76844 Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Rules and Regulations 

Dated: December 16, 2004. 

Peter Lichtenbaum, 

Assistant Secretary for Export 

Administration.

[FR Doc. 04–28104 Filed 12–22–04; 8:45 am] 

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 179

[Docket No. 2003F–0088] 

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 by establishing 

a new maximum permitted energy level 

of x rays for treating food of 7.5 million 

electron volts (MeV) provided that the x 

rays are generated from machine sources 

that use tantalum or gold as the target 

material, with no change in the 

maximum permitted dose levels or uses 

currently permitted by FDA’s food 

additive regulations. This action is in 

response to a petition filed by Ion Beam 

Applications.

DATES: This rule is effective December 

23, 2004. Submit written objections and 

request for a hearing by January 24, 

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. 2003F–0088, 

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. 2003F–0088 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 March 13, 2003 (68 FR 

12087), FDA announced that a food 

additive petition (FAP 3M4745) had 

been filed by Ion Beam Applications 

(IBA), 6000 Poplar Ave., suite 426, 

Memphis, TN. Since the publication of 

this notice, IBA has been sold to PPM 

Ventures, which subsequently changed 

its name to Sterigenics International, 

Inc., 2015 Spring Rd., suite 650, Oak 

Brook, IL 60523. As a result, the rights 

to FAP 3M4745 have been transferred 

from IBA to Sterigenics International, 

Inc. The petition proposed that the food 

additive regulations in § 179.26 Ionizing 

radiation for the treatment of food (21 

CFR 179.26) be amended by increasing 

the maximum permitted energy level of 

x rays for treating food to 7.5 MeV from 

the currently permitted maximum level 

of 5 MeV. Higher x ray energy will 

result in an increased concentration of 

x rays in the forward direction and 

increased penetration of these x rays in 

materials. This increased emission 

efficiency (i.e., concentration of x rays 

produced in the forward direction) will 

result in reduced treatment time for 

food, and therefore, higher production 

rates and lower treatment costs. The 

increased penetration of 7.5 MeV versus 

5 MeV x rays will allow for the 

irradiation of larger packages.

II. Evaluation of Safety

A source of radiation used to treat 

food meets the definition of a food 

additive under 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 7.5 MeV X Rays

A. Safety Concerns of Higher Energy X 

rays

The maximum energy limit of an xray machine is the maximum energy of 

the individual x-ray photons produced 

by that machine. When individual 

photons of x rays are absorbed by food, 

the absorbed energy causes atoms to be 

ionized until all the energy is converted 

into heat or chemical change. The 

amount of change in the food will 

depend on the total energy absorbed 

(i.e., dose). Because this petition seeks 

only to raise the maximum energy limit 

for x rays used for treating food, with no 

change in the maximum doses currently 

permitted by § 179.26, FDA concludes 

that the petition presents no new 

chemical issue, and that the only safety 

issue to be addressed is the potential for 

inducing radioactivity in the food.

Food, as well as other natural 

materials, displays low levels of 

naturally occurring radioactivity, such 

as that due to the presence of 

potassium-40 or carbon-14. To assess 

the safety of increasing the maximum 

energy of x rays to 7.5 MeV, the 

petitioner evaluated the potential for 7.5 

MeV x rays to induce additional 

radioactivity in food. X rays with 

energies above an atom’s threshold 

energy are capable of ejecting neutrons 

or protons from the nuclei of some 

atoms that have absorbed the x-ray 

energy. The threshold energy needed to 

cause the emission of a proton is higher 

than 7.5 MeV; therefore, the primary 

mechanism for inducing radioactivity in 

food by 7.5 MeV x rays will be from the 

loss of a neutron. This may in some 

cases result in the formation of 

radioactive nuclei. Radioactive nuclei 

are unstable and decay to a more stable 

form, spontaneously emitting particles 

and electromagnetic radiation in the 

form of gamma rays (i.e., high-energy 

photons). Often, this transition can 

occur very rapidly, such that an isotope 

produced in food from x rays will decay 

to a stable, nonradioactive state before 

leaving the irradiation facility. However, 

some radioactive isotopes could be 

sufficiently stable to be present in food 

Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Rules and Regulations 76845

1Thirty kGy is close to a sterilizing dose. Foods, 

generally, would not be irradiated at such a high 

dose.

