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On April 18, 2016, the U.S. Food and Drug Administration (FDA) issued a new Import Alert for “Aquacultured Shrimp and Prawns from Peninsular Malaysia Due to Presence of Drug Residues from Unapproved Animal Drugs or the Presence of Unsafe Food Additives (Import Alert 16-136).”  FDA testing revealed that approximately one-third of shrimp and prawn imports from peninsular Malaysia contained residues of nitrofurans and/or chloramphenicol.  This is an alarming amount, considering that Malaysia was one of the top 10 suppliers of shrimp and prawns to the United States in 2014.

FDA considers prolonged exposure to Nitrofurans and chloramphenicol as a risk to human health. Both drugs are carcinogens, and use of the drugs in animals may contribute to antimicrobial resistance.  Shrimp or prawns containing nitrofurans and/or chloramphenicol are considered adulterated.

The Import Alert means that all shipments of shrimp and prawns from peninsular Malaysia (with the exception of Sabah and Sarawak) are subject to Detention Without Physical Examination (DWPE) upon arrival to the United States.  According to FDA, “the owner or consignee of the affected goods should provide the results of a private laboratory analysis of a representative sample(s) collected from the affected article as evidence that the product does not bear or contain any nitrofuran or chloramphenicol residues” in order to secure release of a shipment detained under this Alert.

There are multiple pre-existing alerts similar to Import Alert 16-136, such as Import Alert 16-129 for “Detention Without Physical Examination of Seafood Products Due to Nitrofurans.”  Records indicate that this Import Alert has been around since at least 2009.  So why would FDA create a new Import Alert for virtually the same issue?

Essentially, the existing Import Alerts require that a facility be specifically found to be shipping adulterated products in order to be added to the “Red List” of those alerts. With this new alert, however, the prevalence of violation from peninsular Malaysia provides FDA with evidence to believe that all manufacturers from that region appear violative. As a result, all Malaysian companies exporting shrimp and prawns to the United States will find their shipments stopped by FDA, and they will need to submit evidence of compliance for each shipment in order for the products to be released into the US.

Food facilities in Malaysia that export shrimp or prawns to the United States can petition FDA for exemption (also known as being put on the “Green List“) from Import Alert 16-136.  The petition process is lengthy, as it requires documentation of corrective actions or preventive measures, proof of approximately five to twelve compliant shipments, and a written petition.  Registrar Corp’s Import Alerts Department can guide facilities through the Import Alert petition process, including organizing the petition and submitting it to FDA.

For assistance with FDA Import Alerts, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-Hours a day at www.registrarcorp.com/livehelp.

         

On April 25, 2016, the U.S. Food and Drug Administration (FDA) hosted a webinar on the agency’s final rule for Sanitary Transportation of Human and Animal Food.  The rule aims to prevent contamination of food during transportation by establishing requirements for covered businesses to use sanitary transportation practices.  Published on April 6, 2016, the Sanitary Transportation rule is the sixth major rule to be finalized under FDA’s Food Safety Modernization Act (FSMA).

Who is Covered?

Those covered by the Sanitary Transportation rule include shippers, loaders, carriers, and receivers of human and animal food transported by motor or rail vehicle within the United States.  This is true even if the food does not enter interstate commerce.  The rule does not apply to transportation by ship or air due to limitations laid out in the law.

There are some exemptions to the Sanitary Transportation rule.  Examples include:

  • Transportation activities performed by a farm
  • Transportation of food that is transshipped through the United States to another country
  • Transportation of food that is completely enclosed by a container, except a food that requires temperature control for safety
  • Transportation of food located in facilities regulated exclusively by the U.S. Dept. of Agriculture

FDA also intends to publish waivers that would exempt certain groups from the Sanitary Transportation rule. See FDA’s Sanitary Transportation Fact Sheet for a complete list of exemptions and intended waivers.

Key Requirements

The Sanitary Transportation rule requires vehicles and transportation equipment to be designed and maintained so that the food they transport remain safe.  For example, they must be adequately cleanable and capable of maintaining temperatures necessary for the safe transport of food.  The rule also requires that measurements be taken to ensure food is not contaminated by other food or non-food items (raw food, foods containing allergens, or pests, for example).  Shippers, loaders, carriers, and receivers must develop written procedures detailing how they will ensure the safe transportation of food according to their specific requirements under the rule.

In some cases, one responsible party, such as the shipper, can sign their responsibilities over to another party, such as the carrier, in a signed statement of consent.  When a shipper and carrier agree that the carrier is responsible for sanitary conditions during transport, the carrier personnel must be trained in sanitary transportation practices. As with other rules under FSMA, records relating to any activity performed under the rule, including training and any written procedures, must be properly maintained.

Compliance Dates

Most covered businesses are required to comply with FDA’s Sanitary Transportation rule by April 6, 2017 (one year after the rule’s publication).  Small businesses have one additional year to comply.  For purposes of this rule, FDA defines small businesses as “businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts.”

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations, including new requirements under FSMA.  If you have questions about FDA’s Sanitary Transportation rule or any other FSMA rules, contact Registrar Corp at +1-757-224-0177.  Live help is available 24 hours a day at www.registrarcorp.com/livehelp.

         

It’s now easier than ever for global sourcing and compliance departments to find and document the FDA compliance status of current and prospective suppliers.  Registrar Corp’s FDA Compliance Monitor has new easy-to-use filters that allow users to filter suppliers’ compliance statuses by FDA Inspection Classifications, Warning Letters, Import Alerts, and Import Refusals.

