We are pleased that the FDA Food Safety Modernization Act currently on its way to the President contains the amendment proposed by Sen. Jon Tester (MT) and Sen. Kay Hagan (NC) that protects thousands of small farms and small processing facilities from onerous and expensive new federal regulations.
We know that different people have different views on the Federal Food Safety Modernization Act as a whole some supported it, some opposed it, and others stayed neutral. Regardless of these differences, however, the Tester-Hagan amendment provides important protections for local producers. This victory is thanks to the thousands of emails, phone calls, sign on letters to Senators, letters to the editor, and other grassroots actions that you took part in.
The protections for small producers provoked an 11th hour flip flop on the part of the large industrial scale produce growers and processors. United Fresh and other large commodity groups that had supported the bill for over a year turned around and opposed it due to the Tester-Hagan amendment, underscoring how exceptional this victory is. Because of the industry opposition, we will need to be vigilant against attempts to strip out the small-farm protections in the next Congress or to weaken them through the rulemaking or enforcement processes.
Since there has been confusion about the Tester-Hagan amendment, below is a brief summary. This summary obviously does not cover all of the various scenarios that food producers will face in determining what is, and is not, required of them under the bill; it is intended only as a brief overview.
We plan to work on fact sheets to help producers, as well as proposals for how the FDA should interpret and implement the portions of the bill that have been left to the agencys rulemaking process. If your organization would like to be involved in an informal working group on this project, please let us know.
I. FACILITIES: businesses that store, hold, manufacture or process food. All facilities must still register with the FDA, as has been the case since passage of the Bioterrorism Act of 2002. Farms and retail food establishments are exempt, but these were narrowly defined under the Bioterrorism Act.
The Tester-Hagan amendment clarifies that businesses that sell more than half of their products directly to individual consumers are exempt as retail food establishments even if they process the food at a different location than where the sale occurs, such as a farmers market or farm stand.
Qualifying facilities, while they must register, are exempt from the provisions of Sec. 103 of the food safety bill, the Hazard Analysis and Preventive Controls. Qualifying facilities are those that have gross sales of less than $500,000 (averaged over three years, and adjusted for inflation) and that sell more than half to qualifying end users. Qualifying facilities can either demonstrate compliance with state and local laws or submit a short summary of their plan to analyze hazards and prevention.
Qualifying end users are individual consumers (with no limitation on location) or restaurants and retail establishments that are either in-state or within 275 miles of the facility.
FDA is also directed to define very small facilities that are exempt from Section 103s Hazard Analysis and Preventative Control requirements. The definition is to be based on the results of a study that looks at the incidence of foodborne illness in relation to food producers scale and type of operation.
Small-scale, direct-marketing farms are exempt from the provisions of Sec. 105, the produce safety standards in which FDA would regulate growing and harvesting practices. Exempt farms are those with sales of less than $500,000 (averaged over three years, and adjusted for inflation) and that sell more than half to qualifying end users. Qualifying end users are defined the same as in the facilities definition.
A big thank you to Judith McGeary of the Farm and Ranch Freedom Alliance and Margaret E. MacDonald of the Western Organization of Resource Councils for their tireless work on the Tester-Hagan amendment.