54106 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

seller of futures who is the buyer of the 

corresponding commodity or derivatives 

position. A third party could be permitted to 

facilitate the purchase and sale of the 

commodity or derivatives position as long as 

the commodity or derivatives position is 

passed through to the party that receives the 

futures position. The transaction would have 

to result in an actual transfer of ownership 

of the commodity or derivatives position. It 

also would have to be between parties with 

different beneficial owners or under separate 

control, who had possession, right of 

possession, or right to future possession of 

the commodity or derivatives position prior 

to the trade, the ability to perform the 

transaction, and resulting in a transfer of 

title. 

(B) Pricing. The price differential between 

the futures leg and the commodities leg or 

derivatives position should reflect 

commercial realities, and at least one leg of 

the transaction should be priced at the 

prevailing market price. 

(C) Transitory exchange of futures for 

commodities or for derivatives positions. 

Parties to an exchange of futures for 

commodities or for derivatives positions 

could be permitted to engage in a separate 

but related cash transaction that offsets the 

cash leg of the exchange of futures for 

commodities or for derivatives positions. The 

related cash transaction would have to result 

in an actual transfer of ownership of the 

commodity or derivatives position and 

demonstrate other indicia of being a bona 

fide transaction as described in paragraph (a). 

The cash transaction must be able to stand 

on its own as a commercially appropriate 

transaction, with no obligation on either 

party that the cash transaction be dependent 

upon the execution of the related exchange 

of futures for commodities or for derivatives 

positions, or vice versa. 

(D) Reporting. Exchanges of futures for 

commodities or for derivatives positions 

should be reported to the contract market 

within a reasonable period of time. 

(E) Publication. The contract market would 

publicize daily the total quantity of 

exchanges of futures for commodities or for 

derivatives positions that are included in the 

total volume of trading, as required by 

§ 16.01 of this chapter. 

(iv) Office trades. [Reserved] 

(v) Transfer trades. [Reserved] 

Issued in Washington, DC on September 

12, 2008 by the Commission. 

David Stawick, 

Secretary of the Commission. 

[FR Doc. E8–21865 Filed 9–17–08; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2007–N–0465] 

RIN 0910–AF61 

Label Requirement for Food That Has 

Been Refused Admission into the 

United States 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a 

proposed rule that would require 

owners or consignees to label imported 

food that is refused entry into the 

United States. The label would read, 

‘‘UNITED STATES: REFUSED ENTRY.’’ 

The proposal would describe the label’s 

characteristics (such as its size) and 

processes for verifying that the label has 

been affixed properly. We are taking this 

action to prevent the reintroduction of 

refused food into the United States, to 

facilitate the examination of imported 

food, and to implement part of the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002. 

DATES: Submit written or electronic 

comments on the proposed rule by 

December 2, 2008. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 

October 20, 2008, (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2007–N– 

0465, by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

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. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described 

previously, in the ADDRESSES portion of 

this document under Electronic 

Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number and Regulatory 

Information Number (RIN) 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: 

Philip L. Chao, Office of Policy and 

Planning (HF–23), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–0587. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

A. How Did the Idea of Marking Refused 

Food Imports Originate? 

Section 801 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

381) authorizes us to examine foods, 

drugs, devices, and cosmetics that are 

imported or offered for import into the 

United States and to refuse admission to 

products that appear, from examination 

or otherwise, to be (among other things) 

adulterated or misbranded. 

Our examination of food imports 

usually begins with an electronic prior 

notice and then an entry review to 

determine whether additional scrutiny 

at arrival or thereafter is warranted. We 

may, based on our review, permit the 

goods to proceed without further 

examination. We may take additional 

steps to determine whether the 

shipment appears to comply with the 

act, including: (1) Visually examining 

the goods; (2) taking samples of the 

goods for laboratory analysis; (3) 

verifying the registration, declarations, 

and certifications for the goods; and/or 

(4) requesting supporting 

documentation. If our additional 


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examination shows that the food 

appears to be in compliance with the 

act, we allow the shipment to proceed. 

If the food appears not to be in 

compliance, we issue a notice that the 

shipment has been detained, and the 

owner or consignee has an informal 

opportunity to provide evidence or 

testimony that the food complies with 

the act or to submit a plan to 

recondition the food (21 CFR 1.94 and 

1.95). If the importer is unable to 

demonstrate that the food complies with 

the act and reconditioning has failed to 

bring the food into compliance, we 

refuse admission to the food. Section 

801(a) of the act provides that, if refused 

foods are not re-exported within 90 days 

of refusal (or such other time as 

Customs and Border Protection (CBP) 

permits), CBP ensures that the food is 

destroyed. 

In the Federal Register of January 22, 

2001 (66 FR 6502), we published a 

proposed rule (the 2001 proposed rule) 

that would require importers or 

consignees whose food is refused entry 

into the United States for safety reasons 

to mark the refused foods. The mark 

would state, ‘‘UNITED STATES 

REFUSED ENTRY.’’ The proposed rule 

also would prohibit persons from 

refusing to affix this mark on refused 

food, from importing or offering to 

import a previously refused food, and 

from altering, removing, tampering 

with, or concealing a mark. 

We issued the 2001 proposed rule to 

address a practice known as ‘‘port 

shopping.’’ In general, when FDA 

refuses to admit a food into the United 

States, the food must be exported from 

the United States or destroyed. 

However, instead of simply exporting or 

destroying the refused food, some 

unscrupulous persons attempt to bring 

the refused food back into the United 

States by shipping it to another port in 

hopes that the food will be admitted 

into the United States at that other port. 

The 2001 proposed rule also was in 

response to an April 1998 report by the 

General Accounting Office (GAO), 1998 

hearings held by the Senate Committee 

on Governmental Affairs’ Permanent 

Subcommittee on Investigations, and a 

July 3, 1999, Presidential memorandum 

(see GAO, ‘‘Food Safety: Federal Efforts 

to Ensure the Safety of Imported Foods 

are Inconsistent and Unreliable’’ (GAO/ 

RCED–98–103); The Safety of Food 

Imports: Fraud & Deception in the Food 

Import Process; Hearings Before the 

Senate Committee on Governmental 

Affairs, Permanent Subcommittee on 

Investigations, September 10, 1998; 

‘‘Memorandum on the Safety of 

Imported Foods,’’ Weekly Compilation 

of Presidential Documents, 

Administration of William J. Clinton, 

1999, July 3, at pages 1277 through 

1278). The GAO report and the Senate 

subcommittee hearings discussed 

marking refused foods as a way to 

enhance the safety of imported foods 

(see 66 FR 6502 at 6503). The July 3, 

1999, memorandum from then-President 

Clinton to the Secretary of Health and 

Human Services and the Secretary of the 

Treasury also discussed imported food 

safety. The memorandum identified 

food safety as a high priority and 

directed the Secretaries to take all 

actions available to ‘‘prohibit the 

reimportation of food that has been 

previously refused admission and has 

not been brought into compliance with 

United States laws and regulations (so 

called ‘‘port shopping’’), and require the 

marking of shipping containers and/or 

papers of imported food that is refused 

admission for safety reasons’’ (id.). 

B. What Happened to the Previous Effort 

to Require Marking of Refused Food? 

We received 13 comments on the 

2001 proposed rule and were nearing 

completion of a final rule when, on June 

12, 2002, the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) (Public Law 107–188) became law. 

Section 308(a) of the Bioterrorism Act 

created a new section 801(n) of the act, 

which provides additional express 

authority to require labels on refused 

foods. Section 801(n)(1) of the act states 

that we may require the owner or 

consignee of a food that had been 

refused admission into the United States 

to ‘‘affix to the container of the food a 

label that clearly and conspicuously 

bears the statement: ‘UNITED STATES: 

REFUSED ENTRY’.’’ Section 801(n)(2) 

of the act requires the owner or 

consignee of the food involved to pay all 

expenses in connection with affixing the 

label. Section 801(n)(3) of the act states 

that a requirement under section 

801(n)(1) of the act remains in effect 

until we determine that the food has 

been brought into compliance with the 

act. 

The Bioterrorism Act made clear that 

the new provisions were not intended to 

detract from our existing authority to 

require refused food imports to be 

marked as such. Section 308(c) of the 

Bioterrorism Act states that, ‘‘nothing in 

this section shall be construed to limit 

the authority of the Secretary of Health 

and Human Services or the Secretary of 

the Treasury to require the marking of 

refused articles of food under any other 

provision of law.’’ Nonetheless, the new 

statutory requirements differed from our 

2001 proposed rule in several ways, and 

these differences led us to withdraw the 

2001 proposed rule on August 21, 2002 

(67 FR 54138), and re-examine how we 

should implement this authority. 

We summarize the principal 

differences between our earlier 2001 

proposed rule and the requirements in 

section 801(n) of the act here. 