The filters also facilitate documentation and compliance reporting requirements of FDA’s new Preventive Controls and Foreign Supplier Verification Program (FSVP) rules.  These rules require FDA-registered food facilities and importers of food and beverages to monitor and document the compliance statuses of each of their suppliers. Users can utilize the filters to craft custom compliance reports and print them at any time from their Compliance Dashboard.  For example, a user could create a report of all of their suppliers that are subject to an FDA Import Alert to minimize the probability of costly detentions.

Registrar Corp is an FDA consulting firm that helps businesses comply with U.S. FDA regulations. Registrar Corp’s FDA Compliance Monitor is a powerful quality assurance and compliance tool that allows users to monitor the FDA Compliance Status of current and prospective suppliers.

Try the FDA Compliance Monitor free for 60 days (no credit card required).

Learn more about Registrar Corp’s FDA Compliance Monitor.

         

On November 27th, 2015, the U.S. Food and Drug Administration (FDA) published a final rule establishing the Foreign Supplier Verification Program (FSVP), one of the seven major rules of FDA’s Food Safety Modernization Act (FSMA).  FSVP regulations place new responsibilities upon importers to verify that the food they import into the United States has been produced in a manner that meets US safety standards.  Importantly, the “food” that is covered by this final rule includes not only food for consumption and food additives, but also:

  • Food contact substances (FCSs), and
  • Substances that have both food and non-food uses, if the substance is reasonably likely to be directed to a food use.

What are Food Contact Substances?

FDA defines a food contact substance as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in the food.”  Examples of FCSs include polymers, can coatings, and sealants for lids.  An FCS is a single substance used to compose a Food Contact Material (FCM).  FCMs are then used to create Food Contact Articles, such as films, bottles, trays, etc.

What does this mean for importers?

U.S. importers of food contact substances will be required to monitor the manufacturers of the FCSs for compliance with FDA regulations and create verification programs for each FCS they import. The compliance date for most importers is May 27th, 2017 (18 months from the publication date of the rule).

In March 2016, FDA hosted a public meeting focused on FSMA’s provisions as they relate to importers. During the public comment session, there were several exchanges regarding the relationship between FCSs and FSVP.  FDA officials reiterated that FCSs did indeed fall under FSVP and revealed an interesting piece of information: FCSs are not covered by existing equivalency agreements, such as the one reached with New Zealand and those currently in the works for Australia and Canada.  Furthermore, FCSs will not qualify for the Voluntary Qualified Importer Program (VQIP).

Registrar Corp will inform industry as more information becomes available on the regulation of FCSs under FSVP.  It is prudent for importers to understand the FSVP regulations that apply to the products they import.  Assessing requirements under FSVP and starting the compliance process early may save you from costly mistakes later on.

Registrar Corp’s FDA Compliance Monitor allows importers to monitor their suppliers for Import Alerts and Warning Letters as required by FSVP.  For assistance determining what FSVP requirements apply to the products you import and how Registrar Corp can help you comply, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-Hours a day at www.registrarcorp.com/livehelp.

         

All food facilities that manufacture, process, pack, or store food, beverages, or dietary supplements for consumption in the United States are required to register with the U.S. Food and Drug Administration (FDA). According to a Freedom of Information Act (FOIA) request obtained by Registrar Corp, there were 207,655 food facilities registered with FDA as of January 1, 2016. Of those registered food facilities, 120,822 were located outside of the United States. See the number of registrations by country here.

fda, food facility registration

The ten countries with the largest number of FDA registered food facilities remain the same in 2016 as those reported in 2015:
1. United States (86,773)
2. Japan (13,941)
3. France (10,450)
4. Italy (10,125)
5. China (9,667)
6. Mexico (9,575)
7. Canada (6,690)
8. Spain (4,688)
9. Republic of Korea (3,921)
10. India (3,455)

The 207,655 registered facilities reported in the FOIA request is significantly lower than the 300,539 registered food facilities FDA reported on the agency’s Food Facility Registration Statistics page on February 4, 2016. According to FDA, this is because facilities that engage in more than one activity (manufacturing, labeling, etc.) are recorded multiple times on FDA’s website, thus leading to inflated registration numbers.
Registrar Corp’s 2016 FOIA request shows a 24% increase in registrations since 2015. From 2014 to 2015, however, the firm’s data showed a 14% decrease in registrations. According to FDA, there was also a large drop in the number of registered facilities from 2012 to 2013 due to facilities failing to renew their registration during FDA’s biennial renewal period.

Registrar Corp expects this pattern to continue: an increase in registrations from odd to even years, and a significant decrease from even to odd years. This is because many facilities are unaware of or forget about FDA’s biennial registration renewal requirement, a requirement established under the Food Safety Modernization Act (FSMA) in 2011. Under FSMA, food facilities must renew their FDA registrations each even-numbered year between October 1 and December 31. The first registration renewal period occurred in 2012. The next registration renewal period will begin on October 1, 2016.

Registrar Corp is an FDA consulting firm headquartered in Hampton, Virginia, USA with 19 regional offices around the world. The firm can help you determine whether your facility must be registered with FDA and verify whether your food facility has a valid FDA registration at no cost. Registrar Corp can also register facilities and renew registrations with FDA as well as provide Certificates of Registration that may be used to ensure buyers that your registration is valid. For more information about FDA registration requirements, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

This blog was originally published as a press release.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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