Author: Lauren Gwin, Small Farms Program, Oregon State University
Publish Date: Spring 2013
What is FSMA?
Two years ago, Congress passed and President Obama signed the first overhaul of food safety laws since the 1930s: the Food Safety Modernization Act (FSMA). The law applies to farms and food facilities – manufacturing/processing, packing, and holding – and was designed to prevent food borne illness.
The important – and hard-fought – “Tester/Hagen” amendments to FSMA were written to assure that there would still be a place for small-scale, sustainable agriculture. Provisions include:
- Create scale- (and risk-) appropriate regulations for small farms serving local and regional markets;
- Allow on-farm conservation and beneficial wildlife practices;
- Complement, not contradict, organic standards;
- Minimize extra regulations for low-risk, value-added processing.
Draft Rules Seeking Comment
On January 4 of this year, the U.S. Food and Drug Administration released draft regulations to implement FSMA. Sustainable agriculture advocates are busy deciphering the hundreds of pages of regulations, to see whether the intent of Tester/Hagen has survived intact.
The two rules to watch are the “produce rule” and the “preventive controls” rule.
The produce rule contains standards for growing, harvesting, packing, and holding produce for human consumption. It focuses on microbial contamination and creates standards for personnel qualifications and training; health and hygiene; agricultural water; biological soil amendments; domesticated and wild animals; growing, harvesting, packing, and holding; equipment, tools, buildings, and sanitation; and sprouts.
The proposed produce rule includes exemptions for smaller farms and farms that sell locally and regionally:
- Farms that earn less than $25,000 in farm revenue (gross) per year are entirely exempt;
- Farms that earn less than $500,000 of farm revenue (gross) per year AND sell the majority of their produce direct-to-consumer AND within a 275-mile radius or within the same state are “partially exempt” and are only required to follow labeling requirements for traceability.
The preventive controls rule applies to facilities that manufacture and process food for human consumption. The two major requirements are a hazard analysis and risk-based preventive controls and updated good manufacturing practices. In the draft rule, FDA lists a number of activities and facilities not covered by the rule, including specific low-risk activities by small and very small businesses; farm activities (as defined by FDA); and certain facilities that only store packaged foods or raw agricultural commodities for processing.
As with the produce rule, facilities are “partially exempt” if earning less than $500,000 in annual gross revenue and selling more than half directly to consumers or to retail food establishments that sell direct, all in the same state or within a 275-mile radius. Partially exempt facilities still have to document compliance with non-federal food safety laws and notify their customers or submit a HACCP plan.
Exemptions are not assured or permanent. FDA can revoke any exemption if a farm or facility is at all involved with a food safety problem. Conditions for exemptions may be more complicated when implemented than as described in the proposed rule. And, finally, retailers, distributors, and others who buy produce may decide not to recognize any exemptions, even if FDA does.
Tuning In, Weighing In
The National Sustainable Agriculture Coalition is a good place to stay up to date on what the draft rules, as written, might mean for small farms and sustainable ag. NSAC will launch a grassroots campaign later this month to encourage farmers to comment on the draft rules.
It is worth remembering that the Tester/Hagen amendments to FSMA were very controversial, with many strong interests solidly against them. Those interests, including consumer protection groups, are working very hard now to weaken the whole and partial exemptions. Food safety is everyone’s responsibility – no matter what size your farm is – but regulations can be scale- and risk-appropriate.
Comments on the draft rules are due to FDA by May 16. To submit comments on line, go to http://www.regulations.gov/ and follow instructions. You will need these docket numbers:
- Produce Rule: Docket Number FDA-2011-N-0920
- Preventive Controls Rule: Docket Number FDA-2011-N-0921