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Deadline Extended! Submit Comments by Nov. 22
FDA Proposed FSMA Regulations due by 11:59 p.m. Eastern  
 
Under the FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) is proposing regulations that will make it much harder, if not impossible, for farmers to use traditional, sustainable farming methods. Moreover, the proposed rules will bury food producers and food hubs in time-consuming and expensive paperwork. Ultimately, consumers will face higher prices and reduced availability of healthy, safe food. FDA extended the comment period due to recent technical difficulties with the regulations.gov website.

Help protect sustainable farmers and keep local food available and affordable.



While small-scale, direct-marketing producers are to be protected by the Tester-Hagan exemption ,  FDA's plan for implementing the exemption puts most producers at risk [see Action Alert].  Beyond this, there are many good family farmers and food producers who do not have access to direct markets or who sell more than allowed under the exemption, but who are not big enough to absorb the costs that will be imposed by the FDA's proposed rules. 

 

FDA has failed to provide a sound scientific basis for many of the requirements, choosing instead to take a "guilty until proven innocent" approach to traditional farming methods. This places unfair and unnecessary burdens on farmers who use sustainable inputs such manure and compost teas, as well as those with diversified livestock-crop farms.   

 

For more details, visit bit.ly/fsma-take-action   

 

Please add your voice! Submit your comments on both rules!    

 Note: you can submit multiple times if you have more to add or a different point to make.  

   Share the Action Alert, bit.ly/FRN12806 

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ACTION:  SUBMIT COMMENTS TO FDA 
Submit Comments to FDA before midnight Friday,  November 22, 2013 (11:59 p.m. Eastern) 

 

Please personalize your comments; simply submitting a form letter will be counted as only one comment regardless of how many are sent. View sample comments below; the italicized portion will help you personalize your message. You may post your same comment for both rules.

 

To submit comments online, go to:

TIP: 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.

Simple Steps for submitting comments online:  

    1. Enter your comment in the "Comment" box or type "see attached". If you are attaching comments as a separate file, click on "Choose files" to select and upload your document.
    2. Enter your "First Name" and "Last Name".
    3. If you want to give your "Zip/Postal Code" and/or "Email Address", click the box for "I want to provide my contact information" and enter your information. Otherwise, leave box unchecked
    4. Click the box to deselect "I am submitting on behalf of a third party" to remove the fields for "Submitter's Representative" and "Organization Name".
    5. For "Category," select "Individual Consumer" or "Private Industry".
    6. Click "Continue" to see "Your Preview" and verify the information you entered. You may click "Edit" if you need to make changes; otherwise, click the box "I read and understand the statement above" and click "Submit Comment".

SEE SAMPLE COMMENTS 


 

      Share the FSMA Action Alert with others: bit.ly/frn12806    

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SAMPLE COMMENT FOR FDA  

It is very important that you personalize these comments!  

Form letters will all be counted as a single submission regardless how many received.

 

Use the sample below as a starter; the italicized portions 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!    

 

Then add statements relevant to the rule you're commenting on.  You can use talking points listed at the end of this alert; remember, the concerns over the Tester-Hagan exemption apply to both proposed rules.

   

After you've created your personalized message for each proposed rule, you may copy/paste the content into the "Comment" box. See steps above 

 

====== Sample Starter Comments ======

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.

   

For farmers:  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:

 

[state your concerns]

 

Sincerely,

[Your Name] 

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TALKING POINTS   

Issues FDA needs to address in the proposed FSMA rules   

 

You may copy/paste the points to include in your comments or formulate your own statements. The Tester-Hagan exemption applies to both proposed regulations; so your statement(s) can be included for both.

 

TESTER-HAGAN "QUALIFIED EXEMPTION"  

    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 [FDA-2011-N-0921]:

    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 [FDA-2011-N-0920]:

    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.

TAKE ACTION NOW - Submit Comments  

 

Share the FSMA Action Alert with others: bit.ly/frn12806     

 
Farm-to-Consumer Legal Defense Fund, a 501(c)(4) nonprofit, defends the rights and broadens the freedoms of family farms and artisan food producers while protecting consumer access to raw milk and nutrient-dense foods. Learn more About Us  or check out the FTCLDF 2013 Summary.  

Membership benefits include the possibility of representation in court; the Fund typically pays for all court costs. The Fund is not an insurance company and cannot guarantee representation on all legal matters. Your membership fees and donations help to keep local food sources available and preserve family farms facing unjust enforcement actions.

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