wwoods2 on DSK1DXX6B1PROD with PROPOSALS PART 1
Federal Register /
Vol. 75, No. 83 / Friday, April 30, 20
10 / Proposed Rules
commodity on what might otherwise be an empty return trip (Ref. 8). GAO concluded that the extent to which the same trucks might subsequently carry food could not be determined at the time of the report because federal regulations did not require that type of recordkeeping.
In 1994, a large multi-state outbreak of salmonellosis was associated with an ice cream mix that became contaminated during transport in tanker trucks that had previously hauled raw liquid eggs (Ref. 9). Public health officials who analyzed data and information associated with 150 confirmed cases of salmonellosis in the State of Minnesota concluded that the outbreak may have affected more than 29,000 persons in Minnesota and more than 224,000 persons nationwide (Ref. 9).
In July 1999, an outbreak of Salmonella Muenchen occurred in 15 States and 2 Canadian provinces with more than 300 cases reported (66 FR 6138 at 6172, January 19, 2001). The product was fresh orange juice, a portion of which was imported. Several serotypes of Salmonella were isolated from tanker truckloads of juice tested at the United States/Mexican border. In such circumstances, there is a potential that Salmonella from one contaminated shipment could contaminate future shipments.
In 2007, the Motor Carrier Division of the Michigan State Police reported 22 cases of illegal and unsafe food transport on Michigan highways during 2006 (Ref. 10). The report listed findings such as:
Raw poultry hanging from the roof
inside the cargo area of a truck, with juices dripping onto open boxes of produce below, and with juices from the raw poultry dripping out onto the pavement from under the rear cargo box doors. The food was being transported in an unrefrigerated truck with an internal temperature greater than 70° F;
Truck(s) with no refrigeration unit;
Truck(s) with the refrigeration unit
turned off or not working; and
Truck(s) with a working
refrigeration unit that was not set at the correct temperature.
As with the 1999 transport of contaminated orange juice in tanker truckloads, recent outbreaks of foodborne disease demonstrate the possibility of contaminated foods being widely transported, which could lead to cross-contamination between shipments. For example, in 2009, peanut butter and peanut paste were confirmed as the source of a large multi- state outbreak caused by Salmonella Typhimurium (74 FR 10598, March 11,
2009). These peanut-derived products were manufactured by two facilities owned by a single firm and distributed through various channels (Refs. 11 and 12). The firm recalled a large number of its products, including products distributed in 1,700–pound tanker containers, because the products had the potential to be contaminated with Salmonella (Ref. 13).
B. Sanitary Food Transportation Act of 1990 and Associated Actions by the U.S. Department of Transportation
After receiving the 1990 GAO report, Congress enacted the Sanitary Food Transportation Act of 1990 (1990 SFTA) (49 U.S.C. 5701 et seq. (2000), amended by Public Law 109–59 (2005)). The 1990 SFTA directed the U.S. Department of Transportation (DOT) to prescribe regulations regarding the transportation of food and food additives (including food and food additives intended for consumption by animals) in motor vehicles and rail vehicles that are used to transport nonfood products that would make the food or food additives unsafe to humans or animals.3 In essence, the 1990 SFTA directed DOT to establish regulations to prevent food or food additives transported in tank trucks, rail tank cars, or cargo tanks (tank vehicles) from being contaminated by nonfood products that are simultaneously or previously transported in those tank vehicles. Section 5704(b) of the 1990 SFTA specifically directed DOT to publish a list of acceptable nonfood products that DOT (in consultation with the Secretaries of the USDA, U.S. Department of Health and Human Services (HHS), and the Administrator of the Environmental Protection Agency) determined would not make food or food additives unsafe to humans or animals because of transportation of the nonfood products in a tank vehicle used to transport food or food additives.
On May 21, 1993, DOT’s Research and Special Programs Administration (RSPA) issued a notice of proposed rulemaking (the 1993 NPRM) (58 FR 29698) that would restrict a cargo tank, tank car, or portable tank to carrying either food products or nonfood products. Under the 1993 NPRM, a cargo tank, tank car, or portable tank that carried food products would have been prohibited from carrying nonfood products. In the 1993 NPRM, RSPA
The 1990 SFTA also directed DOT to prescribe regulations regarding the transportation of cosmetics, devices, or drugs in motor vehicles and rail vehicles that are used to transport nonfood products that would make the cosmetics, devices, or drugs unsafe to humans. We do not discuss those provisions in this document. 3
stated that it had not identified any nonfood products that were acceptable to be carried in a tank vehicle that carries food products and, therefore, was not issuing a list of acceptable nonfood products within the meaning of section 5704(b) of the 1990 SFTA. For motor and rail vehicles other than tank vehicles, RSPA also proposed to forbid the transportation of food products in the same vehicle as poisons, infectious substances, hazardous wastes, or solid wastes (i.e., ‘‘unacceptable nonfood products’’). However, such vehicles would be allowed to carry unacceptable nonfood products before or after they carried food products, provided the vehicles were free of any contaminating residues.
Subsequent to the publication of the 1993 NPRM, in a report issued on March 27, 1998, DOT’s Office of the Inspector General (DOT/OIG) found that (1) DOT did not have the expertise to implement the 1990 SFTA, (2) performing food inspections could be incompatible with significant aspects of DOT’s safety inspection operations, and (3) FDA had the requisite expertise, capability, and a directly related primary mission for regulating food safety (Ref. 14). DOT/OIG concluded that HHS/FDA should have primary responsibility for food transportation safety (Ref. 14).
Comments to the 1993 NPRM generally opposed its proposed provisions and recommended that DOT defer to FDA and USDA on food safety issues (69 FR 76423, December 21, 2004). In light of both these comments and the 1998 report of DOT/OIG, RSPA issued a supplemental notice of proposed rulemaking (69 FR 76423, December 21, 2004) (the 2004 SNPRM). Under the 2004 SNPRM, RSPA’s regulations would reference requirements and recommendations, established by USDA or FDA, applying to persons who transport (or offer for transportation) food or food products by motor vehicle or rail car.
RSPA did not issue a final rule based on the 2004 SNPRM. Following the enactment of the 2005 SFTA (see discussion in section I.D of this document), which amended the 1990 SFTA and directed HHS (and, by delegation, FDA) to issue regulations prescribing sanitary transportation practices to ensure the safe transportation of food, DOT’s Pipeline and Hazardous Materials Safety Administration (formerly RSPA) withdrew both the 1993 NPRM and the 2004 SNPRM (70 FR 76228, December 23, 2005).
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