Click here for latest action alert posted on October 16, 2013.

(July 15, 2013): We fought hard for the Tester-Hagan amendment to exempt small-scale, direct-marketing farms from the most burdensome aspects of the Food Safety Modernization Act (FSMA).  This exemption is essential to the continued vitality of the local foods movement.

Now the FDA is proposing rules that make it very easy for the agency to force even small-scale farmers to comply with the extensive, burdensome FSMA regulations, and all but impossible for such farmers to protect themselves.

Under the proposed rules, if the FDA decides to revoke the Tester-Hagan exemption and force a small-scale, direct-marketing farmer to comply with the new federal requirements:

• 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.

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.  

The same issues apply to small-scale food processors.  Under the FDA’s definition, “processors” 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.

Please take a moment to tell the FDA to respect the letter and spirit of the Tester-Hagan amendment and ensure due process if a farmer or food manufacturer comes under scrutiny.  Sample comments and more information are below.
 

Click here for the key issues we identified in our initial review of the proposed rule.

And stay tuned for future FSMA updates! The FDA has proposed over 1,200 pages of regulations, many of which would seriously harm numerous mid-sized farms that produce high-quality food but do not qualify for the Tester-Hagan amendment.  We will be sending out additional alerts on the most problematic provisions.
 

TAKE ACTION

TAKE ACTION #1

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 producers.
 

Click here for sample comments or you can click here for more information. 

 
HOW TO SUBMIT COMMENTS ONLINE TO THE FDA:

• 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
  • Facilities Rule
• 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:

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

Include the docket number in your comments:
•   Produce Rule is FDA-2011-N-0921
•   Facilities Rule  is FDA-2011-N-0920

TAKE ACTION #2

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.

• To contact your U.S. Representative: www.house.gov
• To contact your U.S. Senators: www.senate.gov
• Or call the Capitol Switchboard: 202-224-3121

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.

SAMPLE COMMENTS
It is very important that you personalize these comments!  Form comments will all be counted as a single submission.  Just a couple of sentences at the beginning – who you are and why this is important to you – make a difference.  If you have a personal story to share, about your farm or a farm you buy food from, that’s even better!

I urge the FDA to change the provisions governing “qualified exemptions” for small farms and food processors.  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 farmer’s or food processor’s exemption would lead to the food producer having to close down in most cases.

Specifically, the FDA should make the following changes:

1)  Provide at least 90 days for the farmer or food processorto assemble and submit the arguments and evidence in opposition to the revocation;
2)  Grant a hearing upon request;
3)  Establish evidentiary standards for FDA to investigate a farm or food processors,  as well as evidentiary standards for the decision to revoke the exemption;
4)  Provide two years for the farmer or food processor to come into full compliance with the regulations after revocation is final; and
5)  Provide a method for the farmer or food processor to apply for the exemption to be re-instated.

The agency has other methods, besides revoking the Tester-Hagan exemption, to deal with situations where there is an actual threat to people’s health or a time-sensitive issue.  The revocation of the exemption is a very serious step, and small-scale, direct-marketing food producers should be given all appropriate due process protections.

Sincerely,
Name

MORE INFORMATION

 
The Food Safety Modernization Act’s (FSMA’s) extensive new requirements for food producers favor large-scale industrial producers over small-scale sustainable producers.  Senator Tester of Montana fought for an amendment, co-sponsored by Senator Hagan of North Carolina, to exempt local food producers from the most burdensome portions of the bill, namely the regulations governing on-farm growing of produce and the hazard analysis plans for “facilities,” which would include anyone doing any processing.

Under the Tester-Hagan amendment, producers who gross under half a million dollars (adjusted for inflation) and who sell more than half their products directly to individual consumers or to local retailers and restaurants are exempt from these new federal regulations.

The Tester-Hagan amendment is vital for protecting vulnerable, small-scale businesses that are providing safe, healthy food for their local communities.

At the urging of FDA and some special interest groups, FSMA included a provision that allows the FDA to withdraw the exemption from farms or facilities under specific conditions.  The FDA’s proposed rules to implement this provision undermine the intent of the Tester-Hagan amendment and abuse normal concepts of due process.

I.     The Timing of the Revocation

The first and most significant problem is the timing of the withdrawal.  Under the proposed regulations, the farmer or food processor must come into compliance with all of the regulations within 60 days of FDA notifying it that the exemption is being revoked.  Even if the producers challenges the decision, the time for compliance is not extended.

Full compliance with all of the rules within 60 days will be impossible for the majority of small producers.  In effect, these proposed rules mean that any producer whose exemption is revoked will be put out of business.

