Food Safety banner

What’s at Stake


Download a .pdf of this report

In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) — mandating the first overhaul to U.S. food safety laws since 1938. Since then, the USDA Food and Drug Administration (FDA) has been working to assemble a draft of the new rules.  They have now released the 3,500+ page document, and we have until November 15th to voice our concerns via comment, after which they will produce a final draft. Once that final draft is written, we will be stuck with whatever the FDA has written, so it is vital that we give input now!

The rules cover all aspects of produce farm operation – everything from testing of water and soil amendments to training regimens to value-added activities.  While food safety needs to be of paramount concern, we as beginning farmers, organic farmers, and small farmers need to be cautious of how the rules will impact our operations.  In the words of former U.S. Department of Agriculture Deputy Secretary Kathleen Merrigan, the new rules have the potential to “destroy some operations.” In fact, for many diversified farms, the average annual cost to comply with the proposed rules is about half or more of what many farmers might, in a good year, expect in profits if certain ambiguities in the FSMA rule are not addressed.

There are two rules that you may want to comment on: the Produce Rule and the Preventive Controls Rule. The first relates to how vegetables are grown and handled; the second covers food processing facilities, farms that do processing on-site (even as simple as chopping or drying veggies) and farms that source in items from other farms. Comments on the two rules need to be submitted separately (two sheets of paper) with the appropriate docket numbers. The docket number for the Produce Rule is FDA-2011-N-0921 and the docket number for the Preventive Controls rule is FDA-2011-N-0920.


A. Farms with annual gross revenue less than $500k or “small farms”

     What the FDA rules say:

A proposed section of the regulations exempts small, local farms from much of the requirements, but there are some major problems with the exemption that could still impact the small farm.

The FDA’s exemption defines qualified farms as those with:

  • annual sales under $500,000 (averaged over the past three years), and
  • more than 50% of revenue coming from direct sales to an end-user (consumer, store, restaurant, etc.) within the state or a 275 radius of the farm

Farms with less than $25,000 in sales are excluded from all regulations, regardless of location of sales.

What does it mean?  On paper, a farm that fits that definition (they are referred to as a “qualified exempt farm”) must include its name and complete business address on either a food packaging label on the produce, on a sign that is displayed at the point of sale with the produce, on documents delivered with the produce in the normal course of business, or an electronic notice in an internet sale.

    Think you’re covered?  Here are a few points to consider:

  • First, revenue is calculated from a farm’s entire revenue, not just vegetables covered by the rules.   That means that a small vegetable operation on a large enough dairy, beef, or wheat farm won’t be covered.
  • The FDA can withdraw an exemption if a foodborne illness is linked to your farm. However, THEY CAN ALSO WITHDRAW YOUR EXEMPTION EVEN IF THEY ONLY SUSPECT A PROBLEM.  This is the “material conditions” clause and it means that the FDA has a huge amount of leeway on pulling exemptions.  
  • Once a withdrawal notice is issued, the farmer receiving the withdrawal order must either comply with all rules within 60 days or appeal the order within 10 days.  The appeals process will take the farmer through a hearing process.  In terms of circumstances for withdrawal, FDA does not establish a strong evidentiary standard for issuing a withdrawal order.  FDA also fails to define key terms in the “material conditions” clause to clarify the situations that would lead to a withdrawal.
  • There is no clear path for re-applying for an exemption if it is withdrawn.  The farmer is basically left with a “one strike and you’re out” rule.
  • Lastly, there is a concern that some larger stores that purchase local food are going to require strict adherence to all the regulations for their suppliers, regardless of the farm’s size.  This means that we need to make sure the rules are right for ALL farms.

     NYFC Recommendations:

The FDA should only look at “covered produce” (ie, that which is covered by the produce rule) when assessing a farm’s total revenue to decide whether they qualify for an exemption.  A farm that has a small vegetable operation and a larger  – but unrelated – animal or grain operation should not be disqualified from the $500,000 partial exemption and the $25,000 full exemption.

The full exemption should be raised from $25,000 to $50,000.

When withdrawing an exemption, the FDA should be required to show credible and substantive proof to justify the exemption.
The FDA needs to lay out a clear process for farms to reapply for exempt status if their exemption has been previously withdrawn.

The FDA should provide clear recommendations for what record-keeping is reasonable for an exempt farm to keep in order to be able to challenge a withdrawal notice.

