Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Proposed Rules 22713 

Aviation Administration, Southwest 

Region, 2601 Meacham Blvd., Fort 

Worth, TX 76137; telephone: (817) 321– 

7716. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

Interested parties are invited to 

participate in this proposed rulemaking 

by submitting such written data, views, 

or arguments, as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers and be submitted in 

triplicate to the address listed above. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this notice must submit with those 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to 

Docket No. FAA–2010–0406/Airspace 

Docket No. 10–ASW–8.’’ The postcard 

will be date/time stamped and returned 

to the commenter. 

Availability of NPRMs 

An electronic copy of this document 

may be downloaded through the 

Internet at http://www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s Web page at http:// 

www.faa.gov/airports_airtraffic/ 

air_traffic/publications/ 

airspace_amendments/. 

You may review the public docket 

containing the proposal, any comments 

received and any final disposition in 

person in the Dockets Office (see 

ADDRESSES section for address and 

phone number) between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. An informal docket 

may also be examined during normal 

business hours at the office of the 

Central Service Center, 2601 Meacham 

Blvd., Fort Worth, TX 76137. 

Persons interested in being placed on 

a mailing list for future NPRMs should 

contact the FAA’s Office of Rulemaking 

(202) 267–9677, to request a copy of 

Advisory Circular No. 11–2A, Notice of 

Proposed Rulemaking Distribution 

System, which describes the application 

procedure. 

The Proposal 

This action proposes to amend Title 

14, Code of Federal Regulations (14 

CFR), Part 71 by establishing Class D 

airspace at San Marcos Municipal 

Airport, San Marcos, TX. An air traffic 

control tower established at the airport 

has made controlled airspace necessary 

for the safety and management of IFR 

operations. 

Class D airspace areas are published 

in Paragraph 5000 of FAA Order 

7400.9T, signed August 27, 2009 and 

effective September 15, 2009, which is 

incorporated by reference in 14 CFR 

71.1. The Class D airspace designation 

listed in this document would be 

published subsequently in the Order. 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore, (1) is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under DOT Regulatory Policies 

and Procedures (44 FR 11034; February 

26, 1979); and (3) does not warrant 

preparation of a Regulatory Evaluation 

as the anticipated impact is so minimal. 

Since this is a routine matter that will 

only affect air traffic procedures and air 

navigation, it is certified that this rule, 

when promulgated, will not have a 

significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the U.S. Code. Subtitle 1, 

Section 106 describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the agency’s 

authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it would 

establish controlled airspace at San 

Marcos Municipal Airport, San Marcos, 

TX. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (Air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR Part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(g); 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9T, 

Airspace Designations and Reporting 

Points, signed August 27, 2009, and 

effective September 15, 2009, is 

amended as follows: 

Paragraph 5000 Class D Airspace. 

* * * * * 

AGL TX D San Marcos Municipal Airport, 

TX [New] 

San Marcos Municipal Airport, TX 

(Lat. 29°53′34′′ N., long. 97°51′47′′ W.) 

That airspace extending upward from the 

surface to and including 3,100 feet MSL 

within a 4.2-mile radius of San Marcos 

Municipal Airport, and within 1 mile each 

side of the 313° bearing from the airport 

extending from the 4.2-mile radius to 4.6 

miles northwest of the airport. This Class D 

airspace area is effective during the specific 

dates and times established in advance by a 

Notice to Airmen. The effective dates and 

times will thereafter be continuously 

published in the Airport/Facility Directory. 

Issued in Fort Worth, TX on April 19, 

2010. 

Anthony D. Roetzel, 

Manager, Operations Support Group, ATO 

Central Service Center. 

[FR Doc. 2010–10039 Filed 4–29–10; 8:45 am] 

BILLING CODE 4901–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2010–N–0013] 

RIN 0910–AG52 

Implementation of Sanitary Food 

Transportation Act of 2005 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: 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 


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1With 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. 

2USDA’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). 

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: 

• FAX: 301–827–6870. 

• 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 

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 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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3The 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. 

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 multistate 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 

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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4As 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). 

5The 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. 

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.’’ 

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.’’ 

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

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 109–59, 119 Stat. 

1911, 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; and 

• Requires the Secretary of DOT, in 

consultation with the Secretaries of 

HHS and USDA, to establish procedures 

for transportation safety inspections for 

the purpose of identifying suspected 

incidents of contamination or 

adulteration of a food.5

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. 

