How can I begin to describe the draft regulations for the Food Safety Modernization Act (FSMA)?

On January 4, 2013, FDA came out with two sets of proposed rules, stating that comments from the public are due by May 16, 2013. One set of proposed rules relates to processed foods and the other one to produce. There are three additional sets of proposed rules yet to come; they are related to: imported produce and other foods; accreditation of third-party auditors in other countries; and preventive controls at animal food facilities that are similar to those proposed for human foods. For now, I am limiting my commentary to the produce-related rules.

This proposal applies to the produce industry (including farmers) and is called the Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption Proposed Rule (144 pages); it focuses on areas of risk for fruit and vegetable production, including agricultural water; biological soil amendments; health and hygiene; domesticated and wild animals; and equipment, tools and buildings.

The FDA estimated that 1.75 million cases of foodborne illness would be prevented annually by this regulation, with an annual benefit of $1.04 billion. They estimated that compliance with the proposed rule will cost domestic farms $459.6 million.  The estimated average annual cost for very small farms (less than $250,000 in annual revenues) is $4,697, $12,972 for small farms (between $250,000 and $500,000 in annual revenues) and $30,566 for large farms. 

Reading through the proposed rules is not a simple process.  I suggest starting with the published summary, which is available at:

http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm?source=govdelivery

Small farms would be eligible for the qualified exemption; they must meet all of the following conditions during the 3-year period preceding the applicable calendar year:

1. Their average annual revenues were less than $500,000 (adjusted for inflation);

2. Their average annual revenues from products sold directly to consumers, stores and restaurants exceeded the average annual revenues of the farm’s sales to all other buyers;

3. Their direct market sales occurred in the same state as the farm, or within 275 miles of the farm (whichever is greater); and

4. The name and complete business address of the farm where the produce was grown are conspicuously displayed at the point of purchase, if the produce is not otherwise labeled.

I will be back with more information regarding the FSMA’s proposed rule for produce by the end of February.

Shermain Hardesty, shermain@primal.ucdavis.edu

Small-scale growers can get reimbursed for part of their food safety audit, testing, or training expenses.

California’s Department of Food and Agriculture (CDFA) has a reimbursement program to assist specialty crop producers with the cost of first time food safety audits, informational assessments, water and/or soil testing, and training regarding Good Agricultural Practices (GAPs).  Small-scale growers can be reimbursed for up to $200 for these expenses.

To request a reimbursement, growers should download the application form, complete it, and mail it to CDFA as indicated on the form. Only completed applications with original signatures will be processed. Funds are available on a first come, first serve basis until the funds are depleted, or July 31, 2013.

For consumers, the effects of food safety practices can seem simple, though critically important: You’re either sick from the food you eat or you’re not.

But for producers, food safety comes in many shades of risk at many critical points in their business operations: water testing, worker hygiene, harvest techniques, postharvest cooling and storage, previous land use, wildlife and more.

To help small-scale farmers better plan for food safety concerns, several UC Cooperative Extension farm advisors are being trained in food safety audits and are planning food safety workshops. The project is led by Shermain Hardesty and Richard Molinar of the Small Farm Program, with funding from the UC Division of Agriculture and Natural Resources.

The group is beginning to offer workshops for farmers in eight regions of California.

Why now?
New FDA regulations are being developed for the Food Safety Modernization Act that will affect food producers, among others. The act includes an exemption for farms whose annual sales were less than $500,000 on average during the last three years, with the majority of their product sold directly to consumers, farmers markets and restaurants within the state or within a 275-mile radius.

"Even though it exempts many small farmers, the Food Safety Modernization Act says the exempt producers would still need to comply with any food safety regulations from state and local governments,"  Hardesty said.

Trevor Suslow, UC Cooperative Extension specialist in food safety at UC Davis, has said that the FDA can withdraw the exemption with cause.

“Whether or not the exemption will hold, I think, is incumbent on everybody,” he said.