2The concentrations of elements in the reference 

food were chosen to be reasonably close to those of 

meat because, compared to other foods, meat is 

likely to be the food that receives the highest doses 

and that is consumed in the largest quantities. 

Although the concentrations of trace elements in 

foods can vary significantly, the difference in the 

radiation exposure to humans from consumption of 

one irradiated food and another food due to these 

variances would be insignificant.

when ingested. Radioactive atoms decay 

at a rate specific to their identity and, 

if taken into the body, could emit 

ionizing energy that would be absorbed 

in tissues in the body. Whether any 

emitted energy would increase the risk 

of harm to health depends on the 

amount and type of radiation absorbed 

by the body and the site of absorption.

Two reports in the petition provide 

the petitioner’s primary basis that the 

petitioned use of 7.5 MeV x-ray 

radiation is safe. One report, from the 

International Atomic Energy Agency 

(IAEA), addresses natural and induced 

radioactivity in food treated with 

radiation, including high energy x rays 

(Ref. 1). The second report, by Gregoire 

et al., assesses the induced activities in 

fresh meat and in meat ash irradiated 

with high-energy x rays using evidence 

provided by theoretical calculations and 

experimental measurement (Ref. 2). As 

part of its review, FDA contracted with 

the Department of Energy, Oak Ridge 

National Laboratory (ORNL), for an 

independent evaluation of data in the 

petition (Ref. 3).

B. Neutron-Induced Radioactivity in 

Food

The IAEA report provides a 

compilation of available data on natural 

and induced radioactivity in food and 

investigates to what extent increases in 

absorbed dose in food or increased 

energy levels of radiation sources used 

to irradiate food could induce 

radioactivity in the food. One of the 

scenarios considered in the report was 

the potential for inducing radioactivity 

in food after being irradiated with 7.5 

MeV x rays (using an x-ray target of 

tantalum or gold) to a dose of 30 

kiloGray (kGy).1 The report compared 

possible radiation exposure in humans 

from induced radioactivity in food to 

that from natural radioactivity in food. 

A reference food model was used for 

this analysis with an elemental 

composition similar to that of meat.2

The report concluded that consuming 

40 kilograms (kg) (88 pounds) per year 

of reference food with an absorbed dose 

of 30 kGy (a dose more than six times 

the maximum permitted dose level of 

4.5 kGy permitted by FDA for 

refrigerated meat and meat products), 

would result in an estimated human 

radiation exposure of 1.3 x 10-3

millisieverts/year (yr) (mSv/yr) (a dose 

300 times less than the yearly dose due 

to natural radioactivity from food) (Ref. 

1). The calculation assumed that the 

food would be eaten immediately after 

being irradiated. However, the 

radioisotopes with the greatest 

probability of being produced decay 

quite rapidly. Therefore, because of 

radioactive decay, any radioactivity in 

the treated food, which would normally 

be consumed more than 24 hours after 

treatment, would actually be 

significantly less at the time of 

consumption.

The report by Gregoire et al. provided 

theoretical estimates and experimental 

results of the radiological implications 

of irradiating meat with higher energy x 

rays. Induced activities in meat 

irradiated at 15 kGy with 7.5 MeV x rays 

and a resultant human exposure to 

radiation were calculated. Based on the 

most abundant isotopes produced in 

meat by neutron capture reactions at 

thresholds below 7.5 MeV, and 

assuming a person consumes 40 kg of 

meat per year and a 24-hour delay 

between irradiation and consumption, 

the corresponding dose to humans was 

calculated to be 0.2 x 10-3 mSv/yr.

