Summary of the Key Points of the Tester-Hagan Amendment

• Clarifies that businesses that sell more than half of their products directly to individual consumers are exempt from both the existing registration and the new HACCP-type requirements, whether or not they are processing the food at a location different from where the sale occurs.
• Adds a new exemption for businesses that gross less than half a million dollars (adjusted for inflation) and that sell more than half of their products directly to consumers or to local restaurants and retail establishments. These businesses must submit paperwork showing that they qualify for the exemption and that they comply with state and local laws in order to be exempt from the new HACCP-type requirements.
• Exempts farms that gross less than half a million dollars (adjusted for inflation) and that sell more than half of their products directly to consumers or to local restaurants and retail establishments from the FDA’s new “produce safety standards,” which would tell farmers how to grow and harvest their crops.
• Directs FDA to conduct a study in the next 18 months to look at the incidence of food-borne illness in relation to food producers’ scale and type of operation. Directs FDA to use this study to define “very small businesses” that will also be exempt from the HACCP-type requirements

Myths and Facts

Several questions have been raised about whether the Tester-Hagan amendment requires farmers to register with the FDA and comply with GAPs, or whether it will create problems of FDA becoming even more intrusive into local foods. While these concerns are understandable, a review of the existing law and the specifics of the Tester-Hagan amendment show that they are not accurate.

The Tester-Hagan Amendment Does NOT Require Farmers to Register with FDA or Comply With GAPs

Although it doesn’t use the term GAPS, the concern about FDA telling farmers how to grow and harvest crops is based on Section 105 of the bill, which authorizes FDA to issues “produce safety standards.” Page 51 of the bill includes the Tester-Hagan language and exempts farms that gross under half a million (adjusted for inflation) and that sell more than half their products directly to individual consumers, local restaurants, or local retail food establishments. There is no requirement for the farm to submit paperwork to the FDA or to register under the Tester-Hagan amendment.

The Tester-Hagan Amendment Does NOT Create New Requirements for Facilities to Register with FDA

The issue of regulating facilities is much more complex because it involved existing law as well as the new provisions of S510. “Facilities” are any business that processes, manufactures, holds, or stores food. Under the 2002 Bioterrorism Act, all facilities must register with the FDA. Those regulations have been in force for several years, although enforcement has been very lax.

“Farms” are not “facilities.” But if the farm processes or manufactures food, it becomes classified as a facility.

“Retail food establishments” are also not facilities. Retail food establishments are entities whose primary purpose is to sell to consumers, specifically those businesses that sell more than half of their products directly to individual consumers (not businesses, so the direct sales does not include sales to restaurants, etc). But there is also a catch on the retail food establishments issue, namely that the Bioterrorism law is based on each location registering. So if a business processes food at one location and sell at another – such as someone who makes jams in their kitchen and then sells it at the local farmers market – the existing law is unclear as to whether or not they would be a retail food establishment. FDA has made conflicting statements over whether such operations would have to register under the EXISTING law.

S510 would layer extensive HACCP-type requirements on every facility that has to register under the existing law. The Tester-Hagan amendment’s purpose was to try to mitigate that harm for small-scale producers. Politically, it was not going to be able to undo the existing Bioterrorism Act.

Even so, the Tester-Hagan amendment does fix one of the problems with the existing Bioterrorism Act requirements. The amendment directs FDA to clarify its definition of “retail food establishment” to include businesses that sell more than half their products directly to consumers at locations such as roadside stands and farmers markets, and through CSAs. (See pages 11-12 of the bill.)

So, under existing law, the farmer who makes a few jars of jam from his produce and sells them at a farmers market may have to register with the FDA under the Bioterrorism Act because he doesn’t qualify as either a “farm” or a “retail food establishment.” The same is true for the small-scale breadmaker or cheesemaker. And under S510, that farmer/breadmaker/cheesemaker would have to go through the full HACCP-type process. Under the Tester-Hagan amendment, that farmer/breadmaker/cheesemaker would now be exempt from both the registration requirement and the HACCP process as a “retail food establishment.”

