As of Oct. 28, the FDA has received 2,349 comments on the “produce safety rule.” Just think how many thousands more will arrive before the deadline on Nov. 15!

Check out the docket for the proposed rule on the website here.

 Generally, we can expect that some of the industry heavy hitters will file comments closer to the deadline, but that is not to say that we have not seen some thoughtful comments on the rule so far.

Filing a comment in late October, “Elizabeth” writes about the produce rule and the preventive control rule from the perspective of a farming operation in Oregon,

Since my family operates a small farm and my daughter is in the process of beginning a larger farm in Oregon, we are aware of the problems created if the Food Safety Modernization Act does not consider how it might negatively impact small farms without positively affecting food safety.

We are able to operate in a clean and reliable manner because we are able to give attention to detail. Our friend told us about on her small farm where my daughter interned that her milk pus counts were far below typical numbers. We consume our own products and we want safe, healthy food.

HOWEVER, we need to achieve quality food without bearing expenses that would put us out of business as we scarcely can make a living already with food prices being so low for the producer.

Both Rules. The cost of compliance needs to be kept to a minimum and FDA needs to provide free training to very small producers.

Produce Rule.

E coli is not an appropriate measure of water borne illness as it has various strains and other organisms such as Salmonella are not necessarily associated with it. Weekly water tests are too expensive for the smaller operations and unnecessary.

Manure applications should not be treated like other soil amendments nor should rules interfere with conservation practices.

Manure and compost applications do not need to be separated from harvest time by more than the National Organic Program requires.


Also writing in late October, “Danny” says the FDA rules shouldn’t drive small producers out of business, but may have that effect. From his comment:

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

I am a farmers market manager in a low-income neighborhood on the South Side of Chicago writing because I am concerned about the impact that FDA’s proposed FSMA rules will have on the ability of low-income communities served by farmers markets to continue to purchase fresh food. I ask you to ensure that new regulations do not put family farms out of business, harm farmers’ soil, water, and wildlife conservation efforts, or shut down the growth of local and regional healthy food systems!

If local farms went out of business due to the rules, it would severely limit underserved communities access to fresh foods. I manage the 61st Street Farmers Market in Chicago (Woodlawn community). Nearly 70% of low-income shoppers at the market that use an EBT/SNAP card purchase ALL of their fresh produce from local, family farmers at the market. Because the neighborhood is a food desert, there are no large grocery stores or other outlets to purchase fresh produce. If farmers are unable to come to market due to the proposed rules, residents will have no source of produce (and farmers no source of income).

I urge you to modify the rules so that they:

Allow farmers to use sustainable farming practices, including those already allowed and encouraged by existing federal organic standards and conservation programs. Specifically, FDA must not exceed the strict standards for the use of manure and compost used in certified organic production and regulated by the National Organic Program.

Ensure that diversified and innovative farms, particularly those pioneering models for increased access to healthy, local foods, continue to grow and thrive without being stifled. Specifically, FDA needs to clarify two key definitions: first, as Congress required, FDA must affirm that farmers markets, CSAs, roadside stands, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are therefore not facilities subject to additional regulation. Second, FDA should adopt at least the $1,000,000 threshold for a very small business and base it on the value of ‘regulated product,’ not ‘all food,’ to ensure smaller farms and businesses (like food hubs) fall under the scale-appropriate requirements and aren’t subject to high cost, industrial-scale regulation.

Provide options that treat family farms fairly, with due process and without excessive costs. Specifically, FDA must clearly define the “material conditions” that lead to a withdrawal of a farmer’s protected status in scientifically measurable terms. FDA must also outline a clear, fair, process for justifying the withdrawal of a farmer’s protected status and for how a farmer can regain that status.

Thank you for your consideration,


Another comment , from “Amy,” also talks of the over-regulation of the small producer.

I run a small farmers market in South Dakota. It is the only source for local foods year round. The community relies on the market and our small family farms rely on the market to make a living. We have spent years earning the trust, respect, and admiration of the community by providing a safe, clean market with reliable, trustworthy vendors. This rule will unduly harm our market and thousands like us. In fact, I fear it will force us to close leaving a huge gap for healthy local foods for consumers and subtracting a big source of income for small farmers. This country was on track to self-sustaining communities and food systems. That will all be for naught with this rule. Specifically, I am concerned:

They’re too expensive.

The rules could cost farmers over half of their profits and will keep beginners from starting to farm.

They treat farmers unfairly.

FDA is claiming broad authority to revoke small farmers’ protections without any proof of a public health threat.

They will reduce access to fresh, healthy food.

Local food distributors like food hubs could close, and new food businesses will not launch.

They make it harder for farms to diversify.

Grain, dairy, and livestock farmers could be denied access to emerging local food markets.

They will over-regulate local food.

The rules could consider farmers markets, roadside stands, and community-supported agriculture programs “manufacturing facilities” subject to additional regulation.

They treat pickles like a dangerous substance.

The rules fail to protect a host of low-risk processing activities done by smaller farms and processors.

They make it nearly impossible to use natural fertilizers like manure and compost.

Farmers will be pushed to use chemicals instead of natural fertilizers.

They require excessive water testing on farms.

Farmers using water from streams and lakes will be required to pay for weekly water tests regardless of risk or cost.

They could harm wildlife and degrade our soil and water.

The rules could force farmers to halt safe practices that protect our natural resources and wildlife.


These critical comments of the FDA’s proposed rules come from the orientation of small farmers/farmers’ markets, but don’t think that large produce associations and big commercial growers will rubber stamp the FDA’s proposed food safety rules, either.

Water testing standards and the “one-size-fits-all” requirement for all covered produce trouble the industry, as do the exclusions and exemptions for smaller operations. Other issues in the produce rule include the definition of “farm” and “produce” (includes seeds and flowers?). For the preventive controls rule, industry groups are likely to say that mandatory testing of raw materials and finished product, mandatory environmental monitoring for pathogen and mandatory supplier approval and verification must go.

We’ll keep a close eye on the growing volume of comments to the FDA. Based on the record so far, the agency shouldn’t expect many ringing endorsements of their work.