He expects the regulations will be implemented in tiers, with smaller farms having three years to comply once the regulations are final.

Even without regulations in place, more buyers — including packinghouses, retailers and at least one certified organic distributor — are requiring farmers to meet food safety standards. Insurance companies are also, in some instances, cancelling policies or hiking rates for small farmers who have not documented their food safety practices, according to Hardesty.

Many farmers who work with large packinghouses, sell to major distributors or are members of a commodity-specific commission have already established their food safety practices to adhere to standards of their industries.

But smaller farmers who grow multiple crops or who aren't part of a commission may still be looking for food safety guidance, which these workshops aim to provide.

"Most of the growers I work with are exempt, but even so, they are very concerned about how it will affect them," said Cindy Fake, one of the UC Cooperative Extension farm advisors who is part of the project and works in Placer and Nevada counties. "There is a lot of awareness of what is coming down the line."

Food safety basics
The workshops will include presentations about food safety as it relates to regulatory and business trends, previous land use, workers, water, wildlife, waste, soils, harvest, transportation, traceability and farm mapping. What should a farmer do with all this information?

“First and foremost, farmers should have some sort of food safety manual, a written food safety manual for their individual farm,” explained Richard Molinar, UC Cooperative Extension farm advisor in Fresno County. “And then if they want or need to be certified, that’s a second step with a third-party auditor.”

In his session, Suslow examined the link between fresh produce, outbreaks and illnesses. Leafy greens, melons and tomatoes have been associated with a combined 65 percent of produce-related outbreaks, between 1996 and 2009.

He listed key areas of food safety for all farming and shipping:

• Water: pre-harvest and postharvest
• Workers: hygiene and training
• Waste: manure and compost
• Wildlife: intrusion and fecal
• Recordkeeping
• Traceability

Food safety programs, he explained, depend on multiple hurdles to help prevent biological, chemical and physical hazards from entering food, surviving, growing and persisting.

Cold chain management is one critical aspect of postharvest food safety. Bacteria can double in a very short period of time if cold chain management is neglected.

“In just a few hours, you can go from something that won’t affect most of us to something that would make you sick,” Suslow said.

Workshops

Food safety workshops for this project will be held in multiple regions around the state. The first such workshop, scheduled for April 12 in Santa Rosa, has already sold out.

Registration is available for the next food safety workshop, May 3 in Stockton. The workshop is free to attend, though pre-registration is required.

Additional workshops will be planned by UC Cooperative Extension farm advisors participating in the project, who are located in Lake, Sonoma, San Joaquin, Placer, Nevada, Santa Clara, Fresno, Ventura and San Diego counties.

All food safety workshops associated with this project will be included on the Small Farm Program's calendar as well.

Some additional resources, recommended by farm advisors on this project:

• Creating a food safety manual:
• California small farm food safety manual from UC Cooperative Extension
• On Farm Food Safety project is part of Familyfarmed.org and can help farmers create a customized food safety plan. Suslow was a technical advisor to this project, along with a national team of stakeholders and specialists.
• Good Agricultural Practices Food Safety Plan template from Penn State Extension
• Books from UC ANR:
• Small Farm Handbook includes a chapter on postharvest handling and safety of perishable crops
• Organic Vegetable Production Manual includes a chapter on postharvest handling for organic vegetable crops
• Free publications from UC authors (PDFs)
• Postharvest chlorination
• Water Disinfection: A practical approach to calculating dose values for preharvest and postharvest applications
• Postharvest Handling for Organic Crops

Back to the newsletter: Find more Small Farm News articles from our Vol 1. 2012 edition.

There was a surprise waiting for the food safety auditor when he looked around for signs of wildlife, though the farmer had told him his farm didn’t have any rodent problems. Under a bin were some tunnels, one of which contained a dead mouse.

“You don’t want an inspector to find a dead mouse 6 feet from your strawberries,” said Richard Molinar, UC Cooperative Extension farm advisor, in recounting the story. “First you need to think about everything in the field, but then you also have to be aware of burrows in your neighbor’s field.”