Theoretical estimates of induced 

activity can be more reliable than direct 

measurements, especially for low levels 

of activity. However, to check the 

validity of the theoretical estimates, 

Gregoire et al. compared their 

predictions with experimental data. 

Experimental results from a 1991 study 

by Wakeford and Blackburn were 

discussed. This study investigated the 

irradiation of codfish, rice, and a 

macerated meat product with x rays 

produced by an electron linear 

accelerator that generated electrons at 

energies up to 12 MeV and 

predominately at 8 MeV (Ref. 4). These 

foods received radiation doses ranging 

from 8.8 to 14 kGy. Induced activities in 

the foods were reported to be 

approximately the same as natural 

background levels, and dropped 

quickly. The report also summarized the 

results from another study in which 

induced activities in fresh meat and in 

meat ash were measured after being 

irradiated with x rays generated at 7.3 

MeV and 8.1 MeV at doses of 15 kGy 

and 8.6 kGy, respectively. Based on the 

measured activity from the two 

experiments and assuming a 

consumption of 40 kg/y of irradiated 

meat and a 24-hour delay time between 

irradiation and consumption, the total 

annual dose from meat due to treatment 

with higher energy x rays was 

determined to be 0.24 to 0.29 x 10-3

mSv/yr, a dose about 1,500 times lower 

than the 0.39 mSv received per year 

from consumption of food due to 

naturally occurring radionuclides (Ref. 

3). Because most meat would be 

consumed more than 24 hours after 

treatment, the annual dose from the 

irradiated meat would be far less than 

the dose indicated from these 

experiments.

ORNL evaluated the information in 

the IAEA report. ORNL estimated 

induced activities in beef irradiated to 

15 kGy with 7.5 MeV x rays and the 

resultant dose from consumption of the 

treated food (Ref. 3). ORNL used the 

elemental composition of beef for their 

analysis because its composition is 

similar both to that of the reference food 

used in the IAEA report and to food in 

general. From this information, ORNL 

determined induced radioactivity in 

beef and used this to estimate a 

potential radiation dose to humans from 

consumption of the food. The annual 

effective dose based on consumption of 

40 kg/yr of beef was calculated to be 0.4 

x 10-3 mSv, which is approximately 

1,000 times less than the annual 

effective dose from consumption of 

foods due to naturally occurring 

radioactivity, and is consistent with the 

results from both the IAEA report and 

the Gregoire et al. report. In addition to 

beef, ORNL also calculated the effective 

annual dose from consumption of pork, 

poultry, and eggs treated with 7.5 MeV 

x rays and an absorbed dose of 15 kGy, 

ORNL determined that based on the 

average quantity of beef, pork, poultry, 

and eggs consumed in a year, the total 

effective annual human exposure from 

consumption of these irradiated foods 

would be 1.0 x 10-3 mSv/yr, which is 

about 400 times less than the 0.39 mSv/

yr that people receive due to natural 

radioactivity in food. It is also important 

to note that this estimated exposure is 

highly conservative because it assumes 

the following: (1) That all of the beef, 

pork, poultry, and eggs that a person 

consumes in a year has been irradiated, 

(2) that these foods are consumed 

within 24 hours after irradiation, and, 

(3) that such foods would be treated 

with an average dose of 15 kGy, which 

is significantly higher than both the 

currently maximum permitted dose for 

these foods as well as doses that would 

be practical to apply to foods in 

commerce.

The results discussed previously 

considered potential radiation exposure 

for humans from consumption of 

various foods irradiated with high 

energy x rays. Although foods other 

than those that were studied may be 

irradiated with 7.5 MeV x rays, the 

76846 Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Rules and Regulations 

compositions of the foods that were 

considered are representative of foods in 

general. Even at absorbed doses that are 

higher than those normally used in 

practice, the results clearly show that 

any radioactivity that may be induced in 

any food treated with 7.5 MeV x rays 

will be trivially low and that any 

potential human exposure due to 

consumption of irradiated food will be 

inconsequential compared to that from 

radionuclides that are present naturally 

in food.

