Federal Register / Vol. 69, No. 244 / Tuesday, December 21, 2004 / Rules and Regulations 76401

(d) Purchases and sales of futures for 

commodities or for derivatives 

positions; and 

(e) Options exercised.

(Approved by the Office of Management and 

Budget under control number 3038–0009)

§ 18.02 [Removed and Reserved.]

■ 18. Remove and reserve § 18.02.

§ 18.06 [Removed and Reserved.]

■ 19. Remove and reserve § 18.06.

PART 19—REPORTS BY PERSONS 

HOLDING BONA FIDE HEDGE 

POSITIONS PURSUANT TO § 1.3(Z) OF 

THIS CHAPTER AND BY MERCHANTS 

AND DEALERS IN COTTON

■ 20. The authority citation for part 19 

continues to read as follows:

Authority: 7 U.S.C. 6g(a), 6i and 12a(5), 

unless otherwise noted.

■ 21. In § 19.00, revise paragraph (a)(1) 

and the first sentence of (a)(3) to read as 

follows:

§ 19.00 General provisions. 

(a) * * *

(1) All persons holding or controlling 

futures and option positions that are 

reportable pursuant to § 15.00(b)(2) of 

this chapter and any part of which 

constitute bona fide hedging positions 

as defined in § 1.3(z) of this chapter;

* * * * *

(3) All persons holding or controlling 

positions for future delivery that are 

reportable pursuant to § 15.00(b)(1) of 

this chapter who have received a special 

call for series ’04 reports from the 

Commission or its designee. * * *

* * * * *

PART 21—SPECIAL CALLS

■ 22. The authority citation for part 21 

continues to read as follows:

Authority: 7 U.S.C. 1a, 2, 2a, 4, 6a, 6c, 6f, 

6g, 6i, 6k, 6m, 6n, 7, 7a, 12a, 19 and 21; 5 

U.S.C. 552 and 552(b), unless otherwise 

noted.

§ 21.02a [Removed]

■ 23. Remove § 21.02a.

Issued in Washington, DC on December 14, 

2004 by the Commission. 

Jean A. Webb, 

Secretary of the Commission.

[FR Doc. 04–27750 Filed 12–20–04; 8:45 am] 

BILLING CODE 6351–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 1993F–0357]

Irradiation in the Production, 

Processing, and Handling of Food

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 a source of fast (high 

energy) neutrons to inspect containers 

that may contain food. This action is in 

response to a petition filed by Science 

Applications International Corp. (SAIC).

DATES: This rule is effective December 

21, 2004. Submit written or electronic 

objections and requests for a hearing by 

January 20, 2005. See section VII of this 

document for information on the filing 

of objections.

ADDRESSES: You may submit written 

objections and requests for a hearing, 

identified by Docket No. 1993F–0357, 

by any of the following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments.

• Agency Web site: http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 1993F–0357 in the 

subject line of your e-mail message.

• FAX: 301–827–6870.

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

objections received will be posted 

without change to http://www.fda.gov/

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document.

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.fda.gov/ohrms/dockets/

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Celeste Johnston, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, 301–436–1282.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal 

Register of November 18, 1993 (58 FR 

60860), FDA announced that a food 

additive petition (FAP 3M4399) had 

been filed by Science Applications 

International Corp., 2950 Patrick Henry 

Dr., Santa Clara, CA 95054. The petition 

proposed that the food additive 

regulations in § 179.21 Sources of 

radiation used for inspection of food, for 

inspection of packaged food, and for 

controlling food processing (21 CFR 

179.21) be amended to provide for the 

safe use of a source of fast (high energy) 

neutrons to inspect cargo containers that 

may contain food. In a letter dated 

January 9, 1998, FDA was informed by 

Ancore Corp. that they were previously 

the division of SAIC responsible for this 

petition but had been reorganized into 

a separate company. The letter 

explained that as part of this 

reorganization, the rights to FAP 

3M4399 had been transferred from SAIC 

to Ancore Corp. (same address as SAIC).

When the petition was filed on 

November 18, 1993, it contained an 

environmental assessment (EA). In the 

notice of filing for this petition, the 

agency announced that it was placing 

the EA submitted with this petition on 

display at the Division of Dockets 

Management for public review and 

comment. No comments on the EA were 

received. Based on the original EA, FDA 

prepared a finding of no significant 

impact to the environment dated May 

31, 1994. On July 29, 1997, FDA 

published revised regulations under 

part 25 (21 CFR part 25), which became 

effective on August 28, 1997. On May 

12, 2003, the petitioner submitted a 

claim of categorical exclusion under the 

new § 25.32(j), in accordance with the 

procedures in § 25.15(a) and (d). 

