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Proposed Food Safety Regs Stir Farmer Anger, Especially on Water and Manure

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This article comes from the NOFA/Massachusetts 2013 September Issue Newsletter

by Jack Kittredge, NOFA/Mass Policy Director

The US Food and Drug Administration (FDA) has
begun “listening sessions” around the country about
its proposed implementation of the Food Safety
Modernization Act (FSMA). The FDA has estimated
that it could cost small farms up to $13,000 annually to
comply with the new regs, and the officials in attendance
at these hearings have gotten quite an earful.
On August 19, in Augusta Maine, farmers told state and
federal officials that: “You’re going to be putting farms
out of business” despite no evidence that food safety
problems have surfaced on small operations. In New
Hampshire, on August 20, about 300 farmers and others
attended a similar session in Hanover to voice their
Although roughly 60 percent of US farms (110,000 out
of 190,000) would be exempt from the regs, because of
the $500,000 gross farm income exemption in the law,
many farms were concerned that the exemptions are not
guaranteed and could be taken away by any FDA official
on the grounds that
• the farm engages in some value-added
• gross farm income may exceed the
threshold when all farm activities are added
together, or
• an outbreak of microbial contamination
has been detected on the farm.
On August 22, in Hadley, MA, Peg and John Morse of
the Big Apple Farm in Wrentham, MA testified that,
since they irrigate from three ponds and two wells, they
thought the water testing requirements alone of the new
regs could end up costing them an additional $20,000 per
Recent FSMA Developments & Comment Period
The Summer 2013 issue of The Natural Farmer brought
most NOFA members up to speed on these complex
proposed regs, but several developments since that issue
must be noted. First, the comment period has been
extended to November 15, 2013, to give farmers and
consumers more time to read, understand, and comment
on the regs. Second, the FDA initially decided that these
regs, despite their widespread impact on agricultural land
and practices throughout the country, did not require
an environmental impact statement (EIS). They have
since reversed themselves and are now preparing an
EIS. There is no clarity on what will happen should the
environmental assessment require changes in the regs
– will a new proposed rule be issued or not? But the
assumption has to be that the rules currently proposed
may be binding and we need to respond to them.
Lastly, although there are significant health issues with
pesticide and other farm chemical use, including GMOs
and glyphosate, these are specifically excluded from
FSMA consideration. The Act applies only to microbial
The rest of this article will focus on the most
controversial two provisions – the water and the manure
regulations. (You can get more information on these
two, as well as other provisions of the FSMA, at: http://
Agricultural Water
FDA considers water to be “agricultural water” if it is
intended to or likely to contact produce or food-contact
surfaces. Examples of agricultural water include
irrigation water that is directly applied to the harvestable
portion of a crop, water used for preparing crop sprays,
and water used for washing or cooling harvested
Because the methods for detecting microbial pathogens
in water are so limited, FDA is basing its proposed
standards on monitoring for hazards and testing water
for fecal contamination – specifically for generic E.
coli, which FDA claims is a satisfactory indicator for
determining fecal contamination.
General Water Quality Requirements
Generally, the proposed agricultural water standards
require farmers to ensure that agricultural water is “safe”
and “of adequate sanitary quality for its intended use.”
This general requirement underpins the entire water
If, through any of the scenarios discussed below, a
farmer has determined or has reason to believe that the
agricultural water is not safe or of adequate sanitary
quality, generally the standards require the farmer to
immediately discontinue use of that water on the farm.
The farmer must then take action to address the water 17 September 2013 Newsletter
quality problem in one of two ways:
1. Inspect the on-farm agricultural water
system components that are under the farm’s
control, identify any conditions that could
be causing the problem, make any necessary
changes to fix the problem, and retest the
water to ensure the changes were effective; or
2. Treat the water (see the water
treatment section below).
Water System Inspection Requirements
The proposed standards require a farmer to inspect
his/her agricultural water system at the beginning
of a growing season. In that inspection, a farmer
must identify conditions that may result in hazards
contaminating produce through water, and take into
• The nature of each agricultural water
