Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations 26785

such suspension, revocation,

modification or addition of further

limitations will not have the effect of

modifying the allocation of sugar made

pursuant to the provisions of

subdivision (b) of additional U.S. Note

5.

* * * * *

9. Section 2011.201 is revised to read

as follows:

§ 2011.201 General.

This subpart sets forth the terms and

conditions under which certificates will

be issued to U.S. importers for

importing specialty sugars from

specialty sugar source countries.

Specialty sugars imported from

specialty sugar source countries may not

be entered unless accompanied by a

specialty sugar certificate. This subpart

applies only to the ability to enter

specialty sugar at the in-quota tariff

rates of the quota (subheadings

1701.11.10, 1701.12.10, 1701.91.10,

1701.99.10, 1702.90.10, and 2106.90.44

of the HTS). Nothing in this subpart

shall affect the ability to enter articles at

the over-quota tariff rate (subheadings

1701.11.50, 1701.12.50, 1701.91.30,

1701.99.50, 1702.90.20, 2106.90.46).

10. Section 2011.202 is amended by

removing paragraph (g), redesignating

paragraphs (h) through (j) as paragraphs

(g) through (i), respectively, revising

paragraphs (b), (c), (f), (g), and (i), as

redesignated, and adding a new

paragraph (j) as follows:

§ 2011.202 Definitions.

* * * * *

(b) ‘‘Certificate’’ means a specialty

sugar certificate issued by the Certifying

Authority permitting the entry of

specialty sugar.

(c) ‘‘Certifying Authority’’ means the

Team Leader, Import Quota Programs,

Foreign Agricultural Service, U.S.

Department of Agriculture, or his or her

designee.

* * * * *

(f) ‘‘Person’’ means any individual,

partnership, corporation, association,

estate, trust, or other legal entity, and,

wherever applicable, any unit,

instrumentality, or agency, of a

government, domestic or foreign.

(g) ‘‘Quota’’ means the tariff-rate quota

on imports of sugar provided in

additional U.S. Note 5 to chapter 17 of

the Harmonized Tariff Schedule of the

United States.

* * * * *

(i) ‘‘Specialty sugar’’ means brown

slab sugar (also known as slab sugar

candy), pearl sugar (also known as perl

sugar, perle sugar, and nibs sugar),

vanilla sugar, rock candy, demerara

sugar, dragees for cooking and baking,

fondant (a creamy blend of sugar and

glucose), ti light sugar (99.2% sugar

with the residual comprised of the

artificial sweeteners aspartame and

acesulfame K), caster sugar, golden

syrup, ferdiana granella grossa, golden

granulated sugar, muscovado, molasses

sugar, sugar decorations, sugar cubes,

and other sugars, as determined by the

United States Trade Representative, that

would be considered specialty sugar

products within the normal commerce

of the United States, all of which in

addition:

(1) are sugars, syrups, or molasses

described in subheading 1701.11.10,

1701.12.10, 1701.91.10, 1701.99.10,

1702.90.10, or 2106.90.44 of the

Harmonized Tariff Schedule of the

United States,

(2) are the product of a specialty sugar

source country, and

* * * * *

(j) ‘‘Specialty sugar source country’’

means any country or area to which the

United States Trade Representative has

allocated an amount of the quantity

reserved for the importation of specialty

sugars under additional U.S. Note 5 to

chapter 17 of the Harmonized Tariff

Schedule of the United States.

11. Section 2011.203 is amended by

revising paragraphs (a) and (c) to read as

follows:

§ 2011.203 Issuance of specialty sugar

certificates.

(a) Specialty sugars imported into the

United States from specialty sugar

source countries may be entered only if

such specialty sugars are accompanied

by a certificate issued by the Certifying

Authority.

* * * * *

(c) Subject to quota availability, an

unlimited number of complying

shipments may enter under a given

certificate and a given certificate may

cover more than one type of specialty

sugar. Issuance of a certificate does not

guarantee the entry of any specific

shipment of specialty sugar, but only

permits entry of such sugar if the

amount allocated to the specialty sugar

source country is not already filled.

