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Organic Growers Urged to Comment on FDA’s Draft FSMA Rules

Organic growers are among those sighing in relief now that the U.S. Food and Drug Administration (FDA) has extended the comment period for its proposed produce and preventive-control rules until Nov. 22.

The proposed rules are part of the historic Food Safety Modernization Act (FSMA), which was signed into law on Jan. 4, 2011.

The agency made the decision to extend the comment period based on glitches in the federal government’s electronic system for collecting opinions on its draft regulations.

“The extension is good news,” said organic grower Anne Schwartz, owner of Blue Heron Farm in northwest Washington state. “It was difficult to navigate around the website, and there are a lot of confusing and complicated issues.”

From a farmer’s perspective, there’s more to it than that. The seasonal realities of agriculture also come into play.

“Many growers are just now having the time to deal with this,” Schwartz said, referring to the end of the harvest season in many areas of the country. “The extension is especially beneficial for mid-sized and smaller growers because, unlike the larger farms, they don’t have any staff to work on this during the growing season.”

“It was a smart decision, given the technical difficulties people were having with the electronic system for collecting comments,” said Gwendolyn Wyard of the Organic Trade Association. “This will give everyone a chance to get comments in.”

Like many farmers, organic and conventional alike, Schwartz is hoping for another set of draft rules that will clarify some of the definitions in the proposed rules and that will “incorporate the depth and breadth of the comments coming in.”

“Everyone’s assuming that there will be major revisions to the draft rules as a result of the comments,” said David Granatstein, sustainable agriculture specialist at Sustaining Agriculture and Natural Resources in eastern Washington state. “People think there will be a second draft.”

Why organic growers are concerned

The organic industry generates close to $31 billion in sales and continues to be the fastest-growing sector in agriculture, according to information from the Organic Trade Association.

In commenting on the proposed rules, the association points out that FSMA mandates that FDA develop rules that do not duplicate or conflict with existing U.S. Department of Agriculture (USDA) organic regulations.

It turns out that, in some cases, such as in the proposed regulations about applications of compost and manure, that’s just what happens. For organic growers, this is particularly troubling since they rely on manure and compost to provide nutrients to their crops and to boost the tilth of the soil.

And while some people disparage organic growers for using manure, Schwartz said that, unlike large confined animal feeding operations that spread enormous amounts of raw manure on their fields, or conventional farmers who often use raw manure from confined animal operations on their fields, organic growers must abide by regulations that require them to keep records and monitor their manure and compost applications.

In addition, they have to keep and maintain records showing that they’re producing compost in a way that will kill any pathogens that might be in it, which typically requires that it be kept above a certain temperature for a certain length of time.

Timing comes into the picture when it comes to the way USDA’s organic regulations and the proposed FDA produce rule come into conflict.

Current USDA organic regulations require either a 90- or 120-day waiting period between the application of untreated manure and the harvest of the crop. That time difference is based on whether the edible portion of the crop comes in contact with the soil. In cases like that, the 120-day waiting period comes into play.

As for compost applications, current USDA organic regs don’t call for any waiting period as long as the compost has been produced so it doesn’t have any pathogens in it.

In contrast, the proposed FDA produce rule would require a nine-month waiting period (270 days) until harvest following the application of untreated manure and a 45-day waiting period after the application of compost.

These requirements would apply to all crops covered by the proposed produce safety rule. Generally, these are crops such as lettuce and apples that are eaten raw and therefore don’t go through a cooking process that would kill harmful foodborne pathogens.

According to a recent survey conducted by the Washington State Department of Agriculture and the Organic Trade Association, with responses from more than 300 of the 8,100 certified organic producers in the United States, FDA’s proposed waiting periods between applications and harvest pertaining to compost and untreated manure will reduce their ability to rotate crops. They need to rotate their crops as a pest-management strategy — but also to comply with USDA organic regulations regarding its crop-rotation standard.

A document from the Organic Trade Association points out that, while scientific literature cited in the proposed produce safety rule supports concerns that manure and compost pose a food-safety risk, it does not support the waiting period proposed by FDA.

“Aligning with USDA’s organic regulations for the use of manure and expanding options for compost-use patterns and quality testing will eliminate regulatory conflict without reducing food safety,” the group says.

Concern over water-quality testing standards

The Organic Trade Association points to compliance with water-quality standards in FDA’s proposed rules as “the greatest obstacle” produce growers will face. Many farmers who use surface water have indicated that the water-quality testing intervals proposed in the rule will put their farms out of business.

To see why the organic growers are so concerned, you need only to look at Washington state, where surface water (water from streams, rivers, lakes, reservoirs, ponds and irrigation ditches) is the major source of irrigation water.

Thanks to its arid climate and large-scale irrigation projects, Eastern Washington produces 65 percent of the nation’s organic apples and 61 percent of its organic pears.

