Federal Register: April 30, 2010 (Volume 75, Number 83)
DOCID: fr30ap10-17 FR Doc 2010-10078
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
CFR Citation: 21 CFR Part 1
Docket ID: [Docket No. FDA-2010-N-0013]
RIN ID: RIN 0910-AG52
NOTICE: PROPOSED RULES
DOCUMENT ACTION: Advance notice of proposed rulemaking.
Implementation of Sanitary Food Transportation Act of 2005
DATES: Submit electronic or written comments by August 30, 2010.
The Food and Drug Administration (FDA) is issuing an advance
notice of proposed rulemaking (ANPRM) to request data and information
on the food transportation industry and its practices. FDA also is [[Page 22714]]
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.
Implementation of Sanitary Food Transportation Act (of 2005)
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.
\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.
\2\ 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).
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 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 longdistance transport of garbage was
clearly on the increase. GAO also concluded that longdistance
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
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 multistate 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:
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 crosscontamination between shipments. For example, in 2009,
peanut butter and peanut paste were confirmed as the source of a large
multistate outbreak caused by Salmonella Typhimurium (74 FR 10598,
March 11, 2009). These peanutderived 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 1,700pound 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 10959 (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.
\3\ 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.
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 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).
C. The 1996 Joint ANPRM
In 1996, FDA and FSIS jointly issued an advance notice of proposed
rulemaking (61 FR 59372, November 22, 1996) (the 1996 joint ANPRM). FDA
and FSIS issued the 1996 joint ANPRM in part to address FDA's safety
concerns regarding the transportation of food raised by a 1994 outbreak
of salmonellosis involving ice cream mix that became contaminated
during transport in tanker trucks that had previously hauled raw liquid
eggs (Ref. 9). In the 1996 joint ANPRM, FDA and FSIS requested comments
and information about approaches FDA and FSIS might take, under
existing legal authorities, to foster food safety improvements that may
be needed in the transportation and storage of potentially hazardous foods.\4\
\4\ As discussed in the 1996 joint ANPRM (61 FR 59372), potentially hazardous foods, including meat, poultry, eggs and egg products, fish, seafood, and dairy products, are those that are capable of supporting the rapid multiplication of microorganisms that cause foodborne illness. Currently, we generally use the term ``Time/Temperature Control for Safety (TCS) Food'' rather than ``potentially hazardous food'' and define a TCS food as a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation (Ref. 14). Examples of TCS foods include the foods identified as potentially hazardous foods in the 1996 joint ANPRM, and plant foods such as raw seed sprouts and cut melons (Ref. 14).
FDA took no subsequent action on the 1996 joint ANPRM. Data and information received in response to the 1996 joint ANPRM are now more than 10 years old.
D. The 2005 SFTA
In 2005, Congress passed the 2005 SFTA, Public Law 10959, 119 Stat. 1911, which:
\5\ The procedures DOT would establish are outside the scope of this document. We intend to assist DOT as appropriate in developing DOT's procedures for these inspections.
1. Our Responsibilities Under Section 416 of the Act
The statutory authority in section 416 of the act extends to
broader aspects of the sanitary transportation of food than the
statutory authority in the 1990 SFTA, which was primarily directed
toward preventing the contamination of food products by previously
hauled nonfood products. The authority in section 416 of the act places
a statutory obligation upon HHS (and, by delegation, to FDA) to issue
regulations establishing requirements for the food transportation
industry to use sanitary transportation practices to ensure that food
is not transported under conditions that may render food adulterated.
We describe key provisions of section 416 of the act in the following bulleted paragraphs.
transportation\6\ of food to use sanitary transportation practices prescribed by us to ensure that food is not transported under conditions that may render the food adulterated.
\6\ ``Transportation'' is defined by section 416(a)) of the act (21 U.S.C. 350e(a)) as ``any movement in commerce by a motor vehicle or rail vehicle.''