source (e.g., ground water or surface water);
• The extent of the farmer’s control over
each source;
• The degree of protection of each source;
• Use of adjacent or nearby land; and
• The likelihood of hazards being
introduced in the water by a farm upstream.
Water Treatment Requirements
If the water is not safe due to conditions beyond a
farmer’s control, and therefore the farmer has to treat the
water according to the proposed rule, then FDA suggests
treating water with an antimicrobial compound. FDA
notes, however, that any chemical used to treat water
would need to be registered with the Environmental
Protection Agency and that, presently, there is no such
registration for chemical treatment of irrigation water.
FDA assumes that this issue will be addressed and a new
registered product created before farmers must comply
with the water standards (see compliance information
Water Testing Requirements
A farmer would not be required to test his/her agricultural
water if he/she:
• Uses water from public water systems
and has public water system results or
certificates of compliance; or
• Treats the water according to the water
treatment requirements (see above).
For farmers that have to test water, FDA is proposing two
numerical standards for testing:
1. No detectible E. coli present per 100 ml
of water: This standard would apply to water
used for an activity during and after harvest,
water used to make agricultural teas, and water
used in sprout irrigation.
2. No more than 235 colony forming units
(CFUs) generic E. coli per 100 ml for a single
water sample, and a rolling geometric mean
of five samples of no more than 126 CFU per
100 ml: This standard would apply to water
used for growing activities (except for sprouts)
that directly contact the harvestable portion of
the crop. FDA is also allowing farmers to offer
an alternative to this standard (see below).
To determine whether agricultural water meets the above
standards, FDA is proposing testing frequencies based on
the type of agricultural water used. The most stringent
testing frequencies apply to untreated surface water:
• If the untreated surface water is from a
source where a “significant quantity of runoff”
is likely to drain into it (e.g., a river or lake),
then a farmer must test the water at least every
seven days during the growing season.
• If the untreated surface water is from
a source where underground aquifer water is
transferred to a surface water containment in
a way that minimizes runoff drainage into the
containment (e.g., on-farm constructed water
reservoir), then a farmer must test the water
at least once each month during the growing
For other water sources, such as ground water, FDA
is proposing that farmers test at the beginning of each
growing season, and every three months thereafter during
the growing season.
FDA is allowing farmers to use alternatives to
requirements for testing water and taking action based
on those tests when agricultural water is used during
growing of covered produce (other than sprouts).
Farmers are expected to provide documentation showing
that the alternative method is supported by adequate
scientific data indicating that the alternative would
provide the same level of public health protection and
would not result in adulterated produce. This alternatives
option is not applicable to water used during and after
harvest, water used to make agricultural teas, and water
used in sprout irrigation.
Compliance Dates
Because the agricultural water standard is based on
limited scientific evidence, because there are huge
research gaps in agricultural water issues, and because
the proposed standards are untenable at this time, FDA is
proposing extended compliance dates for the agricultural
water standards.
For the water testing, monitoring, and associated
recordkeeping requirements, FDA is proposing the
following compliance dates from the time that the final
Produce Rule goes into effect:
• Six years for very small businesses,
• Five years for small businesses, and
• Four years for all other farms.
FDA Needs to Hear from YOU About Agricultural
If you use agricultural water, FDA needs to hear from
you about how these proposed rules might impact your
farm operation. See below for how to comment.
Manure and Compost
Farmers use soil amendments such as manure and
compost to improve soil fertility and soil quality, and to
enhance populations of beneficial microorganisms in the
soil. Sustainable and organic producers in particular rely
on manure and compost instead of synthetic chemicals to
add fertility to their fields.
The Food Safety Modernization Act (FSMA) requires
the Food and Drug Administration (FDA) to develop
regulations aimed at improving the safety of produce.
Soil amendments such as manure have been identified
as a potential vector for pathogens that may contaminate
produce, and Congress required FDA to include standards
for “soil amendments” when developing new regulations.
In the proposed Produce Rule, FDA has developed