12. Section 2011.204 is revised to read

as follows:

§ 2011.204 Entry of specialty sugars.

An importer or the importer’s agent

must present a certificate to the

appropriate customs official at the date

of entry of specialty sugars. Entry of

specialty sugars shall be allowed only in

conformity with the description of

sugars and other conditions, if any,

stated in the certificate.

13. Section 2011.206 is amended by

revising paragraph (c) to read as follows:

§ 2011.206 Suspension or revocation of

individual certificates.

* * * * *

(c) The determination of the

Certifying Authority under paragraph (a)

that the importer has failed to comply

with the requirements of this subpart

may be appealed to the Director, Import

Policy and Trade Analysis Division,

Foreign Agricultural Service (FAS), U.S.

Department of Agriculture, Washington,

D.C. 20250, within 30 days from the

date of suspension or revocation. The

request for reconsideration shall be

presented in writing and shall

specifically state the reason or reasons

why such determination should not

stand. The Director shall provide such

person with an opportunity for an

informal hearing on such matter. A

further appeal may be made to the

Administrator, FAS, U.S. Department of

Agriculture, Washington, D.C. 20250,

within five working days of receipt of

the notification of the Director’s

decision. The Certifying Authority may

take action under paragraph (b) during

the pendency of any appeal.

14. Section 2011.207(a) is revised to

read as follows:

§ 2011.207 Suspension of the certificate

system.

(a) Suspension. The U.S. Trade

Representative may suspend the

provisions of this subpart whenever he

or she determines that the quota is no

longer in force or that this subpart is no

longer necessary to implement the

quota. Notice of such suspension and

the effective date thereof shall be

published in the Federal Register.

* * * * *

15. Subpart B of part 2011 is amended

by adding § 2011.208 to read as follows:

§ 2011.208 Paperwork Reduction Act

assigned number.

The Office of Management and Budget

(OMB) has approved the information

collection requirements contained in the

regulations in this subpart in

accordance with 44 U.S.C. Chapter 25

and OMB control number 0551–0014

has been assigned with corresponding

clearance effective through April 30,

1997.

Subpart C—[Removed]

16. Subpart C of part 2011 is removed.

Signed at Washington, D.C. on May 15,

1996.

Charlene Barshefsky

Acting United States Trade Representative

[FR Doc. 96–12807 Filed 5–28–96; 8:45 am]

BILLING CODE 3190–01–M
26786 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 94F–0189]

Food Additives Permitted for Direct

Addition to Food for Human

Consumption; Dimethyl Dicarbonate

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of dimethyl dicarbonate

(DMDC) as a yeast inhibitor in sports

drinks and fruit or juice sparklers. This

action is in response to a petition filed

by Miles, Inc. (now Bayer Corp.).

DATES: Effective May 29, 1996; written

objections and requests for a hearing by

June 28, 1996.

ADDRESSES: Written objections may be

sent to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Martha D. Peiperl, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3077.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of June 28, 1994 (59 FR 33299),

FDA announced that a food additive

petition (FAP 4A4420) had been filed by

Miles, Inc., Mobay Rd., Pittsburgh, PA

15205–9741 (now Bayer Corp., 100

Bayer Rd., Pittsburgh, PA 15205–9741),

proposing that the food additive

regulations in § 172.133 Dimethyl

dicarbonate (21 CFR 172.133) be

amended to provide for the safe use of

DMDC as a yeast inhibitor in sports

drinks and fruit or juice sparklers. The

petition defines sports drinks as

carbonated or noncarbonated, nonjuicecontaining (less than or equal to 1

percent juice), flavored or unflavored

beverages containing added electrolytes

(5–20 milliequivalents (meq)/liter

sodium ion (Na+) and 3–7 meq/liter

potassium ion (K+)). Fruit or juice

sparklers are defined as carbonated,

dilute beverages containing juice, fruit

flavor, or both, with juice content not to

exceed 50 percent.