TABLE 1—PRINCIPAL DIFFERENCES BETWEEN FDA’S JANUARY 22, 2001, PROPOSED RULE AND SECTION 801(N) OF THE

ACT

Provision in the January 22, 2001 Proposed Rule Provision in Section 801(n) of the Act 

Would authorize marking of food that was refused admission into the 

United States for safety reasons 

Authorizes labels on the container of food that was refused admission 

into the United States, except for food that is required to be destroyed 

Would require the mark to be at least 2.5 centimeters or 1 inch high 

and to be clear, conspicuous, and permanently affixed 

Requires the label statement to be clear and conspicuous 

Mark would state, ‘‘UNITED STATES REFUSED ENTRY’’ Label states, ‘‘UNITED STATES: REFUSED ENTRY’’ 

No express provision regarding fees Requires owner or consignee of the food involved to pay all expenses 

in connection with affixing the label and authorizes liens in event of 

default of such payment 


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54108 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

TABLE 1—PRINCIPAL DIFFERENCES BETWEEN FDA’S JANUARY 22, 2001, PROPOSED RULE AND SECTION 801(N) OF THE

ACT—Continued 

Provision in the January 22, 2001 Proposed Rule Provision in Section 801(n) of the Act 

Would require the mark to go on the food’s packing container, if possible, and to an invoice, bill of lading, and any other shipping document accompanying the food when it is exported Label to be affixed to the container 

Would prohibit altering, tampering with, or concealing a mark Food is misbranded if: it fails to bear a label (concerning the fact that 

the food has been refused admission); the food presents a threat of 

serious adverse health consequences or death to humans or animals; and, upon or after notifying the owner or consignee involved 

that a label is required, the owner or consignee is informed that the 

food presents such a threat. 

On July 18, 2007, President George W. 

Bush established an Interagency 

Working Group on Import Safety to 

conduct a comprehensive review of 

import safety practices and to determine 

areas for improvement. On November 6, 

2007, the Working Group submitted its 

report, Action Plan for Import Safety: A 

Roadmap for Continual Improvement, 

to the President. Publishing this 

proposed rule by mid-2008 was a 

planned action in the report. 

This proposed rule would, among 

other things, implement section 801(n) 

of the act and address labeling the 

documents associated with foods that 

have been refused admission, whether 

or not the foods have ‘‘containers’’ as we 

propose to define that term for purposes 

of section 801(n) of the act. 

II. Description of the Proposed Rule 

A. Introduction 

We are proposing to amend our 

import regulations to create a new 

§ 1.98, entitled ‘‘Label requirement on 

food imports refused admission into the 

United States.’’ The proposal would 

require all owners or consignees to label 

the shipping container of food refused 

admission into the United States under 

section 801(a) of the act, as well as any 

documents (including electronic 

documents) accompanying the food. 

The label would make it more difficult 

for imported food that has been refused 

admission into the United States to 

evade import controls and would 

complement our other efforts to monitor 

food imports. 

There is no direct counterpart to 

section 801(n) of the act with respect to 

food that has been produced 

domestically rather than imported. Food 

produced domestically that is not in 

compliance with the act is subject to a 

range of regulatory and enforcement 

actions. For example, we may seek to 

seize the food under section 304 of the 

act (21 U.S.C. 334), seek an injunction 

under section 302 of the act (21 U.S.C. 

332), or request that a firm voluntarily 

initiate a recall. 

B. Who Is Subject to the Label 

Requirement? (Proposed § 1.98(a)) 

In general, proposed § 1.98(a) would 

state that you are subject to the rule if 

you are an owner or consignee of an 

imported food (including food for 

animals) which we have refused to 

admit into the United States (other than 

a food which must be destroyed). The 

proposal would require you to affix 

labels stating, ‘‘UNITED STATES: 

REFUSED ENTRY,’’ as described in 

proposed § 1.98(b) and (c) (which we 

discuss later in part II.C and II.D of this 

document). 

Under our pre-existing import 

program, when an FDA-regulated food 

product is offered for import, we review 

electronic information about the 

product provided under the prior notice 

procedures described in 21 CFR 1.276 

through 1.285. If prior notice 

requirements are satisfied, we then 

conduct an admissibility review to 

determine whether the food meets the 

safety and quality standards under the 

act and its implementing regulations 

that likewise apply to food produced or 

grown in the United States. If our 

review of that information determines 

that further evaluation of the 

information or article is unnecessary, 

we notify CBP that the article may 

proceed without further FDA 

examination. If further evaluation is 

deemed necessary, our staff may request 

additional information to make an 

admissibility determination or may 

examine or sample the product. Finally, 

if our review indicates that the product 

appears ‘‘by examination or otherwise’’ 

to be subject to refusal of admission 

under section 801(a) of the act (e.g., 

appears to be adulterated or 

misbranded), we will take appropriate 

action, and notify the owner or 

consignee and customs broker that we 

are detaining the shipment by sending 

a ‘‘Notice of FDA Action.’’ 

The Notice of FDA Action specifies 

the nature of the violations identified 

through our evaluation and designates 

an address where the recipient may 

present information to us. If the person 

receiving the Notice of FDA Action 

accepts the refusal of admission or if our 

district office determines, after 

reviewing the information provided to 

it, that the imported food continues to 

appear to be in violation, we then issue 

a ‘‘Notice of Refusal of Admission.’’ The 

Notice of Refusal of Admission finalizes 

the charges and provides for the food’s 

exportation or destruction within 90 

days of the notice’s date or within 

timeframes set by CBP. We intend to 

modify these types of notices to state 

that a refused food import is subject to 

the labeling requirements described in 

this proposal and to indicate whether a 

refused food presents a threat of serious 

adverse consequences or death to 

humans or animals because of the 

misbranding requirement seen at section 

403(v) of the act (21 U.S.C. 343(v)). 

Under section 403(v) of the act, a food 

is misbranded if: (1) It fails to bear a 

label required by regulation under 

section 801(n)(1) of the act; (2) we find 

that the food presents a threat of serious 

adverse consequences or death to 

humans or animals; and (3) upon or 

after notification that the label is 

required, we inform the owner or 

consignee that the food presents such a 

threat. 

Proposed § 1.98(a) reference to owners 

and consignees of an imported food 

reflects the language in section 801(n)(1) 

of the act. However, for purposes of 

proposed § 1.98, we intend to interpret 

‘‘owner’’ and ‘‘consignee’’ to include 

persons acting on the owner’s or 

consignee’s behalf, such as the owner’s 

employees and agents. This practical 

and common sense interpretation would 

preclude arguments we have seen in 

other regulatory contexts where parties 

have argued that a particular statutory 

or regulatory requirement is too 

burdensome because only the specific 


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Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 54109 

individual owner, and not any 

employee or agent retained by the 

owner, can satisfy the requirement. 

Here, if an owner instructs its employee 

or agent to affix the label to a shipping 

container or documents, we would 

consider the employee or agent to be 

acting on the owner’s behalf and the 

employee’s or agent’s action to be 

consistent with section 801(n)(1) of the 

act and proposed § 1.98(a). 

Proposed § 1.98(a) also would state 

that imported food includes ‘‘food for 

animals.’’ This reflects the fact that 

animal food or feed falls within the 

definition of ‘‘food’’ in section 201(f) of 

the act (21 U.S.C. 321(f)). 

C. What Does the Label Look Like? 

(Proposed § 1.98(b)) 

Proposed § 1.98(b) would require the 

label to state, ‘‘UNITED STATES: 

REFUSED ENTRY’’ in capital letters and 

in black ink on a white background. For 

labels that are to be affixed to shipping 

containers, proposed § 1.98(b)(1) would 

require the label’s letters to use either an 

Arial or Univers font style and be at 

least 72 points in size. The label would 

use uppercase letters only. (We discuss 

shipping containers and documents in 

greater detail in part II.D of this 

document.) 

For labels that are to be affixed to 

documents (including electronic 

documents), proposed § 1.98(b)(2) 

would require the label’s letters to be in 

black ink, use either an Arial or Univers 

font style, and be at least 36 points in 

size. The label would use uppercase 

letters only. We tentatively have 

decided to specify the label’s fonts and 

sizes in proposed § 1.98(b)(1) and (b)(2) 

because such a requirement would make 

the label clear, conspicuous, and easy to 

read and identify and would minimize 

uncertainty about what the terms 

‘‘clear’’ and ‘‘conspicuous’’ mean. 

Based on our experience with the 

2001 proposed rule, we expect that 

some individuals may want the rule to 

require some indication of why the food 

was refused entry rather than limit the 

label to the language specified by 

section 801(n)(1) of the act. We 

tentatively have decided against 

requiring such explanations in the 

proposed rule because the words, 

‘‘UNITED STATES: REFUSED ENTRY,’’ 

are specified in section 801(n)(1) of the 

act. Unlike our 2001 proposed rule, the 

label would be applied to all foods that 

are refused entry. If we were to require 

the label to explain the reasons for 

refusing to admit the food into the 

United States, importers, owners, and 

consignees would have to have multiple 

labels (to cover the various possible 

reasons for refusing entry) or would 

have to use ‘‘fill in the blank’’ labels 

which could then be illegible (if the 

reasons are handwritten) or difficult to 

use (if the reasons are machine-printed). 