standards directed to “biological soil amendments of
animal origin” – e.g., manure and compost that includes
animal waste and human waste.
In addition to requiring standards on soil amendments,
Congress also specified that FDA could not propose
requirements that conflict with or duplicate the
requirements for certified organic production. Manure
and compost are critical soil amendments in certified
organic production and in sustainable farming systems,
and it is important that new standards work for these
types of systems. Congress also required FDA to take
into consideration conservation and environmental
practice standards such as those by USDA’s Natural
Resources Conservation Service, which offers assistance
with nutrient management and composting facilities,
among other things.
Proposed Standards Directed to Manure and
The requirements only apply to biological soil
amendments of animal origin – including manure,
bloodmeal, and fish emulsion – and human waste.
They also address agricultural tea (“compost tea”).
They do no apply to non-biological soil amendments
(e.g., physical or chemical) and they do not apply to soil
amendments of non-animal origin such as yard waste,
purely vegetative matter, or shrub trimmings.
Broadly, the proposed standards seek to avoid
contamination of “covered” produce by pathogens
potentially present in biological soil amendments
of animal origin. Generally, the proposed standards
set treatment requirements for soil amendments and
minimum intervals between application and harvest.
A 45-day interval is required if the amendment has been
applied in a manner that minimizes the potential for
contact with covered produce during or after application,
and if the amendment has undergone a scientifically valid
controlled composting process that satisfies the microbial
standard for Salmonella and fecal coliforms.
This 45-day interval is in conflict with the National
Organic Program (NOP) regulations, which do not
require an interval between application and harvest for
manure treated by a composting process that is consistent
with NOP composting standards.
For situations that would require the 45-day interval,
FDA will accept “alternative” methods if they are
scientifically valid, controlled composting processes
supported by adequate scientific information or data.
In the case of agricultural tea, the water used must meet
the requirements of the water standards.
FDA considers a soil amendment to be untreated if it has
not been processed by a scientifically valid treatment
method, has been contaminated after treatment, has
been recombined with an untreated amendment, or is
contaminated with a hazard. FDA considers agricultural
tea to be untreated if it contains an agricultural tea
FDA is proposing to require a nine-month interval
between application and harvest if the soil amendment
is untreated and there is chance that the amendment will
come into contact with covered produce after application.
This nine-month interval is in direct conflict with the
National Organic Program regulations, which require
a three or four-month application interval for untreated
manure depending on whether the edible portion of
the crop comes into contact with the soil indirectly or 19 September 2013 Newsletter
directly, respectively. This proposed requirement and the
45-day interval in compost (see above) are also in direct
conflict with FSMA, which requires standards not to
conflict with NOP regulations.
Additional Requirements
FDA does not allow the use of human waste for growing
covered produce, except for sewage sludge biosolids that
are used according to Environmental Protection Agency
To accompany these proposed standards, FDA lays out
specific recordkeeping requirements.
What the Proposed Standards Do Not Require
The proposed standards for biological soil amendments
of animal origin do not apply to soil amendments of
purely non-animal origin. Additionally, the requirements
do not apply to physical or chemical soil amendments,
such as synthetic fertilizers.
These standards do not apply to animal feces deposited
in a field by wild or domesticated animals. Separate
standards apply in that instance.
FDA Needs to Hear from YOU About Manure and Compost:

If you use soil amendments such as manure or compost
that uses animal waste, FDA needs to hear from you
about how these proposed rules might impact your farm
How to Comment
You can comment online or by mail. For step-by-step
instructions and help in commenting online, go to http://
To comment by mail, type or hand-write your comments
and mail them to this address:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
All submissions received must include the following:
• Your Name
• Your Organization (if any)
• The appropriate docket number (the
agricultural water and manure and compost
regs are part of the Produce Rule):
• For the Preventive Controls Rule: FDA-
2011-N-0920 and RIN 0910-AG36
• For the Produce Rule: FDA-
2011-N-0921, and RIN 0910-AG35

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