DMDC is currently approved in

§ 172.133 for use as a yeast inhibitor in

wine, dealcoholized wine, and low

alcohol wine (53 FR 41325, October 21,

1988; and 58 FR 6088, January 26, 1993)

and in ready-to-drink tea beverages (59

FR 5317, February 4, 1994) (hereinafter

referred to as the October 1988 final

rule, the January 1993 final rule, and the

February 1994 final rule, respectively).

As discussed below, FDA has

evaluated data in the petition and other

relevant material and concludes that

DMDC is efficacious in preventing the

growth of yeasts and molds in sports

drinks and fruit or juice sparklers and

that the proposed use of DMDC is safe.

II. Determination of Safety

Under the so-called ‘‘general safety

clause’’ in section 409(c)(3)(A) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 348(c)(3)(A)), a food

additive cannot be approved for a

particular use unless a fair evaluation of

the data available to FDA establishes

that the additive is safe for that use.

FDA’s food additive regulations (21 CFR

170.3(i)) define safe as ‘‘a reasonable

certainty in the minds of competent

scientists that the substance is not

harmful under the intended conditions

of use.’’

The food additive anticancer or

Delaney clause in section 409(c)(3)(A) of

the act (21 U.S.C. 348(c)(3)(A)) further

provides that no food additive shall be

deemed to be safe if it is found to induce

cancer when ingested by man or animal.

Importantly, however, the Delaney

clause applies to the additive itself and

not to the impurities in the additive.

That is, where an additive itself has not

been shown to cause cancer, but

contains a carcinogenic impurity, the

additive is properly evaluated under the

general safety clause using risk

assessment procedures to determine

whether there is a reasonable certainty

that no harm will result from the

proposed use of the additive, Scott v.

FDA, 728 F.2d 322 (6th Cir. 1984).

III. Safety of DMDC in Sports Drinks

and Fruit or Juice Sparklers

DMDC is currently permitted as a

yeast inhibitor in wine and wine

substitutes (dealcoholized wine and

low-alcohol wine) and in ready-to-drink

tea beverages under § 172.133. In the

October 1988, January 1993, and

February 1994 final rules, the agency

concluded that, because DMDC

decomposes almost immediately after

addition to aqueous beverages, there

will be virtually no exposure to the

additive from the consumption of the

above-listed beverages.

Data submitted in the petition to

support the proposed use of the additive

at levels up to 250 parts per million

(ppm) in sports drinks and fruit or juice

sparklers are consistent with these

findings. Specifically, data from a study

of sparkling juice drink formulated with

250 ppm DMDC showed no detectable

amount of the additive (limit of

detection (LOD) = 40 parts per billion

(ppb)) after 4 hours (Ref. 1). A study of

water with 250 ppm DMDC added

yielded the same result (Ref. 1). Based

on these data and data incorporated

from the petition that resulted in the

October 1988 final rule (FAP 2A3636),

the agency concludes that there will be

virtually no consumer exposure to

DMDC, per se, from the use of the

additive in sports drinks and fruit or

juice sparklers. Therefore, FDA

concludes that DMDC itself presents no

hazard to the consumer.

IV. Safety of Substances That May be

Present in Sports Drinks and Fruit or

Juice Sparklers Due to the Use of the

Additive

DMDC is unstable in aqueous solution

and breaks down almost immediately

after addition to beverages. In aqueous

liquids, the principal breakdown

products are methanol and carbon

dioxide. Dimethyl carbonate (DMC) may

be present as an impurity in DMDC.

Section 172.133 sets a specification of

0.2 percent DMC in DMDC. DMDC also

may react with traces of ammonium

ions in beverages to produce methyl

carbamate (MC), a known carcinogen.

