Date: Jan 04, 2013

Exactly a year after the expected release of the proposed Produce Safety Rule, the U.S. Food and Drug Administration (FDA) published that proposed rule for public comment today.  This follows the adoption of the Food Safety Modernization Act (FSMA) signed into law two years ago by President Obama that aims to reduce foodborne illness outbreaks of foods produced domestically as well as imported foods. Two proposed rules were released today: 1. The “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Preventive Controls for Foods Rule) and; 2. The “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (Produce Rule) which establish a framework of enforceable standards for both domestic and foreign producers and processors.  The Produce Rule would establish standards in five discrete areas consistent with FDA’s thinking on the major pathways for contamination:  the microbial quality of water; employee hygiene; materials that are put into the soil (i.e. manure); animal intrusion into growing fields that might contribute to contamination; and equipment, tools and buildings. The Preventive Controls Rule will establish standards around hazard analysis and the establishment and implementation of risk based preventive controls in facilities.  The nearly 1,600-pages of these proposed rules and attending documents will be the focus of Western Growers efforts during the next few weeks. Further information and analysis from WG will be forthcoming.  Today’s announcement marks the beginning of a 120-day comment period. FDA is actively encouraging feedback to help inform and perfect these rules.

In a conference call to reporters today, FDA Commissioner Margaret Hamburg said that the goal of the Rule is the strengthening of the food safety system and the prevention of foodborne illness outbreaks – the cornerstone of the FSMA.  This is a shift from a reactive focus to a preventive one.  Instead of responding to outbreaks, the FDA along with an alliance of all stakeholders would strive to prevent outbreaks.  This will help restore the loss of confidence that steers consumers away from consumption of fresh and healthy vegetables and fruits. 

In a press release, Michael Taylor, deputy commissioner for foods and veterinary medicine stated, “We know one-size-fits-all rules won’t work.  We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”  Commissioner Hamburg was also quoted in the release: “The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners. Our proposed rules reflect the input we have received from these stakeholders and we look forward to working with the public as they review the proposed rules.”

On the conference call Hamburg acknowledged that no strategy can achieve zero-risk but the implementation of reasonable, science-based steps and scientifically sound practices can be taken at each step.  She emphasized the FDA’s approach to making the Rule is to be sure the regulations can work for all businesses, large and small, with as much flexibility as possible. She expects a good robust dialogue with stakeholders. Answering a reporter’s question, she said the FDA was committed to an on-going “dynamic process” and that there will be a “need to have a continual updating” whenever science brings new answers.  She reminded everyone that the law has an exemption for small farms and businesses, but that they hope that farms of all sizes would pay attention to all food safety practices and when problems arise the FDA would engage.

The final cost of the implementation of the Rules and how they would be paid for is still undetermined.  The 113th Congress could appropriate funds, and/or the FDA could impose user fees, or both. The manner in which compliance will be verified is still being discussed.  FDA intends to work with state governments as well and publish additional rules in the coming weeks that may provide more insight into how third party audits may play a role.  No definitive explanation was given for the long-delayed release of The Produce Rule except to say the process was comprehensive, complicated and involved the gathering of extensive outreach by the FDA to the produce industry, consumer community, other government agencies and the international community. The Produce Safety Alliance will play an important role providing education and technical assistance to implement and comply with this rule.

Western Growers will analyze and offer comment on the proposed rules but also encourages all members to familiarize themselves with the proposals.  Comments, concerns and questions can be directed to Hank Giclas and are welcome at any time.

WG Staff Contact

Hank Giclas
Sr. Vice President, Strategic Planning, Science & Technology

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