FDA launches online portal for animal product export

New portal and electronic process will reduce amount of time it takes for manufacturer to apply for and receive export certificates.

Tim Lundeen, Editor

June 22, 2020

4 Min Read
FDA launches online portal for animal product export

The Food & Drug Administration’s Center for Veterinary Medicine (CVM) announced June 22 the launch of a new online system that will enable animal food, drug and device manufacturers to apply for, track and receive export certificates electronically for the first time.

FDA said it anticipates that the newly available electronic certificates will help facilitate exports by assisting the industry in fulfilling CVM's importing country requirements for certification of CVM-regulated animal products. The CVM Export Certification Application & Tracking System (eCATS) will also provide a tool for foreign governments to verify the authenticity of export certificates provided to them by the industry, the agency said.

According to the announcement, manufacturers exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA. FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory or marketing status based on available information at the time FDA issues the certificate.

The new portal and electronic process will reduce the amount of time it takes for a manufacturer to apply for and receive export certificates. Once an application determination has been made, the industry recipient will be notified electronically, and the recipient can access the export certificate at any time via the online system (CVM will continue to print and mail the "Certificate of a Pharmaceutical Product" to the industry).

FDA said the new tool will also simplify the process for applying for multiple certificates and enable foreign governments to verify the authenticity of a manufacturer’s export certificate via the website, enabling faster import processing. The new portal will also help FDA efficiently review the applications in a paperless environment and better track applications and export certificates that have been issued, the announcement said.

Previously, manufacturers of CVM-regulated products were required to submit a paper application via mail. Once the application was received, CVM would review the application and issue the resulting export certificate back through the mail.

Although CVM will continue to accept hard-copy applications, it is strongly encouraging the industry to utilize the new portal to apply for export certificates for faster processing and issuance of these documents. Industry applicants can create accounts and access the new portal starting June 22. Foreign government officials can also begin using the portal to verify certificates.

Manufacturers that have trouble completing the application or would like to submit an application in writing should contact [email protected]. For additional questions, users should refer to the CVM eCATS User Guide: Step-by-Step Instructions for Industry Applicants.

Improved trade

The American Feed Industry Assn. (AFIA) applauded the "long-awaited major milestone," noting that it will bring about improved trade for U.S. animal food products abroad.

The federal agency announced today that it will start issuing Current Good Manufacturing Practice (CGMP) certificates to animal food manufacturers looking to export feed, feed ingredients and pet food products, making it possible for facilities located across America to obtain these certificates for export where and if required and eliminating inconsistencies in state regulations.

“With an increasing number of international regulatory bodies requiring Good Manufacturing Practice certificates from manufacturers to document their compliance, it was imperative that the United States establish a mechanism for obtaining such a certificate. AFIA has been pushing for this process that will allow the continued flow of animal food products to our international buyers and stem the ongoing loss of millions of dollars in missed trade opportunities,” said AFIA president and chief executive officer Constance Cullman. “Thanks to the hard work of the staff at the FDA CVM, animal food manufacturers in all 50 states, not just the dozen states that already had processes for issuing GMP certificates, will have the ability to obtain these certificates.”

According to AFIA, Brazil has required GMP certificates for over a decade. Without a mechanism in place for a U.S. federal authority to issue GMP certificates, only manufacturers operating in 12 states with a state-based GMP certification program could export their products to Brazil. Inconsistencies across the state-issued certificates also caused confusion and highlighted the need for a federal program as more countries begin requiring certification.

Mexico, the feed industry’s largest export destination, is expected to implement a GMP certificate requirement soon, AFIA said, which noted that without this program, more than $1.6 billion in exports to Mexico would be at risk.

The Food Safety Modernization Act (FSMA) gave FDA the authority to issue and charge fees for export certificates for animal food; however, the agency opted to delay issuing the certificates until all-sized manufacturing facilities were required to be in compliance with FSMA’s CGMP regulations and could be inspected, AFIA said. As of last October, all-sized facilities must comply with these regulations and inspections are ongoing.

The CGMP compliance language will be added to the Certificates of Free Sale through CVM eCATS. Step-by-step instructions for submitting an application for a CGMP certificate into CVM eCATS are listed on FDA’s website, AFIA said.

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