In previous evaluations of DMDC, the

agency, in accordance with § 171.1 (21

CFR 171.1), reviewed the safety not only

of DMDC but also of its decomposition

products in aqueous beverages. The

results of the agency’s analysis of the

additive’s use in wine and wine

substitutes were discussed extensively

in the October 1988 and January 1993

final rules, and its use in ready-to-drink

tea beverages was discussed in the

February 1994 final rule. The agency

applied the same type of analysis as in

past reviews to its review of the

petitioned use of DMDC. Aspects of the

safety evaluation that were not

previously addressed in final rules for

other uses of DMDC are discussed

below.

A. Methanol

As stated in previous final rules on

DMDC, the tolerable (safe) level of

exposure to methanol is 7.1 to 8.4

milligrams per kilogram body weight

per day (mg/kg body weight/day), or

approximately 426 to 504 mg/person/

day for a 60 kg adult. FDA estimates that

the cumulative methanol exposure for a

consumer at the 90th percentile from its

presence naturally in untreated fruit

juice and wine and from all uses of
Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations 26787

DMDC, including its currently regulated

uses and the proposed use in sports

drinks and fruit or juice sparklers, is 59

mg/person/day (Ref. 2). This estimate is

based on a maximum level of methanol

that can be derived from DMDC of 48.7

ppm methanol per 100 ppm DMDC

used. This level is less than one-seventh

of the tolerable safe level. The agency,

therefore, concludes that there is an

adequate margin of safety between total

methanol consumption from all sources,

including the petitioned use of DMDC,

and the amount of methanol that can be

safely ingested.

B. Methyl Carbamate

The reaction of ammonium ions in

beverages with DMDC produces MC, a

known carcinogen. The petitioner

provided data showing that MC was

detected at a level of 3.7 ppb in a fruit

sparkler formulated with 250 ppm

DMDC. MC was not detected in DMDCtreated sports drinks, using an analytical

method with an LOD of 0.5 ppb. Using

the residual level of 3.7 ppb and the

LOD of 0.5 ppb for MC in fruit sparklers

and sports drinks, respectively, the

agency estimates the exposure to MC for

all ages from the petitioned use of

DMDC to be 1.5 microgram/person/day

at the 90th percentile (Ref. 1). Using

established procedures for quantitative

risk assessment, the agency estimates

that the 90th percentile upper-bound

lifetime risk from potential exposure to

MC from the petitioned use of DMDC is

1.5 x 10-8, or less than 1 in 67 million,

and the 90th percentile upper-bound

lifetime risk from exposure to MC from

all approved and petitioned uses of

DMDC is 1.8 x 10-8, or less than 1 in 56

million (Refs. 1 and 3).

Therefore, the agency concludes that

there is a reasonable certainty of no

harm from the exposure to MC that may

result from the use of up to 250 ppm of

DMDC in sports drinks and fruit or juice

sparklers.

V. Conclusion on Safety

FDA has evaluated all of the data in

the petition pertaining to the use of

DMDC in sports drinks and fruit or juice

sparklers, as well as other data in its

files, and concludes that the additive is

safe for its proposed use.

To ensure the safe use of the additive

in sports drinks and fruit or juice

sparklers, FDA, under 21 U.S.C.

348(c)(1)(A), finds that it is necessary to

require directions on the food additive

label limiting the level of use of the

additive in these beverages to 250 ppm.

In accordance with § 171.1(h), the

petition and the documents that FDA

considered and relied upon in reaching

its decision to approve the petition are

available for inspection at the Center for

Food Safety and Applied Nutrition by

appointment with the information

contact person listed above. As

provided in § 171.1(h), the agency will

delete from the documents any

materials that are not available for

public disclosure before making the

documents available for inspection.