C. The Need to Limit the X-Ray Target 

Material

Neutrons emitted from the x-ray target 

in the x-ray generator can also enter 

food and induce radioactivity. 

Therefore, FDA considered whether 

there is a need to specify or limit the xray target material to minimize neutron 

production from this source. Materials 

with photoneutron threshold energies 

below 7.5 MeV can produce 

photoneutrons, which could also be 

captured in the foods being irradiated. 

The petitioner has proposed the use of 

tantalum and gold as x-ray target 

materials. The x-ray energy levels 

needed to eject a neutron from the two 

common isotopes of tantalum (Ta-180 

and Ta-181) are 6.6 and 7.6 MeV, 

respectively, but the neutron production 

from 7.5 MeV x rays is insignificant, and 

considerably less than from tungsten, a 

common x-ray target material (Refs. 1 

and 3). Gold also does not produce 

significant numbers of neutrons when 

impinged with 7.5 MeV x rays (Ref. 1). 

Therefore, FDA concludes that tantalum 

and gold are acceptable x-ray target 

materials for the proposed use and is 

specifying these two x-ray target 

materials as a condition of safe use for 

machine sources of 7.5 MeV x rays.

IV. Conclusion of Safety

FDA has evaluated the data submitted 

in the petition and other relevant 

material and concludes that any added 

radioactivity in food from the use of 7.5 

MeV x rays will be trivial compared to 

that from radionuclides that are present 

naturally in food. Therefore, the agency 

concludes that the proposed use of 7.5 

MeV x rays for treating food is safe and 

that the conditions listed in § 179.26 

should be amended as set forth in this 

document.

In accordance with § 171.1(h) (21 CFR 

171.1(h)), the petition and the 

documents that FDA considered and 

relied upon in reaching the agency’s 

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 previously considered 

the environmental effects of this rule as 

announced in the notice of filing for 

FAP 3M4745 (68 FR 12087). No new 

information or comments have been 

received that would affect the agency’s 

previous determination that there is no 

significant impact on the human 

environment and that an environmental 

impact statement is not required.

VI. Paperwork Reduction Act of 1995

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required.

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 by (see DATES). 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 (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday.

1. International Atomic Energy 

Agency, ‘‘Natural and Induced 

Radioactivity in Food,’’ IAEA–

TECDOC–1287, Food and 

Environmental Protection Section, 

IAEA, Vienna, 2002.

2. Gregoire, O., Cleland, M. L., 

Wakeford, Mittendorfer, et al., 

‘‘Radiological Safety of Food Irradiation 

With High Energy X-Rays: Theoretical 

Expectations and Experimental 

Evidence,’’ 2002.

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

Ross, R. H., et al., ‘‘Assessment of 

Petition to Increase the Maximum X-Ray 

Energy to 7.5 MeV from the Value of 5.0 

MeV for the Treatment of Food by 

Ionizing Radiation,’’ ORNL–2003–1, 

Oak Ridge National Laboratory, Life 

Sciences Division, 2003.

4. Wakeford, C. A., Blackburn R., and 

Swallow, A. J., ‘‘Induction and 

Detection of Radioactivity in Foodstuffs 

Irradiated With 10 MeV Electrons and 

X-Rays,’’ Radiation Physics and 

Chemistry, vol. 38, No. 1, pp. 29–38, 

1991.

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 179.26 is amended by 

revising paragraph (a)(3) and by adding 

paragraph (a)(4) to read as follows:

§ 179.26 Ionizing radiation for the 

treatment of food.

* * * * *

(a) * * *

(3) X rays generated from machine 

sources at energies not to exceed 5 

million electron volts (MeV), except as 

permitted by paragraph (a)(4) of this 

section.

