The U.S. Department of Agriculture (USDA), Agricultural Marketing Service (AMS), and the U.S. Food and Drug Administration (FDA) are separate federal agencies with different missions. However, they share a robust working relationship when it comes to the 2011 Food Safety Modernization Act (FSMA), which shifts the focus from responding to food contamination after it occurs to preventing it in the first place.
Once these FSMA directives are finalized and enforced, farmers that grow, harvest, pack, and ship fruits and vegetables will be regulated by the FDA. Since these are new federal regulations, many growers may find themselves in unfamiliar territory on their own farms; but the USDA is prepared to help the growing community comply with the new regulations with its many programs and services.
Background
The Food Safety Modernization Act was passed by Congress and signed by President Obama on January 4, 2011, and requires the FDA to draft the majority of the reports, studies, and regulations specified in the law. Two of the primary regulations or proposed rules drafted by the FDA will impact fruit and vegetable growers and packers, depending on their location, the size of their operation, farming activities, and agricultural practices used.
The Produce Safety rule lays out food safety requirements for many of the farmers who grow fruits and vegetables, while the Preventive Controls for Human Foods rule will affect businesses that process and manufacture food for human consumption. Some farms both grow and process food and will have to comply with the requirements of each category. Both rules have exemptions for the smallest farms and businesses (with sales of under $500,000 annually).
Draft regulations were published in the Federal Register on January 16, 2013, inviting the public to submit comments. The FDA then held public meetings across the nation to get more comments and feedback. The agency also attended state and industry-sponsored listening sessions and farm tours.
The extended comment period closed in late November 2013 and the FDA then worked through the arduous task of reviewing each and every comment. This included reviewing more than 15,000 comments submitted for the proposed Produce Safety rule and several thousand comments for the Preventive Controls for Human Foods rule.
Based on these comments, the FDA published supplemental proposals revising specific technical requirements in these two regulations and asked for additional public comment. This comment period closed on December 15, 2014, and the FDA has been reviewing the latest comments.
Compliance
The Produce Safety rule is expected to become “final” or take effect in late December 2015 with an extended, staggered compliance timeline. The timeline will be based on the dollar value of annual produce sales (over a rolling average of the three previous years) for farm businesses categorized as “very small,” “small,” and “all others,” and the compliance dates are proposed for December of 2019, 2018, and 2017, respectively. Each size category will have an additional two years to comply with certain water requirements (2021, 2020, and 2019, respectively). In addition to the Produce Safety rule, growers and packers may also be impacted by one or more of the other prevention-oriented FSMA regulations depending on the type of operation and its location. These are the aforementioned Preventive Controls for Human Foods rule, Preventive Controls for Animal Foods rule, and Foreign Supplier Verification Program.