VI. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

The agency received one comment on

the environmental assessment in

response to the filing notice published

in the Federal Register of June 28, 1994

(59 FR 33299). The comment states that

approval of the subject additive could

have two environmental benefits due to

switching from hot-fill bottling of sports

drinks and sparklers to cold-fill. The

comment claims that this switch could

greatly reduce water usage in the

bottling process and could reduce

cooling water flow into municipal

wastewater treatment plants. However,

the comment did not provide

quantitative data on the magnitude of

the claimed environmental benefits of

the approval of this petition. FDA has

concluded that the comment does not

affect the agency’s determination that

the approval of this petition will have

no significant impact on the

environment. This comment can be seen

at the Dockets Management Branch,

along with the petitioner’s

environmental assessment and the

agency’s finding of no significant

impact.

VII. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before June 28, 1996, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

VIII. 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. Memorandum from the Chemistry

Review Branch to the Direct Additives

Branch, ‘‘FAP 4A4420–Dimethyl Dicarbonate

as a Yeast Inhibitor in Sports Drinks and in

Fruit or Juice Sparkling Beverages,’’ dated

July 8, 1994.

2. Memorandum from the Chemistry

Review Branch to the Direct Additives

Branch, ‘‘FAP 4A4420–DMDC as a Yeast

Inhibitor in Sports Drinks and Sparkling

Fruit or Juice Beverages. Background

Methanol Exposure,’’ dated May 8, 1996.

3. Memorandum from the Direct Additives

Branch to the Quantitative Risk Assessment

Committee, ‘‘Estimation of the Upper-Bound

Lifetime Risk from Methyl Carbamate (MC)

Formed by the Reaction of Ammonium Ions

with Dimethyl Dicarbonate (DMDC) During

the Use of DMDC as Requested in FAP

4A4420 (Miles Inc.),’’ dated May 23, 1995.

List of Subjects in 21 CFR Part 172

Food additives, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 172 is

amended as follows:

PART 172—FOOD ADDITIVES

PERMITTED FOR DIRECT ADDITION

TO FOOD FOR HUMAN

CONSUMPTION

1. The authority citation for 21 CFR

part 172 continues to read as follows:

Authority: Secs. 201, 401, 402, 409, 701,

721 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 342, 348, 371, 379e).

2. Section 172.133 is amended by

adding new paragraphs (b)(3) and (b)(4)
26788 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations

and by revising paragraph (c)(2) to read

as follows:

§ 172.133 Dimethyl dicarbonate.

* * * * *

(b) * * *

(3) Inhibitor of yeast in carbonated or

noncarbonated, nonjuice-containing

(less than or equal to 1 percent juice),

flavored or unflavored beverages

containing added electrolytes (5–20

milliequivalents (meq)/liter sodium ion

(Na+) and 3–7 meq/liter potassium ion

(K+)). The additive may be added to the

beverage in an amount not to exceed

250 ppm.

(4) Inhibitor of yeast in carbonated,

dilute beverages containing juice, fruit

flavor, or both, with juice content not to

exceed 50 percent. The additive may be

added to the beverage in an amount not

to exceed 250 ppm.

(c) * * *

(2) Directions to provide that not more

than 200 ppm of dimethyl dicarbonate

will be added to the wine,

dealcoholized wine, or low alcohol

wine and not more than 250 ppm of

dimethyl dicarbonate will be added to

the ready-to-drink tea or to the

beverages described in parts (b)(3) and

(b)(4) of this section.

Dated: May 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13303 Filed 5–28–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 301 and 602

[TD 8671]

RIN 1545–AS83

Taxpayer Identifying Numbers (TINs)

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations.

SUMMARY: This document contains final

regulations relating to requirements for

furnishing a taxpayer identifying

number on returns, statements, or other

documents. These regulations set forth

procedures for requesting a taxpayer

identifying number for certain alien

individuals for whom a social security

number is not available. These numbers

are called ‘‘IRS individual taxpayer

identification numbers.’’ These

regulations also require foreign persons

to furnish a taxpayer identifying number

on their tax returns.

DATES: These regulations are effective

May 29, 1996.

