Industry Listens and Waits on FSMA

By Tina Caparella

Like many in the food and feed industry, pet food companies are anxiously awaiting the final regulations of the Food Safety Modernization Act (FSMA) signed into law in January 2011 and required to be in place by July 2012. Those who attended the third annual Feed and Pet Food Joint Conference in St. Louis, MO, in early October still didn’t hear exactly when the regulations would be released, except “maybe a sneak peek sometime in November.”

Over 300 participants listened to presentations primarily focusing on government regulations at the conference held by the Pet Food Institute and National Grain and Feed Association (NGFA). Dr. Dan McChesney, director of the Food and Drug Administration (FDA) Office of Surveillance and Compliance/Center for Veterinary Medicine, declared that the United States (US) has the safest food and feed supply in the world, “however, we have become a global supply system and the current FDA inspection system, albeit good, cannot keep up.” He explained that FSMA mandates a change in how FDA does its work, breaking it down into the “Big Four Rules + 1”: produce, preventive controls for human food, preventive controls for animal food, foreign supplier verification program, and third party certification being the plus one.

McChesney reiterated that the current US food safety system is not sustainable as a reactive system and that FSMA moves the system to a preventive approach. He then remarked that FDA has accomplished “a lot” on FSMA, reminding all that the bovine spongiform encephalopathy regulations took four years to finalize. All FSMA proposed regulations, except third party certification, are currently being reviewed by the Office of Management and Budget, with pet food labeling regulations having a two- to three-year implementation period. McChesney encouraged everyone to sign up for updates on the FSMA website at

On a positive note, pet food recalls for the period October 2011 to September 2012 are down from the previous year, with 24 recalling firms this year compared to 64 during the same timeframe in 2011, and 85 total products recalled in 2012, down from 212 the previous year.

Switching gears to FDA inspection and training plans in a post-FSMA world was Scott MacIntire, director of FDA’s Chicago District Office, who encouraged feed manufacturers to reach out to their respective FDA state officials and begin a dialogue. Under a revised leadership, FDA’s Food and Feed Operations now focuses only on one product instead of all FDA product areas and physically inspects less than one percent of all imports, which this year total 24 million shipments of food, devices, drugs, and cosmetics at US ports of entry. MacIntire estimated that 15 to 20 percent of all food now consumed in the United States originates outside the country, up to 40 percent of drugs Americans take are imported, and up to 80 percent of the active pharmaceutical ingredients in those drugs come from foreign sources.

“We’re good cops,” MacIntire declared. “We only have to play bad cop when companies don’t regularly comply.” He noted that in the FDA Investigations Operations Manual, photos may now be used to document violations and the agency will do dioxin samples for surveillance.

Ross Korves, economic policy analyst, The ProExporter Network, focused on the impacts the US drought and ethanol production are having on the feed and pet food industries’ primary plant-based ingredients. He stated that world carryover stocks of corn and soybeans are very tight with plantings just beginning in Brazil and South America.

“If we don’t get a crop out of South America like we expect, we’re going to be in bigger trouble than we think we are,” Korves warned. Although ethanol producers are scaling back, estimated to use about 4.5 billion bushels of corn in 2012 compared to five billion in 2011, Korves does not expect the Renewal Fuel Standard to disappear. He also doesn’t anticipate US corn ethanol production to grow much more, but instead be supplemented by imports of sugar cane ethanol from Brazil.

Dr. Craig Henry, Deloitte and Touche, LLP discussed developing and implementing a supply chain verification program that FDA and customers may demand.

“Supply chain management is about due diligence to assure products in from the supplier meet required regulatory, legal, and contractual standards of safety,” he explained, adding that the biggest hurdle of FSMA is that feed manufacturers are going to have to know the supplier to a supplier to their supplier, all the way down the chain. Henry also made note that regulators will ultimately require a responsible party (company) to protect the consumer first and the brand second, that government agencies have a lot more tools in the form of regulations than they did five years ago, and that documentation, including accredited third-party certification, will be key to ensuring compliance.

