On March 18, FDA hosted a stakeholder call to discuss food safety and food supply questions related to Coronavirus Disease 2019 (COVID-19). Key points from the call, as detailed by The Acheson Group, include:
- There is no evidence of foodborne transmission of COVID-19.
- There are no shortages of food in the food supply.
- If you are in the food and agriculture sectors, you are considered critical infrastructure.
- In addition to “postponing most foreign facility inspections through April,” FDA has also “temporarily postponed all domestic routine surveillance facility inspections.” Those that are “for cause” and/or “mission-critical” will proceed. (See below for more information.)
- The majority of FDA inspections will be announced.
Listen to a recording by of the full briefing by calling toll free 866-463-4971. There is no passcode. The recording will be available until March 18, 2021 10:59 PM (CT). Or download an audio file from FDA.
FDA also is maintaining a regularly updated webpage on COVID-19 with sections on What’s New, FAQs, New Guidance, Events, and other information.
FSVP Temporary Policy Guidance. In FDA’s new guidance on its intention to temporarily not enforce supplier verification onsite audit requirements for receiving facilities and importers under FSMA in response to the COVID-19 pandemic, the agency stated that it does not intend to enforce the onsite audit requirements if other supplier verification methods are used instead.
With governments across the globe instituting travel restrictions and advisories in an effort to curb the spread of COVID-19 the ability of receiving facilities and FSVP importers to conduct or obtain onsite audits of their suppliers is greatly impacted. Therefore, the guidance outlines the circumstances under which FDA does not intend to enforce the requirement to conduct or obtain an onsite audit of a food supplier when the food supplier is in a country or region covered by a government travel restriction or advisory related to COVID-19.
Specifically, FDA does not intend to enforce the requirement for an onsite audit in the following circumstances:
- A receiving facility or FSVP importer has determined that an onsite audit is the appropriate verification activity for an approved supplier, as reflected by its written food safety plan or FSVP;
- The supplier that is due for an onsite audit is in a region or country covered by a government travel restriction or travel advisory related to COVID-19;
- Because of the travel restriction or travel advisory, it is temporarily impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite audit of the supplier; and
- The receiving facility or FSVP importer temporarily selects an alternative verification activity or activities, such as sampling and testing food or reviewing relevant food safety records, and modifies its food safety plan or FSVP to incorporate the alternative activity or activities. The alternative verification activity or activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control (or, for FSVP, the hazard that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
FDA anticipates that receiving facilities and FSVP importers will resume onsite audits within a reasonable period of time after it becomes practicable to do so, and update their food safety plans and FSVPs accordingly. FDA intends to provide timely notice before withdrawing this policy.
Editor's note: In its recent Fumigants & Pheromones enewsletter, Insects Limited included its annual list of the Top 15 Clothes Moth Cities in the U.S.
For 2019, the top four cities for clothes moth remain unchanged; New York City, Boston, Philadelphia and Los Angeles. Minneapolis inched up two spots to grab the final spot in the top five. The state of Texas made big leaps this year as Dallas moved up considerably, and Houston joined the list while Atlanta dropped off.
Eastern Seaboard. The Eastern Seaboard again owns the top three spots on this list with NYC, Boston and Philadelphia highlighting those spots.
Other cities. Los Angeles remained steady at the No. 4 spot. Denver tied with Dallas by moving up four spots from 13th to 9th. Washington DC was the biggest mover overall on the list, dropping from the 5th spot to the 12th. Chicago moved up from 8th to 6th.
Texas. Moth populations in Texas look like they are on the rise with Dallas moving from 11th to 7th on the list and Houston coming out of nowhere and moving right into the 11th spot.
Webbing clothes moth, Tineola bisselliella, appear to continue to be on a rapid rise in many metropolitan areas. Research has suggested that the webbing clothes moth does not come into our homes and businesses from natural reservoirs (E.g. bird nests, dead animals) but instead travels from person to person1.
This type of behavior is called synanthropic, which means the clothes moths benefit from an association with humans and the habitats that humans create. As we pass along our wool rugs, blankets, sweaters, fur coats and feather pillows, etc. to family members, friends or other means of trade, we also move the moths from location to location. The densely populated northern portion of the Eastern Seaboard (Maine to Washington DC) again accounted for over 70% of the clothes moth sales for the entire country. As people move about the country, they carry the clothes moths with them, so even if your city isn’t on this list now, be prepared because they still might be coming your way soon!
In response to the COVID-19 outbreak, FDA has postponed most foreign inspections through April. Inspections outside the U.S. deemed
FDA based the decision on the State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees; CDC travel recommendations; access restrictions being imposed on foreign visitors by certain countries; guidance from the Office of Personnel Management; and the importance of the health and safety of its employees. “Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods,” the FDA statement said, adding, “We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”
As an interim measure, FDA is employing additional tools to ensure the safety of products imported to the U.S., including denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition, and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. FDA exercised this authority when it postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak.
FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. The agency also has the ability through our risk-based import screening tool (PREDICT) to focus its examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak. FDA also is keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. The agency can refuse admission of products that fail sample testing or may violate other applicable legal requirements.
As this remains a dynamic situation, the agency will continue to assess and calibrate its approach as needed to help advance federal response efforts in the fight against this outbreak.