6502 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules

Actions Compliance times Procedures

(1) Check your maintenance records to determine whether this AD applies to your airplane

by doing the following:

(i) Check the maintenance records to determine

whether a 0513166 series plastic control

wheel is installed. The owner/operator holding at least a private pilot certificate as authorized by section 43.7 of the Federal Aviation Regulations (14 CFR 43.7) may check

the maintenance records.

(ii) If, by checking the maintenance records, the

pilot can positively show that no 0513166 series plastic control wheels are installed, then

the inspection, testing, and replacement requirements of this AD do not apply. The AD

is complied with after you make an entry into

the aircraft records that shows compliance

with this portion of the AD, in accordance

with section 43.9 of the Federal Aviation

Regulations (14 CFR 43.9).

Required within 100 hours time-in-service

(TIS) after the effective date of this AD.

No special procedures required to check the

maintenance records.

(2) For any affected airplane where at least one

0513166 series plastic control wheel is installed, do the following:

(i) Inspect each control wheel for cracks; and

(ii) Conduct a pull test on each control wheel

Before further flight after the maintenance

records check or within 100 hour TIS after

the effective date of this AD, and reinspect

afterward at intervals not to exceed 12

months until all control wheels are replaced

with FAA-approved control wheels that are

not 0513166 series plastic control wheels.

Do this following the instructions of Cessna

Service Letter No. 64–8, dated February

14, 1964.

(3) Replace any cracked control wheel or any

control wheel that does not pass any pull

test, with an FAA-approved control wheel that

is not a 0513166 series plastic control wheel.

Do this replacement before further flight after

the inspection where the cracked or failed

control wheel is found.

Do the replacements following the instructions

in the applicable maintenance or service

manual.

(4) Do not install, on any affected airplane, a

0513166 series plastic control wheel.

As of the effective date of this AD ................... Not Applicable.

(5) You may replace all control wheels with

wheels that are not part number 0513166, as

terminating action for the repetitive inspection

and test requirement of this AD.

You may replace all control wheels at any

time, except for those control wheels that

are cracked or do not pass a pull test. Such

wheels must be replaced prior to further

flight, as required by paragraph (d)(3) of

this AD.

Do the replacements following the instructions

in the applicable maintenance or service

manual.

(e) Can I comply with this AD in any other

way? You may use an alternative method of

compliance or adjust the compliance time if:

(1) Your alternative method of compliance

provides an equivalent level of safety; and

(2) The Manager, Wichita Aircraft

Certification Office (ACO), approves your

alternative. Send your request through an

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, Wichita ACO.

Note 2: This AD applies to each airplane

identified in paragraph (a) of this AD,

regardless of whether it has been modified,

altered, or repaired in the area subject to the

requirements of this AD. For airplanes that

have been modified, altered, or repaired so

that the performance of the requirements of

this AD is affected, the owner/operator must

request approval for an alternative method of

compliance in accordance with paragraph (e)

of this AD. You should include in the request

an assessment of the effect of the

modification, alteration, or repair on the

unsafe condition addressed by this AD; and,

if you have not eliminated the unsafe

condition, specific actions you propose to

address it.

(f) Where can I get information about any

already-approved alternative methods of

compliance? Contact Eual Conditt, Aerospace

Engineer, Wichita Aircraft Certification

Office, FAA, 1801 Airport Road, MidContinent Airport, Wichita, Kansas 67209;

telephone: (316) 946–4128; facsimile: (316)

946–4407.

(g) What if I need to fly the airplane to

another location to comply with this AD? The

FAA can issue a special flight permit under

sections 21.197 and 21.199 of the Federal

Aviation Regulations (14 CFR 21.197 and

21.199) to operate your airplane to a location

where you can accomplish the requirements

of this AD.

(h) How do I get copies of the documents

referenced in this AD? You may get the

service information referenced in the AD

from Cessna Aircraft Company, Product

Support, P.O. Box 7706, Wichita, Kansas

67277; or you may examine this document at

FAA, Central Region, Office of the Regional

Counsel, 901 Locust, Room 506, Kansas City,

Missouri 64106.

Issued in Kansas City, Missouri, on January

11, 2001.

Marvin R. Nuss,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 01–1665 Filed 1–19–01; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 00N–1633]

RIN 0910-AB95

Marking Requirements for and

Prohibitions on the Reimportation of

Imported Food Products That Have

Been Refused Admission into the

United States

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the food import regulations to

require food products which, for safety

reasons, are refused entry into the

United States to be marked ‘‘UNITED

STATES REFUSED ENTRY.’’ The

proposed rule would also prohibit

persons from refusing to affix this mark

on refused food, from importing or

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules 6503

offering to import a previously refused

food, and from altering, removing,

tampering with, or concealing a mark.

The proposed rule is intended to protect

the public health against unsafe

imported food products and to facilitate

the examination of imported products.

DATES: Submit written comments by

April 9, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy,

Planning, and Legislation (HF–23), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3380.

SUPPLEMENTARY INFORMATION:

I. Introduction

Section 801 of the Federal Food, Drug,

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

381) authorizes FDA to examine foods,

drugs, devices, and cosmetics imported

or offered for import into the United

States and to refuse admission to

products under certain conditions.

Imported products are subject to the

same statutory and regulatory

requirements as domestic products. For

example, a domestic food product must

not be adulterated or misbranded.

Similarly, an imported food that is

intended for sale in the United States

must not be adulterated or misbranded.

FDA’s examination of imports often

begins with a review of records to

determine whether additional scrutiny

is warranted. FDA may, based on its

review of the records, permit the goods

to proceed, visually examine or take

samples of the goods for laboratory

analysis, or verify the registration,

listing, declarations, and certifications

for the product. For food products,

visual examinations may be inadequate

for detecting suspected microbiological

contamination, pesticide residues, and

other toxic elements, so FDA may take

samples of an imported food product for

further examination. If the examination

shows that the food product appears to

be in compliance with U.S.

requirements, FDA releases the

shipment to proceed into U.S.

commerce. If the food product appears

to be not in compliance, the importer

has an opportunity to provide evidence

or testimony that the food product

complies with U.S. requirements or to

submit a plan to recondition the food

product to bring it into compliance if

such reconditioning is possible. If, after

the importer has had an opportunity to

present its views or if reconditioning

failed to bring the food into compliance,

the food product is not in compliance,

FDA may refuse admission to the food

product. If refused products are not

reexported within 90 days of refusal, the

U.S. Customs Service (Customs Service)

will have the products destroyed.

