Text

Requests Commission Approve Final Rule 10CFR40 Suspending Exemption Permitting Use of Glass Enamel & Glass Enamel Frit Containing Small Amounts of U
	ML20244C364
Person / Time
Issue date:	06/13/1983
From:	Dircks W; NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	;
References
	TASK-RIA, TASK-SE SECY-83-230, NUDOCS 8307070479
	Download: ML20244C364 (41)
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o June 13, 1983 '% . . . . . #; SECY-83-230 RULEMAKING ISSUE !

(Affirmation) J For: The Commissioners From: William J. Dircks Executive Director for Operations

Subject:

SUSPENSION OF EXEMPTION PERMITTING USE OF GLASS ENAMEL AND GLASS ENAMEL FRIT CONTAINING SMALL AMOUNTS OF URANIUM

Purpose:

To obtain Commission approval of a final rule suspending the subject exemption.

Category: This paper covers a minor policy matter for Commission consideration.

Issue: Should the Commission suspend the exemption to prohibit further import of cloisonne jewelry and similar products containing uranium into the U.S.?

Discussion: In January 1983, the staff informed the Commission of the status of an investigation of possible radiation hazards associated with certain cloisonne jewelry which is decorated with a glass enamel containing small amounts of uranium. The New York State Department of Health has recommended that consumers discard the jewelry or return it to their supplier because it constitutes a source of unnecessary exposure to low-level radiation. To the best of our knowledge all such jewelry is imported. Possession,

!, use, transfer or import of glass enamel and glass enamel frit con-taining up to 10% uranium is permitted under the exemption in 10 CFP 40.13(c)(2)(iii), which was incorporated into the regulation by the l

Atomic Energy Commission in 1964. The staff issued a public announcement concerning the jewelry on February 1, 1983 (Enclo-sure 5) which concluded that normal use of such cloisonne jewelry does not constitute an immediate or significant health hazard.

l At the staff's request a radiological analysis of the cloisonne jewelry was performed by the Department of Energy's Radiological and Environmental Sciences Laboratory (RESL), Idaho Falls, Idaho.

Based on the analysis and other information from Regional offices and States, the staff has conducted a radiological assessment of use of the cloisonne jewelry by consumers. A report of the assessment is enclosed (Enclosure 6). The staff's conclusions are as follows:

1. About 10 percent of the cloisonne jewelry is radioactive as a result of the uranium content in the glass enamel.

CONTACT:

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2. The uranium content of those enamels containing uranium was measured on several samples and was in the range of 3 to 7 percent by weight, which falls within the exemption speci-fied in 10 CFR Part 40.

3. The radiation dose rate at contact with the surface of the jewelry enamel was measured to range from 3 to 7 millirems per hour (primarily beta radiation), but the dose rate decreases rapidly with distance from the surface of the jewelry.

4. There was no removable radioactivity detected on any sample.

5. The risk to individuals wearing the jewelry is within acceptable boundaries.

Based on these conclusions, the staff believes that there is no need to recall the jewelry or issue public warnings about the jewelry presently in circulation. However, the cloisonne jewelry containing uranium could represent a widespread source of unneces-sary exposure to radiation without compensating benefit. This appears inconsistent with guidance provided by the Federal Radi-ation Council (FRC Report No. 1, May 13, 1960). Furthermore, the AEC policy statement on consumer products published in 1965 (Enclosure 7) considers that the use of radioactive material in toys, novelties, and adornments may be of marginal benefit. On April 24', 1969, the AEC denied a petition for rulemaking requesting that cufflinks made from depleted uranium be exempt from licensing requirements (34 FR 6870). In denying the petition, the AEC stated that the use of depleted uranium in adornments such as cufflinks would result in a small increase of radiation exposure among the -

general public without commensurate benefit. Therefore, the staff recommends that the NRC reevaluate the exempt use of glass enamel and glass enamel frit containing uranium. If needed, a notice of proposed rulemaking will be published following reevaluation and -

public comments will be sought. -

l The staff has considered whether during the period of reevaluation l

NRC should prohibit further increase in circulation of cloisonne

jewelry containing uranium in the U.S. Individual staff members

l. have questioned, in view of the fact that the risk is small, whether

l. such a prohibition is necessary. However, the staff recommends l

that the Commission suspend the exemption for glass enamel and L

glass enamel frit during the reevaluation period, because as l stated above the jewelry potentially represents a widespread sour e of very small radiation exposure without compensating benefit. l The suspension would have the effect of prohibiting importation of the cloisonne jewelry containing uranium into the U.S. for commercial distribution. The recommended suspension is worded such that persons who receive, possess, use or transfer items i

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, .. w covered under the exemption that were imported or ordered for importation before the suspension date will continue.to be exempted from licensing requirements. Persons who wish to dispose of the jewelry voluntarily may discard it as ordinary trash. Such disposal is satisfactory. because the jewelry does not present a significant health hazard even if it is worn in direct contact with the' skin for long periods of time.

