It’s Time for Farmers, Foodies to Speak Out Against FDA ‘Safety’ Rules
The federal Food and Drug Administration (FDA) has proposed regulations imposing new
safety requirements for farms and food businesses, under the Food Safety Modernization Act
(FSMA). Everything from salad mixes and salsas to cheese and u-pick fruit will be affected, and
the costs for local food producers will be crushing. Local food producers and supporters must
act now, and tell FDA to keep its hands off local food.
1. Rules Too Expensive for Farms and Families, and Increase Dependence on Imports
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How many farms will go out of business? FDA’s numbers show that the typical produce farm with less than
$250,000 in sales will spend 6% of its revenue to comply with proposed on-farm regulations. The average net
income for farmers nationally was 10% of sales in 2011; so for almost all small farms, FSMA will consume more
than half those profits. FDA admits that the rules will reduce the number of new farms entering business.
The rules will drive up the cost of food. FDA claims that a consumer would pay $4,500 per year to avoid
foodborne illness from produce—even though the average U.S. household spends only $715 on produce each year.
FDA’s calculations show that 73% of the costs of the new rules for food facilities will be borne by businesses with
20 or fewer employees, even though these businesses produce just 4% of the food consumed in the US.
The existing, market-based food safety system in the US is working. The Centers for Disease Control estimates
that only 1,500 deaths from foodborne illness are due to domestic sources each year, and much of that is from
chicken and seafood, which FSMA doesn’t address. FDA admits that the rules will force many domestic producers
out of business, making the US more dependent on riskier imported produce and processed foods.
2. FDA Evading Congressional Intent to Protect Local Foods and Farming
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Local food distributors will close, new ones will not launch. ‘Food hubs’ and other cooperative community-based
local food businesses allow more farmers direct access to local retail and institutional customers and present a low
risk for causing food safety outbreaks. USDA research shows these small businesses need annual revenues of $1
million to $6 million to be viable, but FDA wants to subject them to the highest possible standards if they have
revenues as low as $250,000. We’ve seen this scenario before: Industrial-scale food safety rules for meat
processors in the 1990’s forced closure of most small-scale livestock processing facilities, which today is a barrier
to increasing sales of locally-produced meats.
Congress chose not to impose FSMA on farms and food makers selling mostly to local customers if their revenues
are under $500,000/year. But FDA is claiming virtually unfettered authority to withdraw those safe harbors
without proof of any public health threat. The proposed rules allow FDA to deem entire classes of foods,
facilities, and processes safety threats without specific findings that a food from a particular farm or facility is
likely to harm consumers. And there is no way for a small local food business to get its exemption back.
Traditional grain and livestock farms denied access to local food markets. The proposed FDA rules count animal
feed and livestock sales toward the $500,000 income limit, even though FSMA does not apply to those products. A
u-pick strawberry operation on a 200-acre soybean farm will be subject to the same requirements as California’s
packaged berry industry.
FSMA instructs FDA to exclude farmers markets, roadside stands, and community-supported agriculture
programs from the requirement to register as manufacturing facilities. The agency did not do it.
The rules set up businesses for ‘gotcha’ inspections, instead of helping farmers and small business manage the
safety risks relevant to their particular businesses.
Specific Provisions of the Rule that Will Hurt Local Food and Organic Farming
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FDA assumes produce farms have one or a few crops. The rules are designed with large monoculture fruit &
vegetable operations in mind—FDA assumes that most farms are only growing produce three months out of the
year. So they have not calculated the costs of complying with the rules accurately for farms with longer production
cycles and multiple crops.
Manure effectively eliminated as a fertilizer. Manure is a proven low-risk fertilizer on organic farms. USDA
organic standards allow farms to use raw manure for fertilizer if it is applied three to four months prior to crop
harvest, depending on the crop. FDA increases manure withdrawal period to nine months, making application of
manure fertilizer useless. Congress ordered that that FSMA produce safety rules should not conflict with the
National Organic Program, but FDA is ignoring this mandate.
Water tests every week of the growing season. Farms using water from creeks, streams and rivers on produce
crops will have to test their water every 7 days if the water touches the edible parts of a crop. That’s 10 times as
often as current food safety standards, and the typical cost for one water test is $50. Even worse, available water
testing systems don’t test for actual pathogens, but for harmless bacteria that are present everywhere, including
human digestive tracts (generic E. coli). Yet if a test comes back higher than FDA’s tolerance, the farm must stop
using the water source until it can treat that water with chemicals. Water used to make compost tea must have
zero generic E. coli.
Farms may have to register with FDA. The agency is seeking comments on the idea of requiring all farms to
submit to registration.
Inspectors won’t know anything about farming. The FSMA produce rules cover at least 70,000 farms, and there
are nowhere near enough inspectors available today to enforce standards on that many businesses.
Putting a label on a raw produce item or package of raw produce is ‘food processing.’ This simple and essential
act for produce marketing turns a farm into a manufacturing facility, subject to industrial manufacturing standards.
Huge investments required in washing and packing lines. Farms and packing sheds don’t just have to keep their
equipment clean, but must ensure that all equipment is ‘designed’ to prevent contamination, with no surface
seams. In other words, only the newest, most expensive stainless steel equipment will do.
Food hubs must have a compliance officer. Because cooperative local produce packing and distribution facilities
are classified as food manufacturing ‘facilities’, those operations must have someone on staff and available at all
times who has been trained as a manufacturing safety specialist, and who manages the firm’s safety plan and
recordkeeping.
Food hubs and food makers face huge new paperwork burdens. These businesses must have extensive food
safety plans, keep records of implementing the plan, periodically verify these plans are working, and keep records
of those verification activities.
Farms that aren’t subject to FSMA may not be able to sell produce to food hubs or food makers. FDA is
considering requiring that these facilities buy only from farms that conform to the produce regulations. So if
Congress excluded a farm from the produce rule because it sells the majority of its food locally and has sales under
$500,000, those farms would lose markets unless they comply with FSMA anyway.
If a farm, CSA or farm stand handles produce from another farm, the farm becomes a ‘food processing facility.’
Any kind of cooperative model of produce packing and distribution will be subject to industrial manufacturing
standards.
Low volumes of wastewater from food processing activities must be disposed of ‘properly.’ NC law allows farms
and food businesses to land apply water used in washing produce and making value-added goods, up to 1,000
gallons per day. FDA inspectors have discretion to insist on full-fledged sewage treatment systems for this waste,
in spite of state law protections.