Additionally, under section 304 of the

act (21 U.S.C. 334), FDA may initiate

seizure and condemnation proceedings

against any article of food that is

adulterated or misbranded, or which

may not be introduced into interstate

commerce under section 404 of the act

(21 U.S.C. 344). A court may, after

seizure and condemnation of an

imported article, order the article to be

destroyed or permit the article to be

reexported (see United States v. Food,

2,998 Cases, 64 F.3d 984 (5th Cir.

1995)). The Customs Service also has

seizure procedures (see 19 U.S.C.

1595a).

In recent years, the demand on FDA’s

resources for reviewing food imports

has increased significantly. For

example, in 1985, approximately

950,000 line items of goods were offered

for import into the United States. (A line

item corresponds to a specific item on

an invoice or shipping papers.) By 1998,

the number of line items had increased

to over 3 million (see statement by

William B. Schultz, Deputy

Commissioner for Policy, Food and

Drug Administration, before the

Permanent Subcommittee on

Investigations, Senate Committee on

Government Affairs, September 24,

1998). FDA’s ability to inspect a

sufficient proportion of imports has

been severely hampered by this

increase. Currently, FDA examines or

samples less than 2 percent of imported

foods for compliance with FDA

requirements.

FDA is aware that some unscrupulous

importers use various measures to

subvert this process in order to

introduce unsafe food products into the

United States. In April 1998, the

General Accounting Office (GAO) issued

a report entitled ‘‘Food Safety: Federal

Efforts to Ensure the Safety of Imported

Foods are Inconsistent and Unreliable’’

(GAO/RCED–98–103). The GAO report

stated that some importers evade import

controls and are able to introduce

contaminated, adulterated, or unsafe

food into the United States even when

FDA refused to admit the food and the

Customs Service ordered the food to be

reexported or destroyed. In particular,

the GAO report noted that FDA does not

require that refused foods be marked as

‘‘refused entry.’’

Additionally, in 1998, the Senate

Governmental Affairs Committee’s

Permanent Investigations Subcommittee

held hearings on the safety of food

imports. The Committee heard

testimony about various methods used

to avoid food safety inspections and to

introduce adulterated food into the

United States. These methods included

reimporting refused goods through

another U.S. port (‘‘port shopping’’) and

substituting trash or other items for

adulterated food products for which

FDA has refused entry so that the trash

and other items, rather than the

adulterated food products, were

destroyed or reexported (Ref. 2)

(statement of ‘‘Former Customs

Broker’’). Placing a clearly identifiable

mark on food imports that have been

refused admission for safety reasons

would help curtail the reintroduction of

unsafe food products into the United

States.

On July 3, 1999, the President issued

a memorandum to the Secretary of

Health and Human Services and the

Secretary of the Treasury (the

Secretaries) on the safety of imported

foods. The memorandum identified food

safety as a high priority and, among

other things, 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....’’

II. Description of the Proposed Rule

A. Introduction

FDA is proposing to amend its import

regulations to create a new § 1.98

entitled ‘‘Marking Requirements for and

Prohibitions on the Reimportation of

Food Products That Have Been Refused

Admission into the United States.’’ The

proposal would require importers or

consignees to mark food (including

animal feed) that FDA refuses to admit,

for safety reasons, into the United

States. The mark should make it more

difficult for imported food products that

have been refused admission into the

United States to evade import controls

and would complement FDA’s efforts to

monitor food imports more effectively.

The proposed rule would also prohibit

importers from reimporting refused

shipments.

FDA and the Customs Service held

two public meetings to discuss imported

food safety on February 10, 2000, in Los

Angeles, CA, and on February 17, 2000,

in Washington, DC. Several comments

were made concerning marking refused

food imports, and FDA addresses those

6504 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules

comments as part of this description of

the proposed rule.

B. Who Must Affix the Mark?

If you are an importer or consignee of

a shipment of imported food that FDA

has refused to admit for safety reasons,

you would be subject to the rule. (For

purposes of this rule, the reference to

‘‘safety reasons’’ means that consuming

the imported food could adversely affect

a person’s health.) Under proposed

§ 1.98(a), if FDA has refused to admit

your imported food into the United

States for safety reasons, you must mark

the refused food as ‘‘UNITED STATES

REFUSED ENTRY.’’ An FDA employee

or FDA-designated official (such as an

FDA-commissioned official) would

supervise the marking process.

In contrast, if FDA refused admission

of your imported food for other

nonsafety reasons, you would not be

subject to this rule. For example, if FDA

refused to admit your imported food

because it was labeled in a foreign

language, you would not have to mark

the refused food product. If, however,

FDA refused to admit your imported

food because it contained an unsafe

ingredient, you would have to mark the

refused product in accordance with the

regulation.

C. What Must the Mark Look Like?

Proposed § 1.98(b) would require you

to make the mark in capital letters at

least 2.5 centimeters (cm) or 1 inch

high. The mark would state ‘‘UNITED

STATES REFUSED ENTRY.’’ The

mark’s language and format are similar

to those used by the U.S. Department of

Agriculture on meat and meat food

products that have been refused

admission into the United States (9 CFR

327.26(c)).

Some comments during a public

meeting suggested that the mark include

some indication of why the food

product was refused entry instead of

stating simply that the food was refused

entry. FDA has not included this

suggestion in the proposed rule because

the text of the proposed mark, ‘‘UNITED

STATES REFUSED ENTRY,’’ is

applicable to all products that are

refused entry for safety reasons and is

similar to a mark used by the U.S.

Department of Agriculture. If FDA

required the mark to explain the reasons

for the refusal, importers and consignees

would need multiple marks (to cover

the various possible reasons for refusing

entry) or would need to use ‘‘fill in the

blank’’ marks which could then be

illegible (if the reasons are handwritten)

or difficult to use (if the reasons are

machine-printed). Nevertheless, FDA

welcomes additional comment on this

point.