I recommend issuance of a notice of rulemaking to amend Part 40 to suspend the effectiveness of the exemption provided in S 40.13(c)(2)(iii) for glass enamel and glass enamel frit containing source material until the completion of final Commission action based on staff reevaluation of these exempt uses or June 30, 1985, whichever comes first.

The' staff has prepared a draft regulatory analysis (Enclosure 4).-

The analysis indicated that the economic impact, including impact to small entities, of the suspension is very small because (1) continuing exemption is provided for cloisonne jewelry con-taining uranium imported or ordered for importation before the suspension date, (2) a large fraction (about 90%) of cloisonne jewelry does not.contain uranium, and thus, will not be affected by this suspension, and (3) there are nonradioactive substitute colors available.

Recommendations: That the Commission:

1. Approve the notice of rulemaking (Enclosure 1) which would suspend the exemption in 10 CFR 40.13(c)(2)(iii) pertaining to glass enamel and glass enamel frit.

2. Note 1

j That in accordance with 10 CFR 51.5(d)(3), neither an environmental impact statement nor a negative declara-

-tion is needed since the amendments'are nonsubstantive and insignificant from the standpoint of environmental I. impact; 1

l . This final rule contains no information collection

! requirements and therefore is not subject to the l requirements of the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et. seq.);

c. The requirements of the Regulatory Flexibility. Act

/ (5 U.S.C. 601 et. seq.) do not apply because the rule is issued in final form without a notice of proposed rulemaking;

d. The appropriate Congressional Committees will be informed l by a letter such as Enclosure 2; 1

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e. A public announcement, such as Enclosure 3, will be issued; and

f. Copies of the amendments will be distributed to affected and interested persons by the Office of Administration.

/

Willia J. Dircks Executive Director for Operations

Enclosures:

1. Notice of Final Rulemaking

2. Draft Congressional Letter

3. Draft Public Announcement

'4. Draft Regulatory Analysis

5. Public Announcement issued on February 1, 1983

6. Staff Radiological Assessment Report

7. AEC policy statement on consumer products (1965)

Commissioners' comments should be provided directly to the Office of the Secretary by c.o.D. Thesday, June 28, 1983.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Tuesday, June 21, 1983, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised 6f when comments may be expected.

This paper is tentatively scheduled for affirmation at an Open Meeting during the Week of June 20, 1983. Please refer to the appropriate Weekly Commission Schedule, when published, for a specific date and time.

DISTRIBUTION:

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NUCLEAR REGULATORY COMMISSION 10 CFR Part 40

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Suspension of Exemption Permitting Use of Glass Enamel and Glass Enamel Frit Containing Small Amounts of Uranium AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule: Suspension.

SUMMARY

The Nuclear Regulatory Commission (NRC) is suspending its regu-lations that provide for an exemption from licensing requirements appli-cable to the possession and use of source material. The suspended exemp-tion covers glass enamel and glass enamel frit containing small amounts of source material. The NRC plans to reevaluate the exempt use of glass enamel and glass enamel frit containing uranium on consumer products such as cloisonne jewelry. The suspension is intended to prohibit further increase in the circulation of cloisonne jewelry containing uranium until the NRC completes its final action following the reevaluation.

EFFECTIVE DATE:

FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555 (301-443-5825).

SUPPLEMENTARY INFORMATION: On January 25, 1983 the New York State Depart-ment of Haalth announced that it had found some pieces of cloisonne jewelry to be radioactive. The radiation was a result of the ur'nium a used to produce golden yellow and beige colors in the brightly colored glass enamel of the jewelry. Available information indicates that all of 1 Enclosure 1

a'. th2 cloisonne' jewelry found to contain uranium has b:en imported. There is no known manufacturer in the United States.

The addition of various uranium salts to glass enamel dates back at least to the early part of this century. Uranium salts are used in only a few enamels to obtain certain colors.

