Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices 25339 

fingerprinted again, provided in each 

case that the appropriate documentation 

is made available to the Licensee’s 

reviewing official. However, all other 

applicable requirements must be 

satisfied to allow any individual 

unescorted access to the facility. 

D. The Licensee may allow any 

individual who currently has 

unescorted access, in accordance with 

applicable requirements, to continue to 

have unescorted access, pending a 

decision by the reviewing official (based 

on fingerprinting and a FBI criminal 

history records check) that the 

individual may continue to have 

unescorted access. The licensee shall 

complete implementation of the 

requirements of Attachment 2 to this 

Order by July 30, 2007. 

Licensee responses to Condition A.2. 

shall be submitted to the Director, Office 

of Nuclear Reactor Regulation, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555. 

The Director, Office of Nuclear 

Reactor Regulation, may, in writing, 

relax or rescind any of the above 

conditions upon demonstration of good 

cause by the Licensee. 

IV 

In accordance with 10 CFR 2.202, the 

Licensee must, and any other person 

adversely affected by this Order may, 

submit an answer to this Order, and 

may request a hearing on this Order, 

within twenty (20) days of the date of 

this Order. Where good cause is shown, 

consideration will be given to extending 

the time to request a hearing. A request 

for extension of time in which to submit 

an answer or request a hearing must be 

made in writing to the Director, Office 

of Nuclear Reactor Regulation, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555, and include a 

statement of good cause for the 

extension. The answer may consent to 

this Order. Unless the answer consents 

to this Order, the answer shall, in 

writing and under oath or affirmation, 

specifically set forth the matters of fact 

and law on which the Licensee or other 

person adversely affected relies and the 

reasons as to why the Order should not 

have been issued. Any answer or 

request for a hearing shall be submitted 

to the Secretary, Office of the Secretary, 

U.S. Nuclear Regulatory Commission, 

ATTN: Rulemakings and Adjudications 

Staff, Washington, DC 20555. Copies 

also shall be sent to the Director, Office 

of Nuclear Reactor Regulation, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555, to the Assistant 

General Counsel for Material Litigation 

and Enforcement at the same address, 

and to the Licensee if the answer or 

hearing request is by a person other than 

the Licensee. Because of possible delays 

in delivery of mail to United States 

Government offices, it is requested that 

answers and requests for hearing be 

transmitted to the Secretary of the 

Commission either by means of 

facsimile transmission to 301–415–1101 

or by e-mail to hearingdocket@nrc.gov 

and also to the Office of the General 

Counsel either by means of facsimile 

transmission to 301–415–3725 or by email to OGCMailCenter@nrc.gov. If a 

person other than the Licensee requests 

a hearing, that person shall set forth 

with particularity the manner in which 

his/her interest is adversely affected by 

this Order and shall address the criteria 

set forth in 10 CFR 2.309. 

If a hearing is requested by the 

Licensee or a person whose interest is 

adversely affected, the Commission will 

issue an Order designating the time and 

place of any hearing. If a hearing is held, 

the issue to be considered at such 

hearing shall be whether this Order 

should be sustained. 

Pursuant to 10 CFR 2.202(c)(2)(i), the 

Licensee may, in addition to demanding 

a hearing, at the time the answer is filed 

or sooner, move the presiding officer to 

set aside the immediate effectiveness of 

the Order on the ground that the Order, 

including the need for immediate 

effectiveness, is not based on adequate 

evidence but on mere suspicion, 

unfounded allegations, or error. In the 

absence of any request for hearing, or 

written approval of an extension of time 

in which to request a hearing, the 

provisions as specified above in Section 

III shall be final twenty (20) days from 

the date of this Order without further 

Order or proceedings. 

If an extension of time for requesting 

a hearing has been approved, the 

provisions as specified above in Section 

III shall be final when the extension 

expires, if a hearing request has not 

been received. AN ANSWER OR A 

REQUEST FOR HEARING SHALL NOT 

STAY THE IMMEDIATE 

EFFECTIVENESS OF THIS ORDER. 

Dated this 30th day of April 2007. 

For the Nuclear Regulatory Commission. 

James T. Wiggins, 

Acting Director, Office of Nuclear Reactor 

Regulation. 

[FR Doc. 07–2207 Filed 5–3–07; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

Report to Congress on Abnormal 

Occurrences Fiscal Year 2006; 

Dissemination of Information 

Section 208 of the Energy 

Reorganization Act of 1974 (Public Law 

93–438) defines an abnormal occurrence 

(AO) as an unscheduled incident or 

event which the U.S. Nuclear 

Regulatory Commission (NRC) 

determines to be significant from the 

standpoint of public health or safety. 