Proposed § 1.98(b)(1) would require

the mark to be permanent, clear, and

conspicuous. This will help ensure that

the mark is noticeable. For example, if

the mark is affixed to a bill of lading,

you could place the mark diagonally

across the center of the document and

use colored ink. However, the proposal

would not specify any particular

method of marking. In other words, you

can use adhesive labels, ink stamps, or

any other marking tool or device so long

as the mark is at least 2.5 cm or 1 inch

high, uses the correct language, is clear

and conspicuous, and is permanently

affixed to the refused imported food’s

container (where possible) and to

shipping documents accompanying the

imported food before it leaves the port

of entry.

Another comment at a public meeting

suggested that the mark be in ‘‘invisible

ink’’ that FDA would be able to see

through the use of some scanning

device. Some individuals expressed

concern about how a visible mark

would affect the refused product’s

ability to enter a foreign country or

return to the exporting country. This

proposed rule does not include the use

of ‘‘invisible ink.’’ One important

benefit of the mark is that it is supposed

to be clear and conspicuous; this will

make it easier for FDA and the Customs

Service to detect attempts to bring

refused food products back into the

United States. If the mark could only be

seen by using some unspecified device,

FDA and the Customs Service might

find it difficult to determine whether

the mark was correctly applied, to see

the mark on goods that are being

reintroduced into the United States in

spite of an earlier refusal, or to readily

distinguish between foods that should

be admitted into the United States from

foods that have already been refused

entry. FDA invites comment on this

point.

FDA also invites comments on

whether the rule should use or allow for

different size requirements due to the

variety of food packages and product

sizes and whether the rule should

require any particular form of marking.

D. Where Must the Mark Go?

Proposed § 1.98(b)(1) would require

you to affix the mark permanently to the

packing container holding the refused

food and on invoices, bills of lading,

and any other documents accompanying

the food when it is exported from the

United States. The proposal would

explain that, for purposes of thois rule,

a packing container is any container

used to pack one or more immediate

containers of the refused food and that

an immediate container is any container

which holds an imported food for sale

to the ultimate consumer. For example,

assume that you have a box that holds

24 cans of imported food. the box would

be the packing container, and each can

would be an immediate container. You

would, under the proposal, mark the

box rather than mark each can. FDA

would not require you to mark every

individual retail unit (unless the

immediate container also happens to be

the packing container, such as a large

bag of rice or flour). If the mark cannot

be permanently affixed to a packing

container (as with bulk agricultural

commodities, such as a railcar of wheat,

a truckload of potatoes, or a tanker of

corn syrup) you would only have to

place the mark on documents

accompanying the food when it leaves

the United States.

Several comments at the public

meeting said the mark should go on

cargo containers used to transport large

amounts of imported food products.

Others suggested using seals on cargo

containers instead of merely marking

the containers. FDA interpreted these

comments concerning cargo containers

as applying the mark or seal on items

such as rail cars, containers to be

attached to trucks, and other large,

reusable containers. FDA has not

included the comments’ suggestions in

this proposed rule. By proposing to

require the mark to be clear,

conspicuous, and permanent, FDA

intends to make it difficult for a person

to ‘‘port shop’’ or to conceal refused

food. If the mark were placed on a large,

reusable cargo container (such as a

tractor trailer or rail car), it would be

easy to defeat the rule simply by moving

the refused food from the marked cargo

container to an unmarked container. For

example, if the mark is on a container

attached to a truck instead of the

packing containers holding the refused

food product, the intent behind the rule

could be defeated by shifting the refused

food product from the marked tractor

trailer to an unmarked one. In contrast,

if the mark is on the packing containers

(such as boxes or wrapped shipping

palettes) holding the refused food, it

will be more difficult, both in terms of

time and cost, to open and repackage

the refused food, and thus evade the

rule’s purpose. FDA invites additional

comment on this point.

E. When Must You Affix the Mark?

Proposed § 1.98(b)(2) would require

you to affix the mark, under the

supervision of an FDA employee or

person designated by FDA, before the

food is exported. This is to ensure that

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules 6505

you place the mark, as required, on the

refused food before the food leaves the

United States.

F. Enforcement Issues

If this rule is finalized with a

prohibition on the reimportation of

refused food, reimportation of refused

food in violation of this rule would

constitute a violation of 19 U.S.C. 1595a

which would then permit the Customs

Service to seize, forfeit, and destroy the

goods after following the appropriate

procedures. Thus, proposed § 1.98(c)

would prohibit you from: (1) Importing

or offering to import any food that has

been previously refused admission into

the United States and marked as

‘‘UNITED STATES REFUSED ENTRY;’’

and (2) altering, removing, tampering

with, or concealing a mark. If you refuse

to affix a mark on a refused food import,

FDA and the Customs Service might

deny permission to re-export the refused

food product, order the product to be

destroyed, and take other regulatory

action against you and the refused food.

The Customs Service might also assess

civil money penalties under 19 U.S.C.

1592 or 1595a(b) if you alter, remove,

tamper with, or conceal a mark.

G. Authority Citation Changes

FDA is also proposing to amend the

authority citation for 21 CFR part 1 to

include references to sections 704 of the

act (21 U.S.C. 374) and 801 of the act

and section 361 of the Public Health

Service Act (the PHS Act) (42 U.S.C.

264). These statutory provisions provide

additional legal authority to issue the

proposed rule (as explained in section

III of this document).

III. Legal Authority

Section 801(a) of the act states that

FDA shall refuse to admit imported food

into the United States if the imported

food has 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 (21 U.S.C. 342 and

343) describe when a food is adulterated

and misbranded respectively. Section

701(a) of the act (21 U.S.C. 371(a))

authorizes the agency to issue

regulations for the efficient enforcement

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

authorizes FDA and the Department of

the Treasury to jointly prescribe

regulations for the efficient enforcement

of section 801 of the act.

The proposed rule is within FDA’s

authority at sections 402, 403, 701, and

801 of the act. Because marking refused

goods would permit FDA to more

efficiently enforce section 801 of the act,

FDA is authorized to impose marking

requirements on such food products.

