Countdown to test-and-hold

by Bernard Shire
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By the end of this year, or at the latest, early next year, USDA’s Food Safety and Inspection Service (FSIS) and state inspection agencies will be requiring all federally and state inspected meat and poultry plants in the United States to hold product when it is being tested for pathogens.

During the spring, FSIS published a notice, along with a request for comments in the Federal Register, saying it would not determine whether meat and poultry products are adulterated and are able to be shipped in commerce until all test results have been received.

The government inspection agency says it is accepting comments on this notice setting this major change of policy for 90 days, until July 11. With possible changes to be made to the notice due to comments submitted by industry, consumer groups and other interested parties, it is highly unlikely mandatory “test-and-hold” will go into effect until late in 2011 or early in 2012. But there is no doubt plants will have to control their products while being sampled by FSIS or state inspection agencies, or even when their own testing takes place. According to an FSIS spokesman, after receiving and analyzing the comments, the agency will respond, make any appropriate changes to the policy and procedures, and announce the effective date of the new policy in a subsequent Federal Register notice.

The required test-and-hold procedure comes about as a result of a petition submitted in 2008 by the American Meat Institute to Richard Raymond, undersecretary for food safety at the time. The trade association asked Secretary of Agriculture Tom Vilsack again a year later.

Three years before the petition was first submitted, AMI, the American Association of Meat Processors, which represents mostly small and very small meat and poultry processors, and six other national trade groups published Industry Best Practices for Holding Tested Products, which provided guidance for plants to hold raw and ready-to-eat products until test results about the safety of the products are received. Copies of ‘Best Practices’, printed by AMI, were sent to every federally inspected plant in the US. AAMP announced its availability to its members, including federally and state-inspected plants, custom and retail-exempt establishments, and distributed it at affiliate meetings. Other participating trade associations distributed it to their own members.

Mandatory test and hold
Although FSIS has recommended all plants hold products while they are being tested, it never mandated it until now. That is because for years, it strongly urged plants to take this action, and because national and state trade associations have urged their members to do this.

But once it became apparent that meat and poultry product recalls were taking place due to processing establishments shipping products to customers while samples of those lots were being tested for pathogens and adulterants, there was no doubt what FSIS would do. The agency decided to make the policy mandatory in order to eliminate recalls that wouldn’t have taken place if product had been held. Undersecretary for Food Safety Dr. Elisabeth Hagen noted, “We have had the recommendation out there for industry for some time, and industry has established this as a best practice shared among many members. I think we’ve looked at the data, and we’ve looked at how many recalls could have been prevented, and at this point, we thought this was the right thing to do.”

She says 44 recalls occurring between 2007 and 2009 could have been prevented if product had been held until test results came back. The recommendation also came as part of recommendations by President Obama’s Food Safety Working Group, which is making efforts to modernize America’s food-safety system.

But “test-and-hold” has posed great challenges to some plants, especially small and very small operations. They include small plant owners who sell products on the same day for immediate use; establishments making products with a short shelf-life; plants with little or no space to store product while waiting for test results.

Mark Dopp, AMI senior vice president for regulatory affairs and the agency’s legal counsel, says AMI prefers to call the practice “controlling” the product, rather than “holding” it until it comes back negative from testing. He says there are numerous ways for meat and poultry plants to control tested product until results are known.

“The simplest example would be sending beef trimmings being shipped somewhere else for grinding,” he says. “The product could be put into a truck onto the road, kept in the first company’s control until the results of the test being done on the lot come back negative. The central issue here is, whether the company producing the product has control of it until the results come back. The product could also be sealed, with the key being not put into commerce.”

The AMI petition was precipitated by increasing numbers of recalls. “If you go back and look at the recalls taking place because of product being turned over to customers before test results, you’ll see it wasn’t so much E. coli O157:H7, but ready-to-eat [RTE] product calls, including Listeria,” he says. Dopp adds the increasing numbers of recalls were starting to draw more attention on Capitol Hill in Washington. Members of Congress were wondering if more attention needed to be paid to food safety, including possibly tougher inspection laws and regulations. This concern on “The Hill” was leading meat and poultry trade associations to the conclusion something needed to be done beyond “encouraging” meat and poultry plants to hold products being tested by USDA. “There was a feeling out there that industry was not really acting in a responsible way, especially if product wasn’t being controlled until testing came back negative,” Dopp says. That feeling resulted in the AMI petition for mandatory “test and hold.”