Make no mistake – this was a hotly negotiated provision.

That didn’t end the issue, though, because the question is, what about food producers who sell their products directly to local restaurants, co-ops, and other local outlets that are very important to the growth of the local foods movement? The “retail food establishment” exemption, even as broadened by the Tester-Hagan amendment, requires a majority of sales to individual consumers, not businesses.

That’s where the Tester-Hagan amendment kicks in again. A business that is a “facility” (i.e. that doesn’t qualify for the exemptions for farms or retail food establishments) can avoid going through the HACCP-type process by showing that it qualifies, i.e. that it has gross sales under half a million and sells more than half directly to qualified end users (individual consumers, or local restaurants and local retailers). Yes, that will require some paperwork. I would have preferred that it didn’t, and that the onus rest with the agency, but this is what was politically achievable.

Final results under the Tester-Hagan amendment:

1) Farms that grow fruits and vegetables will NOT have to comply with the produce safety standards (sometimes referred to as GAPs) if they gross under half a million (adjusted for inflation) and sell more than half their products directly to consumers, local restaurants, or local retailers. The farms are not required to register. They do have to either put label on or display a sign with the farm name and address. And if FDA directly links the farm to an outbreak, the exemption can be withdrawn for that farm; the onus to prove the basis for the withdrawal is on the agency, not the farm. (See pages 51-53 of the bill.)

2) Businesses that process foods and sell more than half their products directly to individual consumers (not businesses) will not have to register with FDA nor comply with the HACCP-requirements. (See pages 11-12 of the bill.)

3) Businesses that process foods and sell LESS than half their products directly to individual consumers may have another option if they qualify (i.e. gross under half a million and sell more than half their products to individual consumers, local restaurants, and local retailers combined). They can produce paperwork showing (1) that they qualify and (2) that they comply with any applicable local and state laws. If so, they still have to register because of the existing requirements under the Bioterrorism Act, but they do not have to go through the extensive HACCP-type requirements that will be added on under S510. Again, there is withdrawal provision that places the onus on the agency. (See pages 19-24 of the bill.)

The Tester-Hagan Amendment Directs FDA to Conduct a Study to, For the First Time, Look at Foodborne Illness Risks in Relation to the Scale and Type of Operation

The bill directs FDA to conduct a study that would, for the first time, look at the issues of scale and type of processes in relation to foodborne illness. (See pages 24-26 of the bill.) It does not mandate that any individual person hand over the information to the government. Also, FDA is directed to provide a report to Congress within 18 months. Regardless of the agency’s motivations, it would be logistically impossible for it to send agents to every small farm and food processor in the country in that time period. The most feasible course of action is for the agency to use existing data on food distribution (from the census) and outbreaks (from CDC and state health departments), and do follow-up investigations on the source of the outbreaks. And, as is always the case for local foods producers, we need to stay informed and be ready to respond if the agency does try to overstep.

And there’s a positive reason behind this study. In arguing that local foods and small farms are safer and should not be regulated by FDA, we don’t have a lot of hard data to back us up. The directive to do a study is the first attempt to get data to show that smaller-scale producers who don’t commingle their products and who do less processing and transportation produce safer food.

None of this is a perfect solution – S510 and the Tester-Hagan amendment involved very ugly sausage making. The Tester-Hagan amendment ultimately fixes some of the existing problems caused by the 2002 Bioterrorism Law and a very significant part of the problems that would be caused if S510 passes. But it is, at its heart, damage control. That isn’t the fault of Senators Tester or Hagan or any of the people who advocated for this amendment. It’s due to the Agribusiness capture of FDA and much of Congress, a problem that has developed over decades and that we will need to spend the next decade fighting.

By:
Judith McGeary
Farm and Ranch Freedom Alliance
Judith@FarmAndRanchFreedom.org
254-697-2661