Because the environmental record for 

the FAP was outdated, the agency 

reviewed the claim of categorical 

exclusion under § 25.32(j) for this final 

rule and found it to be warranted.

II. Evaluation of Safety

A source of radiation used for the 

purpose of inspection of foods meets the 

definition of a food additive under 

76402 Federal Register / Vol. 69, No. 244 / Tuesday, December 21, 2004 / Rules and Regulations 

section 201(s) of the Federal Food, Drug, 

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

321(s)). Under section 409(c)(3)(A) of 

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 in 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.’’

III. Evaluation of the Safety of the 

Petitioned Use of a Source of Radiation

A. Background on Pulsed Fast Neutron 

Analysis

Neutron-based techniques can be used 

to screen large cargo containers for 

contraband such as explosives, chemical 

warfare agents, and illegal drugs. Unlike 

conventional systems based on x rays or 

gamma rays, surveillance systems 

employing neutrons are able to provide 

more specific information on a cargo’s 

elemental composition. When a neutron 

beam is directed at a target, the neutrons 

interact with target nuclei by either 

scattering or by nuclear reactions such 

as neutron capture by the target nuclei. 

Some captured neutrons result in the 

production of unstable isotopes that 

decay by emitting characteristic gamma 

rays, which can be detected and used to 

identify emitting chemical elements. 

Using gamma ray spectroscopy, 

information can be obtained on the 

concentration of chemical elements of 

the scanned object. Because the 

concentrations of certain elements in 

these types of illicit materials are 

characteristically different from other 

materials, such illicit materials can be 

detected. The present petition proposes 

the use of a pulsed fast neutron analysis 

system employing a beam of high energy 

neutrons at energies up to 9 million 

electron volts (MeV) to inspect large 

cargo containers and trucks that may 

contain food, provided that the 

maximum dose absorbed by the food 

does not exceed 0.01 gray (Gy). The 

scanning neutron beam operates in one 

of two modes, fast scan and directed 

search. Most containers would be 

exposed to a fast scan search only. 

During a fast scan, the beam impinges 

on any one position in the container for 

at most 1 second. Suspicious containers 

may be subjected to a directed search. 

A typical directed search would focus 

the beam on one position in the 

container for 10 seconds, but it is 

possible that it may be necessary to 

dwell on one location for up to 5 

minutes.

B. Radiolysis Products

One of the safety issues considered by 

FDA when it is evaluating a source of 

radiation used to inspect or treat food is 

the potential for formation of products 

generated in the food by radiationinduced chemical reactions (radiolysis 

products). The types and amounts of 

these products generated in the food 

depend on the chemical constituents of 

the food and on the conditions of 

irradiation. Radiation chemistry of 

components of food previously has been 

discussed in detail in the agency’s final 

rule permitting the irradiation of meat 

(62 FR 64107, December 3, 1997). As 

stated in the meat irradiation final rule, 

most of the radiolysis products that are 

generated from food irradiation are also 

found in foods that have not been 

irradiated. Some of these compounds 

are also produced by heating foods, and, 

in the case of heating, are produced in 

amounts far greater than the trace 

amounts that result from irradiating 

foods.

The amount of radiolysis products 

generated in food increases with 

increasing absorbed dose of radiation. 

FDA has previously established that 

gamma rays from radionuclides of 

cobalt-60 or cesium-137, high-energy 

electrons up to 10 MeV, and x rays up 

to 5 MeV are safe for the treatment of 

different types of food at doses ranging 

from 0.3 kiloGray (kGy) to 30 kGy, 

depending on the type of food. Because 

the current petition proposes to limit 

the maximum absorbed dose to 0.01 Gy 

(a dose at least 30,000 times less than 

these approved uses), the amounts of 

radiolysis products generated in food 

from the petitioned source of radiation 

will be less than from these approved 

sources. Accordingly, FDA has 

concluded that the proposed use is safe 

in terms of exposure to potential 

radiolysis products.

C. Neutron-Induced Radioactivity

Neutrons have a greater propensity to 

induce radioactivity in scanned 

materials than x rays and gamma rays of 

the same energy. To assess the 

induction of radioactivity in food by 

neutron irradiation from a cargo 

surveillance system, the petitioner 

submitted a 1992 report (the Harwell 

Report) that was prepared by Harwell 

Laboratory of the United Kingdom’s 

Atomic Energy Authority (Ref. 1) and a 

study that was performed by the 

petitioner (Ref. 2). FDA contracted for 

an independent evaluation of the data in 

the petition by the U.S. Department of 

Energy, Oak Ridge National Laboratory 

(ORNL) (Ref. 3). The references provide 

the primary basis for FDA’s conclusion 

regarding the safety of the petitioned 

use of neutron radiation.

