Today it was announced that FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D. is retiring and Frank Yiannas, vice president of foods safety at Walmart, will join FDA as the Deputy Commissioner for Food Policy and Response.
FDA Commissioner Scott Gottlieb, M.D. made the announcement in an email to agency employees. Yiannas will have a different title than Ostroff’s, which is reflective of the reorganization at the agency—FDA will reportedly be creating a new office called the Office of Food Policy and Response. Yiannas will also reportedly take on the role of senior scientific advisor to Commissioner Gottlieb on issues related to food safety and supply chain.
Ostroff will retire in January 2019 and will assist in the transition of Yiannas into his new role at FDA.
Is the FDA Unified and Listing Systems (FURLS) system with its newly updated electronic Export Listing Module (ELM) a pathway to overseas markets or just one more regulatory hurdle that has been put in place by the U.S. government to impede export of U.S.-processed foods? A review of the new updates is needed to provide the answer to this question.
Regardless of the answer to this question, whether your company is already participating in this program or is looking for new markets outside the United States in countries that do not require the FDA listing of U.S. food companies, you must understand how the FURLS system works, how to electronically register and better understand the regulatory challenges of the importing country.
The FDA recently released a notification that their FDA Unified and Listing Systems (FURLS) system has been updated to include an Export Listing Module (ELM). This update allows U.S. food manufacturers to electronically submit, and for FDA to receive and process requests for inclusion on the export lists for FDA-regulated food products and present these lists to countries that require them, whether your company is already participating in this program or is looking for new markets outside the United States.
As background, the FDA has established and maintains export lists for countries that require some assurance that U.S. food manufacturers exporting to these countries, at a minimum, meet all applicable food safety regulations enforced by FDA. These lists, in an unofficial way, serve as a “certification” by the FDA, representing the U.S. government, that either included facilities have provided information to the FDA to assert they are in compliance with the importing country’s regulations and requirements or, more likely, that the U.S. food manufacturer is meeting the currently applicable U.S. laws and regulations.
Other options for U.S. food manufacturers that are interested or already exporting to countries that do not require the FDA lists, include the FDA’s export certificates, which give the agency’s official attestation concerning a product’s regulatory or marketing status. The fact that FDA has issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate. CFSAN issues “certificates of export” for seafood, food additives and food contact substances. CFSAN issues “certificates of free sale” for land food, dietary supplements, infant formula, medical foods and foods for special dietary use. U.S. firms wishing to apply for an export certificate for a food product may log in to FDA Industry Systems and submit an online application through the Certificate Application Process.
Need to learn more about supplier verification? TraceGains is here to help! Download our Foreign Supplier Verification Program Guidebook to learn the ins and outs of this complicated FSMA addition. TraceGains enlisted the help of Marc Sanchez, regulatory attorney specializing in FDA and USDA law, and Shawn Stevens, a global food safety lawyer, to provide insight and break down some of the confusion.
Back to the FDA list option. It is important to note that companies may request to be included on these lists at any time; however, updates to the lists are only published quarterly by the FDA. Additionally, final listing decisions are made by the competent authority of the importing country. This is to say, there can be a short or lengthy process between the time when FDA updates the list for a particular country and when that country formally accepts the updated list. Since there is no downside for a company to appear on one FDA list or many (lists maintained for each country), this potential delay in official acceptance of the list should drive U.S. food companies to apply to be on all of the country lists, before there is a specific need to do so. Remember the old adage, “When you are in a hurry, inevitably you end up standing in the slowest line.”
Market access for U.S.-manufactured dairy products to the EU, China and Chile, for example, are subject to these listing requirements in order to gain market access. Do ensure you have verified that your dairy product meets the standards and labeling requirements for the country to which you wish to export, as it is likely that a foreign country’s dairy product requirements will not necessarily be the same as what is found in the United States. Another example is that in order to export U.S.-manufactured collagen and gelatin products to the EU, companies must provide a laboratory report from an accredited, private laboratory demonstrating that the products comply with the established criteria. For exporters of U.S.-manufactured/processed seafood products to the EU or China, inclusion on the FDA-maintained list is required, as well as an export certificate which is provided by the National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program after FDA listing has been completed.
Finally, U.S.-manufactured infant formula exports to China are also subject to listing requirements. It should be noted that the China Certification and Accreditation Administration (CNCA) defines infant formula as food intended for children up to 36 months of age, known as “infant and young children formula”. This differs from the U.S. definition. Please be advised that CNCA requires new applicants to submit evidence of third-party certification of compliance with Chinese laws and regulations as part of the application process. CNCA also requires that infant formula manufacturers/processors submit an Establishment Registration Application with additional information to CNCA.
One of the most important keys to gaining access to overseas markets is to get your company enrolled on as many of these FDA lists as possible, obtain FDA certificates of free sale ahead of time, and make sure you update your information and keep it current within the various FDA electronic database systems.