The Federal Reports Elimination and 

Sunset Act of 1995 (Public Law 104–66) 

requires that AOs be reported to 

Congress annually. During fiscal year 

2006, nine events that occurred at 

facilities licensed or otherwise regulated 

by the NRC and/or Agreements States 

were determined to be AOs. The report 

describes three events at facilities 

licensed by the NRC. The three AOs at 

NRC-licensed facilities included a spill 

of high-enriched uranium solution at a 

fuel fabrication facility, a medical event, 

and an unintended dose to an mbryo/ 

fetus. The report also addresses six AOs 

at facilities licensed by Agreement 

States. [Agreement States are those 

States that have entered into formal 

agreements with the NRC pursuant to 

Section 274 of the Atomic Energy Act 

(AEA) to regulate certain quantities of 

AEA licensed material at facilities 

located within their borders.] Currently, 

there are 34 Agreement States. During 

Fiscal Year 2006, Agreement States 

reported six events that occurred at 

Agreement State-licensed facilities, 

including four medical events, one 

unintended dose to an embryo/fetus, 

and one industrial event. As required by 

Section 208, the discussion for each 

event includes the date and place, the 

nature and probable consequences, the 

cause or causes, and the action taken to 

prevent recurrence. Each event is also 

being described in NUREG–0090, Vol. 

29, ‘‘Report to Congress on Abnormal 

Occurrences, Fiscal Year 2006.’’ This 

report is available electronically at the 

NRC Web site http://www.nrc.gov/ 

reading-rm/doc-collections/nuregs/staff/ 

. 

Nuclear Power Plants 

During this period, no events at U.S. 

nuclear power plants were significant 

enough to be reported as AOs. 

* * * * * 

Fuel Cycle Facilities 

(Other Than Nuclear Power Plants) 

During this reporting period, one 

event at an NRC-licensed fuel 

fabrication facility was significant 


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enough to be reported as an AO based 

on the criteria in Appendix A to this 

report. 

06–01 Spill of High-Enriched 

Uranium Solution at Nuclear Fuel 

Services in Erwin, Tennessee. 

Date and Place—March 6, 2006, 

Erwin, Tennessee. 

Nature and Probable Consequences— 

In a facility authorized to process highenriched uranium (HEU), a transfer of 

HEU solution through a transfer line 

resulted in a portion of the HEU 

solution, approximately 35 liters, 

leaking into a glovebox where criticality 

was possible and subsequently to the 

floor where criticality was also possible 

because of the presence of an elevator 

pit. 

Immediately before the event, the 

facility operator decided to move the 

unused filter glovebox to another 

location. Workers opened and drained 

the filters so that the filter glovebox 

could be moved. After draining the 

filters, workers failed to reseal the 

system tightly. During the next transfer 

of HEU solution through the line, HEU 

solution leaked into the filter glovebox. 

On several occasions before the event, 

workers had reported signs of a 

yellowish liquid in the filter glovebox. 

Supervisors had failed to fully 

investigate the reports because they 

assumed the yellowish liquid was 

natural uranium solution which had 

been used to initially test the process. 

Criticality was possible in the filter 

glovebox because of the size and shape 

of the glovebox and because there were 

no controls in the filter glovebox to 

prevent accumulation of solution. The 

solution leaked out of the filter glovebox 

through uncontrolled drains to the floor. 

Investigation of the event revealed that 

the floor contained an uncontrolled 

accumulation point, an elevator pit, 

where criticality was also possible. In 

different circumstances, the total 

volume of the transfer would have been 

more than enough for criticality to be 

possible in the filter glovebox or the 

elevator pit. If a criticality accident had 

occurred in the filter glovebox or the 

elevator pit, it is likely that at least one 

worker would have received an 

exposure high enough to cause acute 

health effects or death. The NRC 

conducted a team inspection to 

determine the root causes of the event 

and performed a series of three 

readiness reviews before allowing this 

portion of the facility to restart. The 

NRC issued an order to the licensee 

delineating specific actions designed to 

address this and other performance 

issues at the facility. 

Cause(s)—Failure to maintain 

configuration control of facility 

equipment and failure to comply with 

procedures. 

Actions Taken to Prevent 

Recurrence—The operator stopped all 

processing of HEU in the affected 

processing area, removed the enclosure 

and associated piping, filled in an 

uncontrolled accumulation point (the 

elevator pit) with concrete, and 

conducted an extensive review to 

identify any similar configuration 

issues. 