The Harwell Report assessed the 

radiological implications of the use of 

neutron-based cargo surveillance 

techniques on cargoes of food. Three 

cargo scenarios were investigated; semiinfinite slabs (representing inspection of 

a large transport container of food), 1 

kilogram (kg) of food in a 20-kg suitcase 

(representing airport inspection of a 

piece of luggage containing a small 

quantity of food (e.g., a lunch)), and 2-

meter high pallets of food. Calculations 

were made for 17 different types of food 

simulating exposure to 0.5 Gy of 

neutrons (50 times higher than the 

maximum petitioned dose level of 0.01 

Gy) with energies of 1, 2, 5, 8, and 14 

MeV. Calculations included induced 

activities and the resultant doses to 

consumers after ingesting foods 5 

minutes to 1 month after inspection. In 

addition, in selecting the food to be 

used for the cargo scenarios, three types 

of food were considered for the 

calculations based upon the chemical 

elements of the foods (e.g. calcium, iron, 

magnesium, sodium, potassium): A 

single distribution representing the 

maximum credible concentrations of the 

elements in any food; a single 

‘‘reference’’ distribution of 47 elements 

obtained from studies of dietary intake; 

and distributions corresponding to 

elemental concentrations in 17 common 

food types. Of these three distributions, 

the one considered the most realistic 

was the single ‘‘reference’’ distribution 

because it is based on the daily 

elemental requirements for ‘‘reference’’

man. For this distribution, the report 

provided calculations of radiation dose 

per unit activity intake into the body for 

induced activities of the neutronirradiated ‘‘reference’’ food at a 

consumption rate of 2.88 kg of food per 

day and the resultant dose to reference 

man after ingesting the foods 

immediately after inspection and up to 

1 month after inspection. Prior to 

irradiation, the ingestion dose of 

‘‘reference’’ food is reported to be 1.823 

x10-10 Sieverts per gram (Sv/g). The 

authors calculated that, depending on 

the energy of the neutron beam and an 

absorbed dose in the reference food of 

0.5 Gy, the ingestion doses from 

consuming the ‘‘reference’’ food 1 hour, 

8 hours, and 1 day after irradiation 

would range from 9.2 x 10-10 to 3.2 x 

10-9 Sv/g, 5.3 x 10-10 to 1.7 x 10-9 Sv/

g, and 3.7 x10-10 to 9.2x10-10 Sv/g, 

respectively. As this example and others 

below illustrate, any induced 

radioactivity is small and dissipates 

rapidly. Therefore, within 1 day, the 

ingestion dose from inspected foods 

Federal Register / Vol. 69, No. 244 / Tuesday, December 21, 2004 / Rules and Regulations 76403

1This dose is based on data from the National 

Council on Radiation Protection and Measurements, 

Ionizing Radiation Exposures of the Population of 

the United States, 1987.

would be essentially the same from 

natural radioactivity in the same food. 

FDA notes that the Harwell Report 

addresses a neutron dose 50 times 

higher than that proposed in the 

petition and reports radioactivity in the 

food within 24 hours of inspection. 

Because food subject to this regulation 

would be inspected at a far lower dose, 

and would unlikely be consumed 

within 24 hours of inspection 

considering the logistics of food 

transportation, any residual induced 

radioactivity would be well below what 

occurs naturally.

The calculations provided by the 

petitioner were based on computer 

modeling and estimated the committed 

effective dose equivalents to adults, 

children, and infants due to ingestion of 

neutron-radiation inspected foods 12 

hours after exposure to an 8 MeV 

neutron fluence rate of 5 x 105 n 

cm-2sec-1, for a period of 1 second, 

corresponding to a dose of 0.021 

milliGray (mGy). The petitioner 

identified representative foods, the 

elemental composition of each food, and 

typical values for the annual amount of 

each food ingested. The calculated 

annual effective doses from 

consumption of foods that have been 

irradiated ranged from 3.42 x 10-11 to 

2.01 x 10-8 Sv, which is significantly 

below the annual effective dose from 

natural radioactivity in food that is 

reported to be 3.9 x 10-4 Sv per year1. 