The 60-day limit for responding to a withdrawal notice is too strict a time limit.  If the food safety threat is particularly dangerous, then such a time limit is reasonable, but if the danger is not imminent, farms should be given a longer time period to come into compliance.

back to top

B. Animals on the Farm

     What the FDA rules say:

This part of the rule covers both domestic and wild animals.  Importantly, the FDA acknowledges that the presence of animals in a field does not, in and of itself, constitute a significant food safety risk.  It recognizes the importance of biological diversity and the use of animals on many operations.  It is important to encourage the FDA to maintain this perspective.  Many specific aspects of animal regulation (such as exact ways that draft animals can and can’t be used) are not spelled out.  We need to make sure these regulations clarify what leeway the FDA is giving itself in making those determinations later.

For domesticated animals, the farmer needs to take “necessary measures” (currently not fully spelled out) to prevent animal feces from contacting crops. One suggestion that appears in the rules is to use horse paths that keep draft animals away from the actual food.

For combined animal/vegetable operations, the rules imply a nine-month waiting period after grazing before harvesting any crops grown in that field.  This will have a direct impact on diversified farms that run poultry through their vegetable fields at the end of the season.

Regarding wild animals, a farmer needs to monitor for animal intrusions and not harvest any visibly contaminated crops. The rules do not give any further requirements, such as requiring a certain distance between growing fields and wildlife areas (ie, woods). This is important, because FDA was tasked with not interfering with conservation programs, many of which encourage wildlife areas like buffer strips, windbreaks, and habitat for beneficials.

     NYFC Recommendations:

The FDA should clearly express that no destruction of conservation practices would ever be required for food safety regulation compliance.

There should not be a nine-month delay between animal grazing on a field and use of that field for harvesting crops.  That window needs to be shortened and should reflect the common practices used by diversified operations.

The FDA needs to clearly state that the elimination of draft animals from a farm would never be required for food safety regulation compliance.  Any rules regarding draft animal usage should be assessed for their impact on the viability of draft animal operations.

The FDA needs to conduct a full Environmental Impact Statement (EIS) before implementing any rules that govern land usage and environmental influence.

back to top

C. Manure and Compost

     What the FDA rules say:

The main intent of the proposed regulations is to avoid contamination by pathogens potentially present in animal-based soil amendments.

The requirements only apply to biological soil amendments of animal origin – including manure, bloodmeal, and fish emulsion – and human waste.  They do not apply to non-biological soil amendments (rock dust, etc) and they do not apply to soil amendments of non-animal origin such as yard waste or leaf matter.

The new rules break down animal-based soil amendments (ie, manure) into two types: composted and un-composted. The rules apply to situations where the soil amendment has a chance to come in contact with harvestable food. In some areas, the rules are actually stricter than the current national organic standards, meaning they are likely to have an effect on all farms.  Strict record-keeping is required for all composting and application processes.

For un-composted manure, there is a proposed nine-month interval after application before a harvest. This is a huge step beyond even National Organic Program (NOP) standards, which requires a three or four month interval, and it threatens to change the way farms that integrate grazing with crop production plan their operations.

For composted manure, farmers need a 45-day interval between application and harvest. NOP, by contrast, has no required delay.

There is no interval for amendments that have undergone physical and/or chemical processes (such as pasteurizing) that meet a certain microbial standard.

FDA does not allow the use of human waste for growing covered produce, except for sewage sludge biosolids.

     NYFC Recommendations:

Do not surpass the NOP (organic) regulations that have been time-tested and have an appropriate level of safety.  This means no delay for composted manure (as opposed to the 45-day proposed delay), and a four-month delay for straight manure (as opposed to the nine-month proposed delay).

Do not require compost to be insulated from the ground during the composting process or during storage.  This would make composting unfeasible for smaller operations and does not provide a worthwhile additional safety factor.

Make explicit that batch-by-batch testing for pathogens in composting is not necessary.

back to top

D. Health and Hygiene

     What the FDA rules say:

All farm workers will have to be trained in food handling and in hand washing. A farmer or farm employee can be a certified trainer, but will have to successfully complete food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration.  

The FDA states that it will work with the USDA Agricultural Marketing Service (AMS) to develop a standardized curriculum.
Farms will need to provide bathroom facilities and hand-washing stations close to all packing sheds and fields.

     NYFC Recommendations:

Any requirements of an on-farm trainer in hygiene practices should be waived for smaller operations below a certain number of Full-Time Equivalent employees.

The FDA needs to be more specific on what accreditation it would accept for trainings for on-farm trainers.  Currently the rules do not list any requirements or specific programs.

back to top

E. Water

     What the FDA rules say:

The FDA is proposing to require all non-exempt farms to test all water used for irrigation (where the water may come in contact with the harvestable portion of a crop), washing and cooling post-harvest, making agricultural teas, and irrigating sprouts.