* * * * * 

Other NRC Licensees 

(Industrial Radiographers, Medical 

Institutions, etc.) 

During this reporting period, two 

events at NRC-licensed or regulated 

facilities were significant enough to be 

reported as AOs based on the criteria in 

Appendix A to this report. 

06–02 Medical Event at Bozeman 

Deaconess Hospital in Bozeman, 

Montana. 

Date and Place—May 9, 2006, 

Bozeman, Montana. 

Nature and Probable Consequences— 

The licensee reported that a patient was 

prescribed a brachytherapy treatment of 

145 Gy (14,500 rad) to the prostate gland 

for prostate cancer using 82 iodine-125 

seeds, but instead received a 130 Gy 

(13,000 rad) dose to an unintended 

treatment site. The brachytherapy seeds 

were implanted under ultrasound 

guidance; however, a post-treatment 

computerized tomography scan 

confirmed that only 10 seeds were 

implanted in the prescribed location of 

the prostate, resulting in a dose of 8.6 

Gy (860 rad) delivered to the intended 

treatment site. Concerning the 72 seeds 

not in the intended treatment site, the 

urologist was able to recover 3 seeds 

and determined that 69 seeds were 

implanted inferior to the prostate in the 

wrong treatment site. The referring 

physician and the patient were 

informed of this event and were advised 

that the patient may experience 

discomfort during urination. The NRC 

staff conducted a reactive onsite 

inspection on May 16, 2006. An NRC 

contracted medical consultant 

experienced in radiation oncology 

reviewed the case and agreed with the 

licensee’s analysis and conclusions. An 

NRC inspection report has been issued. 

Cause(s)—This medical event was 

caused by human error because the 

licensee did not verify that the sources 

were positioned in the proper location 

in the prostate. The urologist 

misidentified the anatomy viewed 

under the ultrasound guidance 

procedure. 

Actions Taken to Prevent 

Recurrence—The licensee revised its 

procedures, requiring a fluoroscopic 

examination early in the implant 

procedure to ensure that the seeds are 

placed in the correct location, thus 

resolving any questions concerning 

ultrasound images prior to commencing 

with the implant. The licensee also 

implemented additional staff training. 

* * * * * 

06–03 Dose to an Embryo/Fetus at 

Munson Medical Center in Traverse 

City, Michigan. 

Date and Place—May 3, 2006, 

Traverse City, Michigan. 

Nature and Probable Consequences— 

The licensee reported an unintended 

dose to an embryo/fetus. On May 3, 

2006, the licensee administered a 

therapy dosage of 5.55 GBq (150 mCi) of 

I–131 to a 26-year-old female patient 

who had affirmed in writing that she 

was not pregnant. On May 22, 2006, the 

patient informed the licensee that she 

had been approximately 10 to 14 days 

pregnant at the time of the 

administration. Based on this new 

information, the licensee estimated that 

the dose to the embryo/fetus was 

approximately 400 mSv (40 rem). The 

referring physician and patient were 

informed of this event. The NRCcontracted medical consultant agreed 

with the licensee’s dose estimate and 

concluded that this event should result 

in no harm to the embryo because the 

administration occurred during a stage 

of development when the thyroid does 

not take up iodine. The medical 

consultant recommended that a 

complete thyroid evaluation be 

performed after delivery. 

Cause(s)—This medical event was 

caused by the patient’s incorrect written 

statement that she was not pregnant 

prior to receiving the therapy dosage. 

The licensee did not require an 

independent pregnancy test for women 

of child-bearing age prior to 

administering the dosage. 

Actions Taken to Prevent 

Recurrence—The licensee implemented 

a procedure that requires pregnancy 

tests for all women of childbearing age 

prior to any therapy dosage of 

radioactive material, a checklist to 

ensure that the pregnancy test is 

ordered, and staff training. 

* * * * * 

Agreement State Licensees 

During this reporting period, six 

events at Agreement State-licensed 

facilities were significant enough to be 

reported as AOs based on the criteria in 

Appendix A to this report. 

AS 06–01 Industrial Radiography 

Occupational Overexposure at Anvil 


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International in North Kingston, Rhode 

Island. 

Date and Place—March 3, 2006, 

North Kingston, Rhode Island. 

