ARLINGTON, VIRGINIA, US — The US Food and Drug Administration (FDA) will start issuing Current Good Manufacturing Practice certificates to animal food manufacturers, which the American Feed Industry Association (AFIA) said will improve trade for US animal food products.
The AFIA applauded the FDA for the long-awaited major milestone. Now, manufacturers looking to export feed, feed ingredients and pet food products can obtain these certificates for export where and if required, 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,” said Constance Cullman, president and chief executive officer of the AFIA. “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 US 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, the 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.