Focus on Regulatory: Bridging the Regulation Gap
April 24, 2009
The AFIA's Safe Feed/Safe Food program has been certifying American feed facilities for nearly five years, but a new international version of the program will certify that plants meet European regulations, as well.
American feed and food companies pride themselves as being providers of some of the highest quality, safest products in the world. Feed associations, such as the American Feed Industry Association, have played a role in encouraging and helping their members follow the regulations set forth by the USDA and FDA through the development of third-party certification programs.
In today’s global economy, however, it’s not enough to meet only U.S. regulations. That’s why the AFIA has teamed with the FEFANA, the Feed Additives and Premixtures Association of the European Union, to allow auditors of AFIA’s third-party certification program, Safe Feed/Safe Food, to inspect U.S. manufacturers for compliance with European feed hygiene and ingredient standards. The agreement will facilitate trade between U.S. and European feed and ingredient customers.
Under the agreement, the European Feed Additives and Premixtures-Quality System, or FAMI-QS, which is FEFANA’s quality and feed safety program, will train Facility Certification Institute auditors on FAMI-QS requirements. The AFIA will do the same for FAMI-QS, since the program has similar components. The AFIA will be accepting enrollment applications for this international version of the SF/SF program in the months to come.
In the wake of the recent peanut recall that sickened hundreds and killed nine, consumers are becoming more aware of where food comes from, and seek assurance that their food supply is safe. It is no different for feed manufacturer customers.
“Companies tell us more and more that their customers are asking for proof of compliance with FDA regulations,” says Richard Sellers, AFIA vice president of feed regulation and nutrition. “AFIA’s Safe Feed/Safe Food Certification Program does that and more.”
By successfully completing inspections, SF/SF certified members can give their customers proof that their feed meets the standards and regulations set forth by the FDA.
“An SF/SF inspection consists of 10 sections. Each section has a number of items that clearly identify possible areas of feed safety and what the inspector is required to determine if the facility is to be SF/SF-certified,” says Keith Epperson, AFIA vice president of manufacturing and training.
The 10 sections are: Policy Management and Documents and Records; Human Resources and Training; Facility Planning and Control; Manufacturing and Processing; Monitoring Devices, Infrastructure-building Equipment and Grounds; Ingredient Purchasing and Controls; Identification and Traceability; Customer-related Process; and Control of Non-conforming Product.
If the facility fails to meet any of these criteria in any of these sections, it will not be an SF/SF-certified plant.
The SF/SF program also requires companies to conduct self-audits, thus increasing the feed manufacturer’s understanding of federal and state regulations.
Alltech Biotechnology, a leading animal health and nutrition company has been SF/SF certified since 2005. Becky Timmons, director of applications research and quality assurance at Alltech, says the program has helped them continually adhere to the highest quality standards.
“In order to become certified, FCI audits the facility initially and then once every other year,” says Timmons. “On the off years, you self-certify. Truly the auditing process is a continual program, as you should have random section audits on an ongoing basis as well as management review meetings. AFIA provides the requirements as well as an audit sheet which you can use to set up an internal auditing schedule.”
Participation in AFIA’s SF/SF program may also lead to shorter and/or fewer inspections by the FDA. The FDA has clearly stated it will use the SF/SF program as one risk-ranking tool to help determine where it should focus its limited resources.
FDA officials have also cited the SF/SF program as a leading tool to help the animal feed and pet food industry achieve its goal of providing safe products to its customers and ultimately American consumers.
Some EU regulations are slightly different from United States feed regulations. American companies doing business with European customers have had to rely completely on self-audits to ensure that their feed meets EU standards.
Companies who trade globally, such as Alltech, could use the SF/SF program as an example of how to self-audit for EU regulations, but could not rely on FCI audits alone. “The SF/SF program has not been recognized and did not satisfy the requirements for trading in Europe,” says Timmons. “SF/SF gave us the basic foundation for a system, which we then took further to meet the EU requirements. The EU requirements include a Hazard Analysis and Critical Control Point component in addition to the quality system of SF/SF. SF/SF gave us the experience to add the necessary HACCP components.”
The key difference between EU and FDA regulations is the inclusion of HACCP. In the EU, there are mandatory HACCP regulations, with specific HACCP requirements for feed, ingredient and pet food facilities. EU facilities had to be compliant with HACCP principles starting in 2006, and imports from countries such as the United States have had to comply since 2007.
“U.S. officials and feed and ingredient manufacturers believe there are several routes to making safe feed that meets both government requirements and individual quality standards. HACCP, which is required in the EU, is one such tool, but it is not the only one used by U.S. firms,” says Jerrod Kersey, AFIA director of ingredients and state legislative affairs.
Since American feed companies must now comply with EU regulations in order to trade with Europe, it’s important for associations to create these third-party certification programs because the FDA only inspects for U.S. regulations. “For example, at this time, U.S. officials will not certify that any U.S. facility is compliant with the European Union’s feed hygiene regulation [Regulation 183/2005] and other EU rules,” says Kersey. “Certain EU requirements on the manufacture of feed, pet food and ingredients are generally not found in the United States and vice versa.
“The EU’s focus on implementing Regulation 183/2005 had been initially on its member-states, but now the EU is beginning to apply the regulation to the United States and other countries. This means it’s all the more important for feed industry stakeholders in the United States and the EU to cooperate and boost education and understanding,” says Kersey.
The establishment of an international Safe Feed/Safe Food Certification Program will go a long way toward making sure U.S. and EU firms have the same understanding of the regulations they face. While EU and U.S. regulations vary, the auditing process will help ensure facilities on separate continents are on the same page.
“It makes sense for AFIA to select FEFANA’s FAMI-QS [European Feed Additives and Premixtures-Quality System] program to partner with at this time,” says Kersey. FAMI-QS is one of three such programs recognized by the EU in the European Journal, and it is one of two with an active certification program for ingredients. FAMI-QS is specifically designed to help feed and ingredient makers meet the regulatory requirements of the EU.”
Once the international version of the SF/SF Certification Program is fully up and running, FAMI-QS inspectors will certify U.S. facilities, and FAMI-QS-certified facilities in Europe may apply for SF/SF certification.
If a facility is already in SF/SF and would like to be part of the international program, employees would have to incorporate the additional principles into the plant’s day-to-day routine and inspection process.
If a firm is not currently participating in SF/SF and only wants to be part of the international version of the SF/SF program, then a new type of inspection not already used at the plant would be required. As the basic SF/SF program does not meet EU feed hygiene requirements, a FAMI-QS audit would be required to comply with the EU requirements.
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