The use of uranium in glass enamel-or glass enamel frit is permitted under the NRC's regulations in 10 CFR Part 40. On November 17, 1964, the NRC's predecessor, the Atomic Energy Commission (AEC), published a final rule (29 FR 15363) that exempted from licensing requirements the receipt, possession, use, transfer or import of source material contained in glass enamel and glass enamel frit containing not more than 10 percent by weight of source material. In promulgating that rule, the AEC recognized the long-standing use of uranium to produce colors in glass enamel and stated that "By reason of the low amount of radiation from glass enamel and glass enamel frit and the short period of time a person would use or be near such material, resultant external radiation exposure to the user would be only a small fraction of the limits recommended by the Federal Radiation Council or the International Comm'ission on Radiological Protection."

However, the AEC's evaluation may not have considered the use of uranium frit in jewelry worn next to the skin. A person might wear a piece of cloisonne jewelry, such as a pendant suspended from a neck chain, in contact with his or her skin for relatively long periods of time.

Distribution of the cloisonne jewelry may also be on a wider scale than the AEC anticipated for products using frit.

After the announcement by the State of New York, other States and the NRC examined thousands of pieces of jewelry. A radiological analysis of the cloisonne jewelry was performed by the Department of Energy's Radiological and Environmental Sciences Laboratory located in Idaho Falls, Idaho. Based on this analysis and other information from NRC's Regional Offices and the States, the NRC has conducted a radiological assessment of the use of cloisonne jewelry by consumers. Among the conclusions this assessment were: (1) about 10 percent of the cloisonne jewelry is radio-active as a result of the uranium content in the glass enamel; (2) measure-ments performed for the NRC of pieces containing uranium in the enamels indicated that uranium content was in the range of 3 to 7 percent by weight; (3) the radiation dose rate at contact with the surface of the jewelry 2 E= closure 1

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. ', enamel was'measurad to rarg2 from.3 to 7 millir:ms per hour (primarily beta radiation) but the dose rate decreases rapidly with distance from the surface of the jewelry; (4) there was no removable radioactivity detected on any sample; and (5) the risk to individuals wearing the-jewelry is within acceptable boundaries.

A piece of cloisonne jewelry worn with the radioactive enameled surface in contact with the ' skin for 520 hours0.00602 days 0.144 hours 8.597884e-4 weeks 1.9786e-4 months per year (10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months / week, 52 weeks / year) would deliver a dose of about 2000 to 4000 millirems to a small area of skin in a year. This corresponds to a skin cancer incidence risk of 2 to 4 in a million. The risk of death from these skin cancers is much lower than the incidence of skin cancer. When the radioactive enameled surface of the jewelry is not in direct contact with the skin, the dose to a small area of _ skin from wearing the jewelry 520 hours0.00602 days 0.144 hours 8.597884e-4 weeks 1.9786e-4 months , would be less than 25 millirems.

Although the use of cloisonne jewelry containing uranium does not constitute an immediate or' significant health hazard, the NRC believes the use of the jewelry could constitute an unnecessary exposure to radiation. This view.is based on the principle that there should not be any man-made radiation exposure without the expectation of benefit resulting from the exposure. Further, the NRC and AEC policy on the "Use of Byproduct Material and Source Material - Products Intended for Use by General Public" (30 FR 3462, March 16, ,1965) considers that the use of radioactive material in toys, novelties, and adornments may be of marginal benefit. On April 24, 1969, the AEC denied a petition for rulemaking requesting that cufflinks made from depleted uranium be exempt from licensing requirements (34 FR 6870). In denying the petition, the AEC 4 stated that the use of depleted uranium in adornments such as cufflinks would result in a small increase of radiation exposure among the general public without commensurate benefit. Therefore, the NRC plans to reevaluate the exemption that permits the use of uranium in glass enamel and the use of the glass enamel on an end product such as jewelry.

During the period of reevaluation, the NRC believes it prudent to prohibit further increase in the circulation of cloisonne jewelry containing uranium. Therefore, the NRC is suspending th,e exemption in 10 CFR 40.13(c)(2)(iii) pertaining to glass enamel and glass enamel frit. The l

l 3 Enclosure 1

'. susp;nsion will b2 terminated at the completion of the final NRC action follcwing the reevaluation of the exemption or on June 30, 1985, which-ever comes first.