According to the Tilth Producers of Washington, the proposed new rules require farms that use surface water to test for pathogens every seven days if the water comes into contact with crops that are covered under the proposed produce rule.

Considering how many growers use surface water for irrigation, this is a huge hurdle. In the case of apples, for example, most growers irrigate just the ground under the trees. However, in some areas such as Eastern Washington, where it can get so hot in the summer that the inside of the apples may be 15 degrees hotter than the air temperature, it’s necessary to mist the apples to bring down the temperature. If that isn’t done, 10 to 15 percent of the crop can be lost to sunburn.

And, even though the misting isn’t drenching the fruit, the water is nevertheless hitting the fruit.

“If you’re irrigating from an irrigation canal, how do you deal with that?,” asks sustainable agriculture specialist Granatstein.

Then, too, chlorinating the water in an irrigation canal is not an option, he said.

Deborah Carter, technical issues manager for the Northwest Horticultural Council, said as long as growers don’t water overhead or rely on evaporative cooling to cool the fruit down — in other words, if the water doesn’t touch the fruit — they don’t have to test the water.

But as long as the water touches the fruit, it has to be tested. She points to the federal government’s water-quality standard of 235 colony-forming units per 100 milliliters of water (a gallon of water is about 4,000 milliliters), which is based on water-quality standards for “recreational use of water” (swimming, for example) as one that’s not based on science.

“It will be a major hardship for a lot of growers,” she said. “No one wants a loved one to be ill, but the rules need to be realistic and scientific. It’s because they’re not that FDA is getting so much backlash on this.”

The costs of  weekly water testing will be an economic hurdle for many organic growers.

Recently retired organic apple farmer Bob Brody objects to all of this. He believes it’s in a grower’s best interest to produce safe food.

“There’s nothing that growers want more than a nice, completely clean fruit,” he said. “If you don’t have that and someone gets sick, you’ll be done with.”

What about common sense?

Bulb onions are a good example of regulations gone awry, say growers, researchers and even legislators representing onion-growing regions.

As a starter, Oregon State University researchers have found no evidence in bulb onions of the harmful strain of E. coli that can make people sick, regardless of the source of water or whether the onions have been irrigated with drip or furrow irrigation.

Clint Shock, professor and director of the Malheur Experiment station in Eastern Oregon, led some preliminary trials that revealed that even if there’s a lot of E. coli in the soil or water, the bacteria don’t get internalized into the onion bulbs.

He attributes some of that to the fact that onions are loaded with antimicrobials.

“We had to be careful not to let any onion tissue get into the soil samples we were testing because it would kill all of the E. coli,” Shock said.

He also said that there’s no scientific information that ties bulb onions or garlic to human health problems.

Speaking as a certified professional horticulturist and not as an OSU researcher, Shock told Food Safety News that if FDA doesn’t come up with rules in a more thoughtful way, it will be easier to produce food overseas.

“We really need to strive to protect human health,” he said. “But we have to have a workable government. If not, it will cost the government hundreds of millions of dollars and billions of dollars for the growers. Costs need to be focused on real, identifiable problems so that the benefits greatly exceed the costs. As it is now, we have people writing the rules who are not familiar with agriculture. This is nonsense.”

For organic growers, especially the mid-sized and smaller growers, costs are an extremely important part of the equation. According to the Tilth Producers of Washington, FDA estimates that the produce standards rule will cost farms with annual gross sales between $25,000 and $250,000 an average of $4,697 per year.

Those who want to submit comments by the Nov. 22 deadline may receive help at the Organic Trade Association’s website.

© Food Safety News
  • Rono

    Why not use use 35% food grade hydrogen peroxide diluted down to a 3% for all of your fruits and vegetables? http://www.dfwx.com/h2o2.htm

  • jean w

    I can see things from a health perspective, but things are getting crazy with all the regulations – it’s going to cost way too much for very small growers and farmers to comply. As usual, a law or regulation cannot be made that covers everyone’s circumstance… mostly the expense of it all, plus crazy insurance costs, will probably discourage most from even trying. As if it isn’t hard enough to make a living from a very hard job! It’s a sad fact that things all boil down to liability issues these days. I suppose that is just the way it will be forever. Here’s the solution: Everyone grow their own food and only eat that. That way you will have nobody to blame but yourself if you get sick~ no insurance to collect from either.

    • Peter

      The Government should get out of the food business. Local food does not need Federal regulation.

  • http://LivingOrganic.org/ Amy Pearson

    The Food Agency should revise their rules! They are biased against organic food crops!

  • Ci

    Totally agree FDA should do a better job monitoring the bad food we end up eating! They can’t do anything about the strong lobbies and fight the small striving organic farmers! SHAME!!!