• Section 416(b) (21 U.S.C. 350e(b)) 

requires us to establish regulations 

requiring shippers, carriers by motor 

vehicle or rail vehicle, receivers, and 

other persons engaged in the 

transportation6 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. 

• Section 416(c) (21 U.S.C. 350e(c)) 

addresses the content of the regulations 

to be established under section 416(b). 

Æ 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 vehicle7 for the 

transportation of food); and (E) 

recordkeeping. 

Æ 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. 

• Section 416(d) (21 U.S.C. 350e(d)) 

provides that we may waive any 

requirement under section 416, with 

respect to any class of persons, vehicles, 

food, or nonfood products, if we 

determine 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. 

We must publish in the Federal Register 

any waiver and the reasons for the 

waiver. 

• Section 416(e) (21 U.S.C. 350e(e)) 

provides that State or local requirements 

concerning transportation of food are 

preempted if: (A) complying with both 

the State or local requirement and 

section 416, or a regulation prescribed 

under section 416, is not possible; or (B) 

the State or local requirement as applied 

or enforced is an obstacle to 

accomplishing and carrying out section 

416 or a regulation prescribed under 

section 416. 

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: 

• Sections 402(i) and 301(hh) (21 

U.S.C. 342(i) and 331(hh)): Section 

402(i) provides that a food shall be 

deemed adulterated if it is transported 

or offered for transport by a shipper, 

carrier by motor vehicle or rail vehicle, 

receiver, or any other person engaged in 

the transportation of food under 

conditions that are not in compliance 

with regulations issued under section 

416 of the act. Under section 301(hh), 

the failure (or the causing thereof) by a 

shipper, carrier by motor vehicle or rail 

vehicle, receiver, or any other person 

engaged in the transportation of food to 

comply with the sanitary transportation 

practices prescribed by us under section 

416 is a prohibited act subject to the 

sanctions and penalties provided in 

Chapter III of the act. 

• Sections 703(b) and 301(e) (21 

U.S.C. 373(b) and 331(e)): Section 703(b) 

requires any person subject to section 

416 to permit a designated officer or 

employee who requests required records 

(i.e., records required to be kept in 

accordance with section 416(c)(1)(E)) to 

have access to all such records at 

reasonable times and to copy all such 

records. Under section 301(e), the 

refusal to permit access to or copying of 

any record as required by section 416, 

or the failure to establish or maintain 

any record required under section 416, 

or the refusal to permit access to or 

verification or copying of any such 

required record is a prohibited act 

subject to the sanctions and penalties 

provided in Chapter III of the act. 


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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 (§ 225.65; 41 

FR 52612 at 

52618, November 30, 1976) 

Current Good Manufacturing 

Practice for Medicated Feeds; 

Equipment Cleanout Procedures 

Regulation Requires adequate cleanout 

procedures for all equipment 

used in the manufacture or 

distribution of medicated 

feeds that are essential to 

avoiding unsafe contamination of feeds with drugs 

Implemented requirements in 

section 501(a)(2)(B) of the act 

(21 U.S.C. 351(a)(2)(B)) 

1986; (§ 110.93 51 

FR 22458, June 

19, 1986) 

Current Good Manufacturing 

Practice In Manufacturing, 

Packing, Or Holding Human 

Food; Warehousing and Distribution 

Regulation Requires that storage and transportation of finished food be 

under conditions that will protect food against physical, 

chemical, and microbial contamination as well as against 

deterioration of the food and 

the container 

Issued as part of a broad revision to our current good manufacturing practice (CGMP) 

regulations for food 

1997 

(§§ 589.2000(c) 

through (e); 62 

FR 30936, June 

5, 1997), updated in 2008 

(§§ 589.2000(c) 

through (e); 73 

FR 22720, April 

25, 2008) 

[Related Small Entity Compliance 

Guide (SECG) 

published in 

1998 (Ref. 19)] 

Listing of Specific Substances 

Prohibited From Use in Animal Food or Feed; Requirements for renderers; Requirements for protein blenders, 

feed manufacturers, and distributors; and Requirements 

for persons that intend to separate mammalian and nonmammalian materials 

Regulation Requires distributors of mammalian and nonmammalian 

materials for animal food to 

provide for measures to avoid 

commingling or cross-contamination of the materials 

To provide animal feed protections by prohibiting the feeding of mammalian protein to 

ruminant animals 

1998; (Ref. 20) Guide to Minimize Microbial 

Food Safety Hazards for 

Fresh Fruits and Vegetables**

Guidance Includes recommendations regarding microbial food safety 

hazards and good agricultural 

and management practices 

common to the growing, 

packing, and transporting of 

most fresh fruits and vegetables 

Issued as part of the 1997 Presidential ‘‘Initiative to Ensure 

the Safety of Imported and 

Domestic Fruits and Vegetables’’ (Ref. 21) 