Such a result would be inconsistent 

with the statutory requirement that the 

label ‘‘clearly and conspicuously’’ bear 

the statement. Consequently, proposed 

§ 1.98(b) would only require the label to 

say, ‘‘UNITED STATES: REFUSED 

ENTRY.’’ Nonetheless, neither the act 

nor this proposed rule would prohibit 

further statements as long as they are 

not false or misleading and do not 

prevent the label from being both clear 

and conspicuous. 

Although the proposal would specify 

the label’s text, font style, size, and 

color(s), it would not specify any 

particular type of label. In other words, 

use of adhesive labels, ink stamps, paint 

and stencils, or any other tool or device 

would satisfy the rule’s requirements as 

long as the label is permanent, is the 

correct size and color, and otherwise 

complies with the rule. 

As for the ink used for the label, we 

expect that, based on our experience 

with the 2001 proposed rule, we may 

receive comments requesting a rule that 

would require the label to use ‘‘invisible 

ink’’ that could be seen only by using 

some unspecified scanning device. In 

the past, some comments have 

expressed concern about how a visible 

label might affect the refused food’s 

ability to enter a foreign country or 

return to the exporting country. We 

believe that the use of ‘‘invisible ink’’ 

would be inconsistent with the statutory 

requirement that the label’s text be clear 

and conspicuous. If the labels were 

invisible to the human eye, we would be 

obliged to scan every food product 

offered for import into the United 

States, and implementing section 

801(n)(1) of the act in such a manner 

would be contrary to the statutory intent 

of enabling FDA to identify previously 

refused food quickly and easily. 

D. Where Does the Label Go? (Proposed 

§ 1.98(c)) 

Proposed § 1.98(c) would require the 

label to be affixed to the shipping 

container of refused food and on 

invoices, bills of lading, and other 

documents accompanying the imported 

food. By ‘‘shipping container,’’ we mean 

‘‘an individual container designed for 

shipping one or more immediate 

containers of the refused food, and an 

immediate container is any container 

that holds an imported food for retail 

sale.’’ This definition of ‘‘shipping 

container’’ would include items such as 

boxes, bags, bottles, jars, tanks, drums, 

barrels, and totes because such items are 

individual containers designed for 

shipping food. The definition would 

exclude items such as railroad cars, 

truck trailers and truck trailer bodies 

(also referred to as ‘‘containers’’ or 

‘‘intermodal shipping containers’’ and 

including International Organization for 

Standardization (ISO) standard 

containers or ‘‘ISOtainers’’ and other 

standardized containers that can be 

attached to a vehicle body), ship holds, 

and similar transportation-related items 

because those items are not individual 

containers designed for shipping food. 

Section 801(n)(1) of the act requires 

the label to be affixed to ‘‘the container 

of the food,’’ but the act, the 

Bioterrorism Act, and the legislative 

history for the Bioterrorism Act do not 

define or otherwise explain what 

constitutes a ‘‘container.’’ By referring to 

the ‘‘shipping container,’’ the proposal 

would require placement of the label on 

the container that would normally be 

used in commerce to ship food. For 

example, assume that an imported food 

shipment consists of cardboard cartons 

containing 24 cans of food and that we 

have refused to admit the food into the 

United States. The ‘‘shipping 

containers’’ would be the cartons 

containing the cans rather than each 

can, so the label would go on each 

carton. As another example, assume that 

an imported food shipment consists of 

plastic drums, each drum containing 

five gallons of vegetable oil, and that we 

have refused to admit the food into the 

United States. In this example, the 

‘‘shipping container’’ is the individual 

plastic drum, so the label would go on 

the drums. Note, too, that, in this 

example, the plastic drums are also 

immediate containers, because it is 

likely that the plastic drums are the 

containers that hold the oil for sale to 

others. 

Consistent with section 801(n) of the 

act, the proposal also would require the 

label on the shipping container to be 

clear and conspicuous. While we 

believe that the specifications in 

proposed § 1.98(b) will establish what 

we mean by ‘‘clear,’’ we invite comment 

on whether the rule should attempt to 

explain what ‘‘conspicuous’’ means or 

does not mean. Our concern is that 

individuals may attempt to comply with 

the letter, but not the spirit, of the law 

by placing the labels on the bottom of 

the shipping container. However, it may 

be difficult to describe what 

‘‘conspicuous’’ means for the range of 

shipping containers. For example, if we 

stated that the label cannot go on a 

shipping container’s bottom to prevent 

the label from being obscured, such 

detail might tempt individuals to put 

the label on the container’s top, and 

then stack containers so that the label is 


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obscured. Consequently, we invite 

comment on whether the final rule 

should define or explain what 

‘‘conspicuous’’ means in terms of the 

label’s placement on a shipping 

container and, if so, what that regulatory 

requirement would be. 

The proposal also would require the 

label to be permanently affixed to the 

shipping container, in addition to being 

clear and conspicuous. Although 

section 801(n)(1) of the act does not 

state that the label must be 

‘‘permanent,’’ we believe that proposing 

to require the label to be permanently 

affixed to the refused food is consistent 

with the underlying statutory intent. 

Congress’s goal, in enacting section 

801(n) of the act, was to identify refused 

foods and to preclude the reintroduction 

of refused foods into the United States. 

Without a requirement that the label be 

permanently affixed, then the statutory 

intent could be undermined easily 

because unscrupulous importers, 

owners, or consignees could simply use 

removable labels and remove them 

before attempting to bring the refused 

food back into the United States. We do 

not believe that Congress intended to 

create legal requirements that could be 

so easily defeated, and so the proposal 

would require the label to be 

permanent. 

To illustrate what we mean by 

‘‘permanent,’’ printing ‘‘UNITED 

STATES: REFUSED ENTRY’’ on the 

shipping container in indelible ink 

would constitute a ‘‘permanent’’ label. 

In contrast, printing the same words in 

pencil on the shipping container would 

not be ‘‘permanent’’ because an 

individual could erase the words. As 

another example, using adhesive labels 

that cannot be removed from the 

shipping container after being affixed 

would be ‘‘permanently’’ affixing the 

label. In contrast, using hang tags would 

not be ‘‘permanent’’ because the tags 

can be removed easily. 

Based on our experience with the 

2001 proposed rule, we anticipate that 

some individuals may argue that 

‘‘container’’ should include cargo 

containers or vehicle components, such 

as railroad cars and trailers (which are 

often referred to as ‘‘containers’’) that 

are attached to trucks and that are used 

to transport large quantities of imported 

food. It would be both impractical and 

inappropriate to interpret or implement 

section 801(n)(1) of the act to require 

that the label be affixed to a railroad car, 

truck, ship, or other vehicle, vehicle 

component, or vehicle attachment rather 

than a food’s shipping container. By 

specifying that the label be clear and 

conspicuous, Congress intended to 

make it difficult for a person to ‘‘port 

shop’’ or to conceal previously refused 

food. If the label were placed on a large, 

reusable cargo container (such as a 

tractor trailer or railroad car), one could 

easily defeat this statutory intent simply 

by transferring the refused food from the 

labeled cargo container to an unlabeled 

cargo container. For example, if the 

label is placed on a railroad car instead 

of the shipping containers holding the 

refused food inside the railroad car, the 

intent behind section 801(n)(1) of the 

act and this proposal could be defeated 

by shifting the refused food from the 

labeled railroad car to an unlabeled 

railroad car. In contrast, if the label is 

on the shipping containers (such as 

boxes or bags) holding the refused food, 

it would be more difficult or 

burdensome to unpackage and 

repackage the refused food. In addition, 

a cargo container generally is used to 

transport food to a specific location and, 

once it arrives at that location, the food 

is removed, and the cargo container is 

used to transport another product. 

Requiring labels on a cargo container 

also would inhibit typical business 

practices by requiring that the cargo 

container remain associated with the 

refused food until its exportation. 

There may be situations where the 

imported food has no shipping 

container. In these situations, requiring 

that the label be affixed to the 

documents accompanying the refused 

food is an appropriate mechanism to 

ensure that the fact of refusal is 

communicated to us, CBP, and others. 

Proposed § 1.98(c) would require the 

label on all documents accompanying 

the refused food even when the 

shipping container is labeled. Examples 

of such documents include, but are not 

limited to, bills of lading, bills of sale, 

airway bills, packing lists, and invoices. 

This requirement would implement 

section 403(a)(1) of the act and provide 

additional protection against the reimportation of refused food because 

there are times when we, CBP, and 

others may see documents 

accompanying a shipment, but not 

examine the shipment itself. Section 

308(c) of the Bioterrorism Act states that 

we retain authority to require the 

marking of refused food ‘‘under any 

other provision of law.’’ As we explain 

in section III of this document, section 

403(a)(1) of the act, along with other 

provisions, gives us ample legal 

authority to require the label on 

documents accompanying the refused 

food. 