Nature and Probable Consequences— 

The licensee reported that a 

radiographer and a trainee received 

unintended radiation exposures in 

excess of those specified in the AO 

criteria. The incident occurred at a 

permanent radiography facility and 

involved an iridium-192 source with an 

activity of 3.44 TBq (93 Ci). After 

performing surveys outside a dedicated 

radiography cell, where radiation levels 

confirmed that radiography was in 

process in the cell, the radiographer and 

the trainee went to an alternate location 

and performed equipment maintenance 

and training. They were joined by a 

third radiographer, who was performing 

radiography inside the cell. All three 

radiography personnel entered the cell 

to view the radiography setup and 

examine the guide tube for training 

purposes. However, they entered 

without a survey meter and were 

unaware that the source was still 

exposed. As a result, the first 

radiographer and the trainee handled 

the collimator and guide tube (which 

contained the source) for approximately 

15–60 seconds. The first radiographer 

received a dose to the left hand ranging 

from 1.4 to 2.8 Sv (140 rem to 280 rem). 

The trainee received a dose to the left 

hand ranging from 11 Sv to 85 Sv (1,100 

rem to 8,500 rem). The third 

radiographer did not receive a dose in 

excess of regulatory exposure limits, 

since he did not handle the equipment. 

Cause(s)—This event was caused by 

the failure of radiography personnel to 

follow safety procedures and use survey 

meters inside the cell. 

Actions Taken to Prevent Recurrence. 

Licensee—The licensee provided 

additional training to the personnel. The 

licensee also solicited the assistance of 

a medical physicist and the source 

manufacturer in determining the dose to 

the radiographers. The licensee also 

committed to keep the State updated on 

the medical conditions of the 

radiographer and trainee until they are 

released from medical oversight. 

State Agency—On March 7, 2006, the 

State issued a suspension letter to the 

licensee. On March 8 and March 16, 

2006, the State, accompanied by NRC 

Region I staff, conducted an 

investigation of the event. On April 13, 

2006, the State issued a Notice of 

Violation and on November 3, 2006, 

terminated the license after an onsite 

inspection to confirm decommissioning 

actions. 

AS 06–02 Medical Event at 21st 

Oncology, Inc., in Coral Springs, 

Florida. 

Date and Place—March 31 through 

April 7, 2006, Coral Springs, Florida. 

Nature and Probable Consequences— 

The licensee reported that an 80-yearold female patient received 100 Gy 

(10,000 rad) to an unintended area of 

approximately 2 cm (0.8 in) that was 

three times the prescribed dose for the 

mammosite brachytherapy procedure, 

using a high dose rate (HDR) afterloader 

containing an iridium-192 source with 

an activity of 240.5 GBq (6.5 Ci). The 

patient received less than 30 percent of 

the prescribed dose to the prescribed 

treatment site. The source stopped 6 cm 

(2.4 in) short of the intended position. 

The patient visited the attending 

physician for followup on May 2, 2006. 

The physician discovered that the 

patient’s skin was abnormally red. The 

referring physician, patient, and 

patient’s family were notified of the 

incident. The patient was treated for 

erythema (skin reddening) and moist 

desquamation (skin thinning and 

weeping). 

Cause(s)—This medical event was 

caused by human error. The authorized 

user entered an incorrect distance into 

the computer entry data. 

Actions Taken to Prevent Recurrence. 

Licensee—The licensee developed 

new procedures requiring the 

authorized user to verify the source wire 

distances during HDR treatments and 

provided additional training in these 

procedures. 

State Agency—The State reviewed 

and accepted the licensee’s corrective 

actions. 

* * * * * 

AS 06–03 Medical Event at the 

McKay Dee Hospital, Inc., in Ogden, 

Utah. 

Date and Place—June 19, 2006, 

Ogden, Utah. 

Nature and Probable Consequences— 

The licensee reported that a patient 

undergoing treatment for 

hyperthyroidism received 1.08 GBq 

(29.3 mCi) of I–131 instead of the 

prescribed dosage of 0.56 GBq (15 mCi). 

On June 19, 2006, two patients were 

scheduled to receive I–131 treatments at 

the same time. However, the first patient 

was administered the second patient’s 

prescribed dosage resulting in the 

patient receiving a higher than intended 

dose. The error was identified by the 

licensee prior to the administration of I– 

131 to the second patient. The 

administration resulted in a thyroid 

dose of 1,066 Gy (106,600 rad). The 

patient and referring physician were 

notified of the error. No negative health 

effects from this administration are 

expected. On July 17, 2006, the licensee 

sent a letter to the State confirming that 

a medical event had occurred. 