2001; (§ 120.24(c)); 

66 FR 6138 at 

6172, January 

19, 2001) 

[Related SECG 

published in 

2003 (Ref. 22)] 

Hazard Analysis And Critical 

Control Point (HACCP) Systems; Process Controls 

Regulation Requires that juice processors 

complete a 5-log pathogen reduction treatment and final 

product packaging within a 

single processing facility operating under CGMPs*** (‘‘single 

facility requirement’’) 

Added to the final rule to address comments expressing 

concern about the potential 

for recontamination or regrowth of surviving pathogens 

if individual treatments designed to achieve a 5-log reduction are separated by time 

or space 


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TABLE 1.—FDA REGULATIONS AND GUIDANCES ADDRESSING THE TRANSPORTATION OF FOOD—Continued 

Year & Reference* Title Type Description Circumstances 

2003; (Ref. 16) Guidance on Bulk Transport of 

Juice Concentrates and Certain Shelf Stable Juices 

Guidance Provides industry with recommendations for appropriate 

control measures to use in 

the bulk transport of covered 

juice products to ensure that 

the products do not become 

contaminated or re-contaminated with 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 § 120.24(c) provided that certain conditions 

are met. 

Issued in response to a citizen 

petition requesting an exemption from the requirement in 

§ 120.24(c) when certain 

products manufactured in one 

facility are sent to another facility for final packaging 

2003 (updated 

2007); (Ref. 17) 

Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer 

Stations and Fluid Milk Processors: Food Security Preventive Measures Guidance 

Guidance Identifies the kinds of preventive 

measures operators of bulk 

milk transportation operations 

may take to minimize the risk 

that fluid milk under their control will be subject to tampering or other malicious, 

criminal, or terrorist actions 

Issued in light of the potential 

for tampering or other malicious, criminal, or terrorist actions 

2003 (updated 

2007) (Ref. 18) 

Food Producers, Processors, 

and Transporters: Food Security Preventive Measures 

Guidance 

Guidance Identifies the kinds of preventive 

measures operators of human 

or animal food establishments 

(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 

Issued in light of the potential 

for tampering or other malicious, criminal, or terrorist actions 

2004 (Ref. 19) Guidance for Industry #122: 

Manufacture and Labeling of 

Raw Meat Foods for Companion and Captive Noncompanion Carnivores and 

Omnivores 

Guidance Provides guidance on transport 

of foods that contain raw 

meat, or other raw animal tissues, for consumption by 

dogs, cats, other companion 

or pet animals, and captive 

noncompanion animal carnivores and omnivores 

Issued to address health risks 

when raw meat foods are 

used, particularly by pet owners 

2004 (§ 1.352 and 

§§ 1.360 through 

1.363; 69 FR 

71562, December 9, 2004) 

[Related SECG 

published in 

2004 (Ref. 24)] 

Establishment, Maintenance, 

and Availability of Records: 

What information must transporters establish and maintain?; What are the record retention requirements?; What 

are the record availability requirements?; What records 

are excluded from this subpart?; What are the consequences of failing to establish or maintain records or 

make them available to FDA? 

Regulation Requires persons who transport 

food for humans and animals 

to establish and maintain 

records identifying the immediate previous source of all 

food received, and the immediate subsequent recipient of 

all food released, as well as 

certain other information related to the transported food; 

Sets forth the record retention 

and record availability requirements for transporters 

Implementation of section 306 

of the 2002 Bioterrorism Act, 

which directs the HHS Secretary to issue regulations requiring persons who manufacture, process, pack, transport, 

distribute, receive, hold, or 

import food for humans and 

animals to establish and 

maintain records identifying 

the immediate previous 

source of all food received, 

and the immediate subsequent recipient of all food released 

2005 (revised 

2006) (Ref. 25) 

Notice from FDA to Growers, 

Food Manufacturers, Food 

Warehouse Managers, and 

Transporters of Food Products on Decontamination of 

Transport Vehicles 

Guidance Provides information and references that can be used for 

the decontamination of food 

transport vehicles that have 

been flooded or otherwise impacted by hurricanes, before 

being placed back in service 

to transport or store food 

Developed following Hurricanes 

Katrina and Rita in August 

and September 2005 


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TABLE 1.—FDA REGULATIONS AND GUIDANCES ADDRESSING THE TRANSPORTATION OF FOOD—Continued 