The mark would help ensure that food

products that fail to meet the conditions

for admission into the United States do

not enter or reenter interstate commerce.

Section 704 of the act authorizes FDA

to conduct inspections for the efficient

enforcement of the act. Assuming that

the proposed rule is later finalized, FDA

may need to conduct inspections to help

enforce the rule. Thus, while section

704 of the act does not provide

independent authority to mark refused

food imports, it is relevant to FDA’s

enforcement of the rule.

The proposed rule is also authorized

by sections 301 of the PHS Act (42

U.S.C. 241) and 361 of the PHS Act.

Section 301 of the PHS Act authorizes

FDA to ‘‘render assistance’’ to

appropriate public health authorities in

the conduct of or to promote

coordination of research, investigations,

experiments, demonstrations, and

studies relating to the causes, diagnosis,

treatment, control, and prevention of

disease. Section 361 of the PHS Act

authorizes FDA to issue regulations to

prevent the introduction, transmission,

or spread of communicable diseases

from foreign countries into the United

States. Marking food products that have

been refused entry into the United

States would assist foreign public health

officials to determine whether to take

regulatory action against a particular

product. The mark would alert foreign

countries that the food product has

already been refused admission into the

United States. Marking such food

products would also help prevent the

introduction, transmission, or spread of

communicable diseases into the United

States by making it more difficult for

such rejected food products to enter the

United States through a different port or

to escape detection.

IV. Environmental Impact

FDA 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

FDA tentatively concludes that the

marking requirements proposed in this

document are not subject to review by

the Office of Management and Budget

(OMB) because they do not constitute a

‘‘collection of information’’ under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501-3520). Rather, the proposed

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)).

VI. Federalism

FDA has analyzed this proposed rule

in accordance with the principles set

forth in Executive Order 13132. FDA

has 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, the

agency has concluded that the proposed

rule does not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VII. Analysis of Impacts

A. Introduction

FDA has examined the impacts of the

proposed rule under Executive Order

12866, the Regulatory Flexibility Act (5

U.S.C. 601-612), and the Unfunded

Mandates Reform Act (2 U.S.C. 1501 et

seq.). 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).

Executive Order 12866 considers a rule

to be a ‘‘significant regulatory action’’ if

(among other things) it may have an

annual effect on the economy of $100

million, adversely affecting a sector of

the economy in a material way,

adversely affecting competition, or

adversely affecting jobs. A regulation is

also considered a significant regulatory

action if it raises novel legal or policy

issues arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order. OMB

has determined that this proposed rule

is a significant regulatory action as

defined by Executive Order 12866.

Under the Regulatory Flexibility Act,

if a rule has a significant impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

impact of the rule on small entities. For

reasons explained later in this section,

FDA concludes that the proposed rule,

if finalized, would not have a significant

economic impact on a substantial

6506 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules

number of small entities. Therefore, a

regulatory flexibility analysis is not

required.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104-4) requires that agencies

prepare a written assessment of

anticipated costs and benefits before

proposing any rule that may result in an

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100 million in any

one year (adjusted annually for

inflation).

The Unfunded Mandates Reform Act

does not require FDA to prepare a

statement of costs and benefits for the

proposed rule because the proposed rule

is not expected to result in any 1 year

expenditure that would exceed $100

million adjusted for inflation. The

current inflation-adjusted statutory

threshold is $110 million.

B. The Rationale Behind This Proposed

Rule

The introduction to this proposed rule

explains the reasons, such as ‘‘port

shopping’’ and the President’s July 3,

1999, memorandum on the safety of

imported foods that prompted FDA, in

conjunction with the Customs Service,

to issue this regulation. FDA refers

readers to that discussion if they seek

details regarding the reasons for this

proposal and the problems concerning

the reimportation of previously refused

imported food.

C. Regulatory Options Considered

As described earlier, the proposed

rule would require importers and

consignees whose food products have

been refused admission in to the United

States for safety reasons to mark such

products as ‘‘UNITED STATES

REFUSED ENTRY.’’ This will make it

easier for FDA and the Customs Service

to detect attempts to re-introduce

previously-refused imported food into

the United States.

In drafting this rule, FDA considered

and rejected several alternatives. For

example, one option would be to order

the destruction of all refused food

imports. While this would deter ‘‘port

shopping’’ and similar illegal practices,

this alternative is not feasible because it

would require Federal resources to be

diverted to supervising or otherwise

ensuring that the refused food imports

are stored until they can be destroyed

and that they are actually destroyed.

Additionally, the standard of proof to

support the destruction of violative

products is greater than the standard of

proof for refusing to admit imported

products, so ordering the destruction of

refused food imports would increase,

rather than decrease, the demands on

government field resources. This

alternative would also be extremely

costly to importers since many refused

shipments can be exported and legally

sold or reconditioned for sale in other

countries.

Another alternative would be a ‘‘no

action’’ option. This alternative was

unacceptable because it would allow

illegal practices, such as port shopping,

to continue and would result in the

reentry of previously refused food

imports into the United States.

Consumers who ingested those unsafe

food imports would, in turn, be subject

to foodborne illnesses. Consequently, a

‘‘no action’’ alternative would not

further efforts to protect the public

health.

Another alternative would be to mark

some, but not all, food refused for safety

reasons. This alternative would be less

costly, but would also be less efficient

and less practical. This alternative was

unacceptable because it would create an

opportunity for some refused food

imports to reenter the United States

through port shopping (and to harm

consumers) and because an unmarked,

but previously-refused, food import

would be difficult to detect compared to

a previously-refused and marked food

import. Additionally, marking some, but

not all, refused food would inevitably

create arguments as to FDA’s criteria for

deciding which refused foods should or

should not be marked and whether a

specific food import met that criteria.

For example, if the alternative was to

mark refused food depending on its

geographic origin (under a theory that

some foreign nations regulate exported

food more rigorously than others so that

the United States could relax its

safeguards for foods from those

countries), the result would be both

inefficient and unfair. To illustrate this

point, assume that country A has a food

regulatory system while country B has

a less demanding regulatory system. If

an alternative would mark unsafe food

from country B, but not mark a similar,

unsafe food from country A, such an

alternative would make it possible for

unsafe food from country A to be port

shopped, thereby defeating the intent of

the rule. Marking would then depend on

geographic origin rather than the safety

of the food itself.

