On September 10, 2015 the U.S. Food and Drug Administration (FDA) issued the final Preventive Controls Rule establishing new food safety standards for food processing facilities. The rule – one of seven major rules authorized by the Food Safety Modernization Act (FSMA) – will be officially published in the Federal Register on September 17, at which time compliance timelines start counting down.
In response to the release of the rule, the National Sustainable Agriculture Coalition (NSAC) issued a press statement highlighting areas of the rule where significant improvements have been made, and also areas where additional clarity will need to be provided in order to ensure the rule does not unfairly – and in contravention of FSMA’s statutory requirements – require farms to undergo third party audits. NSAC also urged FDA to expediently finalize the related rule clarifying how farms and food businesses serving local markets will be covered by the Preventive Controls Rule. You can read the press statement here.
NSAC will be undertaking a thorough analysis of the rule, and will publish more analysis on specific provisions relevant to sustainable food and farm systems in the coming days. In particular, we will be looking closely at and publishing information on the:
- Definitions related to farming operations and activities that may trigger the facility definition;
- Classification of various value-added activities, and the corresponding exemption for those activities classified as low-risk;
- Requirements for qualified facilities – including the process for withdrawing and reinstating a qualified exemption;
- Requirements for covered facilities related to environmental monitoring, product testing, and supply chain verification; and
- Compliance timelines for facilities that must register and comply with the rule, including qualified and fully covered facilities.
We will also be updating our “Am I Affected?” flow chart to help farms and food businesses assess whether the Preventive Controls Rule applies to their operations.
You can access the pre-publication version of the final rule here (PDF), as well as via FDA’s website, which includes additional supporting materials. The final rule will officially be published on September 17, 2015.
The final Produce Rule will be issued by late October 2015.
You can also read our recent blog posts on FSMA implementation and appropriations issues to learn more.
Winton Pitcoff says
The link (https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-21920.pdf) goes to a document with supplementary information, which gives a great narrative about the changes and the process, but it’s not to the actual text of the rule. Do you have a link to that? Thanks.
Sophia Kruszewski says
Hi Winton –
The regulatory text of the final rule is in that PDF document, it just doesn’t start until page 818.
When the rule is officially published, on September 17, you’ll be able to access a more easily navigable document via the Federal Register page: https://www.federalregister.gov/articles/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human