April 02, 2009 | Elise Schafer

Focus on Regulatory: Bridging the Regulation Gap

The AFIA's Safe Feed/Safe Food program has been certifying American feed facilities for nearly five years.

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.

Compliance counts

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.

In the News


The Food and Drug Administration announced a 60-day delay, to on or about June 27, in the effective date of its April 2008 final rule banning the use of brains and spinal cords from cattle 30 months or older in all animal feed.

The final rule, which had been scheduled to take effect for products in commerce as of April 27, is designed to further enhance existing U.S. feed regulations that ban the feeding of certain mammalian material to cattle and other ruminants to prevent the establishment or spread of bovine spongiform encephalopathy.

FDA officials said the delay was being announced as part of the Obama administration’s review of final regulations issued by the Bush administration that had not taken effect by inauguration day (Jan. 20). Importantly, while a 30-day comment period will be provided on the final rule as part of the delayed implementation announcement, the agency said it will not entertain comments to change the substance of the rule, only whether implementation should be delayed further. Opponents of the feed rule changes, primarily rendering and livestock organizations, had argued that a delay was needed because the one-year phase-in provided by the FDA did not provide adequate time to prepare for using or disposing of dead stock.

Once implemented, the feed rule changes are expected to have a minimal impact on commercial feed manufacturers, with the principal compliance burden falling on the rendering sector. FDA officials have stated publicly that there is no requirement in the final rule for feed manufacturers to clean out storage tanks containing animal fats to purge tallow residue that may not meet the new feed rule’s purity standard.


Missouri legislators have proposed tougher regulations on grain sales in response to a recent fraud case in northeast Missouri that resulted in $15 million in losses.

In February, state regulators suspended the license and froze assets of T.J. Gieseker Farms and Trucking of Martinsburg, MO, after a routine audit revealed that it owed more than $1.3 million in unpaid grain royalties. The Missouri attorney general has launched a criminal investigation into the missing money.

According to a story in the Hannibal Courier-Post on Feb. 26, the company’s owner and only employee, allegedly quoted farmers a price for their grain and promised to pay them once it was sold. The company then transported the grain to terminals in Mexico, Louisiana, St. Louis and Illinois. When the grain was sold, Gieseker paid farmers little or none of what they were owed and kept the money. Most of the deals were made over the telephone or with a handshake, not a written contract.

The proposed legislation would increase the bonding requirements for licensed grain dealers and set criminal penalties for unlicensed grain dealers. The Missouri speaker of the house also announced creation of an agricultural task force to address the problem and to determine whether Missouri needs an indemnity fund for farmers who might lose money in speculative commodity markets.


Monsanto Co. announced it has completed regulatory submissions in the United States and Canada for the world’s first biotech drought-tolerant corn product developed together with German-based BASF. The company applied for U.S. Department of Agriculture approval of its drought-tolerant corn product following its submission to the Food and Drug Administration last December. It also has completed submissions to the relevant Canadian agencies. Regulatory submissions in key import markets such as Japan, Mexico and Korea will be made in the next several months.

Drought-tolerant corn is designed to provide farmers yield stability during periods when water supply is scarce by mitigating its effects on a corn plant. Field trials for drought-tolerant corn conducted last year in the Western Great Plains met or exceeded the 6% to 10% target yield enhancement — about 7 to 10 bushels/acre — over the average yield of 70 to 130 bushels/acre in some of the key drought-prone areas in the United States .

In any given year, 10 million to 13 million acres of farmland planted to corn in the United States may be affected by at least moderate drought. This first biotech drought-tolerant corn is part of a family of drought-tolerant products Monsanto plans to bring to the market over the next several years.


In March the ethanol industry petitioned the Environmental Protection Agency to raise the limit on ethanol in gasoline to as much as 15%, up from the current cap of 10%.

Ethanol groups told the agency that the 10% limit was “a primary reason” for the industry’s recent slump. Agriculture Secretary Tom Vilsack endorsed raising the cap to 12% to 13%.

Environmental agency officials have said that the 10 percent limit has not hit the industry yet but that the cap will make it difficult to meet the nation’s annual usage mandates in coming years. The agency has been struggling with how to legally justify raising the limit, given unanswered questions about the impact of the increased ethanol content on engines, boats and outdoor equipment.

Obama stated he would make the ultimate decision about increasing the ethanol cap, which he said would involve “reconciling a lot of different issues.”

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