As another example, if the alternative

were to mark refused food imports

based on their potential risk, such as

marking refused foods which, if

consumed, would cause death or serious

illness in humans, such an approach

would be impractical and difficult to

apply. To illustrate this point, assume

that an imported food product appears

to be contaminated because mold is

visible on the product. If marking

depended on whether the moldy food

would cause death or serious illness,

arguments would inevitably arise

concerning the identification of the

mold, its toxicological properties (if

any), the methodology or references

used to analyze the mold or to

determine the seriousness of the health

risk associated with the mold, etc.

D. Benefit-Cost Analysis

1. Strategic Action by Importers

Although the vast majority of

importers and consignees comply with

the act, some attempt to circumvent

Federal law and introduce unsafe food

into U.S. commerce through illegal

means such as port shopping. For these

importers and consignees, measures

such as those contained in this

proposed rule are necessary to deter

illegal conduct.

An importer’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 importers and

consignees to mark ‘‘UNITED STATES

REFUSED ENTRY’’ on imported food

which has been refused admission for

safety reasons changes the expected

profits associated with the initial

decision to attempt to import unsafe

food. A mark also affects 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 importer of

potentially unsafe food can be

represented visually by a decision tree

(see figure 1). This illustrates how

requiring ‘‘UNITED STATES REFUSED

ENTRY’’ on refused imports will alter

an importer’s or consignee’s incentives.

The same tree shows the possible

outcomes and decisions an importer or

consignee can make at each stage of the

importation process. At point A, an

importer or consignee with violative

food first decides whether to attempt to

import the food into the United States.

This decision will be influenced by the

price the importer or consignee can get

for the food if it is successfully

imported, the probability the cargo will

be inspected, and the cost to the

importer 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. If it is found violative,

the importer may choose to recondition

the food to correct the violations. At

point C, FDA refuses admission of the

food. If the food is not destroyed, at

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules 6507

point D the importer or consignee may have the option of re-exporting to a

foreign country or port shopping.

2. The Rule’s Effect on Deterrence

Labeling refused imported foods

as‘‘UNITED STATES REFUSED

ENTRY’’ alters the incentive structure

that importers and consignees face

when deciding whether to introduce

their product into United States

commerce. In particular, there are four

ways that the rule would increase the

deterrence value of the FDA inspection

system.

a. Port shopping will be reduced. One

primary goal of this rule would be to

reduce port shopping. Placing a mark on

a refused food import will reduce the

probability that the refused food import

will be re-imported into the United

States. The cost of port shopping will

increase because resources would have

to be expended to repackage a product

that has been marked. Thus, port

shopping will become relatively less

attractive to importers and consignees.

b. Decrease in the value of re-exported

items. The value of a product destined

for reexport will decrease if it is marked

‘‘UNITED STATES REFUSED ENTRY.’’

After the product has been marked, the

importer or consignee has two costly

choices: (1) Relabel containers or

repackage the product into containers

that do not bear the mark after the

product leaves the United States, or (2)

sell the goods abroad with the mark

intact. It is likely that such a mark

would be viewed less than favorably by

food safety inspectors and importers in

international markets. Thus, the

expected profit from selling goods that

are marked would be lower than if the

mark did not exist, so this loss is in

addition to the loss of value from refusal

alone. Either of the importer’s or

consignee’s choices (repackage or sell

with the mark intact) would lower the

expected profit of reexporting.

c. Reconditioning will become a more

favored alternative. The expected profit

from reconditioning a refused food

import is not likely to change with this

rule. Consequently, since the expected

profits from port shopping and reexporting refused food imports are

expected to fall, reconditioning the

cargo becomes economically more

attractive. FDA expects that more

importers and consignees will choose to

recondition their product.

d. Decrease in the introduction of

unsafe food into the United States. As

with reconditioning, the expected profit

from initially sending a potentially

unsafe product to a foreign port is not

expected to change significantly with

this rule. Therefore, as the expected

profit from attempting to import unsafe

food into the United States is lowered

(because the cost of re-importing and reexporting unsafe food is increased), the

incentive to ship one’s product directly

to a foreign (non-United States) market

is increased. The net result of such a

dynamic is that more unsafe food

products will either be directly shipped

to foreign markets or reconditioned at

the point of export.

3. Benefits From The Rule

a. Health benefits. As described

earlier, the proposed rule, if finalized,

would decrease the number of unsafe

imported food products reaching the

U.S. consumer. The rule should

6508 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules

1Currently FDA is considering a policy that

would recommend the destruction of hazardous

food imports. Because dangerous foods may be reexported without this policy there is the potential

for these foods to be port shopped. This proposed

rule, if finalized, would then also discourage the reimportation of foods that present a direct hazard to

the public health, as well as foods representing an

indirect threat, and the rule’s benefits would be

higher.

discourage attempts to introduce or

reintroduce unsafe imported food into

the United States and encourage the

reconditioning of imported food that

FDA has refused to admit for safety

reasons. Consequently, U.S. consumers

would benefit through a reduction in

the number of foodborne illnesses due

to unsafe imported foods. Because FDA

cannot quantify the amount of illegal reimportation of refused foods, the agency

cannot make a definitive prediction of

the value of the reduced illnesses

arising from this proposed rule.

Although foods that represent a direct

and serious danger to public health are,

in most cases, destroyed,1 refused food

eligible for re-exportation may also

present a health hazard. Typical reasons

for refusal include illegal food or color

additives, pesticide contamination,

foreign objects, poor sanitation, and

unregistered manufacturers or processes

not filed. Each of these reasons for

refusal may represent a health risk.

Illegal food or color additives can cause

allergic reactions in sensitive

individuals. These allergic reactions can

range from mild contact dermatitis to a

severe allergy attack. Also, 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

indicate more serious problems such as

contamination with microbial

pathogens. Pesticide contamination may

represent a long-term cancer risk. 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. ‘‘Process not

filed’’ indicates that FDA has not

approved the canning process the

manufacturer uses. Without FDA

approval, it is not known if the firm is

using a canning process that may result

in botulism contamination. Although

the probability of contamination is low,

botulism is a very severe illness that has

a high mortality rate.