For dates of applicability of these

regulations, see § 301.6109–1(h).

FOR FURTHER INFORMATION CONTACT: Lilo

A. Hester, (202) 874–1490 (not a toll-free

number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

The collection of information

contained in these final regulations has

been reviewed and approved by the

Office of Management and Budget in

accordance with the Paperwork

Reduction Act (44 U.S.C. 3507) under

control number 1545–1461.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless the collection of information

displays a valid control number.

The estimated annual burden for the

collection of information contained in

§ 301.6109–1(d) is reflected in the

burden of Form W–7.

Comments concerning the accuracy of

this burden estimate and suggestions for

reducing this burden should be sent to

the Internal Revenue Service, Attn: IRS

Reports Clearance Officer, PC:FP,

Washington, DC 20224, and to the

Office of Management and Budget, Attn:

Desk Officer for the Department of the

Treasury, Office of Information and

Regulatory Affairs, Washington, DC

20503.

Books or records relating to this

collection of information must be

retained as long as their contents may

become material in the administration

of any internal revenue law. Generally,

tax returns and tax return information

are confidential, as required by 26

U.S.C. 6103.

Background

On June 8, 1995, the IRS published in

the Federal Register (60 FR 30211) the

withdrawal of the notice of proposed

rulemaking published in the Federal

Register on September 27, 1990 at 55 FR

39427, a notice of proposed rulemaking,

and a notice of public hearing relating

to taxpayer identifying numbers as

contained in the Income Tax

Regulations (26 CFR part 301) under

section 6109 of the Internal Revenue

Code (Code).

Written comments responding to the

notice of proposed rulemaking were

received, and a public hearing was held

on September 28, 1995. After

consideration of all the comments, the

proposed regulations under 6109 of the

Code are adopted as revised by this

Treasury decision. The comments and

revisions are discussed below.

Explanation of Provisions and

Revisions

A. Principal Changes

Section 6109 of the Code generally

provides that, when required by

regulations, a person must furnish a

taxpayer identifying number (TIN) for

securing proper identification of that

person on any return, statement, or

other document made under the Code.

The notice of proposed rulemaking

contains two principal changes to the

existing regulations. The first change is

the introduction of a new IRS-issued

TIN, called an IRS individual taxpayer

identification number (ITIN), for use by

alien individuals, whether resident or

nonresident, who currently do not have,

and are not eligible to obtain, social

security numbers. The Social Security

Administration generally limits its

assignment of social security numbers to

individuals who are U.S. citizens and

alien individuals legally admitted to the

United States for permanent residence

or under other immigration categories

which authorize U.S. employment.

Therefore, this change is designed to

help taxpayers (who need a TIN but

cannot qualify for a social security

number) maintain compliance with TIN

requirements under the Code and

regulations.

The second change is to modify the

existing rule set forth in § 301.6109–1(g)

that currently excludes from the general

requirement of providing a TIN, foreign

persons that do not have either (1)

income effectively connected with the

conduct of a U.S. trade or business or

(2) a U.S. office or place of business or

a U.S. fiscal or paying agent. Under

these regulations, the exclusion is

modified to require that any foreign

person who makes a return of tax (i.e.,

income, gift, and estate tax returns,

amended returns, or refund claims, but

excluding information returns) furnish

its TIN on that return. This change is

intended to address the IRS’ and

Treasury’s concern that, without TINs,

taxpayers cannot be identified

efficiently and tax returns cannot be

processed effectively.

B. Comments

Regarding the assignment of ITINs

under § 301.6109–1(d)(3)(iii) of the

proposed regulations, commentators

suggested that the IRS develop a process

whereby either (1) the Social Security

Administration (SSA) issues the ITIN

when the individual is not eligible for

a social security number, or (2) the

Immigration and Naturalization Service

(INS) (within the Department of Justice)

and the U.S. consulate offices (within

the Department of State) issue the ITIN