[cir] Section 416(c)(1) (21 U.S.C. 350e(c)(1)) requires these regulations to prescribe such practices as we determine to be appropriate relating to: (A) sanitation; (B) packaging, isolation, and other protective measures; (C) limitations on the use of vehicles; (D) information to be disclosed (to a carrier by a person arranging for the transportation of food, and to a manufacturer or other person that arranges for the transportation of food by a carrier; or furnishes a tank vehicle or bulk vehicle\7\ for the transportation of food); and (E) recordkeeping.
\7\ ``Bulk vehicle`` is defined by section 416(a) of the act as ``a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.''
[cir] Section 416(c)(2) (21 U.S.C. 350e(c)(2)) requires these regulations to include: (A) a list of nonfood products that we determine may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle; and (B) a list of nonfood products that we determine may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle.
2. Amendments to Sections 301, 402, and 703 of the Act
The 2005 SFTA also amended the act to add or revise provisions as follows:
E. Our Current Regulations and Guidance Documents Addressing Transportation of Food
We have addressed the transportation of food in several regulations
(in Title 21 of the Code of Federal Regulations (21 CFR)) and guidance
documents that are limited in scope. We describe the most relevant
regulations and guidance documents in table 1 of this document. The
regulations DOT proposed in the 2004 SNPRM would have included a
recommendation that each person who offers for transportation or
transports food or food products by motor vehicle or rail car use
guidance documents and materials issued by FDA and USDA, and
specifically identified three of FDA's guidance documents that were
then in effect: FDA Guidance on Bulk Transport of Juice Concentrates
and Certain Shelf Stable Juices; FDA Guidance on Food Security
Preventive Measures for Dairy Farms, Bulk Milk Transporters, Bulk Milk
Transfer Stations, and Fluid Milk Processors; and FDA Guidance on Food
Security Preventive Measures for Food Producers, Processors, and
Transporters (i.e., the guidances in Refs. 16, 17, and 18).
Table 1.FDA Regulations and Guidances Addressing the Transportation of Food Year &
Reference* Title Type Description Circumstances 1976 (Sec. Current Good Regulation Requires adequate Implemented requirements 225.65; 41 FR Manufacturing Practice cleanout procedures for in section 501(a)(2)(B) 52612 at for Medicated Feeds; all equipment used in of the act (21 U.S.C. 52618, Equipment Cleanout the manufacture or 351(a)(2)(B)) November 30, Procedures distribution of 1976) medicated feeds that are essential to avoiding unsafe contamination of feeds with drugs 1986; (Sec. Current Good Regulation Requires that storage and Issued as part of a 110.93 51 FR Manufacturing Practice transportation of broad revision to our 22458, June In Manufacturing, finished food be under current good 19, 1986) Packing, Or Holding conditions that will manufacturing practice Human Food; Warehousing protect food against (CGMP) regulations for and Distribution physical, chemical, and food microbial contamination as well as against deterioration of the food and the container 1997 (Sec. Listing of Specific Regulation Requires distributors of To provide animal feed Sec. Substances Prohibited mammalian and protections by 589.2000(c) From Use in Animal Food nonmammalian materials prohibiting the feeding through (e); or Feed; Requirements for animal food to of mammalian protein to 62 FR 30936, for renderers; provide for measures to ruminant animals June 5, 1997), Requirements for protein avoid commingling or updated in blenders, feed crosscontamination of 2008 (Sec. manufacturers, and the materials Sec. distributors; and
589.2000(c) Requirements for persons
through (e); that intend to separate
73 FR 22720, mammalian and
April 25, nonmammalian materials
