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TAG January 17, 2019 0 Comments

As of Saturday, Jan. 12, the government shutdown set a new, though rather contentious, record for the Trump Administration – becoming the longest shutdown in the history of the U.S. Initiated on December 22, 2018, the first week or so likely had little impact on many government functions, including FDA and USDA. There were the two federal holidays (Christmas and New Year’s), and it’s probable that many federal workers had also planned at least a couple vacation days. Additionally, it is classified as a partial shutdown, because some agencies are funded through 2019 appropriations that passed prior to the shutdown and some functions funded by carryover user fees. But, as the time has dragged on, the impact has continued to grow. Nearly 400,000 employees have been furloughed, while another 400,000-plus “essential personnel” are reporting to work but not being paid until the government reopens. Additionally, those who are working must discontinue all non-essential discretionary functions until the shutdown ends. For FDA this means that, due to the absence of either an FY 2019 appropriation or continuing resolution, only essential personnel are working – and even those are authorized to work only on imminent public health issues. With about 7,000 of FDA’s 17,000 employees (41%) furloughed, and others unable to conduct discretionary functions, even if the government reopened – one way or another – between the time of this writing and your reading, the longevity of the shutdown will have significant impact on food safety, with FDA at least 3 to 4 weeks behind in its work. Due to prior Congressionally approved funding, imported food and USDA inspections are continuing. However, FDA’s routine food safety inspections, of which the agency averages 640 per week, are not considered to be essential functions, thus are not being conducted. However, according to a Twitter thread with FDA Commissioner Dr. Scott Gottlieb, because the agency would not have conducted inspections during the two weeks around Christmas and New Years, last week (of Jan. 7) is the first in which inspections may have been postponed. Additionally, in a January 14 Tweet (the vehicle through which he is staging the majority of his communications at this time), Gottlieb announced that FDA is re-starting high risk food inspections and will be doing compounding inspections this week. Those inspections are being conducted largely by recalling furloughed workers to return to work – unpaid. With responsibilities for the safety of both food and drug safety, he said, “This is requiring hard operational decisions. We’re focused on preserving the function of our programs for as long as we can.” Although the House passed stand-alone bills on Jan. 10 to fund and reopen certain agencies including FDA and USDA, the Senate declined to consider the bills, and the White House has stated that the legislation would likely be vetoed. We would expect that food companies are continuing their own inspections and audits and conducting recalls, as needed, and FDA is still announcing them on its recalls webpage, but all other non-essential web updates and general communications have been halted for both FDA and USDA. As is stated in a Status box atop the home page: “This website will not be updated during a lapse in federal funding. Content on this website will not be current or maintained until funding issues have been resolved.” FDA’s notice is more in-depth and includes information on both the “lapse period” and for employees, but, again, nothing but essential information is available from the agency. The big picture is just as critical with the impact on economic growth of the U.S. increasing the longer the shutdown lasts, and two weeks – which have already come and gone – have been noted as the tipping point. This is, at least in part, due to the fact that government spending contributes 18% of economic output. The economic repercussions also become more critical the longer a shutdown continues. Employees have already missed the first pay period, and those who are furloughed have no guarantee of getting paid for the time they are off. Additionally, because the agencies have no legal authority to accept user fees for FY 2019 until appropriations are enacted, they cannot accept FY 2019 regulatory submissions that require a fee payment. Thus, as agencies use up saved funds, more services will close. It is a challenging time throughout the U.S. and the food industry; and it is one in which we will likely see some separation of the chaff from the grain, i.e., those whose food safety efforts are in place simply to ensure against regulatory violation vs. those implementing food safety as a culture and the right thing to do. As Gottlieb stated in a public message to FDA colleagues, “It’s in times of challenge and uncertainty that the public needs us most. I know we’ll continue to match that obligation in the future.” It has always been an FDA mantra that it is up to the industry to produce safe food. There is no doubt in my mind that is a true statement. So, as we look at the impact of the government shutdown, if the food industry is doing what it should be doing, the impact on public health will be insignificant. Thus, in a responsive challenge to the food industry, I say: It’s in times of such federal uncertainty that the public needs us the most. Are you upholding your obligation to food safety? It is the industry’s answer to that question that will truly determine the extent of the impact of the government shutdown on food safety. 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.


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