Update: FDA has granted the 120 day comment period extension! New deadline to make comments is Sept 16, 2013. ORA and folks in the WORC network are continuing to read through the new rules and assess what they will mean for growers.
1,200 Pages of Food Safety Modernization Act Rules Released Governing Fruit & Vegetable Producers & Processors
While Congress debated the Food Safety Modernization Act throughout 2010, the Western Organization of Resource Councils (WORC), member groups like ORA, allies and the grassroots fought for the Tester-Hagan Amendment to exempt small producers and processors selling primarily to local markets from having to comply with the same onerous regulations designed for large, industrial facilities with long supply chains. The FSMA passed and President Obama signed it in January of 2011. Since then, the FDA has been drafting rules and regulations to implement the new food safety law.
Two years later, on Jan 4, 2013, the FDA released two major proposed rules for safety compliance (over 1000 pages), open for public comment until May 16, 2013:
1. New rules for growing produce:
The proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” rule would establish new rules for farms, including worker training, health and hygiene; agricultural water; biological soil amendments; domesticated and wild animals; growing, harvesting, packing and holding produce; equipment, tools and buildings; sprouts; testing methods; and record keeping.
Thanks to the Tester amendment, farms with average annual sales under $500,000 that sell more than half their food within 275 miles of their farm are exempt from the new rules. The FDA also exempts very small farms with less than $25,000 per year and sales, as well as produce that are generally cooked before eating.
2. New rules for processors:
The proposed “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” rule would establish new rules for food processors, including personnel; plants and grounds; sanitary operations; sanitary facilities and controls; equipment and utensils; processes and controls; warehousing and distribution. They would also require a food safety plans; hazard analysis; preventive controls; recall plan; monitoring; corrective actions; verification; record keeping.
Under the Tester amendment, processors with average annual sales under $500,000 that sell more than half their food within 275 miles of their facilities must comply with modified requirements, including documentation that they either: 1) have identified potential hazards, are implementing preventive controls, and are monitoring to ensure those controls are effective, or 2) are in compliance with State, local, county or other applicable food safety law. Certain low risk foods are also exempt. After the comment period closes (set for 5/16/13), the FDA will review the comments and will likely make some changes before they release a final version of the regulations. The implementation of the regulation ranges from one to five years for different types of producers and processors.
Comment Period Extension Requested
In early March, WORC and our member groups joined with over 270 organizations, food businesses, and farms to request the FDA extend the public comment period on the proposed rules by an extra 120 days. Unless extended, the public comment period closes May 16, 2013. The current comment period does not give consumers or the thousands of family farmers who will be subjected to the new rules a lot of time to read the 1,200 pages of regulations and understand the impact they may have on small and family farmers, especially during the spring planting season. Read the extension request letter here.
ORA will be sending out an Action Alert in the next few weeks to encourage you to make comments on the new proposed rules. We’re helping WORC get through the 1,200 pages and understand what impacts they will have on small and medium producers and processors. In the meantime, you can sign WORC’s online petition to extend the comment period so we have more time to get a handle on the new rules and talk to folks during the Farmers Market season.
You can also learn MUCH more at the upcoming workshop about FSMA rules in Ontario, April 19th. The full day workshop is $20 and requires registration. Click here for more info.