1. Use the sample as a starter for your own comments; you can also view the text online (http://bit.ly/FSMA-sample-letter) or you can download a Word version for editing, from http://bit.ly/FSMA-sample-letter-download 
2. Sign your full name
3. Mail to the address shown on the letter below 

To submit comments online, go to:

• We recommend that you write your comment ahead of time and save it on your computer — there is a time limit when using the Federal Register System, and you may get timed out if you write your comment from scratch.  
• If your comment is less than one page, you can copy and paste it into the comment box. If it is longer, you can instead write “see attached” and UPLOAD a separate document, such as a Word or PDF file, with your comments.
• Uncheck the box that says “I am submitting on behalf of a third party,” so that you do not have to enter an organization name.
• For category, select “individual consumer” or “private industry.”
• Click “continue.”
• Check the box that you have read and understood the statement, and be sure to click “submit comment.” You should be taken to a new screen with a confirmation number.
• Remember that the Tester-Hagan provision is found in both rules, so if you file comments online, be sure to submit them on both rules.

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, such as making jams, grinding grains, or dehydrating vegetables, should not be subject to these regulations.
4. Low-risk activities, when conducted off-farm or by multiple farms working together, 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.

Sincerely,

• Find out who represents you by going to www.house.gov and www.senate.gov or by calling the Capitol Switchboard at 202-224-3121.
• Call and ask to speak to the staffer who handles agricultural issues. Explain that you’re a constituent and that high-quality food is very important to you. Ask your Congressman to contact FDA directly on behalf of you and other constituents.
• Get the staffer’s email address and follow up by sending them a copy of your comments to FDA.

• Leave too much discretion in the hands of individual FDA officials; 
• Do not give small farmers and local food producers enough opportunity to respond to a decision to end their exemption; and 
• Do not give small farmers and local food producers enough time to comply with the rules if their exemption is revoked.

• Compost made without specific heating periods (“static compost”);
• Vermicompost or worm castings;
• Compost teas with any additives, even simple molasses or kelp meal;
• Any compost that does not meet the precise methods and testing requirements specified in the rule.

• A farm that dehydrates fruits, makes pickles, or mills grains; 
• Two farms running a joint CSA and handling each other’s produce;
• A farm that stores food from any other farm or producer (even if they do no processing);
• All sorts of “food hubs” that distribute food from multiple local producers.