In order for the label on the 

documents to be useful in notifying us, 

CBP, and any prospective purchasers of 

diverted food that the food has been 

refused admission into the United 

States, proposed § 1.98(c) also would 

require the label on the documents to be 

clear, conspicuous, and permanently 

affixed. Our concern is that 

unscrupulous importers may attempt to 

undermine a simple regulatory 

requirement that the label go on the 

documents by placing the labels on the 

back of documents or on one page of a 

multi-page document in an effort to 

conceal the label. As another example, 

if we stated that the label must go on the 

‘‘bill of sale,’’ an individual might be 

tempted to place the bill of sale as page 

37 in a 50-page set of documents to 

make the label more difficult to find or 

to refer to the bill of sale by ‘‘sales 

receipt’’ or other name and then argue 

that the label requirement is 

inapplicable because there is no ‘‘bill of 

sale.’’ Thus, we propose to require that 

the label be permanent and go on the 

top page of each document to ensure 

that the label on the document is clear 

and conspicuous. (By ‘‘top page,’’ we 

mean the page that is physically located 

at the top of any single or multi-page 

document. For example, if there are two 

documents accompanying the imported 

food, and one document consists of a 

single page and the other document 

consists of five pages, the label would 

go on the single-paged document and on 

the top page of the five-page document.) 

We also propose that the label be 

permanent because it would undermine 

the requirement that the label be affixed 

to the documents if importers could use 

labels that could be removed at any 

point before re-exportation or reimportation. 

E. How Do You Show You Complied 

With the Label Requirements? (Proposed 

§ 1.98(d)) 

Section 801(n)(1) of the act authorizes 

us to require owners and consignees to 

affix the label to a refused food. 

Consequently, the proposed rule would 

establish clear standards for when food 

must be labeled as ‘‘UNITED STATES: 

REFUSED ENTRY.’’ We note that 

neither of the misbranding provisions 

upon which we rely for the proposed 

labeling requirement hinges on whether 

the refused food is re-offered for import 

(compare section 403(a)(1) and (v) of the 

act with section 402(h) of the act (21 

U.S.C. 342(h))). To ensure that we can 

track compliance with the label 

requirement efficiently, proposed 

§ 1.98(d)(1) would establish several 

mechanisms for demonstrating that the 

label was properly affixed to the 

shipping containers and documents for 

the refused food. For example, the 

owner or consignee could contact the 

FDA district office responsible for the 

food’s entry and: 


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• Arrange to affix the labels in our 

presence or under our supervision. This 

method would probably be used in 

situations where the refused food 

presents a public health hazard or 

where the owner or consignee has a 

history of violations of the act or the 

Public Health Service Act (PHS Act); 

• Submit photographs or other visual 

evidence to us to show that it affixed the 

label to the shipping containers and 

documents. This method could, for 

example, be used in situations where 

the owner or consignee has a good 

record of compliance with the act and 

the PHS Act and the refused food does 

not present a public health hazard; or 

• Develop another means to show 

that it affixed the labels to the shipping 

containers and documents to FDA’s 

satisfaction. For example, we could 

agree to have commissioned State or 

Federal officials supervise the labeling 

process. 

Proposed § 1.98(d)(1) is intended to 

ensure that the shipping container and 

documents for a refused food are 

identified and labeled correctly. The 

provision would give us the option to 

verify that the labels were affixed 

correctly to the shipping container and 

documents by supervision, by reviewing 

visual evidence, or by other means. This 

flexibility would reduce the potential 

burden on owners or consignees. 

Proposed § 1.98(d)(2) would require 

that the labels be affixed promptly. We 

invite comment on how we might 

interpret ‘‘promptly.’’ Under section 

801(a) of the act, the exportation of any 

refused article is require within 90 days 

of the date of notice of such refusal or 

within such additional time as may be 

permitted pursuant to CBP regulations. 

We invite comment on how to frame a 

regulatory requirement to ensure that 

the owner or consignee has a reasonable 

amount of time to affix the required 

labels and that FDA has sufficient 

advance time to make arrangements to 

verify that the labels are affixed 

properly in light of the 90-day deadline 

specified in section 801(a) of the act. 

Any regulatory standards established for 

compliance with the label requirements 

will establish an obligation under the 

CBP bond to label the merchandise. 

Proposed § 1.98(d)(2) would also 

require that the food not be moved until 

the owner or consignee has complied 

with the labeling requirements. This 

requirement would mean that the labels 

must be affixed before the food leaves 

the port of entry or, if the food has 

already been moved from the port of 

entry to another location for storage, 

before the food leaves that storage area 

to be re-exported. 

F. What Fees May We Impose Under the 

Rule? (Proposed § 1.98(e)) 

Section 801(n)(2) of the act expressly 

states that all expenses in connection 

with affixing a label under section 

801(n)(1) of the act ‘‘shall be paid by the 

owner or consignee of the food 

involved, and in default of such 

payment, shall constitute a lien against 

future importations made by such 

owner or consignee.’’ Section 801(c) of 

the act also provides authority for 

imposing expenses on owners and 

consignees for labor with respect to any 

article refused under section 801(a) of 

the act. Consequently, proposed 

§ 1.98(e) would allow us to seek 

reimbursement for our expenses when 

we impose the label on shipping 

containers or when we supervise an 

importer’s affixing of labels on shipping 

containers and documents. These costs 

would normally consist of our 

inspector’s time, the per diem allowance 

under government travel regulations, 

travel expenses (actual cost of travel for 

travel other than by automobile, or 

mileage, toll fees, etc. if travel was by 

automobile), and administrative support 

costs. 

We currently operate a similar 

reimbursement program for costs 

associated with our supervision of 

reconditioning imported articles for 

possible admission into the United 

States (see 21 CFR 1.99); thus, the fees 

we would seek under proposed § 1.98(e) 

would be consistent with existing 

programs. 

III. Legal Authority 

Several sections of the act give us the 

legal authority to issue this rule. First, 

section 801(n) of the act states (among 

other things) that if a food, other than 

a food that is required to be destroyed, 

is refused admission under section 

801(a) of the act, we may require the 

owner or consignee of the food to affix 

to the food’s container a label that 

states, ‘‘UNITED STATES: REFUSED 

ENTRY.’’ Section 403(v) of the act 

provides that food is misbranded if: (1) 

It fails to bear a label required under 

section 801(n)(1) of the act (concerning 

the fact that the food has been refused 

admission); (2) the food presents a 

threat of serious adverse health 

consequences or death to humans or 

animals; and (3) upon or after notifying 

the owner or consignee involved that a 

label is required, the owner or consignee 

is informed that the food presents such 

a threat. In addition, section 801(a) of 

the act authorizes us to refuse to admit 

imported food into the United States if 

the imported food appears to have been 

manufactured, processed, or packed 

under insanitary conditions, is 

forbidden or restricted in sale in the 

country in which it was produced or 

from which it was exported, or is 

adulterated or misbranded. Sections 402 

and 403 of the act describe when a food 

is adulterated and misbranded, 

respectively. 

Under section 403(a)(1) of the act, a 

food is misbranded if its labeling is false 

or misleading in any particular. Section 

201(n) of the act states that, in 

determining whether labeling is 

misleading, we look not only at the 

affirmative representations made in or 

suggested by the labeling, but also ‘‘the 

extent to which the labeling * * * fails 

to reveal facts material in light of such 

representations or material with respect 

to consequences which may result from 

the use or the article * * *.’’ We 

tentatively conclude that the failure to 

reveal, in each document accompanying 

the shipment of food, that the food has 

been refused admission would misbrand 

the food because otherwise the labeling 

would imply that the food may be sold 

legally in the United States when, in 

fact, we have determined that the food 

may not. 

Section 701(a) of the act (21 U.S.C. 

371(a)) also authorizes promulgation of 

regulations for the efficient enforcement 

of the act, and section 701(b) of the act 

specifically authorizes promulgation of 

regulations for the efficient enforcement 

of section 801 of the act. Because 

labeling refused foods would permit us 

and CBP to efficiently enforce sections 

403 and 801 of the act and is expressly 

authorized under section 801 of the act, 

we are authorized to impose labeling 

requirements on such food. The label 

would help ensure that foods that fail to 

meet the conditions for admission into 

the United States are not re-imported 

and do not enter or reenter domestic 

commerce. Sections 801(c) and (n)(2) of 

the act also provide the authority to 

impose the costs of supervising 

compliance with such labeling 

requirements on owners and consignees. 

Finally, the proposed rule also is 

authorized by section 361 of the PHS 

Act (42 U.S.C. 264). Section 361 of the 

PHS Act authorizes us to issue 

regulations to prevent the introduction, 

transmission, or spread of 

communicable diseases from foreign 

countries into the United States. 

Labeling food that has been refused 

entry into the United States will help 

prevent the introduction, transmission, 

or spread of communicable diseases into 

the United States by making it more 

difficult for such rejected food to enter 

the United States through a different 

port or to escape detection. 


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What Are the Consequences of Failing to 

Affix the Labels? 

