In 2013 and early in 2014, the U.S Food and Drug Administration (FDA) released seven major proposed rules mandated under the Food Safety Modernization Act (FSMA). The FDA has missed some deadlines during this rulemaking process and it is now required to promulgate all FSMA regulations according to a court-ordered timeline. At this moment, the FDA has closed all comment periods for the proposed rules.
Although the comment period for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (also known as the Produce Rule) closed in November 2013, a Supplemental Notice related to the Produce Rule is expected to be released sometime this summer to allow impacted parties one last opportunity to provide feedback on specific and complex areas of the rule. While thousands of comments have been received and the FDA is considering these in the course of finalizing the Produce Rule, the FDA has also begun to think about how to implement what is certainly a huge undertaking.
The FDA considers FSMA the most sweeping reform of our food safety laws in more than 70 years and is working on a successful implementation. The FDA’s implementation strategy, also known as the FDA’s operational strategy, was released in May of 2014. On July 29, Western Growers Science & Technology hosted a webinar to provide clarity on the FDA’s implementation strategy as it relates to the Produce Rule. An excellent overview of this strategy was provided by two featured speakers: Dr. Samir Assar, director of the produce safety staff in the FDA’s Center for Food Safety and Applied Nutrition; and Kevin Gerrity, national food expert for the FDA’s Office of Food and Feed Operations (OFFO).
More than ever, the FDA is called to play a critical role in the global food safety system. In order to meet this challenge successfully, a new strategy is needed. Dr. Samir’s remarks confirmed the FDA’s new approach and vision when he talked about the importance of bringing industry into compliance with the Produce Rule by looking at enforcement in a different way. He stated that education is the best way to bring impacted parties into compliance. The FDA’s operational strategy is meant to answer many questions and provides guiding principles for how the strategy can be implemented with respect to food and feed facilities, Produce Rule standards, and import oversight. This document is available online at www.fda.gov.
Even without the rules finalized, a strategy for implementation can be framed at this point. Gerrity is part of the working group charged with this task. He shared some key areas and ideas in his presentation:
• The FDA acknowledges it needs to build regulator capacity and bring in people with farming backgrounds and education. A technical assistance center for investigators is also under consideration.
• In many states, state agricultural investigators would be the ones typically inspecting a farm as opposed to the FDA inspectors.
• Investigators and farmers would need to attend the Produce Safety Alliance (PSA) training and pursue continuing education.
• The FDA’s approach for a farm inspection would be totally different than a facility inspection; unannounced inspections and warning notices may not fit farms as they do with manufacturing facilities.
• The FDA is leaning towards using scheduled inspections and considering the possibility of generating inspection reports the same day so farmers can use them right away.
• The use of intelligent questionnaires and less comprehensive inspections could expedite inspections and leverage resources in some cases.
• Education is the means to achieve compliance. The use of guidance documents, sharing information, providing training and working collaboratively are the tools currently contemplated.
• The FDA’s new approach would have inspectors direct the farmer to the right resources to be in compliance instead of an automatic issuance of citations.
• The U.S. Department of Agriculture, trade associations and other parties will play a key role in optimizing the use of resources and assisting with compliance.
• The use of third party data and programs is also under discussion. Efforts like the Leafy Green Marketing Agreement (LGMA) could assist in avoiding the duplication of current efforts and optimizing resources. The FDA is also looking at different funding mechanisms.
• The FDA aims to bring all impacted parties together and work with buyers to drive compliance with these regulations.
• During the initial implementation steps, the FDA would probably not take legal actions as the FDA desires to regulate farmers by giving them the opportunity to bring their operation into compliance.
Since the release of the Produce Rule, in January 2013, the FDA has shown willingness and openness to the needs of farmers during its FSMA journey. The FDA is working to meet the Produce Rule court deadline of October 31, 2015. Once the rule is published, it will become effective in 60 days. After this effective date, a compliance date will follow, to provide farms with enough time to comply with the provisions of this rule based on the size of the farm and the type of provision — the current proposal suggests a time period of two to six years. Contact Sonia Salas at email@example.com to share your ideas or thoughts on this topic.
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