1998; (Ref. 20) Guide to Minimize Guidance Includes recommendations Issued as part of the Microbial Food Safety regarding microbial food 1997 Presidential Hazards for Fresh Fruits safety hazards and good ``Initiative to Ensure and Vegetables\**\ agricultural and the Safety of Imported management practices and Domestic Fruits and common to the growing, Vegetables'' (Ref. 21) packing, and transporting of most fresh fruits and vegetables 2001; (Sec. Hazard Analysis And Regulation Requires that juice Added to the final rule 120.24(c)); 66 Critical Control Point processors complete a 5 to address comments FR 6138 at (HACCP) Systems; Process log pathogen reduction expressing concern 6172, January Controls treatment and final about the potential for 19, 2001) product packaging within recontamination or [Related SECG a single processing regrowth of surviving published in facility operating under pathogens if individual 2003 (Ref. CGMPs\***\ (``single treatments designed to 22)] facility requirement'') achieve a 5log reduction are separated by time or space [[Page 22718]]
2003; (Ref. 16) Guidance on Bulk Guidance Provides industry with Issued in response to a Transport of Juice recommendations for citizen petition Concentrates and Certain appropriate control requesting an exemption Shelf Stable Juices measures to use in the from the requirement in bulk transport of Sec. 120.24(c) when covered juice products certain products to ensure that the manufactured in one products do not become facility are sent to contaminated or re another facility for contaminated with final packaging microbial pathogens during bulk transport, and stated FDA's intent to consider the exercise of enforcement discretion with respect to the single facility requirement in Sec. 120.24(c) provided that certain conditions are met. 2003 (updated Dairy Farms, Bulk Milk Guidance Identifies the kinds of Issued in light of the 2007); (Ref. Transporters, Bulk Milk preventive measures potential for tampering 17) Transfer Stations and operators of bulk milk or other malicious, Fluid Milk Processors: transportation criminal, or terrorist Food Security Preventive operations may take to actions Measures Guidance minimize the risk that fluid milk under their control will be subject to tampering or other malicious, criminal, or terrorist actions 2003 (updated Food Producers, Guidance Identifies the kinds of Issued in light of the 2007) (Ref. Processors, and preventive measures potential for tampering 18) Transporters: Food operators of human or or other malicious, Security Preventive animal food criminal, or terrorist Measures Guidance establishments actions (including firms that distribute or transport food or food ingredients) may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions 2004 (Ref. 19) Guidance for Industry Guidance Provides guidance on Issued to address health
2007 (Ref. 26) Grade A Pasteurized Milk Model standard Sets forth training To facilitate the Ordinance, Appendix B, for voluntary requirements, evaluation shipment and acceptance Milk Sampling, Hauling adoption by criteria, and standards of milk and milk and Transportation State and to be met by bulk milk products of high local haulers and milk sanitary quality in authorities transporters interstate and intrastate commerce 2008 (Ref. 27) Guidance for Industry: Guidance Recommends practices for Part of recommendations Guide to Minimize transporting freshcut to enhance the safety Microbial Food Safety produce under conditions of freshcut produce by Hazards of FreshCut that will protect the minimizing microbial Fruits and Vegetables food against physical, food safety hazards chemical, and microbiological contamination 2008 (Sec. Cattle Materials Regulation Requires the use of To provide an additional 589.2001(c); Prohibited in Animal dedicated equipment for layer of animal feed 73 FR 22720; Food or Feed to Prevent handling and protections by removing April 25, the Transmission of transporting cattle that material at 2008) Bovine Spongiform materials prohibited in highest risk for Encephalopathy animal feed transmitting BSE through animal feed 2009 (21 CFR Production, Storage, And Regulation Establishes requirements Part of a rule requiring 118.1(b) and Transportation Of Shell for refrigeration of measures to prevent 118.4(e); 74 Eggs shell eggs during Salmonella Enteritidis FR 33030, July transportation in shell eggs during 9, 2009) production, storage, and transportation \*\ All section numbers cited in Table 1 refer to sections in 21 CFR. \**\ We have requested comments and scientific data to enable us to improve this guidance (73 FR 51306, September 2, 2008).
