[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 local farms and on my ability to continue to purchase produce grown by the
farmers in my community.
As a consumer strongly committed to the health and safety of our local food system, I am deeply concerned that
the proposed rules will disproportionately harm the small farms in our region by burdening them with new
financial and time demands that they simply cannot afford to meet. The research behind these rules is sorely
lacking – especially with regard to practices on small farms – 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 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 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 disproportionately burden small farms – The overwhelming
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 local farms. Local farms are submitting many comments describing
in more detail the challenges they will face in implementing these rules, and the final rules must change
to reflect these comments. In particular, 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 sustainable farming practices and do not negatively impact
the environment. You must incorporate the conclusions from your pending environmental impact
analysis into the final rules. Specifically, the rules must change so they do not put small sustainable farms
out of business, or create new incentive for farmers to remove wildlife habitat around their farms, pollute
waterways by stockpiling manure, implement widespread chemical treatment of water, or stop producing
and applying compost.
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 alternatives appropriate for small farms. Local farms lack the resources to
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
consistent 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) 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.
2) Strengthen and expand the exemptions for small farms based on the lower risk they pose to consumers.
3) Listen to the feedback of local farmers and adjust the rules to ensure that their businesses will not suffer.
Thank you for your time and consideration.