FSMA has many tentacles and impacts multiple parts of the food industry. This latest FDA guidance about refusing FDA inspections is another part of that, and is important in relation to controlling your supply-chain risks. In this situation, it is more about safeguarding the continuation of the ability for your foreign supplier to sell to you, rather than you having to approve the suppliers. So, to get to the details, one of the new authorities granted to FDA by FSMA is the right to disallow the import of food into the U.S. if the foreign establishment that produced the food refuses an FDA inspection. And that “refusal of inspection” doesn’t just mean not answering FDA’s knock, it means anything from not responding to FDA’s request within 24 hours, to agreeing to an inspection start date then requesting a later date without reasonable explanation, to a foreign government not allowing the FDA investigator into the country. While the foreign facility can later ask FDA to reschedule the inspection, it could be at least a year before FDA can return. The agency said that while it will attempt to reschedule as soon as possible, it needs to weigh and consider factors such as current inspection priorities, personnel availability, U.S. Travel Warnings and Alerts, and coordination with the foreign government. To provide the industry with information and explanation of foreign inspection refusals and consequences, FDA issued draft guidance last week on Refusal of Inspection by a Foreign Food Establishment or Foreign Government.Following are the key points. What is considered to be a refusal of inspection? Although FDA is not required to pre-announce its inspections, it generally will coordinate inspections of foreign food establishments with both the facility and the foreign government to facilitate the process and ensure that records and personnel will be available. As such, FDA considers refusal of inspection to be any statements, actions, or passive behaviors that prevent or delay it from scheduling or fully conducting an inspection; or are intended to avert inspection or mislead or deceive the FDA investigator. As discussed in the guidance, FDA considers an owner, operator, or agent in charge of a foreign food establishment to have not permitted or refused an inspection if he or she: Does not respond within 24 hours of having received an FDA inspection request by email, fax, or mail, based on documentation of delivery. (FDA may consider delays when known, such as the location in an area with limited access to mail or Internet.) Stops communicating with FDA after initially responding to the request to schedule an inspection. Provides an incomplete or inaccurate response (e.g., claiming it is not operating or does not ship food to the U.S.). Rejects FDA’s scheduling attempt by not agreeing to a date without reasonable explanation. Agrees to a start date then requests a later date without reasonable explanation or documentation of an unforeseen situation which caused the facility to be closed (e.g., severe weather). Prevents the inspection by refusing FDA’s entry on the scheduled dates, establishing unreasonable preconditions, causing delays before or after the inspector’s entry, or interfering with full completion of the inspection. (The guidance provides some specific examples of these) Additionally, a foreign government is considered to have to caused refusal of inspection if it: Does not allow FDA to schedule an inspection as requested or suggest a reasonable alternative date or time frame. Causes a delay that prevents FDA from scheduling an inspection in a timely manner without a reasonable explanation. Does not allow an FDA investigator to enter the country or remain for the inspection without a reasonable basis for the restriction or suggesting a reasonable time frame for its removal (e.g., denying a visa for the FDA investigator). Prevents the FDA investigator from entering the establishment or imposes a condition that delays or prevents the inspection. Causes other unreasonable delays (e.g., making the investigator wait in a room for an unreasonable period of time for access to documentation or a responsible individual, or not allowing access to an operational area until a future date or time). What are the consequences of refusal of inspection? FDA’s related Import Alert (99-32) includes a “Red List” of foreign food establishments for which inspection has been refused. If your facility (or supplier’s facility) is on the Red List, admission into the U.S. will be refused. The facility will remain on the Red List until an inspection is conducted. So, to be removed from the list, the owner, operator, or agent in charge should request and permit an FDA inspection – which, as noted above, could put the facility’s imports on hold for a very long time if the inspection doesn’t fit into FDA’s schedule. What if it is the foreign government that caused the refusal? When the foreign government indicates it will refuse to allow inspection of one or more food facilities in that country, FDA will advise that government of its authority to refuse admission of the food(s) into the U.S., its intention to list the establishment(s) on the Red List, and the impact of that action. If the foreign government continues to refuse multiple requests, FDA will ask the government if that refusal applies to all establishments in their country, and, if so, FDA may Red List all that country’s food facilities, advising the government and food establishment that the facilities will only be removed when the government provides it with written notification that it can schedule and inspect the establishment. The reason that the topic of “refusal of inspection” is important for the food industry is because you need to alert your suppliers to the importance of not refusing an FDA inspection. We suggest that you prepare a memo to suppliers informing them of this, so they are, at least, aware of the consequences of a refusal of inspection. It has been our impression at TAG that many foreign suppliers really don’t understand the impact of FSMA. So, making sure that they don’t find themselves on a 12-month import alert could be critical to protecting your supply chain integrity as well as their business. 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. Learn more at: www.AchesonGroup.com
