[Name]
[Address]
[Date]
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: FDA-2011-N-0921; RIN 0910-AG35 and FDA-2011-N-0920; RIN 0910-AG36
To Whom It May Concern:
I am writing in response to the Food and Drug Administration’s proposed rules on “Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption” and “Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based Preventive Controls for Human Food.” I have profound concerns about these rules with regard to their impact on my farm and neighboring farms.
I operate a small farm in Western MA and am deeply concerned that the proposed rules will burden my farm with new financial and time demands that I simply cannot afford to meet. The research behind these rules is sorely lacking – especially with regard to practices on small farms like mine – and the costs of the rules for local farms
are far too great to justify the highly questionable benefits.
I support federal efforts to reduce foodborne illness originating with large-scale industrial farms and food businesses. Indeed, in an era when our food system is highly consolidated and dominated by a small number of multistate and multinational corporations, the FDA must have authority to enforce basic food safety standards across state lines and issue recalls when necessary.
However, if these rules drive small-scale local farms like mine out of business – as the FDA’s own analysis indicates they will – I strongly believe this will not improve the safety of our food supply. Small farms allow for a shorter supply chain from farm to consumer, so the source of any outbreak is easy to trace, and customers and businesses like mine can quickly respond. Local food systems are thus able to correct food safety threats far more rapidly than large-scale industrialized food systems, which rely on complex traceability requirements and federal oversight.
My specific requests to the FDA are as follows:
1.
You must change the rules so they don’t place excessive burdens on small farms like mine– The vast majority of foodborne illnesses originate in food handling practices after food leaves the farm, or on the
very large farms that dominate our food system – NOT on small farms that market locally. As Congress mandated, the rules already include limited exemptions for farms with gross food sales below $500,000.
These exemptions are crucial, but both rules can and should go further. Many small local farms gross over
$500,000 (netting a tiny fraction of that), while still posing low risk to consumers due to a short supply chain and the ease of tracing products back to the farm. Congress authorizes the FDA to exempt or modify the requirements for small farms that are low risk. Produce from small farms marketing locally
(i.e. in state or within 275 miles) poses a low risk to consumers, and the rules must not drive these farms
out of business.
2.
You must remove restrictive requirements from the rules that are not justified by existing science and
are inappropriate or impractical for my farm. In particular, I am concerned about costly new watertesting requirements, record-keeping requirements, restrictive manure and compost requirements, and

new investments in equipment and supplies that I expect would be needed to comply. Specifically, the produce rule requires a nine-month waiting period between manure application and harvest, more than doubling the waiting period that is currently recommended as the “best practice” in our region. The field research supporting a nine-month waiting period does not exist, and the economic and environmental impacts are untenable. Similarly, water testing requirements and water standards are based on inadequate research and would unacceptably burden small local farms.
3.
You must change the rules so they support the sustainable farming practices of small farms like mine
and do not negatively impact small farms or the environment. It is crucial that you incorporate the conclusions from both your pending environmental impact analysis and your analysis of the impact of this rule on small farms into the final rules.
4.
You must add to the rules a process for protecting the exempt status of small farms not covered by the
rule, and a process for reinstating exemptions that are removed by the FDA. As written, the rule gives the FDA broad powers to remove small farms’ exempt status without due process. Before removing the exempt status of a farm, the FDA should be required to give the farm a “warning letter” so that the farm has an opportunity to fix the identified issues. In order to remove a farm’s exemption, the FDA should be required to justify, with specific scientific information, why the farm’s practices pose unacceptable risk of a foodborne illness outbreak. A farm must then an opportunity to appeal the FDA’s decision to remove its exemption, as well as to take steps to reinstate its exempt status.
5.
The final rules must allow for alternative ways to comply that do not put my farm out of business. It is completely unrealistic to expect farmers like me to have the spare time and resources necessary to research and establish alternatives to these one-size-fits-all rules, even when the rules permit this.
Either the FDA should fund the necessary research for small farms to establish alternative means of compliance that are compatible with local farming practices, or existing state-based food safety programs like the MA Commonwealth Quality Program should be accepted as a means of complying with the rule.
6.
You must change the rules so that they don’t prevent farmers from working together to efficiently bring
their produce to local markets to meet the growing demand for local food. As written, farmers handling even a minimal amount of produce from their neighbors face a much higher regulatory burden.
In closing, I request that you:
1) Strengthen and expand the exemptions for small farms based on the lower risk they pose to consumers.
2) Not impose costly new regulations on the small farms in my region, especially without thoroughly researching the full impact on small farmers, food safety, and the environment.
3) Change the rules so they do not conflict with time-honored, sustainable practices of small farms in this region.
Thank you for your time and consideration.