Sep 1, 2010 12:00 PM
FDA working on safe food transportation regulations mandated by SFTA
Twenty years after the Sanitary Food Transportation Act of 1990 was passed by Congress, the federal government may be just months away from issuing the regulations called for under the law. The Food and Drug Administration (FDA) announced an advance notice of proposed rulemaking (ANPRM) earlier this year.
FDA officials make it clear in the ANPRM that they are absolutely determined to issue regulations covering sanitary transportation practices to be followed by shippers, carriers, receivers, and others involved in food transport. The only real discussion concerns the breadth and scope of the regulations.
Sanitary food transport regulations will be part of a larger agency effort to focus on prevention of food safety problems throughout the food chain. The regulations are expected to address the risks to human or animal health associated with the transportation of food.
In justifying the need for a regulation, the FDA seems to be relying on just a handful of incidents over the past 30-plus years. Tank trailers and railcars were involved in several of the events.
The first incident cited in the ANPRM occurred in 1974. Dogs were sickened by dog food made from contaminated corn gluten. The contamination allegedly occurred because the corn gluten was transported in a railcar that had previously hauled lead monoxide.
During the late 1980s, a number of press reports alleged that refrigerated trucks hauling garbage from the New York/New Jersey area to Midwestern landfills were used to backhaul meat, poultry, and produce. The media frenzy spread to include reports that some tank truck carriers were using the same trailers to haul food and other cargoes, such as “hazardous toxic chemicals.”
In 1994, a large multi-state outbreak of Salmonellosis was associated with an ice cream mix that became contaminated during transport in tank trailers that had previously hauled raw liquid eggs. Public health officials who analyzed data and information associated with 150 confirmed cases of salmonellosis in Minnesota estimated that the outbreak may have affected more than 29,000 persons in that state and more than 224,000 people nationwide, according to FDA officials. Actual numbers were never verified, and this remains just an estimate.
Tank trailers played a role in a July 1999 outbreak of Salmonella Muenchen that occurred in 15 states and two Canadian provinces. More than 300 cases were reported. The product was fresh orange juice, a portion of which was imported. Several serotypes of Salmonella were isolated from tanker truckloads of orange juice tested at the US-Mexico border.
Congress reacted to the events of the late 1980s by passing the Sanitary Food Transportation Act of 1990 (SFTA). The law directed the Department of Transportation (DOT) to establish regulations to prevent food and food additives transported in tank trucks, tank trailers, and tankcars from being contaminated by non-food products that are also transported in those vehicles. The law directed DOT (in consultation with the Department of Agriculture, Health and Human Services, and Environmental Protection Agency) to publish a list of acceptable non-food products that are compatible and would not contaminate a vehicle used to transport food or food additives.
DOT's Research and Special Programs Administration published the first proposed rule prompted by SFTA in 1993. Under that proposal, any cargo tank vehicle or tankcar used for food products would have been prohibited from carrying non-food products. RSPA stated at the time that it had not identified any non-food products that were acceptable to be carried in a cargo tank vehicle that also hauls food products.
During that period, the DOT inspector general raised questions about whether the department had the expertise to develop food transport-type regulations. RSPA issued a supplemental notice of proposed rulemaking (SNPRM) stating that the agency would reference food-related requirements and recommendations from USDA and FDA in any further regulatory efforts on the issue.
RSPA never did issue a final rule based on the 2004 SNPRM. In 2005, Congress renewed SFTA and amended it by transferring regulatory responsibility to the Department of Health and Human Services and FDA. That is why FDA is now in the driver's seat on the renewed SFTA regulatory effort.
Much has changed with regard to the food transport safety issued that prompted Congressional action in the late 1980s and early 1990s. Even as the debate and discussions continued at the federal regulatory level, the food manufacturing and transportation sectors moved proactively to address the critical issues.
“The private sector took action to improve selection of carriers and equipment and of products eligible for transportation prior to cleaning the tanker for a food load, and that was done long before SFTA was passed,” John Conley, president of National Tank Truck Carriers, said in comments that were submitted in response to FDA's ANPRM. “National Tank Truck Carriers (NTTC) has long been involved in the issue of food transportation safety.”
Steps taken by NTTC to address safe food transportation issues included holding several meetings with foodgrade carriers and shippers and developed foodgrade transportation and equipment cleaning information that is still widely in use today. Industry groups continue to address food transport issues.
NTTC worked with other food-related organizations to produce information for the industry, such as the Tank Truck Inspection Guidelines produced by the National Food Processors Association in conjunction with the Corn Refiners Association, Institute of Shortening and Edible Oils, and National Institute of Oilseed products. The Juice Products Association developed its own Model Tanker Wash Guidelines for the Fruit Juice Industry.
NTTC's Tank Truck Cleaning and Environmental Council developed a Tank Truck Cleaning Facility Audit form in the early 1990s. The audit form is widely used throughout the tank truck industry and is regularly updated by the council. The form is available at www.tanktruck.org.
Following the terrorist attacks of September 11, 2001, FDA expressed concerns about potential attacks on the food transportation industry. The potential threat of terrorism involving food was quickly recognized by the trucking industry and shippers.
“NTTC and other organizations developed enhanced security plans and procedures after 9/11 and did address food transportation with efforts that are ongoing today,” Conley says. “It is almost irrefutable that food transportation in the tank truck industry is both safer and more secure than it was at the beginning of this decade. An already outstanding food transportation system was made even better.”
Turning to the current FDA ANPRM, Conley says that while FDA is clearly the lead agency for regulations under SFTA, NTTC urges the agency to work with DOT, which has the most experience in dealing with trucking operations, employees, and equipment. Any food transport regulations must be consistent across the United States, and federal regulations must preempt any state and local regulations on the same issue.
“Tank trucks and their drivers operate across state lines on a daily basis,” Conley says. “A load of orange juice trucked from Florida to Oklahoma, or a load of milk from Wisconsin to Georgia will cross many state lines. Regulatory inconsistency fosters confusion and even noncompliance.”
NTTC also addressed some of the questions raised by FDA in its ANPRM. These questions give insight as to where FDA wants to with its rulemaking effort, and there are indications that the regulatory burden on the food transportation industry could grow significantly.
Information being sought by FDA includes the following:
Which firms should be subject to the regulation? What types of vehicles carry food and are dedicated to food hauling? What types of foods are completely enclosed vs being carried openly?
What sanitation procedures currently exist and are they adequate? Are there protective measures in place to prevent contamination? What other security measures exist to protect food at loading, unloading, and in-transit? How is time/temperature safeguarded?
Is dual transport a common event? With this question, FDA wants to know whether a tank trailer — for instance — would be used to transport food and non-food cargoes. If this is done, how is contamination prevented? What types of non-food products are transported in these operations?
What sort of information is currently provided to the carrier by the food shipper? Is it sufficient to prevent adulteration, or could more be provided (and if so, what type of additional information should be provided to the carrier)?
What records currently are kept, and for how long, by shippers and receivers? How long should they be kept?
What waivers or exemptions should be allowed? Do states (or any other political units) have any current regulations regarding safe transport of food and what are they?
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