While President Trump’s Fiscal Year 2018 Budget of the U.S. Government “A New Foundation For American Greatness,” is unlikely to make it through Congress intact, it is a valuable exercise to review the President’s proposal to understand the direction he is recommending for the finances of the U.S. So, this newsletter takes a look at the sections of the 62-page document that are most relevant to the food industry. While there has been a great deal of news coverage on Trump’s plan to cut moneys from the EPA (in this version, he would slash its budget by 31%), it is less publicized that he also recommends cutting 21% from USDA and up to 18% from Health and Human Services (although HHS cuts are more focused on medical services). With the USDA cuts being the third largest, in percentage, for any agency proposed in the budget, exceeded only by EPA and State Department, it is interesting that the document also includes the statement “Everyone believes in and supports safe food supplies and clean air and water.” What Trump apparently doesn’t believe is that regulation should be a driving force in ensuring this safe food or clean air and water, as he makes clear in the sentences that follow the statement: “But the agencies of the Federal Government have gone way beyond what was originally intended by the Congress. The hallmark feature of these regulations has been a mind-numbing complexity that minimizes the understanding of what constitutes compliance, and maximizes the opportunity for arbitrary and ad hoc bureaucratic decision-making, often through vehicles that may not be a legitimate substitute for notice-and-comment rulemaking, such as guidance and interpretive documents.” We also find it interesting that the guidance that Trump derides in the above statement as “ad hoc bureaucratic decision-making” and non-legitimate “notice-and-comment” substitutes, are the very documents that the industry is clamoring for (e.g., for FSMA), as these provide FDA’s clarification, interpretation, and non-binding recommendations to help the industry better understand and comply with regulations. Additionally, as discussed in a 2011 FDA Fact Sheet and its Foundations of Regulation – FDA (.ppt), guidance documents are, in fact, held to the same comment requirements as are the rules. That is, for all Level 1 guidance, draft guidance is made available for public comment prior to being published as final. (Level 2 guidance which addresses current practices or includes only minor changes to previous documents is not necessarily first put out for comment.) And, whether put out for comment or not and even once the comment period is closed, all dockets remain open for future updates and revisions. It is precisely because guidance is more fluid, and can be revised at any time (e.g., to incorporate new information or policy, applicable public comments, advances in science or technology, etc.), that it is used to supplement the hard-and-fast provisions of regulations. Even with all this, as we stated in our March newsletter (Food Safety Not a Factor in Trump Budget Blueprint), we see the President as prioritizing some very specific agendas, with no real focus on food safety regulation. But that’s not to say it won’t evolve. Mr. Trump has repeatedly stated his disdain for “burdensome” regulations, and he reiterates that stance again with direction to “eliminate every outdated, unnecessary, or ineffective Federal regulation … Even for those regulations we must leave in place, we must strike every provision that is counterproductive, ineffective, or outdated.” Whether such direction makes its way to FSMA or other food safety rules, we can only wait and see. Some have suggested that the cuts being discussed at HHS will result in FSMA being “neutralized” and not effective. I disagree. FSMA is based on fundamental preventive control principles. The approach for FSMA is to look broadly at the risk portfolio and control those risks. Any good food company should be taking that approach anyway. Why? Not to keep FDA off their backs to but to protect their brands. Most likely we will see no increase in the number of inspections and we may see FSMA enforcement being a bit slower than some hoped for. But, the FSMA train has left the station, food companies are moving toward “Risk Based Preventive Controls” as a matter of good business practice, so I really don’t see anything in the current budget announcements that are going to have a major negative impact on food safety overall. As a final comment on this topic for this week, as we have pointed out in the past, the new role that the Department of Justice is playing in the food safety space is still very much alive and well under the Trump Administration. When you take a look at the proposed budget allocation of $27.7 billion for the Department of Justice (DOJ). Although this is a slight cut, the recommended reallocation of DOJ resources puts the money in the hands of “law enforcement, public safety and immigration enforcement programs and activities.” What this – and the Supreme Court’s denial of an appeal by the DeCosters in the egg Salmonella outbreak indictment – means to the food industry, we will cover in our next newsletter. Keep an eye out for it next week! About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
