness every year, 128,000 are hospitalized, and 3,000 die.


Tylenol capsules in blister packages.

Photo: SimonQ
“Tamper-evident” blister packaging and plastic seals around bottle caps became standard in the wake of the Tylenol poisonings.

Not all of these would be prevented by the proposals, but the new rules are part of a broader upgrading in a food industry that, spurred by headlines about illnesses caused by its products, is paying much more attention to sanitation.

You can look back to 1982, when seven people died from cyanide-laced Tylenol, to see how a small number of highly-publicized deaths can turn an industry upside down. The Tylenol murders spawned the “tamper evident” packaging that is now common in foods and ubiquitous in pharmaceuticals.

A parallel trend toward prevention is already underway in the food industry, says Kathleen Glass, associate director of the Food Research Institute at the University of Wisconsin-Madison. “Most of the larger producers and manufacturers are already compliant with the focus on preventative controls. They are already spending an enormous amount of resources validating their food safety systems…”

A lot to love in these regulations (!) ???

The FDA proposals “have captured the very fundamentals of food safety that everyone has been preaching and striving for,” says Martha Roberts, of the Institute of Food and Agricultural Sciences at the University of Florida. “The fundamental approach is to set out a science-based framework for food safety rules.”

Based on a modern understanding of how bacteria, viruses and parasites enter food, the rules demand a science-based approach to excluding or killing pathogens (by cooking or canning, for example).

Inspection report on peanut-butter contamination

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Original images taken from FDA

According to Food Safety News, organizations in and around the food industry warmly greeted the proposal (even as they stipulated that they will be tracking the emerging details):

Grocery Manufacturers Association: We “applaud the Obama Administration and the FDA for releasing the first two sets of proposed regulations from the new FSMA law…”

Center for Science in the Public Interest: “… will also set the stage for growers to use better practices that ensure that the fruits and vegetables we eat are produced under sanitary conditions.”

United Fresh Produce Association: We are “pleased that FDA has published the draft rules and look forward to working with all stakeholders to conduct a thorough review.”

National Sustainable Agriculture Coalition: “Congress rejected a ‘one-size-fits-all’ approach to food safety … that would put small and mid-sized farm operations out of business.”

Consumers Union: The proposals “really go to the heart of the problems we’ve had with food safety in recent years.”

But when we looked for informed comment, several experts responded along these lines: “The new regulations run more than 1,200 pages. I don’t think anyone has had a chance to really digest such a lengthy document. Therefore, I can’t help you.”

What’s new? How do they work?

The proposals give FDA broad new authority over the people who grow, manufacture and handle food.

FDA can:

require comprehensive, prevention-based controls across the food supply.

inspect food producers.

ensure that imported foods meet US safety standards (under a forthcoming rule).

order recalls for food products if necessary.


Man in white coat and white hardhat checks temperature of hot dogs hanging in production facility.

USDA photo by Lester Shepherd.
Since Upton Sinclair’s muckraking 1906 novel The Jungle alerted the public to filthy meat-packing houses, federal food regulators have focused on meat. Here a U.S. Department of Agriculture (USDA) inspector checks if hot dogs are hot enough to prevent pathogenic bacteria from multiplying. The agency’s Hazard Analysis and Critical Control Points focuses on handling at key safety steps in meat production. Under FSMA, FDA is authorized to have inspectors in factories and on farms.

Beyond inspections and hand-washing, the rules break ground in several areas, says Roberts. “There are a lot of new proposals and standards, for example, on agricultural [irrigation] water and biological soil amendments [such as manure].” We asked how a small organic farmer might sterilize manure, and Roberts pointed to hot composting. Under FSMA, a grower must document that the chosen method was effective — and was actually used.

Although many things can make food unhealthy, bacteria, fungi and viruses are FDA’s focus under the Food Safety Modernization Act. “Microbial contamination is drastically more important than physical or chemical contamination, from a public health standpoint,” says Ben Chapman, a food safety expert and assistant professor of family and consumer sciences at North Carolina State University. “We know there are 48 million microbial illnesses” each year.

Filling out the data

The 48-million number (which translates into about one American in six) was an estimate because most food-borne illnesses are not seen by doctors, and even most cases that are seen are not identified in a lab. “For every case of salmonella that is confirmed, there are another 38 illnesses, so that becomes a multiplier,” says Chapman.


Four rows of white eggs sitting neatly in a purple carton.

Uncooked eggs can carry Salmonella, one of the top causes of food poisoning.

We asked if many cases result from consumer errors — failure to cook food sufficiently, say, or cross-contamination in the kitchen, but Chapman told us, “We don’t have data that suggests this is mostly consumer error.”

