wwoods2 on DSK1DXX6B1PROD with PROPOSALS PART 1
Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Proposed Rules
requesting data and information on the contamination of transported foods and any associated outbreaks. FDA is taking this action as part of its implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA), which requires the Secretary of Health and Human Services (HHS) to issue regulations setting forth sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in food transport. This action is also part of a larger agency effort to focus on prevention of food safety problems throughout the food chain. The regulations would address the risks to human or animal health associated with the transportation of food.
DATES: Submit electronic or written comments by August 30, 2010.
ADDRESSES: You may submit comments, identified by Docket No. FDA–2010–N– 0013, by any of the following methods: Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://
www.regulations.gov. Follow the instructions for submitting comments. Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]: Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Regarding the provisions with respect to human food: Michael Kashtock, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740–3835, 301–436–2022. Regarding the provisions with respect to food for animals: Shannon Jordre, Center for Veterinary Medicine (HFV–235), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276– 9229.
SUPPLEMENTARY INFORMATION: I. Background
FDA is issuing this ANPRM as part of its implementation of the 2005 SFTA, which requires the Secretary of HHS to issue regulations setting forth sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in food transport. Food is defined by section 201(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(f)) as ‘‘articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.’’ FDA notes that ‘‘food’’ includes live animals intended for food use and food such as meat and poultry during transport outside of official U.S. Department of Agriculture (USDA) establishments.1 2 This ANPRM is also part of a larger agency effort to focus on prevention of food safety problems throughout the food chain; preventing harm to consumers is the primary principle described in the Key Findings of the President’s Food Safety Working Group (Ref. 3). The regulations would address the risks to human or animal health associated with the transportation of food.
A. Risk for Foodborne Illness Associated With Transportation of Food
Over the past few decades, there have been persistent concerns about the potential that food might become contaminated during transportation; however, only a limited number of such events have been documented. In this section, we discuss the events we are aware of, in chronologic order. The first two events described in the following paragraphs involved contamination of
1 With regard to the latter, FDA notes that, to prevent duplication of effort, its compliance policy is to inform the USDA’s Food Safety and Inspection Service (FSIS) when an apparent violation is encountered involving a meat or poultry product that has left a USDA inspected establishment (Ref. 1). FDA will not normally initiate action involving such products unless USDA does not wish to do so. As FDA moves forward to implement the SFTA, FDA intends to consult with FSIS to harmonize new regulations with current regulations as practicable.
USDA’s Food Safety and Inspection Service (FSIS) has issued guidelines entitled ‘‘FSIS Safety and Security Guidelines for the Transportation and Distribution of Meat, Poultry, and Egg Products’’ (Ref. 2). 2
food for animals; the remainder concerned food for humans.
In 1974, an incident involving contamination of a component of food for animals in a rail car occurred. This case, which FDA investigated after receiving reports of several sickened dogs, involved corn gluten used in dog food. The corn gluten was determined to have been transported in a rail car that had been previously used to transport lead monoxide. Samples taken of the dog food in which the corn gluten was used revealed that it was contaminated with lead monoxide at levels ranging up to 28,000 parts per million. A Class I recall was issued for the dog food and other food for animals manufactured at the same plant within the same time period. Additionally, FDA successfully prosecuted the carrier involved in this incident. See United States v. Penn Central Transportation Co. (S.D. Ill 1978) (Refs. 4 and 5).
In 1989, soybean hulls used as a component in animal feed were contaminated by barium carbonate, a chemical used in rat poison and paint, when they were transported in a rail car that had previously been used to transport the chemical (Refs. 6 and 7). The soybean hulls were incorporated into bulk dairy cow feeds distributed to farms in Louisiana and Texas. The contamination resulted in the deaths of dairy cows in herds from both Louisiana and Texas, and high levels of barium carbonate were detected in milk from two of the affected herds by the State of Louisiana. The manufacturer of the animal feed voluntarily recalled implicated feeds.
During the late 1980s, there were a number of press reports that some trucks that hauled garbage from the New York/New Jersey area to Midwestern landfills were used subsequently to carry meat, poultry, and produce (Ref. 8). An investigation by the U.S. General Accounting Office (GAO, now called the Government Accountability Office) found only limited, anecdotal information about food being transported in trucks that previously carried garbage, the types of trucks doing so, and the foodstuffs carried (Ref. 8). However, in its report (the 1990 GAO report), GAO concluded that long- distance transport of garbage was clearly on the increase. GAO also concluded that long-distance transport of garbage primarily originated in certain northeastern communities that generate more garbage than they can dispose of locally. In these communities, the quantity of consumer goods, including food, arriving by truck exceeded the quantity of goods leaving, and garbage had become a paying trucking
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