Under section 403(v) of the act, a food 

is misbranded if: it fails to bear a label 

required under section 801(n)(1) of the 

act (concerning the fact that the food has 

been refused admission); the food 

presents a threat of serious adverse 

health consequences or death to humans 

or animals; and, upon or after notifying 

the owner or consignee involved that a 

label is required, the owner or consignee 

is informed that the food presents such 

a threat. As discussed previously, we 

intend to provide notification of the 

label requirement and, when 

appropriate, notice that the refused food 

presents a threat of serious adverse 

health consequences when we issue 

notices of refusal. If you receive notice 

to label the shipping container along 

with a notice that the refused food 

presents a threat of serious adverse 

health consequences and you fail to 

label the shipping container as required, 

the refused food is misbranded under 

section 403(v) of the act, and we may 

administratively detain the food under 

section 304(h) of the act and seize the 

food before it is exported or after it is 

re-imported under section 304(a) of the 

act. 

Two situations are not covered by the 

misbranding provision in section 403(v) 

of the act: (1) Failure to label refused 

food that we have not found to present 

a threat of serious adverse health 

consequences; and (2) failure to label 

the documents. As set forth previously, 

we believe that the failure to label the 

shipping container or documents in 

accordance with proposed § 1.98 would 

misbrand the food under section 

403(a)(1) of the act. Accordingly, if you 

fail to label the shipping container or 

documents, the refused food would be 

misbranded under section 403(a)(1) of 

the act and subject to seizure under 

section 304 of the act. Furthermore, the 

prohibited acts pertaining to 

misbranded food in section 301 of the 

act (21 U.S.C. 331) would also apply, 

and anyone who commits a prohibited 

act with respect to the food would be 

subject to an injunction under section 

302 of the act or prosecution under 

section 303 of the act (21 U.S.C. 333). 

In addition, if the food has been 

conditionally released under a customs 

bond, the failure to comply with any 

requirement of this proposed rule may 

be a violation of that bond (see 19 CFR 

113.62(e)), and we could ask CBP to 

pursue liquidated damages from the 

importer of record under 19 CFR 

113.62(l). 

IV. Environmental Impact 

The agency has determined under 21 

CFR 25.30(a), 25.30(k), and 25.32(g) that 

this action is of a type that does not 

individually or cumulatively have a 

significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

V. Paperwork Reduction Act of 1995 

We tentatively conclude that the 

labeling requirements proposed in this 

document are not subject to review by 

the Office of Management and Budget 

because they do not constitute a 

‘‘collection of information’’ under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). Rather, the 

statements are ‘‘public disclosure of 

information originally supplied by the 

Federal government to the recipient for 

the purpose of disclosure to the public’’ 

(5 CFR 1320.3(c)(2)). 

Interested persons are requested to fax 

comments regarding information 

collection by October 20, 2008, to the 

Office of Information and Regulatory 

Affairs, OMB. To ensure that comments 

on information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

VI. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

have concluded that the rule does not 

contain policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

VII. Analysis of Impacts 

A. Preliminary Regulatory Impact 

Analysis 

We have examined the impacts of the 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). We believe that 

this proposed rule is not a significant 

regulatory action as defined by the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because we do not expect this 

cost for any one small owner or 

consignee to be excessive, we certify 

that the proposed rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $130 

million, using the most current (2007) 

Implicit Price Deflator for the Gross 

Domestic Product. We do not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

1. Need for Regulation 

We are taking this action to assist in 

the enforcement of our admissibility 

decisions. Without a label requirement 

for food that has been refused 

admission, owners or consignees whose 

shipments are refused admission could 

simply move their shipment to another 

port and attempt entry again. Without 

labeling violative food products, the 

importer or consignee knows that a 

shipment has been refused, but 

personnel in the next port where the 

food is offered for import would not 

readily know that the shipment has 

been refused. Labeling violative food 

products will help reduce this problem. 

In addition, as discussed in section 

VII.A.4 of this document, this rule 

would help correct both of these 

behaviors by making the importation of 

violative food relatively more 

expensive. 

2. Proposed Rule Coverage 

The proposed rule would require 

owners and consignees whose food has 

been refused admission into the United 

States to label such food as ‘‘UNITED 

STATES: REFUSED ENTRY.’’ This 


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would make it easier for us and CBP to 

detect attempts to introduce previously 

refused imported food into the United 

States. 

By making importation of previously 

refused food more difficult and 

expensive for importers, we expect that 

reconditioning or destruction of refused 

food will become more favored 

alternatives. We also expect that with 

this system in place, importers would be 

less likely to attempt to import violative 

food into the United States in the first 

place. 

3. Regulatory Options Considered 

As described earlier, the proposed 

rule would require owners and 

consignees whose food shipments have 

been refused admission into the United 

States to label such products as 

‘‘UNITED STATES: REFUSED ENTRY.’’ 

This would make it easier for us and 

CBP to detect attempts to introduce 

previously refused imported food into 

the United States. In drafting this 

proposed rule, we considered several 

regulatory alternatives in addition to the 

proposed rule. We considered: (1) No 

additional regulatory action; (2) 

selective enforcement that would allow 

the decision to affix the label to be made 

at the level of individual refused food 

shipments; and (3) the destruction of all 

shipments of food refused admission 

into the United States. Because this 

proposed rule would not be an 

economically significant regulatory 

action, we do not quantitatively 

estimate the benefits and costs of the 

regulatory alternatives to the proposed 

rule. In what follows, we qualitatively 

compare the costs and benefits of the 

regulatory options to the costs and 

benefits of the proposed rule. 

The first option would be no action. 

This alternative would not affect current 

practices, such as port shopping, and 

would result in the introduction of 

previously refused food imports into the 

United States. Consumers who ingested 

those unsafe food imports would, in 

turn, be subject to the risk of foodborne 

illnesses. 

A second option would be a selective 

enforcement mechanism that would 

allow the decision to label to be made 

at the level of individual shipments. 

This alternative would require fewer 

resources for labeling shipments, but 

would require more resources for 

deciding which shipments should be 

labeled. The decision to label would be 

based on factors other than refusal. For 

example, refused food might be labeled 

because it poses a safety risk. The 

decision to label an individual refused 

food shipment could be complex. For 

example, whether a shipment 

contaminated with mold constitutes a 

safety risk depends upon the 

identification of the mold, its 

toxicological properties, and the 

probability of illness resulting from 

exposure to the mold. Deciding whether 

or not the same shipment is adulterated 

and violative is a simpler process. 

Selective enforcement could also lead to 

inconsistent standards between ports of 

entry, which would exacerbate the 

problem of importers choosing ports of 

entry based on the likelihood their cargo 

will be accepted. Finally, the incentive 

for port shopping would be higher 

under this alternative than in the 

proposed rule. This option would be 

close to the proposed rule in costs but 

would generate smaller benefits. 

A third option would be to order the 

destruction of food imports refused for 

safety reasons. While this would deter 

‘‘port shopping’’ and similar practices, 

this alternative would be costlier than 

the proposed rule for three reasons. 

First, it would require more Federal 

resources for supervision of destruction 

than the proposed rule. Second, the 

standard of proof to support the 

destruction of violative products is 

greater than the standard of proof for 

refusing to admit imported products. 

Because the standard of proof is higher 

for destruction than for marking, this 

would lead to more challenges to the 

FDA’s policy and require resources from 

FDA both in establishing the basis for its 

action and defending challenges to such 

action. Third, the costs of this proposed 

rule in destroyed shipments would be 

high. For fiscal year 2006, data drawn 

from the Operation and Administrative 

System for Import Support (OASIS) 

database (Ref. 1) show that 10,340 

shipments were initially refused at the 

intended U.S. port of entry for safety or 

security reasons. The threat of 

destruction should deter importers to 

attempt to import violative food. If we 

assume the number of violative imports 

will decrease by 75 percent and value 

the shipments conservatively at an 

average value of $500,000, the cost of 

this alternative in destroyed cargo alone 

would be about 1.3 billion dollars 

((10,340 shipments) x (25 percent) x 

($500,000)). 

4. Strategic Action by Owners and 

Consignees 

Although the vast majority of owners 

and consignees comply with the act, 

some attempt to circumvent Federal law 

and introduce violative food into United 

States commerce through means such as 

port shopping. For these owners and 

consignees, measures such as those 

contained in this proposed rule are 

necessary to deter port shopping. 

An owner’s or consignee’s decision on 

how to dispose of its cargo is influenced 

by changes in the expected profits 

associated with each of its choices. 

Requiring owners and consignees to 

affix a ‘‘UNITED STATES: REFUSED 

ENTRY’’ label on imported food that has 

been refused admission would change 

the expected profits associated with the 

initial decision to attempt to import 

violative food. A label also would affect 

the expected profits associated with the 

decision to recondition, re-export, or 

port shop after a shipment is found 

violative. 