\***\ If a treated juice is transported to another facility for final packaging or blending and packaging operations, the entire 5log reduction must be repeated (66 FR 6138 at 6172, January 19, 2001). F. Current Industry Practices and Areas Where Food Is At Greatest Risk For Contamination
1. Interstate Food Transportation Assessment Project
In 2007, the Michigan Department of Agriculture released information obtained from its Interstate Food Transportation Assessment Project, conducted with the States of Michigan, Illinois, Indiana, and Ohio (Ref. 28). The purpose of the project was to determine the current state of food safety and food defense in the context of intransit food in interstate commerce. The project identified several areas of concern in food transport that increase the likelihood of food contamination, such as improper refrigeration, transport of raw meat and poultry simultaneously or sequentially in trucks also used to carry fruit and vegetables, food products lacking label or source information, improper packaging, infestation with insects, insanitary storage (e.g., roof leaks and moldy walls, animal blood and food on bed floors), lack of security seals or locks, low driver awareness of safe food temperatures, and inadequate food safety training of drivers (Refs. 28 and 29). Most of the specific instances where food transportation problems were found involved smaller box trucks and transporters of ethnic food; there were ``little or no areas of concern'' identified with larger (semitractor trailer) trucks inspected during the survey (Ref. 28).
2. Report by Eastern Research Group, Inc.
The data and information we received in response to the 1996 joint ANPRM are now dated. To obtain more current data and information, we recently contracted with Eastern Research Group, Inc. (ERG) to undertake a study designed to characterize current baseline practices in the sectors involved in food transportation and to identify current areas where food is at risk for adulteration (Ref. 29). In 2009, ERG issued a report (the ERG report) with its findings (Ref. 29). The ERG report describes the results of a comprehensive literature review pertaining to food handling practices in the food transportation industry. The ERG report also presents the findings from an expert opinion elicitation study, which ERG conducted to identify the main problems that pose microbiological, chemical, and/or physical safety hazards to food during transportation and storage, and to determine the preventive controls needed to address each of the problems identified. The ERG report largely discusses its findings from the perspective of food intended for consumption by humans (e.g., raw seafood, meat, poultry, produce, eggs, and refrigerated foods that are readytoeat) but also reports some findings related to animal feed.
In its report, ERG provides an overview of the domestic food supply
chain (Ref. 29). A manufacturing facility may be served by a tier of
suppliers. These manufacturing facilities then serve distribution
facilities, which eventually serve retailer outlets, including
restaurant retail facilities that serve the end consumer. Some food
manufacturers use thirdparty logistics providers to outsource
transportation procurement, while others organize the transport of
their goods internally. (A thirdparty logistics provider is a firm
that provides outsourced or ``third party'' logistics services to
companies for part or sometimes all of their supply chain management
function.) In this complex system, risk associated with an undetected
problem increases the further one moves back in the supply chain,
because a problem that is introduced further back in the supply chain
system can spread out to many distributors and retailers who serve consumers.
Through its literature review, ERG identified:
transportation and storage (i.e., physical, chemical, and biological contamination) and risk factors during transportation and holding; and
Through its literature review and expert opinion elicitation study,
ERG identified the following 15 problem areas where food may be at risk
for physical, chemical, or biological contamination during transport and storage:
Through its literature review and expert opinion elicitation study, ERG identified the following seven preventive controls with the broadest applicability across all food sectors and modes of transport:
II. Issues and Requests for Data and Information
As already noted, the data and information received in response to the 1996 joint ANPRM are dated and are of limited usefulness. The more recent data and information in the ERG report enhances our understanding of current baseline practices in the food transportation industry, problem areas that pose microbiological, chemical, and/or physical safety hazards to food during transportation and storage, and preventive controls that have the potential to address the problem areas.
The purpose of this document is to obtain data and information that would be more current and of greater relevance than the data and information we received in response to the 1996 joint ANPRM and to augment the more current information in the ERG report. Specifically, we request public comments containing data and information on the issues and questions listed in sections II.A through II.G of this document.
A. Issue 1: Firms Subject to the 2005 SFTA
We are seeking data and information about firms that are subject to the 2005 SFTA and the food for humans or animals that such firms transport. Firms subject to the 2005 SFTA include shippers, carriers by motor vehicle or rail vehicle, receivers, and any other person engaged in the transportation of food. These data and information will enhance our understanding of the characteristics of the firms that are providing food transportation services.