(4) X rays generated from machine 

sources using tantalum or gold as the 

target material and using energies not to 

exceed 7.5 (MeV).

* * * * *

Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Rules and Regulations 76847

1See 31 U.S.C. 5318(g)(1).

2See 31 CFR 103.17–21. The threshold for most 

financial institutions is $5,000; transactions 

conducted at points of sale for money services 

businesses have a reporting threshold of $2,000. See 

31 CFR 103.20.

3See TD F 90–22.47 (depository institutions); TD 

F 22.56 (money services businesses); FinCEN Form 

101 (securities and futures industries); FinCEN 

Form 102 (casinos and card clubs).

4 31 CFR 501.603.

5 31 CFR 501.603(b)(1)(i).

6The specific designations are as follows: 

Specially designated terrorist; foreign terrorist 

organization; specially designated global terrorist; 

specially designated narcotics trafficker; specially 

designated narcotics trafficker kingpin. See 31 CFR 

parts 595, 597, 598 and the Foreign Narcotics 

Kingpin Act, 21 U.S.C. 1901–08, 8 U.S.C. 1182. 

These categories of designations are subject solely 

to blocking requirements.

Dated: December 14, 2004.

Leslye M. Fraser,

Director, Office of Regulations and Policy, 

Center for Food Safety and Applied Nutrition.

[FR Doc. 04–28043 Filed 12–22–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Financial Crimes Enforcement Network 

31 CFR Part 103 

Interpretive Release No. 2004–02—

Unitary Filing of Suspicious Activity 

and Blocking Reports

AGENCY: Financial Crimes Enforcement 

Network (‘‘FinCEN’’), Department of the 

Treasury.

ACTION: Final rule; interpretive release.

SUMMARY: This FinCEN interpretive 

guidance clarifies that reports filed with 

the Department of the Treasury’s Office 

of Foreign Assets Control (‘‘OFAC’’) of 

blocked transactions with Specially 

Designated Global Terrorists, Specially 

Designated Terrorists, Foreign Terrorist 

Organizations, Specially Designated 

Narcotics Trafficker Kingpins, and 

Specially Designated Narcotics 

Traffickers will be deemed by FinCEN 

to fulfill the requirement to file 

suspicious activity reports on such 

transactions for purposes of FinCEN’s 

suspicious activity reporting rules. 

However, the filing of a blocking report 

with OFAC will not be deemed to 

satisfy a financial institution’s 

obligation to file a suspicious activity 

report if the transactions would be 

reportable under FinCEN’s suspicious 

activity reporting rules even if there 

were no OFAC match. Moreover, to the 

extent that the financial institution is in 

possession of information not included 

on the blocking report filed with OFAC, 

a separate suspicious activity report 

should be filed with FinCEN including 

that information.

DATES: This final rule is effective 

December 23, 2004. The DATES section 

of the rule published on December 14, 

2004, at 69 FR 74439 is corrected to read 

as follows: 

DATES: Appendix C is added to part 

103 effective December 14, 2004; 

however, Release 2004–01 is not 

effective until June 13, 2005.

FOR FURTHER INFORMATION CONTACT:

Regulatory Policy and Programs 

Division, 1–800–949–2732, Financial 

Crimes Enforcement Network.

SUPPLEMENTARY INFORMATION: FinCEN is 

publishing this interpretation to clarify 

that the filing of required blocking 

reports with OFAC on transactions 

involving an individual or entity 

designated as a Specially Designated 

Global Terrorist, Specially Designated 

Terrorist, Foreign Terrorist 

Organization, Specially Designated 

Narcotics Trafficker Kingpin, or 

Specially Designated Narcotics 

Trafficker shall be deemed to satisfy the 

requirement, under existing and any 

forthcoming suspicious activity 

reporting regulations, that financial 

institutions file suspicious activity 

reports based on the fact of such a 

match.

List of Subjects in 31 CFR Part 103 

Authority delegations (government 

agencies), Banks, Banking, Currency, 

Investigations, Reporting and 

recordkeeping requirements.