Year & Reference* Title Type Description Circumstances 

2007 (Ref. 26) Grade A Pasteurized Milk Ordinance, Appendix B, Milk 

Sampling, Hauling and Transportation 

Model standard 

for voluntary 

adoption by 

State and local 

authorities 

Sets forth training requirements, 

evaluation criteria, and standards to be met by bulk milk 

haulers and milk transporters 

To facilitate the shipment and 

acceptance of milk and milk 

products of high sanitary 

quality in interstate and intrastate commerce 

2008 (Ref. 27) Guidance for Industry: Guide to 

Minimize Microbial Food 

Safety Hazards of Fresh-Cut 

Fruits and Vegetables 

Guidance Recommends practices for 

transporting fresh-cut produce 

under conditions that will protect the food against physical, 

chemical, and microbiological 

contamination 

Part of recommendations to enhance the safety of fresh-cut 

produce by minimizing microbial food safety hazards 

2008 

(§ 589.2001(c); 

73 FR 22720; 

April 25, 2008) 

Cattle Materials Prohibited in 

Animal Food or Feed to Prevent the Transmission of Bovine Spongiform 

Encephalopathy 

Regulation Requires the use of dedicated 

equipment for handling and 

transporting cattle materials 

prohibited in animal feed 

To provide an additional layer of 

animal feed protections by removing that material at highest risk for transmitting BSE 

through animal feed 

2009 (21 CFR 

118.1(b) and 

118.4(e); 74 FR 

33030, July 9, 

2009) 

Production, Storage, And Transportation Of Shell Eggs Regulation Establishes requirements for refrigeration of shell eggs during transportation Part of a rule requiring measures to prevent Salmonella 

Enteritidis in shell eggs during 

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 5-log 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 in-transit 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 (semi-tractor 

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 ready-toeat) 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 third-party logistics 

providers to outsource transportation 

procurement, while others organize the 

transport of their goods internally. (A 

third-party 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: 

• Existing food transportation 

guidelines prepared by Federal 

agencies, foreign countries, 

international organizations, and trade 

associations; 

• Three types of potential 

contamination that could arise during 


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transportation and storage (i.e., 

physical, chemical, and biological 

contamination) and risk factors during 

transportation and holding; and 

• Best practices for food 

transportation and holding (i.e., 

temperature control, increased security 

and tracking, proper loading/unloading 

practices, monitoring and ensuring the 

sanitation and condition of 

transportation vehicles, good 

communication, employee awareness 

and training, and pest control 

programs). 

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: 

• Improper refrigeration or 

temperature control of food products 

(temperature abuse). This may be 

intentional (abuse or violation of 

practices by drivers, i.e., turning off 

refrigeration units) or unintentional 

(due, for example, to improper holding 

practices or shortages of appropriate 

shipping containers or vessels). 

• Improper management of 

transportation units or storage facilities 

to preclude cross-contamination, 

including improper sanitation, 

backhauling hazardous materials, not 

maintaining tanker wash records, 

improper disposal of wastewater, and 

aluminum phosphide fumigation 

methods in railcar transit; 

• Improper packing of transportation 

units or storage facilities, including 

incorrect use of packing materials and 

poor pallet quality; 

• Improper loading practices, 

conditions, or equipment, including 

improper sanitation of loading 

equipment, not using dedicated units 

where appropriate, inappropriate 

loading patterns, and transporting 

mixed loads that increase the risk for 

cross-contamination; 

• Improper unloading practices, 

conditions, or equipment, including 

improper sanitation of equipment and 

leaving raw materials on loading docks 

after hours; 

• Lack of security for transportation 

units or storage facilities, including lack 

of or improper use of security seals and 

lack of security checks or records of 

transporters; 

• Poor pest control in transportation 

units or storage facilities; 

• Lack of driver/employee training 

and/or supervisor/manager/owner 

knowledge of food safety and/or 

security; 

• Poor transportation unit design and 

construction; 

• Inadequate preventive maintenance 

for transportation units or storage 

facilities, resulting in roof leaks, gaps in 

doors, and dripping condensation or ice 

accumulations; 

• Poor employee hygiene; 

• Inadequate policies for the safe and/ 

or secure transport or storage of foods; 

• Improper handling and tracking of 

rejected loads and salvaged, reworked, 

and returned products or products 

destined for disposal; 