Whether your company faces a foreign market access challenge via being a part of the FDA List or needing to get an FDA “Certificate of Free Sale” or just have questions related to moving product out of a U.S. port and into a foreign port, contact a reputable consulting firm for assistance.
The serious outbreaks over the past few months indicate that industry continues to experience “significant food safety problems”, said Stephen Ostroff, FDA deputy commissioner for foods and veterinary medicine at the IAFP annual meeting last week. He referred to the most recent sizable produce-associated outbreaks involving romaine lettuce, pre-cut melon and veggie trays, as well as the Kellogg Company recall of Honey Smacks cereal and the Rose Acres eggs recall, both of which were due to Salmonella. “We have a lot of work to do,” said Ostroff, adding that the numerous recalls involving kratom products is concerning.
These issues highlight how the increasingly complex supply chain further complicates problems once they arise. Ostroff emphasized the necessity of end-to-end tracing, from product origination to where the consumer can access the product, and that it needs to be efficient, standardized and rapid, especially for commodities. Regarding the E. coli O157:H7 outbreak involving romaine lettuce, FDA is still trying to determine the source and mode of the contamination. And while the recent finding of the outbreak strain in the irrigation canal water is important, it still does not answer the question of how the contamination got into the canal, said Ostroff.
The latest FDA update on the outbreak investigation stated that additional samples are being analyzed on an ongoing basis and any new matches would be publicly disclosed. As of June 28, the CDC announced that the outbreak was over.
Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.
According to an agency news release, the draft guidance will help facilities in the following areas:
“Determine whether they need a supply-chain program;
Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
Establish frequency of supplier verification activities;
Meet documentation and recordkeeping requirements; and
Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”
In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.
The FDA is accepting public comments on the draft for the next 180 days.
FDA has launched a new section of its Data Dashboard to help food importers, manufacturers and processors meet supply chain requirements put forth by FSMA (specifically FSVP, and the PC rules). The dashboard provides ease in finding compliance and enforcement information related to companies.
Do you trust your suppliers? What about your supplier’s suppliers? | Food Safety Supply Chain Conference | June 12–13, 2018 | Learn more“The Foreign Supplier Verification Programs rule requires importers to perform risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. One such activity is an evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety. The Preventive Controls rules require manufacturers/processors to perform supplier approval if the ingredient supplied contains a hazard requiring a supply-chain applied control. Supplier approval includes consideration of the supplier’s compliance with food safety laws and regulations.” – FDA
The agency also made improvements to its supplier evaluation resources page and added it to the dashboard so that companies can simultaneously search several databases. Users can search for information about warning letters, import refusal and import alerts.
Last week FDA announced a new web page that will house information for scientists and other parties that are interested in the agency’s Foods and Veterinary Medicine’s (FVM) research priorities, activities, reporting and tracking. The page has information about the Science and Research Steering Committee (SRSC), a science and research roadmap, and the FVM’s strategic goals—which includes food safety, nutrition, animal health and organizational excellence. Under food safety, the key initiative is to “Protect America’s Consumers and Animals From Foreseeable Hazards Across the Global Farm-to-Table Continuum”.
Eataly USA has recalled its Eataly Artichoke Spread due to undeclared walnuts. A customer who is allergic to walnuts suffered a “light” allergic reaction after consuming the spread.
“The customer declined to fill out the Eataly incident form and just wanted to bring the seriousness of what happened to our attention.” – FDA
After investigating further, it was discovered that the issue was caused by a temporary breakdown in the packaging process, FDA stated in a safety recall.
The product was distributed at the company’s popular New York City Eataly Flatiron location.
Rose Acre Farms has voluntarily recalled eggs from its farm in Hyde County, North Carolina following an investigation by FDA, CDC and other agencies involving Salmonella illnesses. FDA testing determined that eggs produced from this farm are connected to 22 cases of Salmonella Braenderup infections; the CDC is confirming illness information with state health departments.
The exact amount of eggs recalled totals 206,749,248.
The eggs are sold under several brand names, including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, and Sunshine Farms, as well as restaurants.
FDA is advising restaurants and retailers that they should not sell or use any recalled shell eggs. In addition, they should take measures to avoid cross-contamination of the food processing environment and equipment by washing and sanitizing display cases and refrigerators regularly, washing and sanitizing cutting boards, surfaces and utensils, and washing hands with hot water and soap after any cleaning or sanitation process. Consumers are advised not to eat the recalled eggs.
Stephen Ostroff, M.D. deputy commissioner for foods and veterinary medicine, sounds excited about the promise of blockchain. He also continues to enthusiastically wave the flag for whole genome sequencing (WGS) in solving foodborne illness cases. At the recent GMA Science Forum, Ostroff shared his usual update on incidents involving pathogens, agency progress in inspections and FSMA, and what the future holds.
