AFDO COVID-19 Situation Update
Special Edition

Links to most guidance documents and information in this communication can be found on the AFDO COVID-19 Resources Page at for ease of use on an ongoing basis. 
More than 3,131,500 people in the United States have been infected with the coronavirus and at least 133,000 have died, according to a New York Times database. This map shows where the number of new cases is rising and where it is falling in the last 14 days. See more at the New York Times website.

  • Source New York Times July 10, 2020  

See How All 50 States Are Reopening (and Closing Again)

All 50 states had begun to reopen in some way after the coronavirus thrust the country into lockdown starting in March. Now, a growing number of states are 
pausing plans to reopen, amid rising case counts. Several are reimposing restrictions they had lifted earlier — for example, Texas, which closed bars after a spike in cases.

See more at the New York Times website. Updated July 10, 2020.

What is New Today?
FDA Prepares for Resumption of Domestic Inspections With New Risk Assessment System

This morning, Commissioner of Food and Drugs for the FDA Stephen M. Hahn M.D. released plans for resuming domestic inspections.  The announcement follows and can be reviewed here on the FDA website

The U.S. Food and Drug Administration has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March. The White House Guidelines for Opening Up America Again are providing us a roadmap for optimizing operations and new work arrangements, as well as the Centers for Disease Control and Prevention (CDC) guidance for protecting workplace exposures to COVID-19 in non-healthcare settings.

Despite pausing on-site surveillance inspections in the U.S. in March, our investigators have conducted mission critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA requirements. We have had great success by using a number of tools as part of the agency’s risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements. As the COVID-19 pandemic continued, we adjusted our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitizer, diagnostic tests and more.

At the same time, we have been closely monitoring reopening criteria established at the federal, state or county levels and planning to identify when and where to resume domestic inspections, prioritizing the inspections based on risk and other factors.

To arm our investigators with the most reliable and accurate information, the FDA has developed a rating system to assist us in determining when and where it is safest to conduct prioritized domestic inspections. The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. We are also making the Advisory Level data available to our state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract.

The Advisory Level is based upon the outcome of three metrics: Phase of the State (as defined by the White House guidelines) and statistics measured at the county level to gauge the current trend and intensity of infection. When each of these is taken into consideration, the FDA will identify regulatory activities that can occur within the given geographic region. The three main categories of regulatory activity at the county level will be: mission critical inspections only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population and resumption of all regulatory activities.

At this time, we are working toward the goal of restarting on-site inspections during the week of July 20. However, resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area. Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation. The availability of these services will be an important factor in how we determine resuming domestic inspections.

The FDA has also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses. This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff are on-site to assist FDA staff with inspection activities. Due to the nature of retail tobacco inspections, these inspections will not be pre-announced when they resume, as they are undercover operations where the retailer is unaware an inspection is taking place.

The health, safety and well-being of our investigators, as well as the public, are of the utmost importance to us. We will ensure our investigators are outfitted with personal protective equipment and are equipped with other necessary equipment to carry out their work while adhering to state and local guidance as well as applicable CDC guidance. We will continue to work to ensure our prioritized domestic inspections resume appropriately and as safely as possible.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Coming Monday: FDA Release of the New Era of Smarter Food Safety Blueprint

Next Monday, July 13, 2020 at 1:00 PM EDT, FDA Commissioner Stephen M. Hahn, M.D., will release the agency’s plans to create a more digital, traceable and safer food system. We will forward details when we receive them but mark your calendar now. This will be a video message and can be found posted here starting at 1 p.m. EDT. 

Visit the New Era of Smarter Food Safety page on to hear remarks by Dr. Hahn and Deputy Commissioner Frank Yiannas, and to learn more about FDA’s plans to modernize its approach to food safety and reduce the number of foodborne illnesses. 

During his recent keynote for AFDO's World Food Safety Day event, Deputy Commissioner Frank Yiannas outlined the impact of COVID-19 on the Blueprint and talked about its impending release.
You can listen to that recording here. 

Worth Repeating...
AFDO Joins Nearly 350 Public Health Organizations in Supporting CDC Through Letter to Secretary Azar 

The expertise of the U.S. Centers for Disease Control and Prevention (CDC) and all public health agencies is critical to protecting Americans' health during the COVID-19 crisis, said a letter to Health and Human Services Secretary Alex Azar from 347 health and public health organizations released on Tuesday, July 7.

The authoring organizations, including AFDO, expressed "deep concern" about increasing reports of resistance to evidence-based public health messages and threats to public health leaders and agencies, and called on the Secretary to be an advocate for public health. Read the media release here. 

Many of the CDC's stakeholder calls are recorded and available on YouTube. 

Visit this YouTube channel here. 

FDA Releases Updates on Hand Sanitizers with Methanol

FDA is alerting consumers, employers, and health care professionals that additional hand sanitizer products have been added to the agency’s list of products with confirmed and potential methanol contamination. Consumers should check their hand sanitizer products to determine if a product is on this list. Methanol is not an acceptable ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. FDA is aware of reports of adverse events associated with hand sanitizer products, including those contaminated with methanol. FDA encourages health care professionals, consumers, and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program. (When reporting such events, please provide the agency with as much information as possible to identify the product) Read the FDA update here. 
Copyright © 2020 Association of Food and Drug Officials, All rights reserved.

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