Small-scale and/or organic farmers are being alerted to the impending deadline of Monday, Dec. 15, for submitting comments on the Food and Drug Administration’s revisions to the proposed food-safety rules in the Food Safety Modernization Act. Signed into law on Jan. 4, 2011, FSMA focuses on preventing foodborne illnesses instead of merely reacting to them. If success is any measure of why small-scale and organic farmers should submit comments this time around, Roger Noonan, an organic farmer in southern New Hampshire, president of the New England Farmers Union and an active member of the National Sustainable Agriculture Coalition, can supply some good reasons. He told Food Safety News that the original proposed rules governing food-safety standards for produce and food facilities were “tough” and didn’t take into consideration the diversity of small-scale, sustainable and organic farms. The Produce Rule includes standards for growing, harvesting, packing and holding of produce for human consumption. For the most part, it covers produce that will be eaten raw. The Preventive Controls Rule covers facilities that manufacture, process, pack or hold food for human consumption. Some activities carried out on a farm may classify the farm as such a facility. “As soon as you take a knife to the produce, you’re a processor,” said Sarah Hackney, grassroots director at the National Sustainable Agriculture Coalition. “For round one, we mustered up a lot of farmers to comment on the proposed rules,” Noonan said, pointing out that it made a big difference in what was to come. “Now, in this second round, the FDA has made things more amenable to smaller farms. Clearly the comments farmers submitted mattered.” Noonan said that FDA is relatively inexperienced in working with farms, but that the agency has been “very receptive” to what the farmers have to say. “FDA has come a long way,” he said. Even so, there’s still work to be done, he said. All manner of definitions and requirements need to be “straightened out,” which is why small-scale and organic farmers need to throw their hat into the ring once again and submit comments on the revised proposed rules. Tilth Producers of Washington takes a similar tack: “Remember last year when FDA released proposed food-safety rules that didn’t work for small sustainable farms?” reads a Tilth message to “farmers and eaters.” “We commented, they listened … partly.” And while Tilth agrees that the revised proposed food-safety rules “are a lot better,” the group also believes they still threaten the environmental and economic sustainability of small and organic growers. “Every small farmer should be concerned about the impact these regulations could have on their ability to continue to operate safely and profitably,” said Katherine Paul, associate director of the Organic Consumers Association, citing as examples the cost of compliance and some of the water-quality requirements for irrigation water that could be too expensive, or even impossible, for a small farm to follow.

Another cheerleader urging farmers to submit comments is the National Sustainable Agriculture Coalition.

“Commenting is the best and most effective way to weigh in directly with FDA and ensure the final FSMA rules work for sustainable food and farms,” states the coalition’s website. “It is extremely important for the Food and Drug Administration to get these regulations right so that they improve food safety without placing an unfair burden on family farms.”

Some of the changes

According to FDA, the agency is proposing new ways to make the original proposals more flexible, practical and targeted. The changes are based on the input received during an unprecedented level of outreach to stakeholders and valuable input received from farmers and others directly affected by the rules. Thousands of comments were submitted electronically during the comment period.

The proposed changes include:

• Produce Safety: More flexible criteria for determining the safety of agricultural water for certain uses and a tiered approach to water testing.

• Produce Safety: A commitment to conduct extensive research on the safe use of raw manure in growing areas and complete a risk assessment. Pending those actions, FDA is deferring its decision on an appropriate time interval between the application of raw manure and the harvesting of a crop and removing the nine-month interval originally proposed. FDA also proposes eliminating the 45-day minimum application interval for composted manure that meets proposed microbial standards and application requirements.

(In an email to Food Safety News, Gwendolyn Wyard, regulatory director of Organic Standards & Food Safety for the Organic Trade Association, applauded the agency for taking this approach to compost and manure.)

• Preventive Controls for Human and Animal Foods: Requirements that human and animal food facilities, when appropriate, test products and the food facility’s environment, as well as implement certain supplier controls.

• Foreign Supplier Verification Program: A more comprehensive analysis of potential risks associated with foods and foreign suppliers and more flexibility for importers in determining appropriate supplier verification measures based on their evaluation of those risks.

Some of the flaws

As welcome as those proposed changes might be, there are also some flaws, according to Oregon’s Friends of Family Farms: • The exemption procedures still don’t define key terms. This could make it hard for small and direct-market farmers to protect themselves from losing protections under the Tester-Hagan amendment. The amendment grants exemptions for small-scale farms that meet certain tests based on such considerations as income, how much of a farm’s food is marketed directly, and how close to the farm the food is sold. • The definition of “farm” still describes a farm in a way that fails to capture the modern-day reality of farming, which, in addition to multiple parcels of land, includes joint control of packing operations. • The rules on irrigation still rely on the overly strict “recreational water quality standard,” which is based on how safe the water is for recreational swimming (a standard that many opponents say is not based on science). The rules require what the organization refers to as “excessive testing frequencies that are costly and unnecessary.” • The rules still include some “unscientific” requirements for “acceptable compost” processes. As a result, this could make it harder for farmers to use compost on their farms. • The rules don’t go far enough to encourage sustainable conservation practices that enhance food safety. Top 10 fixes and fails The National Sustainable Agriculture Coalition has compiled a list of its top 10 concerns and how the revised draft food-safety rules fix and/or fail the situation for small-scale, sustainable and organic farms. The concerns range from the cost of complying with the rules to excessive water testing on farms.

