FDA Releases Final Guidance for Voluntary Qualified Importer Program

The U.S. Food and Drug Administration is announcing final guidance for industry for a voluntary, fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security. The final guidance is in question-and-answer format to explain how this program will work.

In particular the document address the following points:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

The Food Safety Modernization Act (FSMA), indeed, required FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified in accordance with FDA’s program for Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (see FDA’s third-party certification regulations at 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

Speaking of benefits for companies, they will be the following:

• FDA will expedite entry into the United States for all foods included in an approved VQIP application (VQIP foods). FDA will set screening in its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening system to recognize shipments of food which are the subject of an approved VQIP application to expedite the entry of such food. The system is designed to recognize the information and release the shipment immediately after the receipt of entry information, unless examination and sampling are necessary for public health reasons. (See Question A.5.)

• FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk-based microbiological samples, and to audit VQIP. (See Question A.5.)

• In the examination and/or sampling circumstances identified in the previous bullet, FDA will attempt, to the extent possible, to examine an entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If exportation is warranted, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export from the port preferred by the importer.

• FDA will expedite its laboratory analysis of “for cause” or audit samples of VQIP entries, to the extent possible in accordance with public health priorities.

• FDA will maintain a VQIP Importers Help Desk dedicated to responding to questions and resolving issues raised by VQIP importers about VQIP food and this guidance document. The VQIP Importers Help Desk will be available for assistance with completing the VQIP application and facilitating review of VQIP food that does not receive an immediate release.

• FDA will post a publicly available list of approved VQIP importers on FDA’s VQIP Web page. VQIP importers may choose not to be listed on the VQIP importers list. A VQIP importer’s decision to opt out of being listed on the publicly available list of approved VQIP importers will not have any effect on its participation.

Additional Information

 

Food recalls in EU – Week 8/2016

Last week on EU RASFF (Rapid Alert System for food and feed) we can find the following relevant notifications:

1. Alerts followed by a recall from consumers:

  • Listeria monocytogenes (presence CFU/g) in organic falafel nuggets from the Netherlands, following an official control on the market. Notified by Netherlands, distributed also to Belgium, France, Ireland, Spain and United Kingdom;
  • Mercury (1.18 mg/kg – ppm) in frozen blue shark slices (Prionace glauca) from Spain, following company’s own check. Notified by Italy;
  • Salmonella (presence/25g) in raw milk brie cheese from France, following company’s own check. Notified by France, distributed also to Austria, Czech Republic, Germany and Spain;
  • Salmonella Kentucky (present) in dried parsley from Egypt, following an official control on the market. Notified by Germany, distributed also to Belgium, Finland, France and Netherlands;
  • Traces of milk (casein 0.03 mg/item) in frozen fish gratin from Sweden, with raw material from Denmark, following company’s own check. Notified by Sweden, distributed also to Norway:
  • Undeclared milk ingredient in swiss rolls from Spain, following an official control on the market. Notified by United Kingdom, distributed also to Italy and Portugal;
  • Undeclared mustard and celery in spice mix from Sweden, following company’s own check. Notified by Sweden, distributed also to Finland, Norway and Denmark.

2. Information for attention/for follow up followed by a recall from consumers:

3. Alerts followed by a withdrawal from the market:

  • Listeria monocytogenes (570 CFU/g) in frozen smoked trout from Turkey, via Bulgaria, following an official control on the market. Notified by Netherlands;
  • Mercury (1.845 mg/kg – ppm) in frozen swordfish loins from Vietnam, via Belgium, following an official control on the market. Notified by Czech Republic, distributed also to Denmark, Hungary, Poland, Romania and Slovakia;
  • Plastic fragments in candy bars from the Netherlands, following company’s own check. Notified by Netherlands, distributed also to (see links embedded to reach some of the press release-public warning): Albania, Algeria, Andorra, Angola, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faeroe Islands, Finland, France, Germany, Ghana, Gibraltar, GreeceHong Kong, Hungary,  Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Jordan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Madagascar, Maldives, Malta, Mauritius, Monaco, Morocco, Nepal, New Caledonia, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Tunisia, Turkey, Ukraine, United Arab Emirates, United KingdomWest Bank and Gaza Strip;
  • Unauthorised substance yohimbine in and insufficient labelling of food supplement from the United States, via Sweden, following an official control on the market. Notified by Norway;
  • Unauthorised substance yohimbine in food supplement from the United States, following an official control on the market. Notified by Norway, distributed also to Sweden.

4. Seizures:

5. Border rejections:

Country of notification Countries concerned Subject Action Taken
Italy Italy, United States (O) aflatoxins (B1 = 10.4; Tot. = 11.6 µg/kg – ppb) in shelled almonds from the United States re-dispatch
Ireland Ireland, Pakistan (O), United Kingdom aflatoxins (B1 = 15.7; Tot. = 16.4 µg/kg – ppb) in spice mix from Pakistan official detention
Italy China (O), Italy aflatoxins (B1 = 5.3; Tot. = 6.5 µg/kg – ppb) in shelled peanuts from China  
Italy Egypt (O), Italy aflatoxins (B1 = 92; Tot. = 107 / B1 = 5.1; Tot. = 5.9 µg/kg – ppb) in groundnuts from Egypt placed under customs seals
Germany Germany, Turkey (O) aflatoxins (Tot. = 51.3 µg/kg – ppb) in roasted pistachios and almonds from Turkey import not authorised
Belgium Belgium, Gambia (O) benzo(a)pyrene (7 µg/kg – ppb) in smoked sardinella (Sardinella spp.) from the Gambia import not authorised
Italy India (O), Italy cadmium (2.6 mg/kg – ppm) in frozen squid chunks from India import not authorised
United Kingdom South Korea (O), United Kingdom cadmium (2.9 mg/kg – ppm) in frozen squid (Nototodarus spp.) from South Korea import not authorised
United Kingdom Laos (O), United Kingdom, Vietnam high count of Escherichia coli (1000 CFU/g) in praew leaves (Vietnamese coriander – Polygonum odoratum) from Laos, via Vietnam destruction
Italy Italy, Thailand (O) mercury (0.11 mg/kg – ppm) in pet food from Thailand import not authorised
Italy Commission Services, Italy, Portugal, Vietnam (O) prohibited substance nitrofuran (metabolite) nitrofurazone (SEM) (1.43 µg/kg – ppb) in frozen pangasius fillets from Vietnam import not authorised
Greece Greece, India (O) Salmonella (in 1 out of 5 samples /25g) in hulled sesame seeds from India import not authorised
United Kingdom Laos (O), United Kingdom, Vietnam Salmonella (in 4 out of 5 samples /25g) and high count of Escherichia coli (620 CFU/g) in frozen perilla (Perilla frutescens) from Laos, via Vietnam destruction
Italy Italy, Vietnam (O) too high level of overall migration (141 mg/kg – ppm) from nitrile gloves (food contact materials) from Vietnam re-dispatch
Poland Japan (O), Poland unauthorised colour Rose Bengal in marinated bamboo shoots from Japan destruction
United Kingdom Thailand (O), United Kingdom unauthorised substance carbofuran (0.01 mg/kg – ppm) in aubergines from Thailand destruction
Italy India (O), Italy unauthorised substance propargite (0.29 mg/kg – ppm) in green tea from India placed under customs seals

(Source: RASFF Portal)