- The farmer gets only 10 days to submit a written appeal;
- FDA does not have to grant the farmer a hearing;
- The agency is not held to any specific standard for what evidence must be shown to justify the revocation;
- 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.
- 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.
- 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
I urge the FDA to change the provisions governing “qualified exemptions” for small farms and food producers. The FDA’s proposed rules do not provide sufficient time or due process for the farmer to challenge the agency’s decision to revoke the exemption, nor sufficient time for the farmer to come into compliance with the regulations if the exemption is in fact revoked. In essence, a decision by an FDA official to revoke a farmers’ exemption would lead to the farm or food producer having to close down in most cases.
Specifically, the FDA should make the following changes:
well as evidentiary standards for the decision to revoke the exemption;
- Seeking an injunction or temporary restraining order under 21 U.S.C. 332;
- Seizing the food at issue under 21 U.S.C. §334(a);
- Administrative detention of the food under 21 U.S.C. §334(h)
provisions. Very small farms are given four years for compliance generally, and six years to comply with agricultural water provisions. It is wholly unrealistic to expect a small or very small farm (the only sort of farm that would qualify for the Tester-Hagan provision) to comply with all of the requirements within sixty days.