The decision process of an owner or 

consignee of violative food can be 

represented visually by a decision tree 

(see Figure 1). This decision tree 

illustrates how requiring ‘‘UNITED 

STATES: REFUSED ENTRY’’ on refused 

imports would alter an owner’s or 

consignee’s incentives. The decision 

tree shows the possible outcomes and 

decisions an owner or consignee can 

make at each stage of the importation 

process. At point A, an owner or 

consignee of violative food first decides 

whether to attempt to import the food 

into the United States. This decision is 

influenced by the price the owner or 

consignee can get for the food if it is 

successfully imported, the probability 

the cargo will be inspected, and the cost 

to the owner or consignee if the food is 

inspected and found violative. At point 

B, whether the cargo is inspected is a 

function of factors such as the port of 

entry, FDA’s inspection rate, and the 

type of product. At point C, FDA refuses 

admission of the food. If the food is not 

destroyed, at point D, the owner or 

consignee may have the option of 

exporting to a foreign country, 

reconditioning the food, or port 

shopping. 


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54114 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

The proposed rule’s effect on 

deterrence: Labeling refused imported 

foods as ‘‘UNITED STATES: REFUSED 

ENTRY’’ would alter the incentive 

structure that owners and consignees 

face when deciding whether to 

introduce their product into United 

States commerce. In particular, there are 

four ways that the proposed rule would 

increase the deterrence value of the FDA 

inspection system. 

i. Port shopping would be reduced. 

One primary goal of this proposed rule 

would be to reduce port shopping. 

Requiring a label to be affixed to a 

refused imported food would reduce the 

probability that the refused imported 

food would be reoffered for import into 

the United States. The cost of port 

shopping would increase because 

resources would have to be expended to 

repackage a product that had been 

labeled. Thus, port shopping would 

become relatively less attractive to 

owners and consignees. 

ii. Decrease in the value of reexported items. The value of a product 

destined for re-export would decrease if 

it were labeled ‘‘UNITED STATES: 

REFUSED ENTRY.’’ After the product 

had been labeled, the owner or 

consignee has two costly choices: (1) 

After the product leaves the United 

States, relabel containers or repackage 

the product into containers that do not 

bear the label; or (2) sell the goods 

abroad with the label intact. It is likely 

that food with such a label would be 

viewed less than favorably by food 

safety inspectors and importers in 

international markets. Thus, the 

expected profit from selling goods that 

are labeled would be lower than if the 

label was not present, so this loss is in 

addition to the loss of value from refusal 

alone. Either of the owner’s or 

consignee’s choices (repackage or sell 

with the label intact) would lower the 

expected profit of re-exporting. 

iii. Reconditioning would become a 

more favored alternative. The expected 

profit from reconditioning a refused 

food import would not likely change 

with this proposed rule. Consequently, 

because the expected profits from port 

shopping and re-exporting refused 

imported food would be expected to 

fall, reconditioning the food would 

become economically more attractive. 

We expect that more owners and 

consignees would choose to recondition 

their product. 

iv. Decrease in the introduction of 

violative food into the United States. As 

with reconditioning, the expected profit 

from initially sending a violative and 

potentially unsafe or mislabeled product 

to a foreign port would not be expected 

to change significantly with this 

proposed rule. Therefore, as the 

expected profit from attempting to 

import violative food into the United 

States is lowered (because the cost of reimporting and re-exporting violative 

food is increased), the incentive to ship 

one’s product directly to a foreign (nonUnited States) market would increase. 

The net result of such a dynamic would 

be that more violative food products 

would be either directly shipped to 

foreign markets or reconditioned at the 

point of export. 

5. Benefits from the Proposed Rule 

a. Health benefits. As described 

earlier, the proposed rule, if finalized, 

would decrease the number of refused 

imported food products reaching the 

United States consumer. The proposed 

rule would discourage attempts to offer 

or reoffer violative imported food into 

the United States and encourage the 

reconditioning of imported food which 

we have refused to admit. Consequently, 

United States consumers would benefit 

through a reduction in the number of 

foodborne illnesses due to unsafe or 

mislabeled imported foods. Because we 

cannot quantify the amount of reimportation of refused imported foods, 

we cannot make a definitive prediction 

of the value of the reduced illnesses 


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Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 54115 

arising from this proposed rule. 

Although foods that represent a direct 

and serious danger to public health may 

be destroyed, refused food eligible for 

re-exportation may also present a health 

hazard. Typical reasons for refusing 

entry include illegal food or color 

additives, contamination by a pesticide 

residue or poisonous substance, foreign 

objects, poor sanitation in the 

manufacture of the food, improper 

labeling, and unregistered 

manufacturers. Each of these reasons for 

refusal may represent a health risk. Long 

term exposure to some illegal color 

additives has been linked to cancer. 

Sanitation problems indicate the food 

was held in unsanitary conditions, 

which may suggest more serious 

problems such as contamination with 

microbial pathogens. A single exposure 

to a violative pesticide level is very 

unlikely to result in cancer, but 

prolonged exposure over years may lead 

to increased risk of illness, including 

cancer. Improperly labeled food, among 

other things, may contain allergens 

without duly alerting the consumer. 

Sensitive individuals may experience 

allergic reactions ranging from mild 

contact dermatitis to a severe allergy 

attack. 

Table 2 shows some possible illnesses 

and injuries that may result from 

violative foods and includes their 

symptoms and an average cost per case. 

The quality-adjusted life days (QALDs) 

(Ref. 2) column represents the lost 

utility per day to a consumer from an 

illness, essentially the loss to the 

consumer due to symptoms and 

problems associated with the illness. 

The QALDs are valued in dollars by 

multiplying the number of lost days by 

the value of a statistical life day, $622. 

This value of a statistical life day is 

drawn from the economic literature 

(Ref. 3). The medical cost column is the 

direct medical cost of illness, which 

includes hospitalization and doctor 

visits. Most illnesses arising from E. coli 

O157:H7 or Salmonella are self-limiting 

and short in duration, but some 

illnesses due to Salmonella or E. coli 

O157:H7 can be quite serious. E. coli in 

some cases can result in kidney damage 

or death. Salmonella can trigger chronic 

arthritis and, in a very small percentage 

of cases, can result in death. 

TABLE 2.—COST OF SOME ILLNESSES POTENTIALLY AVERTED BY THE PROPOSED RULE

Potential harm Symptoms QALD loss 

Dollar value 

of lost 

QALDs 

Medical 

Costs Total cost 

Allergens Contact dermatitis Reddening, swelling, itching of skin 2 .1 $1,726 $125 $1,851 

Allergic reaction Difficulty breathing, asthma, rash, possible shock 1 .03 $847 $550 $1,397 

Objects in food Simple dental injury Toothache, headache 0 .23 $189 $0 $189 

Complex dental injury Simple, plus infection 3 .47 $2,852 $3,540 $6,392 

Oral emergency Sharp pain in mouth, face, neck, 

bleeding, plus possible metastatic 

or local infection 

4 .27 $3,510 $3,540 $7,050 

Tracheo-esophageal 

obstruction 

Choking, difficulty breathing, cyanosis, 

hypertension 

0 .48 $395 $0 $395 

Esophageal perforation Pain in chest, bleeding aspiration 

pneumonia, requires surgery 

13 .93 $11,450 $14,160 $25,610 

Canning processes Botulism Nausea, diplopia, blurred vision, lack 

of coordination, Can include loss of 

muscle strength, paralysis, death 

667 .94 $549,047 $29,526 $578,573 

Filth Salmonella Vomiting, nausea, possible arthritis, 

low probability of death 

72 .04 $17,558 $321 $17,880 

Filth E. coli Vomiting, nausea, bloody stools, possible kidney damage, low probability 

of death 

19 .56 $7,750 $485 $8,235 

Sources: We calculated E. coli and Salmonella costs by assuming a QALD value of $822 and a value of a statistical life of $5 million. Objects 

in food, allergens and botulism costs were taken from RTI, Estimating the Value of Consumers’ Loss from Foods Violating the Federal Food, 

Drug, and Cosmetic Act (Ref. 4). 

b. Other consumer benefits. While 

problems such as insects or filth in food 

may not always represent a direct health 

threat, they call into question the 

conditions to which the food was 

exposed. Moreover, consumers who 

purchase food expect it to be clean and 

sanitary. Consumer research shows 

cleanliness is important to consumers. 

For example, the Food Marketing 

Institute found 89 percent of consumers 

surveyed ranked a clean, neat store as a 

very important factor in selecting their 

primary supermarket (Ref. 5). If 

consumers pay a premium because they 

believe that their food is sanitary and 

the food is not, this payment represents 

a social loss. However, we cannot 

quantify this economic loss because we 

do not know what percentage of the 

price of food is a ‘‘cleanliness 

premium.’’ 

6. Costs of the proposed rule 

Costs would include both materials 

and time and would be incurred by both 

FDA and owners or consignees. The 

owners and consignees would bear the 

responsibility for affixing the labels; we 

would verify that the label is affixed. It 

is not clear which method owners and 

consignees would use to label refused 

food imports. Therefore, we have, for 

purposes of this analysis, used an 


dwashington3 on PRODPC61 with PROPOSALS
54116 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

1There are many reasons a shipment may be 

initially refused and subsequently released. For 

example, a violative shipment may be 

reconditioned successfully, samples of food 

suspected to be in violation may test negative, or 

paperwork, originally insufficient, might be 

corrected. 

