An Open Letter to the FDA on Proposed New Rules

Re:  Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921

My name is Michael McClellan, and I own a small organic farm in Bowling Green, Ky. I am by no means a large-scale producer - in fact, I only have 14 acres, but I have been working for the past two years to rebuild our soil and help the farm to recover from past years of neglect and over-grazing. It has now rebounded beautifully and is almost ready for cropping.  Next year should be our first crop of organic fruits and vegetables with a little bit of animal stock (mainly poultry) coming soon thereafter.

I am writing because I am concerned about the impact that FDA’s proposed FSMA rules will have on my small farm and others like me. Besides farming myself, I also buy food from the farmers' market in Bowling Green and I know there are several small farmers there who could potentially be driven out of business by these regulations if they are not enacted with the interest of protecting small farms and the customers who buy from them.  In other words, I ask you to ensure that new regulations do not put safe farms out of business, harm farmers’ soil, water, and wildlife conservation efforts, or shut down the growth of local and regional healthy food systems!

Because of all of the specific issues described below, I urge FDA to publish a second round of draft rules for public comment before finalizing the produce safety and preventive controls regulations.  I know you will be hearing from many other people about these rules, but please remember as you consider, debate, and finalize these rules that ultimately our first order of business must be to protect the largest number of people possible and to support small businesses, which are already practicing good and safe methods of growing and handling food and creating a lot of jobs in the process.

I am specifically concerned about the following issues:

1. Issue: Manure and Compost –  Manure and compost have been used for millennia by farmers around the world without harm to consumers. In fact, there is no better fertilizer than responsible use of aged manures, green manure (plant matter), and compost that is properly aged and prepared.  The Produce Rule directly conflicts with established federal organic standards around using manure and compost – making it effectively impossible for farmers to use manure and creating barriers to the use of compost. If we are going to ban or discourage anything, it should be chemical fertilizers. Manure and compost are not only the most healthful additives possible for the soil, but they are also recyling and solar energy at their best and present not only the BEST fertilizer for a farmer to use, but also the cheapest as it is free or near free.  Although my farm is not yet organically certified, I fully intend to use manure and if that becomes a problem due to these regulations, then it will certainly impact my bottom line dramatically. The only beneficiaries to such a rule will be the fertlizer companies and NOT the consumers or farmers.  I urge you to align your standards for the use of manure and compost with the National Organic Program regulations, specifically that:

a. The interval between application of untreated manure and harvest should be four months, not the nine months proposed by FDA.
b. For compost, there should be no interval between application and harvest if the compost is treated consistently with NOP or similarly rigorous composting standards.
c. To align with current best management practices, insulation of compost should not be required as part of an acceptable treatment process for compost.

2. Issue: Conservation Practices – The Produce Rule fails to protect and promote on-farm conservation practices that help protect our soil, water, and wildlife habitat and places arbitrary restrictions on integrating grazing animals into farm fields. For example, rotating livestock in pastures with the resultant benefits of manure and natural fertilizers and harvesting food crops from those fields not be delayed for nine months. Manure is NOT hazardous waste! Instead, it is nature's way of recycling and if done right, gives us the best possible food with maximum nutrition.

3. Issue: Agricultural Water – The Produce Rule includes costly, burdensome, and unscientific standards for irrigation water – including water testing and treatment requirements.

4. Issue: Diversified Farming Systems – This is a good issue that FDA needs to retain, not change - the Produce Rule acknowledges the importance of diversified farming systems . Every farm should be diversified and the FDA should take an “integrated” approach to the standards that does not set separate requirements for each kind of fruit and vegetable. This integrated approach should be taken in the final regulations.

5. Issue: Value-Added Processing – Farmers who add value to their crops through low-risk on-farm processing should not be subject to the same regulations as high-risk processors.  The Preventive Controls Rule includes a good initial list of low-risk processing activities done on-farm, but FDA fails to include additional activities like making pickles and salsa that are already considered low-risk by many states. I urge you to include a fuller range of low-risk on-farm processing activities in the final regulations, including:

o Acidifying, pickling, and fermenting low-acid fruits and vegetables made in compliance with existing Good Manufacturing Practices
o Baking activities involving grain products
o Roasting grains for animal feed
o Extracting oils from seeds
o Extracting virgin olive oil
o Making molasses from sugarcane and sugar beets
o Making syrups from sorghum, rice, and malted barley

6. Issue: Direct-to-Consumer Marketing – Community Supported Agriculture (CSAs) and other direct-to-consumer businesses should not be subject to regulations for food facilities, despite clear instructions from Congress in FSMA to do just that.  Without this clarification, CSAs and other direct farmer-to-consumer farms that do light processing activities or include produce from another farm in their boxes will be subject to inappropriate, excessive regulations designed for industrial food facilities. Such a regulation will only to help to drive small businesses out of business to the benefit of "Big Ag" and will only hurt the consumer by having fewer organic and local options for food sourcing. Please clarify in the Preventive Controls Rule that CSAs, roadside stands, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are not facilities that must register with FDA and, therefore, are not subject to the Preventive Controls Rule.

7. Issue: All Food vs. Regulated Food – Even though not all food produced on farms is governed by the rules, the value of everything produced on a farm counts toward exemptions and modified regulations – which will make it hard for mid-size farms to diversify their operations.

8. Issue: Definition of “Very Small Business” – The rules set modified requirements for small and very small businesses, but FDA has not settled on a definition for “very small business” and most of their options are unrealistic.  Without a realistic definition, many very small businesses will be regulated like big facilities. A better option is to adopt the $1,000,000 threshold for a very small business and make sure that it is based on the value of regulated product, not the value of all food. This would focus the full regulations on big businesses that produce the vast majority of covered farm and food products, while focusing modified requirements on smaller farms and businesses that represent the majority of producers but only minority of product in the food supply.

Comments Covering Both the Proposed Preventive Controls Rule and the Produce Rule:

9. Issue: Loss of Protections for Local Food (Exemptions and Modified Requirements) –  In the final regulations, FDA must make a robust and fair regulatory framework for the qualified exemptions and modified requirements. Specifically:

o FDA should define “material conditions” as scientifically measurable traits that can be clearly identified in individual cases, and never by conjecture be applied to a whole class of persons, types of operations, or broad description of food being produced.
o FDA should require credible and substantial evidence to justify a withdrawal.
o FDA should establish a clear and fair process for reinstituting a farm or facility’s status if that operation has had their exemption or modified requirement withdrawn.

10. Issue: Excessive Compliance Costs – The costs of compliance are substantial and put an unfair burden on smaller growers. It is certain that some farmers will go out of business, fewer people will start to farm, and more farmers will have to seek off-farm jobs to keep farming. If anything, we should be doing everything possible to encourage MORE people to farm and MORE people to start small food businesses to reduce our imports, increase the quality of our food, and raise the nutritional value of our food, as well as help local economies and rural areas to revive economically. The FDA should find ways to decrease the costs of compliance with the new rules, especially for small and very small farms. FDA must also base the costs on realistic assumptions about length of growing season, farm net income, and feasibility of water testing.

Thank you for your consideration and I hope and pray you will act in the intersets of consumers, farmers, and the small business community and NOT put the interests of large-scale, commercial, agricultural enterprises that rely on chemical inputs, feedlots, and other unhealthy, unsustainable, and ecologically damaging practices. Small farmers are working for America and the American public and we must support their efforts.


Michael McClellan, Owner
"Irish Acres Farm"
Bowling Green, KY

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