Question 1a. What types of vehicles or methods are used to transport food by motor vehicle or rail vehicle (e.g., bulk tank trucks, cargo tanks, and freight containers)?
Question 1b. How much food, and what percentage of food, is carried by each type of vehicle on an annual basis?
Question 1c. What are the amounts and percentages of foods that are transported completely enclosed by packaging, not completely enclosed by packaging (e.g., grain, some fresh produce items), or in bulk tanks (e.g., juices, oils)?
Question 1d. What proportion of vehicles is exclusively dedicated
to transporting foods? What proportion of vehicles transport both food and nonfood products?
B. Issues 2 through 6: Current Practices Used By Firms Subject to the 2005 SFTA
We are seeking data or information on the specific sanitary transportation practices that must be prescribed under regulations we establish under section 416(c)(1) of the act.
1. Issue 2: Sanitation Practices
Question 2a. What industry standards exist for the cleaning of food transportation vehicles?
Question 2b. How are appropriate protocols established for cleaning vehicles (including bulk vehicles and nonbulk vehicles)?
Question 2c. How is the adequacy of cleaning vehicles (including bulk vehicles and nonbulk vehicles) assessed?
2. Issue 3: Packaging, Isolation, and Other Protective Measures
Question 3a. What procedures and practices are in place to prevent contamination of foods not completely enclosed by packaging during transport?
Question 3b. How are the physical integrity and physical security of a food
transport vehicle ensured during its run?
Question 3c. What operations associated with food transport (e.g., intermodal transfer and pumping food from transport tanks into receiving vessels at the destination) pose the greatest potential for contaminating food?
Question 3d. What procedures and practices are in place to ensure temperature control for TCS foods?
3. Issue 4: Limitations on the Use of Vehicles
Question 4a. What types of food products are typically transported simultaneously? What types of food products are typically transported sequentially?
Question 4b. Are there any industry standards or State or local
restrictions on the simultaneous or sequential transport of different categories of food?
4. Issue 5: Information Sharing Among Parties Involved in the Transportation of Food
Through the 2005 SFTA, Congress provided express authority to specify the types of information that must be disclosed to carriers by persons arranging to transport food and to manufacturers or other persons that arrange for the transport of food or furnish a vehicle for the transportation of food. In our exercise of this authority, it is critical that we understand what sort of information exchange is feasible, practical, and/or desirable.
Question 5a. What types of information are currently disclosed to carriers by persons arranging to transport food? In what form is this information disclosed? What additional information would be useful or necessary to achieve the goals of the 2005 SFTA?
Question 5b. What types of information are currently disclosed to manufacturers or other persons that arrange for the transport of food by a carrier? In what form is this information disclosed? What additional information would be useful or necessary to achieve the goals of the 2005 SFTA?
Question 5c. What types of information are currently disclosed to
manufacturers or other persons that furnish a tank vehicle or bulk
vehicle for the transportation of food? In what form is this
information disclosed? What additional information would be useful or necessary to achieve the goals of the 2005 SFTA?
5. Issue 6. Records Currently Kept By Firms Subject to the 2005 SFTA
Question 6a. What types of records are currently kept by persons arranging to transport food? What additional records would be useful or necessary to achieve the goals of the 2005 SFTA? How long should persons arranging to transport food keep applicable records?
Question 6b. What types of information are currently kept by shippers and by carriers by motor vehicle or rail vehicle? What additional records would be useful or necessary to achieve the goals of the 2005 SFTA? How long should shippers and carriers by motor vehicle or rail vehicle keep applicable records?
Question 6c. What types of records are currently kept by receivers
of food? What additional records would be useful or necessary to
achieve the goals of the 2005 SFTA? How long should persons who receive food keep applicable records?
C. Issue 7. Simultaneous or Subsequent Shipment of Nonfood Products in Vehicles Used to Transport Food
Question 7a. Are food products transported simultaneously or sequentially with nonfood products? If the answer to this question is yes, what nonfood products are commonly transported in vehicles that also transport food?