• Improper holding practices for food 

products awaiting shipment or 

inspection, including unattended 

product, delayed holding of product, 

shipping of product while in 

quarantine, and poor rotation and 

throughput; and 

• Lack of traceability for food 

products during transportation 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: 

• Employee awareness and training; 

• Management review of records; 

• Good communication between 

shipper, transporter, and receiver; 

• Appropriate loading procedures for 

transportation units; 

• Appropriate unloading procedures 

for transportation units; 

• Appropriate documentation 

accompanying each load (e.g., tanker 

wash record, seal numbers, temperature 

readings, time in-transit, and time on 

docks); and 

• Appropriate packaging/packing of 

food products and transportation units 

(e.g., good quality pallets, correct use of 

packing materials). 

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 


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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. 


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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? 

III. Comments 

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. 

IV. References 

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/CompliancePolicy

GuidanceManual/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.foodsafety

workinggroup.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. 33– 

34. 

5. FDA, 1975, Memorandum dated June 9, 

1975, from Bureau of Veterinary Medicine to 

General Counsel regarding 026–137G, 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/taintedmilk-and-meat-raise-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 5/8–25/89, 89–559–371/ 

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/RCED–90–161, 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. 1281–1286. 

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, TR–1998–100, 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/RetailFood

Protection/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/GuidanceCompliance

RegulatoryInformation/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/GuidanceCompliance

RegulatoryInformation/GuidanceDocuments/ 

default.htm, Accessed and printed on June 4, 

2009. 

19. FDA, 1998, FDA Guidance for Industry 

#68, Small Entities Compliance Guide for 

Protein Blenders, Feed Manufacturers, and 

Distributors, Available at http:// 

www.fda.gov/downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/UCM052382.pdf, 

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20. FDA, 1998, Guide to Minimize 

Microbial Food Safety Hazards for Fresh 

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2009. 

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on November 30, 2009. 

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Juice HACCP; Small Entity Compliance 

Guide, Available at http://www.fda.gov/ 

Food/GuidanceCompliance

RegulatoryInformation/GuidanceDocuments/ 

default.htm, Accessed and printed on 

September 23, 2009. 

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Manufacture and Labeling of Raw Meat 

Foods for Companion and Captive 

Noncompanion Carnivores and Omnivores, 

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AnimalVeterinary/GuidanceCompliance

Enforcement/GuidanceforIndustry/ 

ucm052662.pdf, Accessed and printed on 

August 4, 2009. 

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About Establishment and Maintenance of 

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default.htm, Accessed and printed on 

September 23, 2009. 

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Food Products on Decontamination of 

Transport Vehicles, Available at http:// 

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November 30, 2009. 

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Appendix B—Milk Sampling, Hauling and 

Transportation, Available at http:// 

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wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Proposed Rules 22723 

1The MOU can be viewed online at http:// 

www.osmre.gov/resources/ref/mou/ 

ASCM061109.pdf. 

HHSF223200730236G, ERG Task No. 

0193.16.001.001. 

Dated: April 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10078 Filed 4–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Parts 780, 784, 816, and 817 

RIN 1029–AC63 

Stream Protection Rule; Environmental 

Impact Statement 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Proposed rule; notice of intent 

to prepare an environmental impact 

statement. 

SUMMARY: We, the Office of Surface 

Mining Reclamation and Enforcement 

(OSM), intend to prepare an 

environmental impact statement (EIS) 

under section 102(2)(C) of the National 

Environmental Policy Act of 1969 

(NEPA) to analyze the effects of 

potential rule revisions under the 

Surface Mining Control and 

Reclamation Act of 1977 (SMCRA or the 

Act) to improve protection of streams 

from the adverse impacts of surface coal 

mining operations. We are requesting 

comments for the purpose of 

determining the scope of the EIS. 

DATES: To ensure consideration, we 

must receive your electronic or written 

comments on June 1, 2010. 

ADDRESSES: You may submit comments 

by any of the following methods, 

although we request that you use 

electronic mail if possible: 

• Electronic mail: Send your 

comments to sra-eis@osmre.gov. 

• Mail, hand-delivery, or courier: 

Send your comments to Office of 

Surface Mining Reclamation and 

Enforcement, Administrative Record, 

Room 252–SIB, 1951 Constitution 

Avenue, NW., Washington, DC 20240. 

FOR FURTHER INFORMATION CONTACT: John 

Craynon, Chief, Division of Regulatory 

Support, Office of Surface Mining 

Reclamation and Enforcement, 1951 

Constitution Ave., NW., MS 202–SIB, 

Washington, DC 20240; Telephone 202– 

208–2866. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Why are we planning to revise our rules? 