Table 1 of this document shows some

possible illnesses and injuries that can

result from unsafe foods and includes

their symptoms and an average cost per

case. The quality-adjusted life days

(QALD) (Ref. 8) 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 QALD’s are valued in dollars by

multiplying the number of lost days by

the value of statistical day, $630 (see 64

FR 36516 at 36523, (July 6, 1999)). This

value of a statistical life day is drawn

from the economic literature (Ref. 10).

The medical cost column is the direct,

medical cost of illness, which includes

hospitalization and doctor visits. Most

illnesses arising from E. Scherichia 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 sometimes

trigger chronic arthritis and in a very

small percentage of cases can result in

death.

TABLE 1.—COST OF SOME ILLNESSES POTENTIALLY AVERTED BY THE RULE

Potential Harm Symptoms QALD

Loss

Dollar Value

of Lost

QALD’s

Medical

Costs Total Cost

Allergens: Contact dermatitis ......................................... Reddening, swelling, itching of skin ............................... 2.10 $1,325 $125 $1,450

Allergens: Allergic reaction ............................................ Difficulty breathing, asthma, rash, possible shock ........ 1.03 $646 $550 $1,196

Objects in food: Simple dental injury ............................. Toothache, headache .................................................... 0.23 $145 $0 $145

Objects in food: Complex dental injury .......................... Simple, plus infection ..................................................... 3.47 $2,187 $3,540 $5,727

Objects in food: Oral emergency ................................... Sharp pain in mouth, face, neck, bleeding, plus possible metastatic or local infection.4.27 $2,687 $3,540 $6,227

Objects in food: Tracheo-esophageal obstruction ......... Choking, difficulty breathing, cyanosis, hypertension .... 0.48 $304 $0 $304

Objects in food: Esophageal perforation ........................ Pain in chest, bleeding aspiration pneumonia, requires

surgery.

13.93 $8,776 $14,160 $22,936

Canning processes: Botulism ........................................ Nausea, diplopia, blurred vision, lack of coordination,

Can include loss of muscle strength, paralysis, death.

667.94 $420,801 $29,526 $450,327

Filth: Salmonella ............................................................. Vomiting, nausea, possible arthritis, low probability of

death.

24.37 $15,357 $2,289 $17,646

Filth: E. coli .................................................................... Vomiting, nausea, bloody stools, possible kidney damage, low probability of death.10.79 $6,797 $4,829 $11,626

1Sources: E. coli and Salmonella costs were taken from ‘‘Flexibility Analysis of the Proposed Rules to Ensure the Safety of Juice and Juice Products,’’ 963 FR

24254 at 24259-24267, (May 1, 1998). 2Objects in food, allergens, and botulism costs were taken from Research Triangle Institute. Estimating the Value of Consumers’ Loss from Foods Violating the

Federal Food, Drug, and Cosmetic Act.

b. Other consumer benefits. While

problems such as insects or filth in food

may not always represent a direct health

threat, they show that the food was not

held in sanitary conditions. 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. If

consumers pay a premium believing

their food is sanitary and the food is not,

this payment represents a social loss.

However, FDA cannot quantify this

economic loss because FDA does not

know what percentage of the price of

food is a ‘‘cleanliness premium.’’

4. Costs of the Rule

Costs include both materials and time

and would be incurred by both FDA and

importers or consignees. The importers

and consignees would bear the

responsibility for marking; FDA would

verify that the mark is affixed to the

refused food. It is not clear which

method importers and consignees will

use to mark refused food imports, so

FDA has, for purposes of this analysis,

used labeling, an inexpensive and time

efficient method, 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 FDA

assumes that three label guns would be

needed at each of the 132 ports. Labels

reading ‘‘UNITED STATES REFUSED

ENTRY’’ would also have to be printed

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules 6509

at an approximate cost of $0.025 per

label.

b. Time—i. Importer’s time. The

number of hours spent applying labels

is a function of the number of rejected

shipments and their size. FDA assumes

the average shipment consists of 500

cartons and will take approximately 3

hours to mark. FDA also assumes the

importer or consignee will hire labor at

the average hourly cost for

transportation and moving occupations

published by the Bureau of Labor

Statistics (BLS), $17.64 (BLS, ‘‘Employer

Costs for Employee Compensation

Summary,’’ 1999). Under these

assumptions, it will cost approximately

$53 in labor (3 hours x $17.64 per hour)

to mark each shipment. It is not clear

how many shipments will need to be

marked. As a baseline, FDA estimates

that 7,338 shipments would be marked.

However, FDA expects more importers

and consignees will decide to

recondition after rejection (percent

correctable in table 2 of this document),

or will not attempt to import previously

refused or unsafe food (expected

avoidance in table 2 of this document),

due to the higher cost of shipments

being rejected. The ‘‘static annual cost’’

is the cost assuming more of the

shipments found violative are corrected

at the port. The ‘‘dynamic annual cost’’

is the ‘‘static annual cost’’ reduced by

the percentage decrease (expected

avoidance) we expect in initial

importation attempts. Based on FDA’s

experience, the agency can estimate the

number of shipments that can be

reconditioned rather than re-exported.

The percentage of shipments that can be

reconditioned is a function of the reason

for refusal. Also, the reduction in the

number of attempted imports of

violative shipments, ‘‘expected

avoidance,’’ is a function of the ease of

correcting the violation before

shipment. Again, FDA bases its

estimates on the agency’s experience.

For example, in fiscal year 1999, FDA

refused admission to 2,260 shipments

because the manufacturer was not

registered or the process was not filed.

Approximately 80 percent of these

shipments can be corrected before

importation or at the port by filing for

process approval or by registering the

manufacturer. This would reduce the

number of shipments that could be

marked from 2,260 to 452. The cost of

marking these shipments would then be

$23,925 in labor costs and $5,651 for

labels for importers. It would cost FDA

$33,229 to confirm the marks had been

made. The sum of these costs is $62,805.

However, because FDA expects

importers and consignees will be less

likely to attempt to import unsafe food

initially (expected avoidance), FDA then

reduces this cost by 50 percent, which

is then $31,402. Added to this cost is a

fraction of the cost of the label guns.