“We still have time to tell FDA why these issues are so important and fix the problems before the rules are finalized,” notes the group’s site.

Who is affected?

The National Sustainable Agriculture Coalition’s site also includes a page entitled, “Am I Affected?” to help farmers and food businesses determine if they will be covered by the proposed rules.

Here are some of the questions and explanations about this topic for farmers to consider:

• Do you grow, harvest, pack, or hold (store) fruits or vegetables? If yes, you may be affected by the Produce Rule.

• Do you process, manufacture, pack, or hold (store) human food? If yes, you may be affected by the Preventive Controls Rule.

• Do you both grow, harvest, pack, or hold (store) fruits or vegetables AND process, manufacture, pack, or hold (store) human food? If yes, you may be affected by both the Produce Rule and the Preventive Controls Rule.

• Are you a food hub, CSA farm, on-farm processor, or direct marketer? (The coalition also has special guidance available for these operations.)

The coalition offers guidance for consumers and farmers that breaks down each issue into plain language and gives pointers on the most effective way to weigh in directly to FDA.

When do these rules kick in?

These are the compliance dates, according to FDA:

• Very small businesses, those with more than $25,000, but no more than $250,000, in annual produce sales, would have four years after the rule’s effective date to comply with most provisions.

• Small businesses, those with more than $250,000, but no more than $500,000, in produce sales, would have three years after the rule’s effective date to comply with most provisions.

• All other farms would have two years after the effective date to comply with most provisions.

• The compliance dates for water-quality standards and related testing and record-keeping provisions would be an additional two years beyond the compliance dates for the rest of the final rule.

The farmer’s voice

“My goal is to minimize the burden of the regulations on smaller farms,” New Hampshire farmer Roger Noonan told Food Safety News. “We want to make sure all of agriculture is engaged in this, not just the large farms.”

That’s important, he said, because small farms play such a vital role in our local economies and also help protect the land from being developed.

“There’s so much more value to them than their economic value,” Noonan said.

When looking at his own concerns, Noonan said the regulations about irrigation water are probably at the top of his list. That’s because most farmers in his region are dependent on surface water — water from rivers and streams.

Instead of requiring frequent testing of the water, he’d prefer that the rules line up with USDA’s Good Agricultural Practices, which generally recommend that water used for irrigation be tested three times a year, although this can vary based on the season, the overall quality of the surface water, and the volume of the available surface water, for example.

Like others, he also said that the definition of a “farm” needs to match up with modern agricultural realities. And he pointed to “food hubs” as a term that needs clearer definition.

“If the growers own the food hub, then we’d want to see them in the agency’s ‘farm definition,’” he said. “That’s especially important for the smaller ones.”

Tristan Klesick, co-owner of Klesick Family Farm in western Washington, told Food Safety News that, like other farmers, he’s concerned about the cost of compliance, pointing out that adding 3 to 4 percent to the cost of doing business adds up to a lot of money for a farm that doesn’t make that big of a profit.

He also said that all the paperwork involved in the record-keeping requirements represents time he can’t be out there working on the farm. While large farms can hire someone to do this, small-scale farms cannot afford that expense.

As for food safety, Klesick ranks it high on his list of priorities. And he goes so far as to say he’s in favor of random food-safety audits.

“The size of a farm shouldn’t be a factor,” he said. “You need to be following good food-safety practices if you want to call yourself a farm. Random audits would raise the food-safety bar.”

He believes that’s especially important for farmers who supply locally produced food to schools, hospitals and restaurants. One bad actor can make buyers apprehensive about the food-safety practices of local farmers in their area.

Looking ahead, Klesick said: “We’ve seen this coming. That’s why we have a brand-new processing facility with city water and services. It will make us more compliant (with food-safety rules).”

Meanwhile, he’s also going to encourage consumers to submit comments to FDA.

Why is this so important?

The demand for locally and regionally grown food keeps growing.

“It’s going through the roof everywhere,” said Sarah Hackney, grassroots director for the National Sustainable Agriculture Coalition. “The challenge is how do we get more locally grown food into the stores, schools, restaurants and hospitals.”

She said that’s why FDA needs to get it right.

“The work is in how the (food-safety) framework can accommodate farmers who want to stay in business, as well as people who want to go into farming,” Hackney said.

As part of that, the agency needs to make sure it doesn’t stifle innovation.

“Food safety is in everyone’s interest,” she said. “That’s why it’s important that the rules work for the growers and the consumers. More good, safe food is a win for everyone.”

How to submit comments

Comments on FDA’s proposed draft rules must be submitted or postmarked by Monday, Dec. 15. Go here for a document that walks you through the steps you need to take to submit comments. Or you can go here for FDA’s instructions on submitting comments.