Cause(s)—This medical event was 

caused by human error. The licensee 

failed to verify the prescribed dosage for 

a specific patient. 

Actions Taken to Prevent Recurrence. 

Licensee—Corrective actions taken by 

the licensee included revising 

procedures to improve patient 

identification techniques and not 

scheduling patients with similar 

treatments at concurrent times. 

State Agency—The State reviewed 

and accepted the licensee’s corrective 

actions. 

* * * * * 

AS 06–04 Medical Event at Central 

Arkansas Radiation Therapy Institute in 

Little Rock, Arkansas. 

Date and Place—March 28, 2006, 

Little Rock, Arkansas. 

Nature and Probable Consequences— 

The licensee reported that a patient 

undergoing implant brachytherapy for 

prostate cancer received a radiation 

dose to an unintended area during an I– 

125 prostate-seed implant procedure. 

The patient was prescribed 108 Gy 

(10,800 rad) to the base of the prostate 

gland with 84 I–125 seeds but it was 

delivered 4 cm (1.6 in) inferior to the 

intended treatment site. The postimplant dose calculation confirmed that 

the dose was delivered to the wrong 

treatment site. The patient will require 

further brachytherapy treatment. The 

patient did not incur adverse health 

effects as a result of the medical event. 

The patient and referring physician 

were notified of the medical event. 

Cause(s)—This medical event was 

caused by human error. The urologist 

was not able to clearly identify the base 

of the prostate gland during the 

ultrasound used to view the target organ 

during the treatment. 

Actions Taken to Prevent Recurrence. 

Licensee—The licensee implemented 

a new policy to ensure that the urologist 

clearly defines the base of the prostate 

and urethra. 

State Agency—The State reviewed 

and accepted the licensee’s corrective 

actions. 

* * * * * 

AS 06–05 Medical Event at 

Children’s Memorial Medical Center in 

Chicago, Illinois. 

Date and Place—July 24, 2006, 

Chicago, Illinois. 

Nature and Probable Consequences— 

The licensee reported that a patient 

received a higher than intended dosage 

of 74 MBq (2 mCi) of I–131 instead of 

the prescribed dosage of 0.19 MBq 


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(0.005 mCi). The physician did not 

prepare a written directive. The 

authorized user noted the error on July 

25, 2006. The licensee estimated a 

whole body dose of 0.0189 Sv (1.89 rem) 

and a dose to the thyroid of 41.4 Sv 

(4,140 rem), based on a 59.2-percent 

uptake. Using the same assumptions, 

the intended dosage of 0.19 MBq (0.005 

mCi) would have given the patient a 

thyroid dose of 0.104 Sv (10.4 rem). The 

patient and referring physician were 

notified of the medical event. The 

patient incurred no adverse health 

effects from the medical event. 

Cause(s)—This medical event was 

caused by inadequate verbal 

communications between the nuclear 

medicine technologist (NMT) and the 

physician and the lack of a written 

directive. 

Actions Taken to Prevent Recurrence. 

Licensee—The licensee reviewed 

previous administrations of radioiodine 

to confirm that this event was an 

isolated occurrence. The licensee added 

additional procedures to ensure proper 

oversight by a physician during all 

future radioidodine administrations. 

State Agency—The State investigated 

the event and concurred with the 

licensee’s dose estimates. The State 

issued a Notice of Violation to the 

licensee. 

* * * * * 

06–06 Dose to an Embryo/Fetus at 

McLeod Regional Medical Center in 

Florence, South Carolina. 

Date and Place—May 26, 2006, 

Florence, South Carolina. 

Nature and Probable Consequences— 

The licensee reported an unintended 

dose to an embryo/fetus. The licensee 

administered 555 MBq (15 mCi) of 

technetium-99m on May 24, 2006, and 

518 KBq (0.014 mCi) of I–131 on May 

25 as a prelude to a thyroid ablation to 

a patient. Prior to the administrations 

and following a detailed explanation 

provided by the physician, the patient 

signed an informed consent indicating 

that she was not pregnant. The 

licensee’s radioactive materials license 

requires that a pregnancy test be done 

on any female of child-bearing age 

undergoing radiation therapy. However, 

the patient convinced the attending 

NMT that she could not possibly be 

pregnant. The NMT did not perform the 

pregnancy test and on May 26, 2006, 

administered 0.548 GBq (14.8 mCi) of I– 

131 to the patient for a thyroid ablation. 

