The Food and Drug Administration’s (FDA) proposed food safety rules threaten family farms and local food production. These rules are open for public comment until November 15, 2013.

In 2010, Congress exempted small farms that market direct to local customers from complying with a new law intended to prevent unsafe food from industrial food facilities. The Western Organization of Resource Councils, a 7 state regional network of which WCC is a member group, played an instrumental role in gaining this exemption under the Tester-Hagan amendment.

Now, FDA’s proposed rules to implement that law essentially take away that exemption from small-scale, direct-marketing farms. The rules would let FDA remove the exemption from individual small farmers if the agency feels the farmer is violating the rules.

Removing the exemption could put most small farmers and food producers out of business.

As proposed, the rules do not give small farmers and local food producers:

Enough opportunity to review and appeal a decision to end their exemption,
An opportunity to address problems cited and keep an exemption, or
Enough time to comply with the rules when an exemption is revoked.
These rules are simply unfair to small family farmers.

Follow this link to submit your comments telling FDA to keep the exemption and ensure due process for small-scale farmers and food producers.

Attend a public forum near you to get informed and speak out!

October 29 – Grand Junction, CO

6:30-8pm Center for Independence, 740 Gunnison, Grand Junction CO

October 30 – Delta, CO

3-4:30 pm Westminster Hall, Delta Presbyterian Church, 4^th& Meeker, Delta, CO

October 30 – Ridgeway, CO

7-8:30 pm Ridgeway Community Center, 201 North Railroad Street, Ridgeway, CO

More Background on FSMA

The Food Safety Modernization Act’s (FSMA’s) extensive new requirements for food producers could favor large-scale industrial producers over small-scale sustainable producers. Senator Jon Tester of Montana fought for an amendment, co-sponsored by Senator Kay 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 includes anyone doing any processing.

Under the Tester-Hagan amendment, producers who gross under half a million dollars 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.

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

Key issues

1. The timing of revocation

Under the proposed regulations, a farm must come into compliance with all of the regulations within 60 days of FDA notifying it that its exemption is being revoked. Even if the farmer 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 farmers. In effect, these proposed rules mean that most farms 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. 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, 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. 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.

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

2. The process of revocation

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

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

FDA also failed to provide post-decision procedural protections, such as the opportunity to file a motion for reconsideration or a motion for stay, 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, a farmer must comply with all of the rules within 60 days of an original letter; given the extensive, expensive regulations, the most likely outcome is that the farmer would be forced out of business. Even if a farmer 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 FDA’s decision.

Interestingly, FDA’s proposed rules include provisions that provide more due process protections for revocations of variances to States and foreign countries. 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 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. FDA should be required to have reason to believe that a farm 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 a revocation must meet, and it should be required to present, at minimum, credible evidence.

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

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

3. The permanency of revocation

FDA’s proposed rule does not provide any way for a farmer 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, FDA would require 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 could impose costs in the tens of thousands of dollars on a small farmer, making it infeasible to continue in business.

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

More information is available here.

About the author

Brenda Bafus-Williams

After working for our Alliance for 32 years, Brenda retired in 2018 and took a two-year hiatus before rejoining the fold as a board member. She is a treasure trove of little known facts about the organization after managing everything from the membership database to our communications. Her other interests include dabbling in a number of artforms, hiking, botany (her college major), t'ai chi and chi gung, and swing dancing. With roots in western Washington state, she has lived in Montrose with her husband Kevin since 1984.

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