Sample Comments to FDA on Food Safety Modernization Act

[CLICK HERE to download the sample FSMA comments in a Word document format or CLICK HERE to see entire sample letter below]

The FDA’s proposed food safety regulations pose significant problems for sustainable farmers, food producers, and food hubs across the country. Under the proposed regulations, many farmers will be forced to comply with high-cost, industrial-scale regulations, and they will be unable to use traditional, sustainable growing practices. Food hubs and local food businesses will be forced to deal with costly and burdensome paperwork. Ultimately, consumers will face increased food prices and reduced availability of locally and sustainably produced foods.

Please add your voice in support of our small farmers and food producers by taking action before the Friday, November 22 deadline.


The italicized portions at the beginning are intended to help you personalize your comments. You don’t have to write a lot – even a couple of sentences can really increase the impact your comments will have!

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Preventive Controls Rule: FDA-2011-N-0920 and RIN 0910-AG36
Produce Standards Rule: FDA-2011-N-0921, and RIN 0910-AG35

I am a ______ [farmer, food producer, consumer, parent…]. I am deeply concerned about the impact that FDA’s proposed rules under FSMA would have on [my farm, my food business, the farms that I buy food from…].

For consumers, do you make an effort to buy from farms that use sustainable practices? Why do you care about these rules? Just a sentence or two is sufficient to explain.

If you are a farmer, explain your farm practices that would be impacted by the rule. Do you use manure, vermicompost, or compost teas? Do you use surface water or multiple different water sources? Do you do rotational grazing of your livestock with your crops, or use draft horses?

Do you have a CSA that involves more than one farm and would thus be required to do a HARPC plan? Do you do low-risk activities, such as bottling honey, grinding grains, or making jam? Do you have staff who could handle the HARPC paperwork or would you need to hire new people?

For food processors or food hubs, could you absorb the cost of writing a HARPC plan? Do you rely on supplies from farms that would be exempt under the Tester-Hagan provision?

I urge the FDA to address the following issues in the proposed FSMA rules:

Tester-Hagan “qualified exemption” in both the Produce Rule and the Preventive Controls Rule:

1. The gross sales test to qualify for the Tester-Hagan provision should be based on sales of food that is subject to FSMA, whether the produce standards or the preventive controls rule. Sales of food that would not be regulated under FSMA should not be included.
2. The FDA should not rush the process of revoking a producer’s Tester-Hagan exemption. The agency has other mechanisms it can use if there is an immediate threat of foodborne illness.

a) The FDA should be held to specific evidentiary standards before it can revoke a farmer’s or food facility’s Tester-Hagan exemption.
b) A farm or facility that is exempt under Tester-Hagan should be given at least 90 days to submit evidence and defend its exemption if FDA seeks to revoke it.
c) If the exemption is revoked, the farm or facility should have at least two years to come into compliance with the FSMA rules.

On-Farm Produce Standards Rule:

1. The FDA’s approach to traditional farming methods, such as diversified livestock-crop farms, the use of working animals, and the use of biological soil amendments, is fundamentally flawed. The agency should not restrict these sustainable methods of farming without data showing an actual, verified increased rate of foodborne illness; the simple fact that these methods include diverse microbiological communities is not a sound scientific basis for restricting them.
2. The waiting period between applying manure and harvesting the crop should be no more than 4 months, and there should be no waiting period between applying compost and harvesting the crop. The excellent track record for safety on organic farms shows that this standard is sufficient.
3. Compost teas and other biological inoculants, including normal additives such as molasses, should be treated the same as compost.
4. Water testing should not be required more often than once a month, and farmers should be able to test less frequently after establishing the safety of their water source through consecutive negative tests. In addition, farmers should be given the option to test for pathogens, rather than having to treat or stop using the water that tested positive for generic e. coli.
5. The provisions on wildlife and domestic livestock need to be clarified to protect farmers who use biologically diverse farming from field inspectors using their discretion to require measures such as fencing or destruction of habitat.

Preventive Controls and HARPC Rule:

1. “Very small facilities” should be defined as being under $1 million in total annual sales, adjusted for inflation. Imposing HARPC requirements on businesses smaller than that is unnecessary and overly burdensome.
2. Any requirement for “supplier verification” should not prevent a facility from purchasing foods or ingredients from farms and facilities that are exempt from the regulations under the Tester-Hagan provision or other exemptions.
3. Low-risk activities conducted by a farm using its own products or using another farms’ products, such as making jams, grinding grains, or dehydrating vegetables, should not be subject to any of these regulations, including both the HARPC requirements and the good manufacturing requirements.  The exemption should apply regardless of the size of the farm.
4. Low-risk activities, when conducted off-farm, should not be subject to the same requirements as high-risk processing activities. The requirements should address both the scale of the operations and the level of risk of the activity.

Full Name