Challenges persist
But that doesn’t make “test-and-hold” easy for everyone, especially small and very small establishments. Jay Wenther, executive director of AAMP, which has supported “test-and-hold” for a long time, says some processors struggle with the process if they make short shelf-life products because the product can’t be held long enough to await test results. “I don’t believe FSIS has really addressed this issue, or in some cases may believe the overall benefit to the industry outweighs the hardship these processors will have to deal with.”

Another issue could be failing to satisfy customer orders because of holding the product. Wenther isn’t sure if filling customer orders when product is being sampled by FSIS will be an issue or not.

“When an inspector gets the request to take the sample, they are typically given 30 days to get the sample,” he says. “Over the years, it has been well-established the inspection personnel are supposed to work with the establishment management so that production is not interrupted significantly, but FSIS gets the sample they are wanting. It’s easier when there is no regulation to deal with, or when a plant and inspector can decide on their own about the timing of the testing or sampling of products, worked out with the plant’s schedule or production requirements.

“But I think this regulation will make establishments take a closer look at their production practices, develop a system that works for them, and communicate with their customers about just-in-time orders,” he adds. “When there is a regulation, the complexity goes up, because FSIS could say, ‘This is the way everyone should do it.’ ”

He notes inspection personnel already work with establishment management to get the samples. There were some initial problems regarding FSIS sampling methods, he says, but over the years that has been greatly improved. “Rarely do I hear of problems regarding this issue,” he says.

Wenther raises one method to avoid problems when a product is being held due to testing. “It depends on the product being tested. If FSIS is taking a ground beef sample for E. coli O157:H7 testing, the establishment could grind a smaller batch of ground beef, stop, clean up, document the sample information and the sanitation procedures, switch source material and produce another lot of product. This would mean less product would be held and production wasn’t hindered by taking the sample,” he says.

While he agrees recalls have spurred the move to mandatory “test-and-hold” practices in the meat and poultry industry, he asserts some recalls that have taken place could not have been avoided simply by retaining control of product.
Wenther criticizes one idea advanced a few years ago to make it easier for very small establishments to carry out “test and hold” successfully. That would involve one company asking another company – a competitor – to make the product for distribution while the first company’s product is undergoing FSIS sampling. “That’s kind of ridiculous,” he says. Another problem, he says, is withholding the mark of inspection and not having pre-shipment review until test results are returned could result in a company manager forgetting to sign off on pre-shipment after the test results come back.

But there are some practices that would make testing and holding product easier and more successful for plants of all sizes, including very small and small ones. AMI’s Dopp says FSIS will permit product to move before test results come back from the agency, as long as product is being controlled by the first establishment, and not yet turned over to a customer. This would include product being shipped in trucks on the road, moving from one location to another.

“The product has to still be under the control of the original establishment, and not yet sold to another customer for further processing or utilization,” he says. “We wanted to eliminate the circumstance where a plant knows it’s been sampled, but hasn’t gotten the result yet, which would result in a recall if the test was positive.”

Dopp notes once or twice in past years, a product was being controlled by the establishment, but got shipped to the customer inadvertently. “That’s just a mistake and people will make mistakes,” he says. “But if you look at the USDA press releases describing recalls, you’ll see many of them indicating the company didn’t hold the product.”

AAMP’s Wenther points to freezing tested, finished products, resulting in a longer shelf-life, or coming up with new systems to identify and track materials based on their supplier or lot – these are some adjustments that could be made to help establishments control tested product. Plants could also take other steps to control tested product, including keeping tested product separated from other products, and working with FSIS inspectors to arrange advance notification (up to 30 days) when samples are taken. “We’ve found is when our members make changes, such as issuing specific guidelines for their operation or using tags to identify lots and shippers, they realize holding the product is a good business practice that can be accomplished,” Wenther says.

An FSIS spokesman says the agency appreciates the concern some very small establishments might lose products or experience disruption in business activities. FSIS inspector notification to the plant of sampling activities ahead of time would help plants deal with this concern. The agency is also seeking additional suggestions in comments to the “test-and-hold” notice.

The better alternative
Dopp says the mandatory test-and-hold regulation is the best way for industry to handle this situation, protecting both itself and consumers. “This rule avoids really bad legislation, which would be a much worse problem to deal with,” he says.

Wenther hopes most of his members have “test and hold” plans in place. But he believes the rigidity of the regulation will be a factor when it is implemented, making it harder for inspectors to avoid hurting a company schedule when they sample.

“I’m sure there will be complications, but if the industry and the agency can work together, we will get through the complications,” he says.

Bernard Shire is a contributing editor based in Lancaster, Pa. Shire also works as a food safety consultant and writer for Shire & Associates LLC.
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