Roberts, formerly deputy commissioner of the Florida Department of Agriculture and Consumer Services, says FDA is moving closer to the source of contamination. “Beforehand, there was very limited addressing by FDA about farms and food safety. They have been going in to investigate foodborne outbreaks once they occurred. The FSMA basically gives FDA more authority to enforce some preventive measures for food safety on farms.”

However, she cautioned that the FDA statistics are confusing, and that the cause of half of all outbreaks (defined as multiple cases of illness) are unknown. “Hypothetically if you have 200 outbreaks you may never discover the actual cause of 100 of the outbreaks.”

Among the 100 explicable outbreaks, Roberts said, “CDC and FDA statistics say 23 percent would be associated with produce consumption.”

And that helps explain why FDA “estimates that close to 1,000,000 illnesses each year are attributable to food that would fall under the scope of this proposed rule.”

What about small farms?

Businesses are seldom thrilled to receive new requirements for procedures, policies and paperwork, and the smaller the business, the more onerous such requirements may seem. How will FDA’s proposal affect the rising number of small, local, organic farms?


Lush green rows of different brassica plants extend the length of a photograph with red and white farm building in background.

Photo: Amy

Many will be entirely exempt: About 79 percent of produce growers “will not be covered by the produce rule because they grow products that are rarely consumed raw, make under $25,000 annually or qualify for a small farm exemption,” according to FDA data analyzed by Food Safety News.

The FSMA law recognized that these operations were unlikely to have a significant impact on public health and safety.


Venders and customers interacting at outdoor market, flowers in foreground.

Photo: Wolfgang Hoffman, University of Wisconsin-Madison
The Dane County Farmers Market is a popular and enduring institution around the State Capitol in Madison, Wis. Most of the sellers will be exempt from the FSMA rules — but should they pay attention anyway?

The effective date for standards will be phased in for larger and more sensitive operations (such as those that grow sprouts, a particular area of concern). However, these farms “likely produce about 85 percent of the produce responsible for causing foodborne illnesses,” according to FDA. More on the standards for different businesses.

However, FDA also says that “close to 1,000,000 illnesses are attributable to food that would fall under the scope of this proposed rule.”

Although these exemptions were set by Congress in FSMA, Roberts believes that all producers have a duty to follow the new rules. “In this world, nobody should buy any product that was not produced under a food safety program.”

Roberts acknowledges that the growing preference for small, local suppliers “is one of the fastest-growing trends. But there still is a moral responsibility: if you produce food, it needs to be produced in a safe manner.”

Chapman agrees. “Regardless, even if individual business are exempt, FSMA sets standards for what they should do. They can be held to that standard if their buyers ask for it.”


Field plowed and planted with small green rows of plants in front of backdrop of hills and white house.

Photo: Wonderlane
This California produce farm may come under new FDA regulations now released for public comment.

Will the revisions make us safer?

So the FSMA proposals seem to be a unique case of all sides agreeing with government regulation. Will they work? Is there enough funding? That issue was on the mind of FDA Commissioner Margaret Hamburg, who said, “Resources remain an ongoing concern.”


Close-up of red grapes with country of origin label in background, indicating the grapes are a product of Chile.

Imported produce now comes under FDA regulation, but imports may pose the biggest challenge to the Act.

“FDA likely won’t have enough funding to support the necessary number of well trained inspectors who understand the issues and can get to all farms and manufacturers,” says Glass. “There will also be a limited number of import inspections, so resources will have to be focused on higher-risk importers or foods.  There will be a significant amount of training for producers which is not yet put together.”

Yet against all these qualms, guarded optimism seems to be the order of the day. As USA Today noted, exceptions for small operations “along with the realization that outbreaks are bad for business have brought the produce industry and much of the rest of the food industry on board as Congress and FDA work to make food safer.”

FSMA and the new rules are “about raising the lowest acceptable standard that society will take,” says Chapman. “For a lot of stuff that FDA has regulated in the past, there were no established rules. This sets those rules, but it’s not a magic bullet. It would surprise me if a year after it’s place if we see drop in foodborne illness. It’s up to how businesses comply with the standards.”

Food safety can get complicated, but the bottom line is simple, Chapman indicates. “When I walk into a business and buy some food, I really want the business to have checked that what they are doing is safe.”

— David J. Tenenbaum


Terry Devitt, editor; Emily Eggleston, project assistant; S.V. Medaris, designer/illustrator; David J. Tenenbaum, feature writer; Amy Toburen, content development executive


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  4. Fun with food safety data
  5. Keep track of the CDC’s foodborne illness investigations
  6. Sprouts: super healthy or risky business?
  7. 7 tips for outsmarting sneaky salmonella
  8. The FDA’s Bad Bug Book: A guide for understanding unsafe microbes in your food