January 3, 2019
BREAKING NEWS:

USDA & FDA to Continue Critical Activities During Shutdown
Greetings!
As you are aware, the US government has been partially shut down since December 22 as a result of budget negotiations. Prime Label is pleased to provide you with an overview of the impact of this shutdown on food regulatory professionals and give some suggestions on how to manage USDA label approvals during this time.
U.S. Department of Agriculture

Food Inspection : USDA FSIS meat, poultry and processed egg inspection services are continuing during the shutdown. FSIS’s local inspectors are among the 61 percent of USDA’s employees that Secretary of Agriculture Sonny Perdue has either “exempted or excepted” from furloughs during the partial shutdown .
FSIS Label Approval : Most of the Office of Policy and Program Development will be furloughed except as minimally required in direct support of USDA field operations. As a result, PLC expects to see the queue of submitted labels increase approval turnaround times; however, LPDS is continuing to review some labels through LSAS at this time. This is consistent with the last shutdown, when a limited staff at LPDS was exempt from furlough and actively supported label approval and industry inquiries throughout the shutdown.

For time-sensitive label approval, PLC recommends evaluating whether LSAS label approval is mandatory. You may want to schedule an appointment with one of our consultants to discuss some alternative options that could allow you to begin using your labels now. Although we cannot shorten the duration of the current 7-week turnaround time at the USDA, we can assist by determining if you qualify for Generic Eligibility, Emergency Approval, or even explore temporary solutions while your label is in the queue.  These measures would allow you to move your project forward confidently without delay. We recommend contacting  labels@primelabel.com  if you would like to get in touch with a consultant, gain a better understanding of Generic Labeling, request a label review for compliance, or discuss our expediting services. We can suggest the best course of action based on your situation.

Other USDA activities that will continue during the shutdown include:
  • USDA food recalls (the most recent was posted December 30);
  • Grain and other commodity inspection, weighing, grading, and IT support services funded by user fees;
  • Inspections for import and export activities to prevent the introduction and dissemination of pests into and out of the U.S., including inspections from Hawaii and Puerto Rico; and
  • USDA’s Market News Service continues to operate because it “provides critically important market information to the agriculture industry.”

Note that USDA and FSIS do not plan to update the agency websites until a new Continuing Resolution is reached.
U.S. Food & Drug Administration

According to a  contingency plan  put forward by HHS, routine regulatory and compliance work for most foods will be paused, including routine inspections of facilities and all work related to nutrition.
During the partial government shutdown, FDA says “agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.”

The activities that will continue include:
  • screening food product imports to the U.S.;
  • maintaining core functions to handle foodborne illness outbreaks;
  • high-risk food recalls (the most recent was posted January 2);
  • civil and criminal investigations when public health is imminently at risk; and
  • addressing other critical public health issues that involve imminent threats to the safety of human life.
Stay Tuned...

Prime Label will notify our Label Alert subscribers as soon as new information is available.

Best,

Jesse Zuehlke, PhD
Prime Label Consultants has been host to the nation's premier food labeling conference since 1989. As food marketers and manufacturers are faced with one of their greatest challenges in two decades - to adjust to sweeping new nutrition and BE rules for packaged products - the Food Label Conference remains in high demand as the place to learn the latest about food labeling compliance. This year boasts an unprecedented range of educational opportunities with more than 35 different breakouts in addition to 9 optional Add-On Trainings. For more details on the Food Label Conference held April 15-16, 2019, click below:
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