FDA’s stated rationale for making the revocation time frame so short is that “either of the two circumstances that could result in our determination that an exemption should be withdrawn … warrant prompt compliance with the rule in the interest of public health.”

Yet FDA is empowered to revoke the exemption absent any immediate threat to public health.  The FDA may revoke the exemption if a foodborne illness outbreak is linked to the farm, whether or not the farm appears to be the cause.  Moreover, FDA may revoke the exemption if it determines it is necessary to “protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated” with the farm.

If there is truly an immediate risk to the public health, the FDA has other options to address the problem.  The agency has multiple enforcement tools at its disposal:

• 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)

Even large-scale farms have two years to come into compliance with the proposed regulations initially, because FDA recognizes that there will be significant costs and logistical barriers. The proposed rules provide small farms with three years to comply with most of the requirements, and five years to comply with the agricultural water provisions.  Very small farms are given four years for compliance generally, and six years to comply with agricultural water provisions.  For food processors, the timeline is one year for large processors, two years for small processors, and three years for very small processors.  It is wholly unrealistic to expect a small or very small producer (the only sort of producer that would qualify for the Tester-Hagan provision) to comply with all of the requirements within sixty days.

We urge the FDA to provide a minimum of two years for producers whose qualified exemption is revoked to comply with the regulations.  If there is a more immediate risk to public health, FDA can use one of the other administrative or judicial tools available to it.

II.     The Process of Revocation

In addition to the lack of time provided for compliance, the process of revocation is flawed.

A producer who wishes to contest the withdrawal of its exemption has only 10 calendar days to submit a written appeal that includes all of the facts and supporting documentation.  While it would be appropriate to require the notice of appeal to be filed promptly, it is completely unrealistic to expect a farmer to be able to marshal all of the arguments and relevant documents on what could be a multitude of issues raised by FDA.

Under the proposed rule, the producer is not entitled to a hearing.  Based only on the information that the producer  is able to gather in 10 days, the hearing officer may determine that there is no issue of fact raised and deny a hearing.

The FDA also failed to provide the usual post-decision procedural protections, such as motion for reconsideration and a motion for stay, both of which are provided for under other federal regulations.

The compressed time frame and lack of procedure is particularly problematic because of the lack of effective judicial review.  First, the farmer or processor must comply with all of the rules within 60 days of the original letter; given the extensive, expensive regulations, the most likely outcome is that the producer will be forced out of business.  Even if the producer can afford to seek judicial relief after this, the courts give significant deference to agency decisions.  Based on a record developed in the space of only 10 days and no hearing, it is highly unlikely that a court would reverse the FDA’s decision.

Interestingly, the FDA’s proposed rules include provisions that provide more due process protections for revocations of variances to States and foreign countries.   The FDA must publish note of its determination that a variance should be modified or revoked in the Federal Register and allow interested parties to submit comments.  Notice and the opportunity for comment will also be given to any States or foreign countries where a variance applies to similarly situated persons.  In other words, under the proposed rules, a small farm can find itself subject to the FDA’s regulations with extremely minimal process; but countries such as China and Mexico are afforded extensive process, including the opportunity for others to weigh in on the issues.

The proposed regulations also fail to set standards for FDA’s action.  The FDA should be required to have reason to believe that a farm or processor exempt under the Tester-Hagan provision poses a potential threat to the public health and safety before investigating, as with most investigations. In addition, the agency needs to set the evidentiary standard which the revocation must meet, and it should be required to present, at a minimum, credible evidence.

We urge the FDA to provide appropriate due process protections, including:

1. Adequate time (at least 90 days)  for a farmer or food processor to gather the evidence and documents supporting the exemption;
2. A hearing if the farmer or food processor requests one;
3. A requirement that the agency have a reasonable basis prior to beginning an investigation of a farm or processor exempt under the Tester-Hagan amendment; and
4. A requirement that the agency provide credible evidence that the exemption should be revoked prior to initiating the revocation process.

III.    The Permanency of Revocation

The FDA’s proposed rule does not provide any way for a farmer or food processor to re-qualify for the Tester-Hagan provision.

Consider a small farm that sells most of its produce directly to consumers (and thus qualifies for Tester-Hagan).  FDA determines that, for some reason, there is a condition on the farm that poses a public health risk related to water contamination.  By revoking the farm’s exemption, however, FDA requires the farm to comply with all of the new regulations, regardless of whether there was any risk associated with the farm’s hygiene, worker, soil amendments, or other practices.  And that farm will remain subject to all of the requirements forever.  These regulations can impose costs in the tens of thousands on a small farmer, making it infeasible to continue.

We urge the FDA to allow for farms and processors to be able to address the specific issue(s) of concern and either maintain or requalify for the exemption.