2 Given a 1 percent inspection rate, an importer 

has a 99 percent chance of getting violative 

shipment into the United States. One out of every 

100 shipments gets caught. Without this rule, the 

odds of getting into the next port, given a refusal, 

are roughly the same as the first port. So if an 

importer plans to port shop a violative shipment at 

least once, they have a 99.9999 percent chance to 

successfully get the shipment into the United 

States. Therefore this proposed rule increases the 

risk of getting caught when shipping a violative 

shipment by a factor of 100 for those that plan on 

port shopping. FDA believes this would yield a 

heavy enough disincentive to warrant the use of 25 

to 75 percent in an ‘‘if-then’’ scenario. 

3There are several ways of verifying that the label 

has been affixed. For the purpose of this analysis, 

our estimates are based on a scenario where FDA 

inspectors supervise the labeling of refused food. 

inexpensive and quick method of 

labeling to estimate costs. 

a. Materials. Placing labels on all the 

packages would require the use of a 

label gun and printed labels. Label guns 

cost approximately $100, and three label 

guns would be needed at each of the 132 

ports. Labels reading ‘‘UNITED 

STATES: REFUSED ENTRY’’ would 

also have to be printed at an 

approximate cost of $0.025 per label. 

We invite comment on the estimation 

that three label guns per port will be 

sufficient to accomplish the labeling 

necessary to comply with the rule. 

b. Time. i. Owner’s or Consignee’s 

Time. The number of hours spent 

applying labels would be a function of 

the number of rejected shipments and 

their size. We assume that the average 

shipment consists of 500 cartons and 

would take approximately 3 hours to 

label. FDA requests comment on this 

assumption. We also assume that the 

owner or consignee would hire labor at 

the average wage rate for transportation 

and moving occupations published by 

the Bureau of Labor Statistics, $13.58, 

plus 30 percent in benefits (Ref. 6). 

Under these assumptions, it would cost 

approximately $53 in labor (3 hours x 

$17.65 per hour) to label each shipment. 

As a baseline, we estimate that 10,340 

shipments would be refused annually. 

However, data drawn from the OASIS 

database (Ref. 1) show that in 2006, 

6,318 of the refused shipments were 

destroyed and 438 were released, 176 

due to successful reconditioning and 

262 for another reason.1 Most refused 

shipments would not have to be labeled. 

However, if the food is reconditioned at 

a different site, then the proposed rule 

would require that food to be labeled. In 

the absence of information, we assume 

that 50 percent of the reconditioned 

shipments would be subject to the 

proposed rule’s label requirement. We 

invite comment on this assumption. 

As shown in table 3 of this document, 

we estimate that roughly 3,672 

shipments would need to be labeled 

initially. This number is used to 

calculate the ‘‘static’’ annual cost shown 

in table 4 of this document. The annual 

cost of labeling these shipments would 

be nearly $195 thousand in labor costs 

and nearly $46 thousand for labels. It 

would cost the government more than 

$55 thousand to confirm the labels had 

been affixed. The sum of these costs is 

about $296 thousand. The static annual 

cost should be viewed as the likely cost 

in the first few years after the proposed 

rule becomes final and as a high 

estimate for costs in later years. We 

invite comment on the data used in 

these calculations, including the 

percentage of reconditioned shipments 

subject to the label requirement and the 

labor cost to owners and consignees. 

As discussed in part VII.A.4 of this 

document, because the relative price of 

refusal would increase due to this 

proposed regulation, we expect more 

owners and consignees would decide to 

recondition after refusal, or will not 

attempt to import potentially violative 

food. The ‘‘dynamic’’ annual cost is the 

‘‘static’’ annual cost reduced by the 

expected percentage decrease (expected 

avoidance) in initial importation 

attempts and the increased number of 

successful reconditioning attempts. We 

do not have the data to predict the 

precise reaction of importers to this 

proposed rule. However, if we assume 

that owners and consignees would 

decrease attempts to import violative 

food by between 25 and 75 percent and 

that they would increase their attempts 

to recondition refusals by between 25 

and 75 percent, we estimate that the 

number of shipments to require marking 

would drop to between 902 and 2,738 

(1,814 for a mean change in imports and 

recondition attempts of 50 percent) 

annually.2 This ‘‘if-then’’ scenario 

yields a mean ‘‘dynamic’’ annual cost of 

$146 thousand. We invite comment on 

our estimates of a 25 to 75 percent 

decrease in violative imports and of a 25 

to 75 percent increase in reconditioning 

attempts. Added to these costs is a 

fraction of the cost of the label guns 

(shown in table 5 of this document). 

Because label guns are durable goods, 

the value of a label gun should not be 

added to the cost of marking each 

shipment. 

TABLE 3.—ANNUAL NUMBER OF REFUSED SHIPMENTS TO BE LABELED

Refusals in 2006 10,340 

Shipments Released After Refusal 

Total Recondition Attempts 185 

Reconditioned Unsuccessfully 9 

Reconditioned and Released 176 

Released After Initial Refusal for 

Other Reason 

262 

Total Released 438 

Shipments Destroyed After Refusal 6,318 

Static Total Number of Refusals to 

be Labeled1

3,672 

Expected Increase in Reconditioning Attempts and Avoidance 50.0% 

Mean Dynamic Total of Refusals 

to be Labeled2

1,814 

1This number is calculated by subtracting 

the number of shipments destroyed, the 

number of shipments released for ‘‘other 

reason’’, and half of the shipments that 

were reconditioned and released from the 

total refusals in 2006. 2This number is calculated by decreasing 

the number of refusal by 50 percent and increasing the percentage of total reconditioning attempts by 50 percent. 

ii. FDA inspector’s time. The 

proposed rule would require us to 

confirm that the owner or consignee 

affixes the label to the refused food 

import or otherwise complies with the 

label requirement.3 We estimate that 

this process would require 

approximately 30 minutes per 

shipment. We estimate the value of an 

FDA inspector’s time based on a GS–10, 

step 5 rate, plus 30 percent in benefits. 

At this hourly rate, FDA’s labor costs for 

each shipment would be $15 (0.5 hours 

x $30 per hour). We request comment 

on these estimates. 

TABLE 4.—MEAN ANNUAL LABELING

COST ESTIMATES

Static Dynamic 

Number of Refusals 

to be Labeled 

3,672 1,814 

FDA Labor Cost per 

Refusal 

$15 $15 

Total FDA Cost $55,080 $27,210 


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Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 54117 

4Using total shipments labeled as a proxy for the 

number of importers affected is an overestimate in 

the sense that some owners or consignees may 

accrue multiple violations. 

5Unless the businesses are repeat offenders, the 

same business will not be affected each year. The 

rule does not affect all owners and consignees of 

shipments, but only those shipments that have been 

refused admission. 

TABLE 4.—MEAN ANNUAL LABELING

COST ESTIMATES—Continued 

Static Dynamic 

Owner/Consignee 

Labor Cost per Refusal 

$53 $53 

Total Owner/Consignee Labor Cost $194,616 $96,142 

Label Cost per Refusal $12.50 $12.50 

Total Label Cost $45,900 $22,675 

Total Owner/Consignee Cost $240,516 $118,817 

Total Annual Cost $295,609 $146,040 

TABLE 5.—FIXED LABELING COSTS

Number of Ports 132 

Label Guns Needed per Port of 

Entry 

3 

Cost per Label Gun $100 

Total Label Gun Costs $39,600 

c. Increased cost of shipments. Foods 

labeled as ‘‘UNITED STATES: REFUSED 

ENTRY’’ would lose value due to 

diminished value in foreign ports, in 

addition to the loss of the United States 

market for the product. The owner or 

consignee would suffer an initial loss of 

value due to rejection of its cargo, 

regardless of the label. How the label 

decreases the value of the food would be 

a function of the initial value of the 

food, type of food, reason for refusal, 

and the reluctance of the new buyer to 

purchase previously refused 

merchandise. This cost represents a 

transfer from the owner or consignee to 

the ultimate purchaser of the product. 

However, there would be an additional 

cost of this proposed rule that is borne 

directly by the owner or consignee, but 

may be passed on to consumers in the 

form of higher food prices. This cost is 

difficult to quantify but it includes the 

increased cost of importing goods 

because of the increased likelihood of 

refusal. It also includes the costs of any 

additional preventive measures taken at 

the point of origin for the shipment. 

7. Summary of Benefits and Costs 

The uncertain nature of the number of 

illnesses prevented and the difficulty in 

quantifying the benefits to consumers of 

having clean foods, regardless of the 

danger, prevents a definitive statement 

about benefits and costs. We expect the 

static costs to be about $300,000; this 

sets a threshold value for the benefits. 

