Day 8 Shutdown Update

As the government shutdown reaches its eighth day, the immediate disruptions—halted USDA payments, suspended FDA submissions, and trade delays—are now giving way to a broader and more subtle pattern of regulatory slowdown. Beyond the obvious, the shutdown is beginning to affect timelines for rulemaking, enforcement actions, and advisory processes that shape long-term regulatory policy.

FDA: Delays Extend Beyond Submissions and Imports

• Core operations remain constrained
  FDA continues to focus on essential public health work, including outbreak response, import entry screening, and the monitoring of critical medical product supply chains. However, internal reports suggest that staff fatigue and resource prioritization are now slowing even carryover-funded review programs.
• User-fee barriers remain unchanged
  FDA is still prohibited from accepting any new submissions requiring user-fee payments. Sponsors attempting to file under the PDUFA, MDUFA, or GDUFA frameworks will continue to face a complete freeze until appropriations resume.
• Rulemaking and comment periods affected
  The Office of the Federal Register and relevant FDA offices have confirmed that regulatory deadlines, including open comment periods on proposed rules and guidance documents, are being extended or paused during the shutdown. This quiet ripple can affect timelines for initiatives under review by CDRH, CFSAN, and CDER.
  For example, planned comment deadlines on certain food labeling and medical device cybersecurity guidance documents have been informally extended, with new dates to be set post-shutdown.
• Public meetings, advisory committees, and workshops canceled or postponed
  FDA’s planned advisory committee meetings and public workshops are being rescheduled. This affects not only applicants awaiting panel review but also industry stakeholders tracking regulatory direction on issues like digital health, AI in clinical evaluation, and food chemical safety.
• Enforcement and inspection cadence thinning
  Domestic and foreign inspections unrelated to immediate safety risks are being deferred. Firms may temporarily see fewer routine inspection activities, though “for-cause” or emergency inspections will continue.

USDA: From Program Shutdowns to Market Blind Spots

• Widespread payment and service suspension persists
  USDA’s Farm Service Agency and Rural Development programs remain offline for new loans, disaster relief, and other support. Local offices continue to report minimal staffing, with some counties fully closed.
• Data and market reporting blackout enters second week
  The absence of NASS, WASDE, and ERS data continues to distort commodity markets and supply forecasting. Producers and traders are now operating without critical federal crop or export sales data for over a week.
• Impact on labeling, permitting, and animal health oversight
  Routine permit reviews, label evaluations, and certain veterinary biological product reviews within APHIS and CVB are delayed. Though user-fee–funded import/export activities continue, processing times are elongating.
• Regulatory timing shifts
  Several USDA rulemakings—especially those concerning organic standards, biotech labeling, and FSIS modernization—are effectively frozen, as Federal Register publication and interagency review processes are on hold.

Trade, Imports, and Border Coordination

• Cumulative port delays
  FDA, USDA, and CBP continue essential import screening, but many brokers are now reporting clearance times stretching to five or more days for FDA-regulated entries.
• Multi-agency coordination slowdowns
  Imports requiring joint oversight (e.g., food, feed, plant, or veterinary goods) face amplified delays. Even small documentation errors are now taking longer to resolve due to absent or furloughed staff in key program offices.
• Operational strain on fee-funded systems
  Some systems—such as APHIS eFile, FDA Unified Registration and Listing System (FURLS), and Prior Notice Center support—remain live but are functioning with reduced staffing, increasing response lag for technical support inquiries.

Less Visible but Significant Effects

Beyond the obvious disruptions, several “quiet” regulatory consequences are emerging:

1. Comment period extensions – Open rulemaking dockets are being automatically extended or temporarily frozen, delaying policy development across food, medical product, and veterinary sectors.
2. Federal Register publication backlog – No new proposed rules, guidance documents, or public notices can be published during the lapse, which pushes agency timelines weeks—if not months—past their original targets.
3. Paused grant reviews and research contracts – FDA’s Office of Regulatory Affairs (ORA) and certain CFSAN-funded food safety research programs are unable to issue new contracts or continue peer-review cycles.
4. Delayed FOIA and disclosure processing – With most legal and administrative staff furloughed, Freedom of Information Act requests are accumulating in backlog.
5. Litigation and enforcement timing shifts – DOJ and HHS litigation teams have begun requesting court-approved extensions for cases involving FDA, USDA, or EPA actions.

Together, these quiet delays reshape the regulatory landscape in ways that will persist long after the government reopens.

Recommendations for Industry

• Track and document regulatory deadlines – Note any open FDA or USDA dockets relevant to your operations. Comment periods and guidance timelines may be automatically extended.
• Monitor Federal Register for updates post-shutdown – Expect a surge in filings as agencies clear accumulated notices.
• Prepare for delayed inspections and correspondence – Once appropriations resume, inspections and enforcement communications will accelerate rapidly.
• Reevaluate launch and import timelines – Build additional time into your regulatory and supply planning.
• Maintain communication channels – Keep your industry and legal teams aligned on shifting deadlines, especially for submissions dependent on user-fee processing.

Outlook

At Day 8, the regulatory system remains operational in fragments but increasingly paralyzed in its policymaking and administrative functions. The visible shutdown of funding and staff is now coupled with invisible consequences—missed comment windows, unprocessed rulemakings, and deferred enforcement—that will complicate the months ahead.

FDA Atty continues to track these developments daily to provide clear guidance for clients navigating shifting submission, import, and compliance landscapes during and after the shutdown.