Surprises like these could lose a farmer points — or even mean failure — in a food safety audit. But this was just a test, a mock audit to help farmers better prepare their own food safety plans.

Background
Focus on food safety — through education, market demand and legislation — has been ramping up since 2007, after E. coli contamination of spinach grown in Salinas. In January of this year, the Food Safety Modernization Act was signed into law, which includes an exemption for growers with annual sales of less than $500,000, if the majority of sales are made directly to local consumers, restaurants or stores. And in late April, USDA formally proposed a national leafy greens marketing agreement similar to the California LGMA already in place.

Though some small farms are exempt from food safety legislation or major marketing agreements, their buyers may still require they adopt and adhere to a food safety plan.

In September 2010 Molinar heard a local packinghouse that contracts with many small-scale growers in Fresno County was requiring all their farmers have a food safety manual.

“And it’s not just [this grower-packer-shipper] and their buyers. It’s many other retailers, wholesalers and processors too,” Molinar said. “It’s really buyer- and consumer-driven, so [for now] it doesn’t matter what FDA or USDA comes up with. If the consumer or the buyer wants to see a food safety program, the farmers and the packers have to come up with it.”

Developing a manual
Since 2007, Molinar has held meetings to educate growers abut food safety, and in 2009 he began working with Jennifer Sowerwine and Christy Getz, both of UC Berkeley, to develop a food safety manual that could help farmers get started.

The manual provides a framework for a food safety plan, with information about standard operating procedures, worker training and recordkeeping. The manual must be personalized to the farm, implemented and documented.

“We wanted something really basic that we could use for small-scale farmers,” Molinar said. “Larger, corporate farms can afford to hire a person to do this for them and have a more complex document. We’re trying to come up with something very simple, but even this one still requires some paperwork and filing documents in the correct part of a binder with envelopes and receipts.”

The manual also requires some decision-making on the part of the farmer, most likely informed by demands of potential buyers.

“Right now it’s so new that for most of the crops — except for leafy greens or fresh-market tomatoes — there aren’t specific guidelines or standards,” he said. But having a basic food safety manual in place for the farm is fairly easy and keeps the farm competitive.

At one of the first mock food safety audits organized by Richard Molinar, the farmer pulled out a shoebox of receipts when asked to show documentation.

Mock audits
Certain buyers or groups may require that farmers have their food safety practices audited. Third-party food safety audits can attest to whether the farm is adhering to its food safety manual and can identify when the plan, related actions or documentation fall short of good agricultural practices (GAPs).

Though private firms can conduct these audits, the California Department of Food and Agriculture also performs verification audits in relation to food safety.

To help educate the region’s farmers, CDFA agreed to do some mock audits on Fresno area farms to help prepare farmers. A handful of mock audits have been conducted with small groups attending to observe.

“Farmers right now do not have to be audited by a third party — that’s up to the buyer — but they should at least have some sort of food safety manual,” Molinar said. “Even though third-party audits aren’t required, we thought it was a good way for farmers to start learning about food safety and look at some of the questions that would be asked.”

Lessons learned from the mock audits can save time, money and embarrassment down the road.

“In the first audit we did, the farmer pulled out a shoebox of receipts, and they weren’t organized. So the auditor is thumbing through the box to look for the receipt,” Molinar said. “You need to be organized because you’re paying the auditor by the hour.”

Increasing market competitiveness
Having a food safety plan in place can certainly improve safety and reduce risk, but it can also make it easier to sell to new buyers who are interested in food safety documentation.

“The main goal is to have our farmers in Fresno — and statewide — ahead of the game in food safety, so that buyers and consumers can be assured that their food is safe,” Molinar said. “It will give our farmers a marketing advantage if they have a food safety program in place because that’s what buyers and consumers want to see.”

Read the rest of Small Farm News, Vol. 1 2011.