Label guns are durable goods and so the

value of a label gun should not be added

to the cost of marking each shipment.

ii. FDA inspector’s time. The

proposed rule would require FDA to

confirm that the importer or consignee

marks the refused food import. FDA

estimates that this process would

require approximately 60 minutes in

travel time and 30 minutes to confirm

marking per shipment. FDA estimates

the value of a FDA inspector’s time

based on a GS-10, step 5 rate, plus 100

percent in overhead. At this hourly rate,

FDA’s labor costs for each shipment

would be $74.

TABLE 2.—ANNUAL LABELING COST ESTIMATES

Reason for Refusal

Manufacturer

Not Registered/Process Not Filed

Illegal Food/

Color Additives

Pesticide

ContaminationSanitation

Total Annual Refusals

Estimated refusals ................................................................................................................. 2,260 1,530 873 2,675 7,338

Percent correctable ............................................................................................................... 80% 0% 0% 50%

Number of refusals to be marked ......................................................................................... 452 1,530 873 1,337 4,192

FDA Costs.

FDA hours per refusal ........................................................................................................... 1.5 1.5 1.5 1.5

FDA hourly rate ..................................................................................................................... $49 $49 $49 $49

Total FDA cost ...................................................................................................................... $33,229 $112,445 $64,160 $98,297 $308,131

Importer Costs.

Importer hours per refusal .................................................................................................... 3 333

Importer hourly rate ............................................................................................................... $17.64 $17.64 $17.64 $17.64

Label costs ............................................................................................................................ $5,651 $19,123 $10,912 $16,717

Total importer cost ................................................................................................................ $29,576 $100,083 $57,106 $87,491 $274,257

Static annual cost .................................................................................................................. $62,805 $212,528 $121,266 $185,789 $582,388

Expected avoidance .............................................................................................................. 50% 50% 15% 15%

Dynamic annual cost ............................................................................................................. $31,402 $106,264 $103,076 $157,921 $398,663

TABLE 3.—FIXED LABELING COSTS

Labeling Guns for Importers

Number of ports 132

Label guns needed per port of entry 3

Cost per label gun $100

TOTAL LABEL GUN COSTS = NUMBER OF PARTS X LABEL GUNS NEEDED PER PORT OF ENTRIES X COST PER LABEL

GUN $39,600

TABLE 4.—TOTAL COSTS

Labeling Guns for Importers

Annual costs $398,663

6510 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules

TABLE 4.—TOTAL COSTS—Continued

Labeling Guns for Importers

Other costs $39,600

TOTAL FIRST-YEAR COSTS $438,263

c. Diminished value of shipments.

Cargo marked ‘‘UNITED STATES

REFUSED ENTRY’’ will lose value due

to diminished value in foreign ports, in

addition to the loss of the U.S. market

for the product. The importer or

consignee suffers an initial loss of value

due to rejection of its cargo, regardless

of the mark. However, there is an

additional loss of value attributable to

the marking that is a cost of this rule.

This loss of value is a cost of the rule

that is borne directly by the importer or

consignee, but may be passed on to

consumers in the form of higher food

prices. This loss ofvalue is difficult to

quantify. How the mark decreases the

value of the cargo would be a function

of the initial value of the cargo, type of

product, reason for refusal, and the

reluctance of the new buyer to purchase

previously refused merchandise.

5. Summary of Benefits and Costs

The uncertain nature of the number of

illnesses prevented and the difficulty in

quantifying the benefits to consumer of

having clean foods, regardless of the

danger, prevents a definitive statement

about benefits and costs. Because FDA

expects the costs to be approximately

$438,263, this sets a threshold value for

the benefits. If the benefits due to

reduced illness and consumer valuation

of clean food exceed $438,263, the rule’s

benefits will exceed its costs.

E. Initial Regulatory Flexibility Analysis

1. Introduction

FDA has examined the economic

implication of these proposed rules as

required by the Regulatory Flexibility

Act (5 U.S.C. 601-612). If a rule would

have a significant economic impact on

a substantial number of small entities,

the Regulatory Flexibility Act requires

agencies to analyze regulatory options

that would lessen the economic effect of

the rule on small entities.

2. Economic Effects on Small Entities

The proposed rule, if finalized, would

affect many small entities, primarily

food importers or consignees. More than

95 percent (1,690 of 1,725 importers

identified through a search in Dialog

Classic) of food importers are small (Ref.

3) as defined by the Small Business

Administration (establishments with

less than 100 employees). These small

importers or consignees will face a cost

of approximately $75 per unsafe food

shipment in time and materials. In

addition, the value of their unsafe food

shipment will fall. This cost is difficult

to quantify, but can be bounded by the

cost of repackaging the merchandise.

FDA does not expect this cost for any

one small importer or consignee to be

significant, so the agency concludes that

this proposed rule does not place a

disproportionate burden on small

businesses. Furthermore, this cost is

borne only by small businesses that

attempt to re-import unsafe, and

previously refused, foods.

3. Regulatory Options

Exempting small businesses from the

proposed rule would lift the burden on

small entities. However, since most

entities affected by the rule are small,

this would effectively negate the rule’s

purpose. For reasons already discussed

in section VII.C of this document, other

regulatory options, such as destroying

all refused food imports, taking no

action, marking some but not all refused

food imports, and marking based on

geographic origin, are not feasible in

light of the proposed rule’s purposes.

FDA also notes that the proposal

contains options (with respect to the

method used to affix the mark) for

importers and consignees, and

importers and consignees whose

shipments are refused admission for

safety reasons may decide to recondition, destroy, or re-export an

unsafe food import. Given these options

available to small entities, FDA did not

consider additional options.

4. Relevant Federal Rules Which May

Duplicate, Overlap, or Conflict With the

Proposed Rule

FDA is not aware of any relevant

Federal rule which may duplicate or

conflict with the proposed rule. The

exportation of refused food products

must also comply with Customs rules

for exportation of refused imports at 19

CFR 12.4, 18.25, 18.26, and 158.45. In

addition, Customs routinely orders

redelivery of refused merchandise under

to the conditions contained in the basic

importation and entry bond. Therefore,

importers of refused food imports must

comply with the bond conditions

contained in 19 CFR 113.62, as required

by 19 CFR 12.3.