Question 7b. What nonfood products may, if shipped in a bulk vehicle, pose a risk of contamination to food that is subsequently transported in the same vehicle?
Question 7c. What nonfood products may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), pose a risk of contamination to food that is simultaneously or subsequently transported in the same vehicle?
Question 7d. Are there any industry standards or State or local restrictions on the simultaneous or sequential transport of food and nonfood products?
D. Issue 8. Acceptable Reasons for Waiver of Requirements
Question 8. What reasons might exist for a waiver of any or all foreseeable requirements under section 416 with respect to any class of persons, vehicles, food, or nonfood products? For any such reason for waiver, identify and provide data and information that would support a possible determination that the waiver (A) will not result in the transportation of food under conditions that would be unsafe for human or animal health; and (B) will not be contrary to the public interest. E. Issue 9. Federal Preemption of State and Local Food Transportation Requirements
Section 416(e) of the act, as amended by the 2005 SFTA, states that a requirement of a State or political subdivision of a State that concerns the transportation of food is preempted if it conflicts with or presents an obstacle to implementing the requirements of this section or a regulation prescribed under this section. FDA is seeking comments on existing requirements of a State or political subdivision of a State regarding the sanitary transportation of food. FDA intends to solicit further comments regarding this provision in the proposed rule.
Question 9. What States or political subdivisions of a State have
requirements for the sanitary transportation of food and what are these requirements?
F. Issue 10. Risk for Foodborne Illness Associated With Transportation of Food
We have limited data and information about outbreaks of foodborne illness associated with transportation of food; see sections I.A and I.F of this document for a description of the data and information currently available to us. There are, however, a number of known areas where food is at risk for adulteration and reported instances of unsafe food transport (Refs. 10, 28, and 29). We are seeking data and information to enable us to focus our regulatory efforts in areas that present the greatest risk to public health.
Question 10a. What data or information are available on investigations that have shown a suspected or documented link between an outbreak of foodborne illness and the transport process?
Question 10b. What data or information are available in instances where food was suspected or documented of being contaminated during transport, even if the food was not implicated in an outbreak of foodborne illness?
Question 10c. What data or information are available from State or local authorities regarding compliance with or enforcement of State or local food transportation requirements?
Question 10d. What are the problem areas where food may be at greatest risk for physical, chemical, or biological contamination during transport?
G. Issue 11. Benefits and Costs
We are seeking data and information to enable us to estimate the benefits and costs of regulations implementing the 2005 SFTA and to estimate of the effects of regulatory options on small entities. [[Page 22722]]
Question 11a. What is the size of carrier firms (e.g., based on annual revenue or on number of vehicles)?
Question 11b. What is the number of small entities that could be affected by regulations implementing the 2005 SFTA?
Question 11c. What steps could be taken to lessen the burden on small entities while still protecting the public health?
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
We have placed the following references on display in the Division of Dockets Management (see ADDRESSES). You may see them between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)
1. FDA, 2005, CPG Sec. 565.100 FDA Jurisdiction Over Meat and Poultry Products. Available at http://www.fda.gov/ICECI/ ComplianceManuals/CompliancePolicyGuidanceManual/ucm074588.htm. Accessed and printed on February 18, 2010.
2. FSIS, 2005, FSIS Safety and Security Guidelines for the Transportation and Distribution of Meat, Poultry, and Egg Products. Accessed and printed on March 31, 2010.
3. Food Safety Working Group, 2009, Key Findings, Available at http://www.foodsafetyworkinggroup.gov/ContentKeyFindings/ HomeKeyFindings.htm. Accessed and printed on January 22, 2010.
4. FDA, 1982, FDA Notice of Judgment No. 31, FDA Consumer, Vol. 16, No. 7, pp. 3334.
5. FDA, 1975, Memorandum dated June 9, 1975, from Bureau of Veterinary Medicine to General Counsel regarding 026137G, Doc 096 447H, Corn Gluten Meal, Veterinary.