Although the absorbed dose in this 

study is approximately 500 times less 

than the maximum petitioned dose level 

of 0.01 Gy (10 mGy), the calculated 

annual effective dose from foods 

inspected with high energy neutrons is 

20 thousand to 11 million times less 

than the annual effective dose from 

naturally occurring radioactivity in 

food.

ORNL performed an independent 

assessment for a subset of foods 

considered by the petitioner, and 

ingestion doses per unit of food were 

found to be in general agreement with 

those presented in the petitioner’s 

supportive documentation. In addition, 

ORNL designed three extreme-case 

scenarios regarding consumption of 

food inspected with pulsed fast 

neutrons. One scenario assumed the 

entire diet has been irradiated for 1 

second and then consumed 12 hours 

later. This scenario, although highly 

conservative, is considered to be the 

most reasonable of the three. The 

second scenario assumed infrequent 

(equivalent to 10 full days of dietary 

needs per year) consumption of food 5 

minutes after it had been irradiated for 

1 second. The third scenario assumes 

infrequent tasting of food immediately 

after it had been irradiated for 5 

minutes. The calculated annual effective 

doses for each scenario is 4.8x10-8 Sv, 

3.4x10-7 Sv, and 1.0x10-5 Sv, 

respectively, which are approximately 

40 to 8,000 times less than the annual 

effective dose from consumption of 

foods due to naturally occurring 

radioactivity.

D. Need for a Lower Energy Limit

The petitioner proposed a range of up 

to 9 MeV and with no lower limit, for 

the source’s average neutron energy. 

Fast neutrons with high energy (greater 

than 1 MeV) are necessary to penetrate 

large cargo containers, whereas lower 

energy neutrons (less than 1 MeV), 

including thermal neutrons, have less 

penetrating power and are more likely 

to induce radioactivity in food. 

Therefore, FDA considered whether the 

data in the petition demonstrate that a 

source of high energy neutrons would 

require a lower energy limit to ensure 

safe use. Although the petitioner 

originally proposed a neutron energy 

range up to 9 MeV, the Harwell Report 

which was submitted by the petitioner 

is based on neutron energy levels 

ranging from 1 to 14 MeV and, therefore, 

supports the safety of neutron energies 

within that range. Because the data in 

the petition do not adequately address 

the issue of induced radioactivity from 

neutrons of energy below 1 MeV, and 

because neutrons with such energy 

levels are not explicitly intended to be 

used, FDA concludes that a minimum 

energy level requirement of 1 MeV is 

appropriate. In addition to this lower 

energy limit, FDA has also concluded 

that, based on information in the 

petition, it is necessary to restrict the 

neutron source to one that produces 

monoenergetic neutrons. A 

monoenergetic source produces 

neutrons within a narrow energy 

distribution compared to a source that is 

not monoenergetic. Such a restriction 

will limit the number of lower energy 

neutrons that are emitted even if the 

source’s average neutron energy is 1 

MeV.

IV. Conclusion of Safety

FDA has evaluated the data submitted 

in the petition and other relevant 

material and concludes that 

consumption of food inspected by a 

source of monoenergetic neutrons 

between 1 and 14 MeV is safe, and that 

the conditions listed in § 179.21 should 

be amended as set forth below. In 

accordance with § 171.1(h) (21 CFR 

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 (see 

FOR FURTHER INFORMATION CONTACT). 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.

V. Environmental Impact

The agency has determined under 21 

CFR 25.32(j) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an EA nor an environmental 

impact statement is required.

VI. Paperwork Reduction Act of 1995

This final rule contains information 

collection requirements that are subject 

to review by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The title, description, and 

respondent description of the 

information collection requirements are 

shown below with an estimate of the 

annual reporting burden. Included in 

the estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each collection of 

information.

Title: Irradiation in the Production, 

Processing, and Handling of Food

Description: The regulation as 

amended requires that monoenergetic 

neutron sources producing neutrons at 

energies not less than 1 MeV but no 

greater than 14 MeV used for inspection 

of container shipments which may 

contain food bear a label stating the 

minimum and maximum energy of 

radiation emitted by the neutron source. 

The label or accompanying labeling 

shall also bear adequate directions for 

safe use and a statement that no food 

shall be exposed to this radiation source 

so as to receive a dose in excess of 0.01 

Gy. This information is needed to 

ensure safe use of the source of 

radiation as a direct food additive.

Description of Respondents: 

Manufacturers of monoenergetic 

neutron radiation source.