Continuing the discussion on FSMA was Rachel Lattimore, partner at Arent Fox, who said the act really changed the inspection game. The term “reasonable” is used throughout the regulation and is open to interpretation by all, from regulators and government agencies, to the courts and industry.

“FDA wants to be a good cop, but they are a cop,” Lattimore reminded. She encouraged manufacturers to have more than one person in a plant/company trained to work with FDA inspectors in case that individual is off work the day an inspector shows up. Companies are also advised to consult an attorney before allowing an inspector to take photos or samples, but if allowed, the company representative should take the same photos and samples as the inspector.

David Fairchild, NGFA, announced the development of the Food Safety Preventive Controls Alliance (FSPCA) under the Institute for Food Safety and Health. FSPCA’s core is to develop a standardized food safety prevention controls training curriculum for food industry personnel that addresses hazard analysis, prevention controls, monitoring, corrective action, verification, and recordkeeping, all elements specified in FSMA. A 27-member steering committee consisting of regulatory, academia, and industry representatives has established a working group, with a further goal of creating an animal feed and pet food steering committee to direct alliance activities specifically related to these food/feed types. The objective is to take the food industry standard curriculum, expected in January 2013, and adapt it to animal feed/pet food.

Going outside the FSMA box to discuss weather and climate change was Dr. Elwynn Taylor, professor of Agricultural Meteorology, Iowa State University, who declared that the climate is changing; it always has, and always will.

“We just don’t know how much and when it will change,” he commented. Taylor then stated that demand for biofuels, which may consume one-third of the world’s agriculture production, is affecting grain prices and that the world is using more fossil fuels than the earth is creating, increasing carbon dioxide levels.

“If we use biofuels that we’ve just grown, it is carbon neutral and saves some fossil fuels,” he remarked. “Biofuel is fine if used wisely. Biofuel does not need to replace fossil fuel, just augment it.” Taylor went on to say that corn is currently not the most efficient crop to produce biofuels, but it is the plant of choice. When corn yield reaches 200 bushels per acre (double what it is now), only then will it be the most efficient biofuel plant.

Charlie Arnot, Center for Food Integrity, examined why science isn’t enough, that consumers need to trust today’s pet and livestock feed industries.

“It’s very important to get the right message to the right audience at the right time,” he stated. More concerns have been raised about pet food because consumers love their pets, therefore they are becoming more aware of what goes into the feed (antibiotics, genetically modified organisms, etc.). Arnot mentioned that shared values between consumers and companies have been shown to be more important in building trust than demonstrating competence through research.

“Science needs to play a different role in how we build trust with consumers,” he noted, adding that transparency is no longer optional. “We are moving from mass communication to masses with communication.” Regarding the lean finely textured beef incident, Arnot advised industry to collectively support “recovery technology” no matter the source (i.e., fruit, beef, etc.) as sustainable and environmentally friendly. He also recommended seeking legislation making it illegal to not report animal abuse if witnessed as opposed to banning cameras, which make it appear the industry has something to hide.

Covering contracting and trade rules were John Augspurger, DeBruce Feed Ingredients, and David Barrett, Cunningham and Eselgroth, LLP. Augspurger said trade rules are important due to volatility and encouraged attendees to know the difference between a contract, a confirmation, a counterparty confirmation, and a broker confirmation, if applicable. He pointed out that anything can be negotiated.

Barrett emphasized that manufacturers must know their suppliers, communication has to flow both ways to be effective, and risk can be allocated in contracts. He also underscored the need to have an arbitration clause in contracts, and that many container shipments follow Grain and Feed Trade Association, or GAFTA, rules out of London, England.

During the conference, attendees had the opportunity to meet with various companies exhibiting their technologies and services. One such exhibitor was Darling International/Griffin Industries debuting their new Dar Pro brand. Steve Thomas, Griffin Industries, commented that although the pet food industry continues to rely on animal proteins as feed ingredients, he has seen a shift to products not labeled “by-products.” He pointed out that pets digest meat products better than plant products.

December 2012 RENDER | back