6. Schneider, K., 1989, ``Tainted Milk and Meat Raise
Vigilance,'' New York Times, May 11, 1989, Available at http:// www.nytimes.com/1989/05/11/us/taintedmilkandmeatraise
vigilance.html, Accessed and printed on July 24, 2009.
7. FDA, 1989, Memorandum dated November 15, 1989, from Case Guidance Branch, Division of Compliance, Center for Veterinary Medicine to New Orleans District Office Regarding Barium Carbonate Contamination, EIR 5/825/89, 89559371/382, Feeds and Ingredients.
8. U.S. Government Accounting Office, 1990, Report to Congressional Requesters, Truck Transport: Little is Known About Hauling Garbage and Food in the Same Vehicles, GAO/RCED90161, Available at http://archive.gao.gov/d23t8/141739.pdf, Accessed and printed on June 3, 2009.
9. Hennessy T.W., Hedberg, C.W., Slutsker, L. et al., 1996, ``A National Outbreak of Salmonella Enteriditis Infections From Ice Cream,'' New England Journal of Medicine, Vol. 334, No. 20, pp. 12811286.
10. Motor Carrier Division, Michigan State Police, 2007,
Commercial Motor Vehicle Enforcement Quarterly, Available at http:// www.michigan.gov/documents/msp/CMV_Quarterly_January_2007_
205099_7.pdf, Accessed and printed on May 28, 2009.
11. FDA, 2009, Recall of Products Containing Peanut Butter; Salmonella Typhimurium, Printed February 4, 2009.
12. FDA, 2009, Safety, FDA's Investigation, (Peanut Products Recall), Printed June 4, 2009.
13. Peanut Corporation of America, 2009, Press release, January 18, 2009, Available at http://www.fda.gov/Safety/Recalls/ ArchiveRecalls/2009/ucm128828.htm, Accessed and printed on June 2, 2009.
14. U.S. Department of Transportation, Office of Inspector General, 1998, Audit Report, Review of Departmental Actions Concerning the Sanitary Food Transportation Act of 1990, Research and Special Programs Administration, TR1998100, Available at http://www.oig.dot.gov/StreamFile?file=/data/pdfdocs/tr1998100.pdf, Accessed and printed on June 3, 2009.
15. FDA, 2009, Food Code, Chapter 1, Purpose and Definitions, Available at http://www.fda.gov/Food/FoodSafety/ RetailFoodProtection/FoodCode/FoodCode2009/ucm186464.htm, Accessed and printed on November 24, 2009.
16. FDA, 2003, Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices, Available at http://www.fda.gov/ Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ default.htm, Accessed and printed on June 4, 2009.
17. FDA, 2007, Dairy Farms, Bulk Milk Transporters, Bulk Milk
Transfer Stations and Fluid Milk Processors: Food Security
Preventive Measures Guidance, Available at http://www.fda.gov/Food/ GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
default.htm, Accessed and printed on June 4, 2009.
18. FDA, 2007, Food Producers, Processors, and Transporters:
Food Security Preventive Measures Guidance, Available at http:// www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/default.htm, Accessed and printed on June 4, 2009.
19. FDA, 1998, FDA Guidance for Industry
20. FDA, 1998, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, Available at http://www.fda.gov/ Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ default.htm, Accessed and printed on June 4, 2009.
21. The White House, Office of the Press Secretary, 1997, President Clinton Announces Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables, Available at http:// clinton4.nara.gov/textonly/WH/New/html/199710028886.html, Accessed and printed on November 30, 2009.
22. FDA, 2003, Guidance for Industry: Juice HACCP; Small Entity Compliance Guide, Available at http://www.fda.gov/Food/
FOR FURTHER INFORMATION CONTACT
Regarding the provisions with respect to human food: Michael Kashtock, Center for Food Safety and Applied Nutrition (HFS317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 207403835, 3014362022.
Regarding the provisions with respect to food for animals: Shannon Jordre, Center for Veterinary Medicine (HFV235), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 2402769229.