76404 Federal Register / Vol. 69, No. 244 / Tuesday, December 21, 2004 / Rules and Regulations 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section 

No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours

per Response Total Hours 

Total Operating 

and Maintenance 

Costs 

179.21(a)(5), 

(b)(1)(iv), and 

(b)(2)(v) 11111 $100

1There are no capital costs associated with this collection of information.

Estimated Annualized Cost for the 

Burden Hours

The operating and maintenance cost 

associated with this collection is $100 

for preparation of labels.

The information collection 

requirements in this final rule have been 

approved under OMB control number 

0910–0549. This approval expires 

January 31, 2005. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number.

VII. Objections

Any person who will be adversely 

affected by this regulation may file with 

the Division of Dockets Management 

(see ADDRESSES) written or electronic 

objections. 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 

are to be submitted and are to 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 Division of Dockets Management 

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

through Friday.

VIII. References

The following references have been placed 

on display in the Division of Dockets 

Management and may be seen by interested 

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

through Friday.

1. Findlay, D. J. S., R. A. Forrest, and G. 

M. Smith, ‘‘Neutron-Induced Activation of 

Food,’’ (Harwell Report), AEA-InTec–1051, 

1992.

2. Ryge, P., I. Bar-Nir, M. Simic, ‘‘Food 

Safety Effects of Inspection by SAIC Pulsed 

Fast Neutron Analysis Explosive Detection 

System,’’ SAIC, 1992.

3. Easterly, C. E., K. F. Eckerman, R. H. 

Ross, D. M. Opresko, ‘‘Assessment of Petition 

to Use Pulsed Fast Neutron Analysis (PFNA) 

in Inspection of Shipping Containers 

Containing Foods,’’ Oak Ridge National 

Laboratory, Life Sciences Division, 2003.

List of Subjects in 21 CFR Part 179

Food additives, Food labeling, Food 

packaging, Radiation protection, 

Reporting and recordkeeping 

requirements, Signs and symbols.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to the 

Director, Center for Food Safety and 

Applied Nutrition, 21 CFR part 179 is 

amended as follows:

PART 179—IRRADIATION IN THE 

PRODUCTION, PROCESSING AND 

HANDLING OF FOOD

■ 1. The authority citation for 21 CFR 

part 179 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 343, 348, 

373, 374.

■ 2. Section 179.21 is amended by 

adding paragraphs (a)(5), (b)(1)(iv), and 

(b)(2)(v) to read as follows:

§ 179.21 Sources of radiation used for 

inspection of food, for inspection of 

packaged food, and for controlling food 

processing.

* * * * *

(a) * * *

(5) Monoenergetic neutron sources 

producing neutrons at energies not less 

than 1 MeV but no greater than 14 MeV.

(b) * * *

(1) * * *

(iv) The minimum and maximum 

energy of radiation emitted by neutron 

source.

(2) * * *

(v) A statement that no food shall be 

exposed to a radiation source listed in 

paragraph (a)(5) of this section so as to 

receive a dose in excess of 0.01 gray 

(Gy).

Dated: December 14, 2004.

Leslye M. Fraser,

Director, Office of Regulations and Policy, 

Center for Food Safety and Applied Nutrition.

[FR Doc. 04–27868 Filed 12–20–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Internal Revenue Service 

26 CFR Part 31

[TD 9167] 

RIN 1545–BC81

Student FICA Exception

AGENCY: Internal Revenue Service (IRS), 

Treasury.

ACTION: Final regulation.

SUMMARY: This document contains final 

regulations providing guidance 

regarding the employment tax 

exceptions for student services. These 

regulations affect schools, colleges, and 

universities and their employees.

DATES: Effective date: December 21, 

2004. 

Applicability date: These regulations 

are applicable for services performed on 

or after April 1, 2005.

FOR FURTHER INFORMATION CONTACT: John 

Richards of the Office of Associate Chief 

Counsel (Tax Exempt and Government 

Entities), (202) 622–6040 (not a toll-free 

number).

SUPPLEMENTARY INFORMATION: 

Background 

This document contains amendments 

to 26 CFR part 31 under sections 

3121(b)(10) and 3306(c)(10)(B) of the 

Internal Revenue Code (Code). These 

sections except from ‘‘employment’’ for 

Federal Insurance Contributions Act 

(FICA) and Federal Unemployment Tax 

Act (FUTA) purposes, respectively, 

service performed in the employ of a 

school, college, or university by a 

student who is enrolled and regularly 

attending classes at such school, college, 

or university. In addition, this 

document contains amendments to 26 

CFR part 31 under section 3121(b)(2).