Department of the Treasury 

1 CFR Chapter I 

Authority and Issuance

■ For the reasons set forth in the 

preamble, part 103 of title 31 of the Code 

of Federal Regulations is amended as 

follows:

PART 103—FINANCIAL 

RECORDKEEPING AND REPORTING 

OF CURRENCY AND FOREIGN 

TRANSACTIONS

■ 1. The authority citation for part 103 

continues to read as follows:

Authority: 12 U.S.C. 1829b and 1951–1959; 

31 U.S.C. 5311–5314 and 5316–5332; title III, 

sec. 312, 313, 314, 319, 326, 352. Pub. L. 

107–56, 115 Stat. 307, 21 U.S.C. 1786(q).

■ 2. Part 103 is amended by adding a 

new Intrepretive Release at the end of 

Appendix C to read as follows:

APPENDIX C TO PART 103—

INTERPRETIVE RULES

* * * * *

Release No. 2004–02 

This FinCEN interpretive guidance clarifies 

that reports filed with the Department of the 

Treasury’s Office of Foreign Assets Control 

(‘‘OFAC’’) of blocked transactions with 

Specially Designated Global Terrorists, 

Specially Designated Terrorists, Foreign 

Terrorist Organizations, Specially Designated 

Narcotics Trafficker Kingpins, and Specially 

Designated Narcotics Traffickers will be 

deemed by FinCEN to fulfill the requirement 

to file suspicious activity reports on such 

transactions for purposes of FinCEN’s 

suspicious activity reporting rules. However, 

the filing of a blocking report with OFAC will 

not be deemed to satisfy a financial 

institution’s obligation to file a suspicious 

activity report if the transactions would be 

reportable under FinCEN’s suspicious 

activity reporting rules even if there were no 

OFAC match. Moreover, to the extent that the 

financial institution is in possession of 

information not included on the blocking 

report filed with OFAC, a separate suspicious 

activity report should be filed with FinCEN 

including that information.

Background 

The Bank Secrecy Act authorizes the 

Secretary of the Treasury to require financial 

institutions to report ‘‘any suspicious 

transaction relevant to a possible violation of 

law or regulation.’’ 1 Under this authority, 

FinCEN has issued regulations requiring 

banks, securities broker-dealers, introducing 

brokers, casinos, futures commission 

merchants, and money services businesses, to 

report suspicious activity that meets a 

particular dollar threshold.2 Each rule 

includes filing procedures requiring that a 

suspicious transaction shall be reported by 

completing a suspicious activity report and 

filing it with FinCEN in a central location to 

be determined by FinCEN. Generally, the 

rules provide a financial institution with 

thirty days from the date of the initial 

detection of suspicious activity to file a 

report, with an additional thirty days if the 

financial institution is unable to identify a 

suspect. Reports are filed on forms developed 

for each industry subject to the reporting 

requirement.3

OFAC administers and enforces economic 

and trade sanctions based on U.S. foreign 

policy and national security goals against 

targeted foreign countries, terrorists, 

international narcotics traffickers, and those 

engaged in activities related to the 

proliferation of weapons of mass destruction. 

OFAC’s Reporting, Procedures and Penalties 

Regulations at 31 CFR part 501 require U.S. 

financial institutions to block and file reports 

on accounts, payments, or transfers in which 

an OFAC-designated country, entity, or 

individual has any interest.4 These reports 

must be filed with OFAC within ten business 

days of the blocking of the property.5

Prior Guidance 

Transactions involving an individual or 

entity designated on OFAC’s list of Specially 

Designated Nationals and Blocked Persons as 

a global terrorist, terrorist, terrorist 

organization, narcotics trafficker, or narcotics 

kingpin 6 may be in furtherance of a criminal 

act, and therefore relevant to a possible 

violation of law. Thus, blocking reports 

related to such persons also describe