VIII. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal by April 9, 2001. Two copies

of any comments are to be submitted,

except that individuals may submit one

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 office above between 9 a.m.

and 4 p.m., Monday through Friday.

References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Bureau of Labor Statistics,

Employer Costs for Employee

Compensation Summary, http://

stats.bls.gov/news.release/ecec.nws.htm

(1999).

2. Congressional Hearing, The Safety

of Food Imports: Fraud and Deception

in the Food Import Process; Hearing

Before the Senate Committee on

Governmental Affairs, Permanent

Subcommittee on Investigations,

September 10, 1998.

3. Dialog Classic. Search of

wholesalers who import with SIC codes

between 5141 to 5149 that are

importers, February 29, 2000.

4. Food and Drug Administration,

‘‘Preliminary Regulatory Impact

Analysis and Initial Regulatory

Flexibility Analysis of the Proposed

Rules to Ensure the Safety of Juice and

Juice Products,’’ (63 FR 24254, May 1,

1998).

5. Food and Drug Administration,

‘‘Preliminary Regulatory Impact

Analysis and Initial Regulatory

Flexibility Analysis of the Proposed

Rule to Require Refrigeration of Shell

Eggs at Retail and Safe Handling

Labels,’’ (64 FR 36516, July 6, 1999).

6. Food Marketing Institute, 1999.

Consumer Attitudes and the

Supermarket. Research International

USA.

7. GAO Report, ‘‘Food Safety: Federal

Efforts to Ensure the Safety of Imported

Foods are Inconsistent and Unreliable’’

(GAO/RCED–98–103).

8. Kaplan, R. M., J. P. Anderson, and

T. G. Ganiats, ‘‘The Quality of WellVerDate 11<MAY>2000 22:43 Jan 19, 2001 Jkt 194001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 E:\FR\FM\22JAP1.SGM pfrm11 PsN: 22JAP1
Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Proposed Rules 6511

Being Scale: Rationale for a Single

Quality of Life Index,’’ edited by

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

of Life Assessment: Key Issues in the

1990s; The Netherlands: Kluwer

Academic Publishers, 1993.

9. 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.

10. Viscusi, W. K., ‘‘The Value of

Risks to Life and Health.’’ Journal of

Economic Literature, Volume 31, pp.

1912-1946, December 1993.

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 of Food

and Drugs, it is proposed that 21 CFR

part 1 be amended as follows:

PART 1—GENERAL ENFORCEMENT

REGULATIONS

1. The authority citation for 21 CFR

part 1 is revised to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 343, 352, 355, 360b, 362, 371,

374, 381; 42 U.S.C. 216, 264.

2. Add section 1.98 to subpart E to

read as follows:

§ 1.98 Marking of food imports refused

entry into the United States.

(a) If you are an importer or consignee

and your imported food has been

refused admission into the United States

for safety reasons and you want to

reexport the food, you must mark the

refused food, before you reexport it,

with the following mark:

(b) You must make the mark at least

2.5 cm. or 1 inch high in capital or

uppercase letters. The mark must be

clear, conspicuous, and permanently

affixed. You also must:

(1) Affix the mark to the packing

container of the food, if possible, and to

an invoice, bill of lading, and any other

shipping document accompanying the

food when it is exported. For purposes

of this rule, a packing container is any

contaner used to pack one or more

immediate containers of the refused

food, and an immediate container is any

container which holds an imported food

for sale to the ultimate consumer. the

term ‘‘packing container’’ excludes

trailers, railroad cars and similar

transportation-related items, and

(2) Affix the mark, under the

supervision of a FDA employee or

individual designated by FDA, before

the food is exported.

(c) You must not:

(1) Import or offer to import any food

that has been previously refused

admission into the United States and

marked as ‘‘UNITED STATES REFUSED

ENTRY;’’ or

(2) Alter, remove, tamper with, or

conceal a ‘‘UNITED STATES REFUSED

ENTRY’’ mark.

Dated: November 28, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

January 9, 2001,

Timothy E. Skud,

Acting Deputy Assistant Secretary.

Department of the Treasury.

[FR Doc. 01–1607 Filed 1–19–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 870

RIN 1029–AB95

Abandoned Mine Land (AML) Fee

Collection and Coal Production

Reporting on the OSM–1 Form

AGENCY: Office of Surface Mining

Reclamation and Enforcement, Interior.

ACTION: Proposed rule; reopening and

extension of the comment period.

SUMMARY: We, the Office of Surface

Mining Reclamation and Enforcement

(OSM) are reopening and extending the

comment period on a proposal to amend

our regulations governing Abandoned

Mine Land (AML) reclamation fee

reporting to allow for the electronic

filing of the information required on the

OSM–1 Form.

DATES: Written comments: We will

accept written comments on the

proposed rule until 5 p.m., Eastern time,

on February 21, 2001.

ADDRESSES: If you wish to comment,

you may submit your comments by any

one of the following methods. You may

mail or hand-deliver comments to the

Office of Surface Mining Reclamation

and Enforcement, Administrative

Record, Room 101, 1951 Constitution

Avenue, NW, Washington, DC 20240.

You may also submit comments to OSM

via the Internet at: osmrules@osmre.gov.

FOR FURTHER INFORMATION CONTACT: Mr.

Sean Spillane, Office of Surface Mining

Reclamation and Enforcement, Denver

Federal Center, Building 20k, Room B–

2005, Denver, Colorado 80225;

Telephone 303–236–0330, Ext. 278. Email: sspkillan@osmre.gov.

SUPPLEMENTARY INFORMATION:

I. Background Information

II. How Would the Electronic Submission

Process Work?

III. How Do I Submit Comments on the

Proposed Rule?

I. Background Information

On February 15, 2000 (65 FR 7706),

we published a proposed rule which

would revise our regulations to allow a

coal operator (or the entity reporting for

the operator) the option of filing the

OSM–1 Form electronically. Because of

the notary requirement in section 402(c)

of the Surface Mining Control and

Reclamation Act of 1977 (SMCRA), the