At approximately 32—34 weeks of 

pregnancy, the patient visited an 

obstetrician and mentioned that she had 

undergone a thyroid ablation procedure 

when she was approximately 17 weeks 

pregnant. The obstetrician notified the 

licensee on October 3, 2006. The 

licensee estimated that the fetus 

received a whole body dose of 0.0517 

Gy (5.17 rad) and a thyroid dose of 

139.2 Gy (13,920 rad). The child was 

born in November 2006. The newborn 

appears to have no apparent problems 

resulting from the radiation exposure 

with the exception of an underactive 

thyroid gland (hypothyrodism). The 

child is currently receiving a small 

amount of thyroid supplement. The 

referring physician and patient were 

notified of the event. 

Cause(s)—This event was caused by 

human error. At the time of the 

administration, the patient indicated 

that she was not pregnant, and the 

licensee failed to perform the required 

pregnancy test. 

Actions Taken To Prevent Recurrence. 

Licensee—The licensee provided 

instructions to staff emphasizing its 

policy to administer a pregnancy test to 

female patients of child-bearing age 

prior to undergoing radiation therapy. 

State Agency—The State reviewed 

and approved the corrective actions 

taken by the licensee and will followup 

at the next inspection. The State is in 

the process of issuing a Notice of 

Violation. 

Dated at Rockville, Maryland this 20th day 

of April 2007. 

For the Nuclear Regulatory Commission. 

Andrew L. Bates, 

Acting Secretary of the Commission. 

[FR Doc. E7–8551 Filed 5–3–07; 8:45 am] 

BILLING CODE 7590–01–P 

OFFICE OF THE UNITED STATES 

TRADE REPRESENTATIVE 

Special 301 Report: Identification of 

Countries That Deny Adequate 

Protection, or Market Access, for 

Intellectual Property Rights Under 

Section 182 of the Trade Act of 1974 

AGENCY: Office of the United States 

Trade Representative. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the United States Trade Representative 

(USTR) has submitted its 2007 ‘‘Special 

301 Report,’’ an annual report on the 

identification of those foreign countries 

that deny adequate and effective 

protection of intellectual property rights 

or deny fair and equitable market access 

to United States persons that rely upon 

intellectual property protection, to the 

Committee on Finance of the United 

States Senate and the Committee on 

Ways and Means of the United States 

House of Representatives, pursuant to 

section 182 of the Trade Act of 1974, as 

amended (the Trade Act) (19 U.S.C. 

2242). 

DATES: The 2007 Special 301 Report was 

released on April 30, 2007. The 2007 

Special 301 Report is available on 

USTR’s Web site at http://www.ustr.gov. 

ADDRESSES: Office of the United States 

Trade Representative, 600 17th Street, 

NW., Washington, DC 20508. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Choe Groves, Director for 

Intellectual Property and Chair of the 

Special 301 Committee at (202) 395– 

4510. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 182 of the Trade Act of 1974, 

as amended by the Omnibus Trade and 

Competitiveness Act of 1988 and the 

Uruguay Round Agreements Act 

(enacted in 1994), under Special 301 

provisions, USTR must identify those 

countries that deny adequate and 

effective protection for intellectual 

property rights (IPR) or deny fair and 

equitable market access for persons that 

rely on intellectual property protection. 

Countries that have the most onerous or 

egregious acts, policies, or practices and 

whose acts, policies, or practices have 

the greatest adverse impact (actual or 

potential) on the relevant U.S. products 

must be designated as ‘‘Priority Foreign 

Countries.’’ 

Priority Foreign Countries are 

potentially subject to an investigation 

under the Section 301 provisions of the 

Trade Act of 1974. USTR may not 

designate a country as a Priority Foreign 

Country if it is entering into good faith 

negotiations or making significant 

progress in bilateral or multilateral 

negotiations to provide adequate and 

effective protection of IPR. 

USTR must decide whether to 

identify countries within 30 days after 

issuance of the annual National Trade 

Estimate Report. In addition, USTR may 

identify a trading partner as a Priority 

Foreign Country or remove such 

identification whenever warranted. 

USTR has created a ‘‘Priority Watch 

List’’ and ‘‘Watch List’’ under Special 

301 provisions. Placement of a trading 

partner on the Priority Watch List or 

Watch List indicates that particular 

problems exist in that country with 

respect to IPR protection, enforcement, 

or market access for persons relying on 

intellectual property. Countries placed 

on the Priority Watch List are the focus 

of increased bilateral attention 

concerning the problem areas. 

Additionally, under Section 306, 

USTR monitors a country’s compliance 

with bilateral intellectual property 

agreements that are the basis for 


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