The FDA’s Center for Veterinary Medicine (CVM) has launched 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.
The federal agency announced 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.
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 (CPP) to industry).
This 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 the FDA to efficiently review the applications in a paper-less environment and better track applications and export certificates that have been issued.
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.
The American Feed Industry Association (AFIA) applauded the agency for achieving a long-awaited major milestone that will bring about improved trade for U.S. animal food products abroad.
“With an increasing number of international regulatory bodies requiring Good Manufacturing Practice certificates from manufacturers to document their compliance, it was imperative that the U.S. establish a mechanism for obtaining such a certificate," says AFIA’s President and CEO Constance Cullman. “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. 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.”
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. Without this program, over $1.6 billion in exports to Mexico would be at risk.
The Food Safety Modernization Act (FSMA) gave the 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. As of last October, all-sized facilities must comply with these regulations and inspections are ongoing. Once all facilities were in compliance, AFIA sent a letter last fall urging the FDA to move forward on this process.
The CGMP compliance language will be added to the Certificates of Free Sale through the CVM’s Export Certification Application and Tracking System (CVM eCATS). Step-by-step instructions for submitting an application for a CGMP certificate into CVM eCATS are listed on FDA’s website.
Although CVM will continue to accept hard copy applications, CVM strongly encourages 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.
For questions, contact CVM.
