FDA rule addresses broken seals at foodgrade product inspections
Jul 1, 2004 12:00 PM
THE FOOD and Drug Administration (FDA) will continue to place an official seal on a bulk foodgrade shipment after an initial seal has been broken for inspection, but will not present an official document to the driver indicating no problems with the product. Instead, the seal number will be listed in the inspector's notes.
The decision was published June 4 in the Federal Register as part of a final rule (21 CFR Parts 1, 10, and 16) pertaining to detention of foodgrade products under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
The tank truck industry had expressed concerns that most tank truckloads of food are sealed at all openings and that these seals will be broken by FDA inspectors who investigate a suspected problem load, which will result in the load being rejected.
As a result, it was requested that FDA develop a process whereby an FDA representative who breaks a seal to gain access to a load that is found not to present a problem would then reseal the load with an FDA seal and so indicate it on an official FDA document. While not required to do so, a receiver may be more inclined to accept the load, the commenters said.
FDA agreed in part with the comment, but was not sure what is meant by an official document upon resealing. Under current practice, which will be continued after the effective date of the rule, whenever FDA reseals a conveyance the replacement seal will be an official FDA metal seal. An FDA document does not accompany the metal seal because the seal is the official indication that FDA has opened and resealed the conveyance. FDA's internal practice is to record the number of the seal in the investigator's official notes.
Another comment from the industry noted bulk transportation of food products in tank trailers and dry bulk trailers is significantly different from packaged or prepared food transportation, and urged the FDA to recognize the differences either in the language of the regulation, or by a separate section strictly dealing with bulk transportation. FDA responded that the agency must include in the detention order any applicable conditions of transportation of the detained article of food. FDA will take into consideration the mode of transportation being used for the detained product, and the form in which the article of food is being transported, for example packaged or dry bulk, when setting forth these conditions.
The tank truck industry also commented that trucks that transport bulk food, including liquid commodities such as vegetable oil, when detained, would result in the trailer being unusable for the period of the detention. FDA responded that in situations involving conveyances, a request can be made for modification of a detention order to offload the cargo to a secure storage facility. However, in some cases, it may not be feasible to offload the cargo. In that case, the conveyance itself might be delayed.
In addition, in some cases, the drivers of tanker trailers may be idled during the detention period. According to FDA, the average wage of a truck driver in July 2002 was $14.40 per hour. “If we assume 100 percent overhead, then idling a truck driver for 30 calendar days would cost an additional $7,000,” FDA said. “Therefore, the total potential cost of detaining one tanker truck and driver for 30 calendar days could be up to $15,000.”
A single administrative detention might involve more than one tanker trailer or other types of equipment. In the analysis of the proposed rule, FDA assumed that any given detention could involve up to 67 truckloads of food. Detaining 67 tanker trailers for up to 30 calendar days could generate estimated costs of up to $1 million.
“Although the costs of detaining conveyances are potentially quite high, the probability that we would need to detain conveyances is quite low,” FDA argued. “None of the 223 enforcement actions that we discussed in the analysis of the proposed rule in the context of estimating the maximum number of times we might use administrative detention per year involved a situation in which we would have detained conveyances. In addition, none of the 24 seizure actions that we took in fiscal year 2002 or in fiscal year 2003 involved a situation in which we would have detained conveyances.”
Nevertheless, FDA said that the estimated cost of delaying a fleet of tanker trucks by 0 to 6 hours would be $0 to $8,000 based on the cost information provided earlier.
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