Please help! The Tester-Hagan amendment exempts small-scale, direct-marketing farms from the most burdensome aspects of the Food Safety Modernization Act (FSMA). This exemption is essential to allow small farmers to interact with the public and provide food for those who choose to purchase directly from a small farmer. This is now in jeopardy again and we need your help!
No Standards For Justification of Revoking of the Amendment
- The farmer gets only 10 days to submit a written appeal;
- FDA does not have to grant the farmer a hearing;
- The farmer must comply with all FSMA regulations within 60 days, which would be impossible for many small farms; and
- There is no way to get the exemption back.
Importantly, there are no standards for justification of revocation of the amendment. This means that the FDA can enforce the revocation at will.
In practical terms, under the agency’s proposed rules, the FDA will be able to target small farms one-by-one and put them out of business, with little to no recourse for the farmers.
Any On Site Food Making Can Be Targeted
The same issues apply to small-scale food manufacturers. Under the FDA’s definition, “manufacturers” include people who make dried fruits, pickles, breads, or any other food that is processed in any way, including farmers who are making value-added products.
The FDA’s justification for the short deadlines and lack of due process is that quick action is needed “in the interest of public health.” But that’s simply not true. Under the statute, FDA can withdraw an exemption not only in cases of a foodborne illness outbreak, but also if the agency determines it is needed to “prevent” an outbreak “based on conduct or conditions” at the farm.
While some cases may involve urgent situations, others will not. Moreover, for the cases that do actually require quick action, the agency has other methods – such as seizing or detaining the food – to protect the public health. The agency’s proposed regulations are not necessary and create a constant threat to small farmers of being put out of business in just a few short months without even an opportunity for a hearing.
Please Act Now
The FDA is accepting public comments before it finalizes the proposed rules. Please submit a comment telling FDA to respect the Tester-Hagan exemption and ensure due process for small-scale farmers and food
Sample comments and more information are below. Here’s how you submit comments to the FDA online:
- There are two proposed rules: one for farmers raising produce; the other for “facilities” where food is processed (which may include, for example, farmers who are canning their products). Please comment on BOTH proposed rules — you can use the same comment, you simply have to go through the process twice.
On-Farm Produce Rule: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0087
Facilities Rule: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0017
- Enter your personal and business information under Section 1, “Enter Information.”
- For “Organization name”, put “none”
- For “Category,” select “individual consumer”
- Enter your comments in the box. We recommend that you write your comment ahead of time and save it on your computer, because 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 simply write “see attached” and UPLOAD a separate document, such as a Word or PDF file, with your comments instead.
- Be sure to click the “submit” button. You should be taken to a new screen with a confirmation number ADDRESS FOR MAILING COMMENTS:
- Produce Rule is FDA-2011-N-0921
- Facilities Rule is FDA-2011-N-0920
More Ways To Take Action
Some members of Congress are considering actions to rein in FDA, so it’s very important to tell your U.S. Representative and U.S. Senators about your concerns for farmers and local food producers.
Send all three officials a copy of your comments to the FDA. Include a personal note at the beginning, asking them to support efforts to require FDA to re-write its regulations to protect small-scale producers. In addition, the rules need to be re-written so that mid-sized family farms are not crushed under overly burdensome regulations that are not based on sound science; we will send future alerts with more details on those aspects, as well.