For two reasons, the annual benefits 

would probably be greater than these 

estimated annual costs. First, the costs 

are likely to decrease over time, perhaps 

to as low as $70 thousand, as owners 

and consignees decrease shipments of 

violative food and increase efforts to 

recondition refusals. Second, stopping 

just one violative shipment from 

entering the United States after refusal 

could cover the costs. For example, in 

2006, nearly 800 food shipments were 

refused because the food contained 

salmonella (Ref. 1). For the period 

between 1996 and 2006, we calculate 

that salmonella outbreaks caused from 2 

to 688 confirmed illnesses (with an 

average of 46 confirmed illnesses) per 

outbreak (Ref. 7). Therefore, if stopping 

just one of the 800 shipments refused 

for containing salmonella from entering 

the United States would avert an 

outbreak, the result would be a savings 

of over $822,000 ($17,880 per illness x 

46 illnesses) in direct medical and 

health costs. This is simply an example, 

using a single reason for refusal, that 

illustrates how high the benefits from 

this proposed rule are likely to be. If 

multiple outbreaks are averted in a 

given year, or even a single outbreak 

involving fatalities, the benefits could 

easily reach the hundreds of millions. 

B. Preliminary Regulatory Flexibility 

Analysis 

As discussed in detail in section VII.A 

of this document, we find that this 

proposed rule would affect up to 1,184 

owners or consignees annually.4 Most of 

these owners or consignees are small 

businesses as defined by the Small 

Business Administration. For the 

purpose of this analysis, we assume that 

all 1,184 affected businesses are small.5

These small owners or consignees 

would face a cost of approximately $65 

per labeled violative food shipment in 

time and materials as calculated in 

section VII.A of this document. In 

addition, the value of their violative 

food shipment would fall. This cost is 

difficult to quantify, but can be bounded 

by the cost of repackaging the 

merchandise. FDA seeks comment on 

the estimates used to calculate the cost 

per labeled shipment. We do not expect 

this cost for any one small owner or 

consignee to be excessive, so we 

conclude that this proposed rule would 

not place a disproportionate burden on 

small businesses. 

Regulatory Alternative Considered for 

Small Businesses 

Exempting small businesses from the 

proposed rule would lift the burden on 

some small entities. However, because 

most entities affected by the proposed 

rule are small, such an exemption 

would effectively negate the proposed 

rule. We also note that the proposed 

rule would not prescribe any particular 

method for affixing the label, and 

owners and consignees whose 

shipments are refused admission may 

decide to re-condition, destroy, or reexport a violative food import. Given 

these flexible alternatives available to 

small entities and the small compliance 

cost of the proposed rule, we did not 

consider additional options. 

C. Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 (Public Law 104–4), requiring 

cost-benefit and other analyses, in 

section 1531(a) defines a significant rule 

as ‘‘a Federal mandate that may result 

in the expenditure by State, local, and 

tribal governments in the aggregate, or 

by the private sector, of $100,000,000 

(adjusted annually for inflation) in any 

1 year.’’ We have determined that this 

proposed rule does not constitute a 

significant rule under the Unfunded 

Mandates Reform Act. 

VIII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 


dwashington3 on PRODPC61 with PROPOSALS
54118 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. U.S. Food and Drug Administration, 

Operational and Administrative System for 

Import Support (OASIS), Available at: http:// 

www.accessdata.fda.gov/scripts/ora/pcb/ 

tutorial/les2_oasis.htm. 

2. Kaplan, R.M., J.P. Anderson, and T.G. 

Ganiats, ‘‘The Quality of Well-being Scale: 

Rationale for a Single Quality of Life Index,’’ 

in Walker, S.R. and Rosser, R.M., eds. Quality 

of Life Assessment: Key Issues in the 1990s, 

The Netherlands: Kluwer Academic 

Publishers, 1993. 

3. Viscusi, W.K., ‘‘The Value of Risks to 

Life and Health.’’ Journal of Economic 

Literature, vol. 31, pp. 1912–1946, December 

1993. 

4. Mauskopf, J.A., Mt French, A.S. Ross, 

D.M. Maguire, R.W. Leukrith, Jr., and K.D. 

Fisher, ‘‘Estimating the Value of Consumers’ 

Loss from Foods Violating the Federal Food, 

Drug, and Cosmetic Act,’’ Research Triangle 

Report to the Center for Food Safety and 

Applied Nutrition, U.S. Food and Drug 

Administration, September 1988. 

5. Food Marketing Institute, 1999, 

Consumer Attitudes and the Supermarket. 

Research International USA. 

6. Bureau of Labor Statistics, 2004 National 

Occupational and Wage Estimates, http:// 

www.bls.gov/oes/, March 2006. 

List of Subjects in 21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, the Public 

Health Service Act, and under authority 

delegated to the Commissioner, we 

propose to amend part 1 as follows: 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

1. The authority citation for 21 CFR 

part 1 continues to read as follows: 

Authority: 15 U.S.C. 1453, 1454, 1455; 19 

U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 

333, 334, 335a, 343, 350c, 350d, 352, 355, 

360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 

216, 241, 243, 262, 264. 

2. Section 1.98 is added to subpart E 

to read as follows: 

§ 1.98 Label requirement on food imports 

refused admission into the United States. 

(a) Who is subject to this label 

requirement and what does the label 

say?—You are subject to this rule if you 

are an owner or consignee of an 

imported food, including food for 

animals, which has been refused 

admission into the United States (other 

than a food that must be destroyed). In 

such situations, you must affix a label 

stating, ‘‘UNITED STATES: REFUSED 

ENTRY’’, as described in paragraphs (b), 

(c), and (d) of this section. 

(b) What does the label look like?—(1) 

Labels for shipping containers—For 

labels that are to be affixed to shipping 

containers (as required by paragraph (c) 

of this section), the letters in the label 

must be at least 72 points in size, appear 

in either an Arial or Univers font, and 

use black ink against a white 

background. The label must use 

uppercase letters only. 

(2) Labels for documents—For labels 

to be affixed to documents (i.e., 

invoices, packing lists, bills of lading, 

and any other documents accompanying 

the refused food, as required by 

paragraph (c) of this section), the letters 

in the label must be in black ink, must 

use either an Arial or Univers font style, 

and must be at least 36 points in size. 

The label must use uppercase letters 

only. 

(c) Where does the label go?—For 

foods that are packaged, the label 

described in paragraph (b)(1) of this 

section must be clear, conspicuous, and 

permanently affixed to the food’s 

shipping container. For purposes of this 

section, the term ‘‘shipping container’’ 

is any container used to pack one or 

more immediate containers of the 

refused food, and an immediate 

container is any container that holds an 

imported food for retail sale. In some 

situations, the food’s immediate 

container may be the same as the 

shipping container. The term ‘‘shipping 

container’’ excludes trailers, railroad 

cars, ships, and similar vehicles, vehicle 

components, and transportation-related 

items. For all foods, regardless of 

whether they are packaged in shipping 

containers, the label described in 

paragraph (b)(2) of this section must be 

clear, conspicuous, and permanently 

affixed to the top page of each document 

accompanying the refused food. 

(d) How do you show that you 

complied with the label requirements?— 

(1) To comply with the label 

requirement described in paragraphs (a) 

and (b) of this section, you must contact 

the FDA district office responsible for 

the food’s entry and arrange to: 

(i) Affix the label(s) in our presence or 

under our supervision; 

(ii) Submit photographs or other 

visual evidence to us to show that you 

affixed the label(s); or 

(iii) Develop another means of 

showing, to FDA’s satisfaction, that you 

affixed the label(s). 

(2) You must affix the label(s) 

promptly, and you must not move the 

food until you have complied with the 

label requirements. 

(e) What fees may we impose?—We 

may seek reimbursement from the 

owner or consignee for expenses 

connected to the affixing of a label 

under this section. These expenses will 

be computed on the basis of our 

inspector’s time, the per diem allowance 

under government regulations, travel 

costs, and administrative support costs. 

We will submit a list of expenses 

incurred to the owner or consignee. 

Dated: September 12, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21813 Filed 9–17–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Part 1910 

[Docket No. OSHA–2008–0012] 

RIN 1218–AC40 

Tree Care Operations 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Department of 

Labor. 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: OSHA is requesting data, 

information, and comment on tree care 

operations, including hazards, fatalities, 

and control measures, that the Agency 

can use in developing a proposed 

standard to control hazards and reduce 

injuries in those operations. 

DATES: Comments must be submitted 

(postmarked, sent, or received) by 

December 17, 2008. 

ADDRESSES: You may submit comments, 

identified by Docket No. OSHA–2008– 

0012, by any of the following methods: 

Electronically: You may submit 

comments and attachments 

electronically at http:// 

www.regulations.gov, which is the 

Federal eRulemaking Portal. Follow the 

instructions online for submitting 

comments. 

Fax: If your comments, including 

attachments, do not exceed 10 pages, 

you may fax them to the OSHA Docket 

Office at 202–693–1648. 

Mail, hand delivery, express mail, 

messenger or courier service: You must 

submit three copies of your comments 

and attachments to the OSHA Docket 

Office, Docket No. OSHA–2008–0012, 

Room N–2625, U.S. Department of 

Labor, 200 Constitution Avenue, NW., 

Washington, DC 20210; telephone 202– 

693–2350 (TTY number 877–889–5627). 


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