The water testing requirements use E. coli as an indicator for pathogens in the water.  The proposed limit is no more than 235 colony forming units (CFU’s) generic E. coli per 100 ml for regular water usage, and 0 CFU’s for water used in the harvesting process and for sprouts.
The only exception is for water from municipal sources (ie, your water comes “from the grid” and you pay a water bill) or if you treat your water with chemicals. For the rest, testing is required during the season:

  • every three months, for “ground water” (ie, from a well)
  • every month, for ground water that is held prior to use in an on-farm pond or reservoir
  • every week, for “surface water” (ie, pumped from a river or lake)

     NYFC Recommendations:

Do not require weekly or monthly water testing.  These time periods are way too high for mid-size farms to be able to comply, and they are unnecessary.  Testing should be required at the outset for new operations, when a new water source is first brought into use and on an annual basis for all surface water sources (reservoirs included).  Ground water should be tested at the outset of an operation, and any additional testing should be related to those results.

The proposed standards of safe water are unrealistic both in CFU level and in the pathogen-indicator used (E. coli).  Further analysis needs to be done into finding a reasonable standard.

The E. coli levels proposed are extremely low – far below standards used in other regulations.  A “0 CFU” level for wash water is completely unrealistic.

Farms that pull water from shared sources should not be punished for pollution that occurs from other sources.  Any restrictions on water safety should involve the larger legal landscape.

The FDA should not promote the use of chemical treatments for irrigation water.  

back to top

F. General Produce Rule Recommendations

     The following are general recommendations that apply to the entire produce rule:

Do not create specific crop-by-crop regulations – this would be an unworkable amount of extra work for diversified operations. 

The proposed “integrated approach” should be kept. (Note – there is a concern that the commodity industry will push for crop-by-crop rules, which is why we need to push the FDA to keep the proposed set-up.)

Be considerate of the high cost that these regulations would impose on beginning farmers.  The impact on the next generation of American farmers needs to be considered, even if it means delaying implementation so as to conduct further analysis.

Do not require farms to register in the same way that facilities do.  This would be an additional hurdle for beginning farmers and would decrease the number of beginning farmers starting their own operations. (Note – the rules do not currently require farm registration, unless farms are also operating as facilities.)

back to top


Note, comments on this rule need to be on a separate comment.  The docket for the Preventive Controls rule is FDA-2011-N-0920.

     What the FDA rules say:

The FDA has put forward a second rule, the Preventative Controls rule, which governs processing facilities. If your business (even if you consider yourself a farm) qualifies as a facility, than you must register as a facility with the FDA and you will be subject to this second set of rules. The big question for farmers is, “what qualifies as a facility?”

The FDA has created a list of actions that a farm could conduct without being considered a facility; these include washing, trimming, packaging, drying, etc.

However, a separate list of “processing” activities includes cutting or slicing, drying to create a distinct commodity (ie, raisins), cooking, freezing, and more. Doing any of these activities automatically triggers a “facility” definition for your farm. Additionally, packaging and selling another farm’s produce automatically defines your operation as a facility. If you buy in another farm’s fruit for your CSA, or you buy in something to supplement a bad crop, you’re technically now a facility.  All facilities must register with the FDA.

Moreover, the rules fail to clarify that Community Supported Agriculture (CSAs) and other direct-to-consumer businesses are not facilities subject to regulations for food facilities, despite clear instructions from Congress in FSMA to do just that.

As with the produce rule, there is an exemption for small, local facilities so that they are exempt from some of the regulations in that rule. However, the sales limit is still up for debate: the FDA has proposed ceilings of $250,000, $500,000, or $1,000,000.  (Alternatively, facilities can also be exempt if their sales ceiling is $500,000 and a majority of sales are to a qualified end-user and are within the state or a 275-mile radius.)

     NYFC Recommendations:

The Preventive Control rule lists many low-risk processing activities that could still be done on-farm without triggering a “facilities” definition and requiring additional compliance.  That list needs to be extended to those low-risk activities that were missed, such as fermenting, pickling, baking grain products and extracting oil.

The FDA needs to clarify that alternative business models such as CSA’s, market stands, and direct marketing operations are not facilities, even though they are the final point of sale to the consumer.  This needs to be spelled out precisely so that the rules cannot be misinterpreted in the future.

There needs to be an allowance for operations that supplement their own production with goods from other farms without being labeled as a facility.  This includes CSA’s that buy in certain products to supplement their own, and market stands that aggregate some produce from other farms.

The FDA has asked for recommendation on how to define a “Very Small Business” for the purposes of the facilities exemption.  The FDA should use $1,000,000 as a threshold for Very Small Business so that small and new businesses are not unfairly targeted while larger facilities are properly regulated.

 back to top




Action Page

Host a Party

Find a Party

What’s at Stake


Small Farms


Soil Amendments

Hygiene and Training

Water Testing

Preventive Controls

Google Hangouts

Submit Comment Now

Additional Resources