The 2018 Food Safety Supply Chain conference features a Blockchain panel discussion | June 12–13 | Learn morePathogens
“There’s been essentially zero change in incidents of pathogens, and in some [cases there have been] increases—despite the fact that we’ve been doing quite a bit to improve the profile of food safety in the United States,” said Ostroff. This isn’t the first time that Ostroff pointed to the fact that foodborne illness is resistant to change, but he still emphasized the disappointment that industry is “way off” from the Healthy People 2020 target rate for pathogens established by the government. “None of these are close to where we thought we would be,” he said, referring to the government’s established target rates for Campylobacter, E.coli O157, Listeria, Salmonella, Vibrio and Yersinia.
Ostroff has previously pointed to improved diagnostics and surveillance systems as being partially responsible for a lack of improvement in the number of foodborne illness cases (due to higher detection rates), but during this particular presentation he brought attention to culture independent diagnostic tests (CIDTs)—which he said are having a “major impact on data collected in FoodNet.” CIDT is relatively new and is more rapid than the culture method, but it doesn’t allow for subtyping or antimicrobial resistance testing.
According to Ostroff, CIDTs have major implications for folks who work in food safety. The overall incidence of infection with foodborne pathogens is not decreasing, and the use of CIDTs makes assessment of trends difficult. CIDTs appear to be finding infections previously undiagnosed or unrecognized. In addition, they could affect the agency’s ability to monitor FSMA impact measures.
Inspections
The agency continues to look at inspection data from both the perspective of the number of inspections and their outcomes. During FY 2017, there were 1253 domestic and 146 foreign inspections. For FY 2018, there have already been 1610 domestic inspections to date.
Enforcement Discretion
In January, FDA issued new enforcement discretion for certain provisions in four FSMA rules. This included resolving issues related to the “farm” definition, requirements for food contact substances under FSVP, and certain written assurances in place for the Preventive Controls (human and animal) rule until FDA comes up with a practical solution to issues raised by stakeholders, Ostroff said.
Oversight of Food Imports
FDA continues to take a risk-based approach to FSVP and overseas inspections. Part of these efforts includes the agency’s systems recognition program where it looks at other mature food safety systems around the world to recognize countries that have programs similar to the United States. Thus far FDA has recognized Australia, Canada and New Zealand food safety systems; It is currently in the process of evaluating European Union members.
Intentional Adulteration Rule
The International Adulteration rule continues to be a hot topic of discussion, especially as it relates to associated costs. FDA is actively working on putting out a draft guidance that will discuss how to conduct vulnerability assessments, along with its interpretation of the rule, according to Ostroff. Part one of the draft should be out “in the very near future”, he said. He added that the agency is trying to be flexible with the rule and although food defense is an important component of food safety, companies should never do anything in the context of food defense that could pose a food safety risk.
Whole Genome Sequencing
WGS provides more precise identification at a genetic level and helps expedite recognition and response time for nearly all current foodborne illness and outbreak investigations. “It’s the new normal—it’s here and it’s here big time,” said Ostroff, adding that the GenomeTrakr network has more than 167,000 isolates sequences in the database and is becoming more and more powerful. “It’s amazing what this tool can do,” he said, citing two recent cases involving strains of Salmonella in papayas and kratom.
Blockchain
“I think blockchain can be really transformational in the world of food safety,” said Ostroff, calling it “traceability on steroids without question”. He thinks the technology could also be useful in addressing food fraud and economically motivated adulteration, and provide more consumer transparency. Right now the FDA is looking very closely at blockchain in context of traceability and FSMA.
Earlier this week the FDA ordered a mandatory recall for all Triangle Pharmanaturals food products that contain powdered kratom as a result of Salmonella contamination. The mandatory action was issued because the company “refused to cooperate with FDA despite repeated attempts to encourage voluntary recall,” FDA stated in a release.
For more than a month, FDA has been investigating a multistate outbreak of Salmonella infections that were linked to products containing kratom, a plant native to Thaland, Malaysia, Indonesia and Papua New Guinea. Over this period of time, there have been several voluntary recalls by companies that provide products containing kratom: PDX Aromatics, Tamarack, Inc., and NutriZone LLC. All of these recalls were due to positive Salmonella product sample results.
Triangle Pharmanaturals, however, was not responsive to FDA’s requests to issue a voluntary recall, even after samples of products manufactured by the company tested positive for Salmonella. “In the course of investigating a multi-state outbreak of salmonella infections linked to kratom products in conjunction with local officials, FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings,” FDA stated.
“Under the FDA Food Safety Modernization Act, the FDA has the authority to order the recall of certain food products when the FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.” – FDA
As of March 14, the CDC reported that 87 people were infected with outbreak strains of Salmonella in 35 states; 27 people have been hospitalized. And as of April 2, 26 different kratom-containing products have tested positive for Salmonella.
FDA is advising consumers to avoid kratom and all kratom-containing products, which have been sold in several forms, including leaves, tea, pills, capsules and powder. “There is no FDA-approved use for kratom and the agency has received concerning reports about the safety of kratom, including deaths associated with its use,” the agency stated.
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