II. What is the proposed federal action? 

III. How do I submit comments? 

IV. How do I request to participate as a 

cooperating agency? 

I. Why are we planning to revise our 

rules? 

On December 12, 2008 (73 FR 75814– 

75885), we published a final rule 

modifying the circumstances under 

which mining activities may be 

conducted in or near perennial or 

intermittent streams. That rule, which 

this document refers to as the 2008 rule, 

took effect January 12, 2009. A total of 

nine organizations challenged the 

validity of the rule in two complaints 

filed on December 22, 2008, and January 

16, 2009 (amended complaint filed 

February 17, 2009): Coal River Mountain 

Watch, et al. v. Salazar, No. 08–2212 

(D.D.C.) (‘‘Coal River’’) and National 

Parks Conservation Ass’n v. Salazar, 

No. 09–115 (D.D.C.) (‘‘NPCA’’). Under 

the terms of a settlement agreement 

signed by the parties on March 19, 2010, 

we agreed to use best efforts to sign a 

proposed rule by February 28, 2011, and 

a final rule by June 29, 2012. We also 

agreed to consult with the Fish and 

Wildlife Service pursuant to the 

Endangered Species Act, as appropriate, 

prior to signing the final action. On 

April 2, 2010, the court granted the 

parties’ motion to hold the judicial 

proceedings in abeyance. 

However, we had already embarked 

on that course following the change of 

Administrations on January 20, 2009. 

On June 11, 2009, the Secretary of the 

Department of the Interior, the 

Administrator of the U.S. 

Environmental Protection Agency 

(EPA), and the Acting Assistant 

Secretary of the Army (Civil Works) 

entered into a memorandum of 

understanding 1 (MOU) implementing 

an interagency action plan designed to 

significantly reduce the harmful 

environmental consequences of surface 

coal mining operations in six 

Appalachian states, while ensuring that 

future mining remains consistent with 

Federal law. Among other things, the 

MOU committed us to consider 

revisions to key provisions of our rules, 

including the 2008 rule and 

approximate original contour 

requirements, to better protect the 

environment and public health from the 

impacts of Appalachian surface coal 

mining. 

Consequently, on November 30, 2009, 

we published an advance notice of 

proposed rulemaking (ANPRM) 

soliciting comments on ten potential 

rulemaking alternatives. See 74 FR 

62664–62668. In addition, consistent 

with the MOU, we invited the public to 

identify other rules that we should 

revise. We also announced our intent to 

prepare a supplement to the EIS 

developed in connection with the 2008 

rule. 

We received approximately 32,750 

comments during the 30-day comment 

period that closed December 30, 2009. 

After evaluating those and other 

comments, we determined that 

development of a comprehensive stream 

protection rule (one that is much 

broader in scope than the 2008 rule) 

would be the most appropriate and 

effective method of achieving the goals 

set forth in the MOU and the ANPRM. 

We believe that this holistic approach 

will better protect streams and related 

environmental values. The broader 

scope of the stream protection rule 

means that we will need to prepare a 

new environmental impact statement 

rather than the supplement to the 2008 

EIS that we originally intended to 

prepare. 

II. What is the proposed federal action? 

The proposed Federal action consists 

of revisions to various provisions of our 

rules to improve protection of streams 

from the impacts of surface coal mining 

operations nationwide. We do not 

believe that it would be fair, 

appropriate, or scientifically valid to 

apply the new protections only in 

central Appalachia, as some 

commenters on the ANPRM advocated. 

Streams are ecologically significant 

regardless of the region in which they 

are located. Principal elements of the 

proposed action include— 

• Adding more extensive and more 

specific permit application 

requirements concerning baseline data 

on hydrology, geology, and aquatic 

biology; the determination of the 

probable hydrologic consequences of 

mining; and the hydrologic reclamation 

plan; as well as more specific 

requirements for the cumulative 

hydrologic impact assessment. 

• Defining the term ‘‘material damage 

to the hydrologic balance outside the 

permit area.’’ This term is critically 

important because, under section 

510(b)(3) of SMCRA, the regulatory 

authority may not approve a permit 

application unless the proposed 

operation has been designed to prevent 

material damage to the hydrologic 

balance outside the permit area. This 

term includes streams downstream of 

the mining operation. 

• Revising the regulations governing 

mining activities in or near streams, 

including mining through streams. 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1