After the effective date of the suspension, (1) manufacturers may not f commercially distribute materials covered under 10 CFR 40.13(C)(2)(iii) y pertaining to glass enamel and glass enamel frit to persons not licensed to possess radioactive material, and (2) importers may not import for commercial distribution glass enamel, glass enamel frit covered in the suspended para- '

graph, or products containing enamel such as cloisonne jewelry (10 CFR ,,! 1 except for products ordered for importation before the suspension date. 'k' However, this suspension does not apply to persons who receive, possess, use or transfer radioactive glass enamel and glass enamel frit, or products containing these items imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before the effective date of the suspension. Therefore, persons who possess these items imported or ordered for importation, or initially distributed by such manufacturers before the effective date of the suspension will continue to be exempt from licensing requirements, and may possess, sell and transfer these items without a license.

It should be noted that the NRC's jurisdiction extends only to items to which uranium or thorium have been added. Pieces of cloisonne jewelry that do not contain uranium or thorium may be imported and distributed in the normal course of business.

The suspension is necessary to prohibit further importation of cloisonne jewelry containing uranium into the U.S. for commercial distribu-tion, thus avoiding additional exposure to the public pending the NRC's reevaluation of the exemption. Because this action must be taken expedi-tiously to be fully effective, the NRC has found that good cause exists for omitting notice of proposed ru'emaking and public procedure thereon as impracticable and contrary te the public interest and has found good cause for making the amendment effective upon publication in the FEDERAL REGISTER without the customary 30-day notice.

4 Enclosure 1 1

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, PAPERWORK REDUCTION ACT' STATEMENT i

This final rule contains no information collection requirements and therefore is not subject to the requirements of the Paperwork Reduction-

' Act of 1980 (44 U.S.C. 3501 et seq.).

REGULATORY ANALYSIS The NRC has prepared a regulatory analysis on this final regulation.

- The analysis examines the costs and benefits of alternatives considered k by the NRC. The analysis-indicated that the economic impact, including-impact to small entities, of this suspension is very small. The analysis is available for inspection in the NRC Public Document Room, 1717 H Street NW., Washington, DC.' Single copies of-the' analysis may be obtained from Dr. Anthany N. Tse,.0ffice of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555 (301-443-5825).

LIST OF SUBJECTS IN 10 CFR PART 40 Government contracts, Hazardous materials - transportation, Nuclear materials, Penalty, Reporting requirements, Source ma.terial, Uranium.

The authority citation for this document'is: Sec. 161b., Pub. L.83-703, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); Sec. 201, Pub. L.93-438, 88 Stat, 1242, as amended (42 U.S.C. 5841).

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended and 5 U.S.C. 552 and 553, the following amendment to 10 CFR Part 40 is published as a dccument subject to codification.

S 40.13 [ Amended]

1. In S 40.13, footnote 1 to paragraph (c)(5)(ii) is redesignated as footnote 2. ~

2. In S 40.13, a new footnote 1 is added to paragraph (c)(2)(iii) to read as follows:

5 Enclosare 1 F

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- 1. The ex1mpticn in 6 40.13(c)(2)(iii) pertaining to glass enam21 and glass enamel frit is suspended on , 1983 until the completion of the final Commission action following reevaluation of the exemption'or June 30, 1985, whichever comes first. ' Persons who receive, possess, use or transfer glass enamel or glass enamel frit covered under this exemption or products;contain.ing these enamels imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before , 1983 are not subject to this suspension.

Dated at Washington, D.C. this day of , 1983.

For the Nuclear Regulatory Commission.

Samuel J. Chilk, Secretary of the Commission.

6 Enclosure 1

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CONGRESSIONAL LETTER

Dear Chairman :

Enclosed for the information of the Subcommittee are copies of a Notice of Final Rulemaking to be published in the Federal Register. The amendment will suspend an exemption provided for glass enamel and glass enamel frit containing small amounts of uranium in 10 CFR 40.

On January 25, 1983 the New York State Department of Health announced th' ' it had found some pieces of cloisonne jewelry to be radioactive. The radiation was a result of the uranium used to produce golden yellow and beige colors in the brightly colored glass enamel of jewelry. To the best of our knowledge all such jewelry is imported. There is no known manufacturer of this type of jewelry in the United States.

After the announcement by the State of New York, other States and the NRC examined thousands of pieces of jewelry. The NRC concluded that the use of the cloisonne jewelry containing uranium does not constitute an immediate or signi-ficant health hazard. However, the NRC believes that the use of the jewelry could constitute an unnecessary exposure to radiation. This view is based on the principle that there should not be any man-made radiation exposure without the expectation of benefit resulting from such exposure. Further, the NRC considers that the use of radioactive material in toys, novelties, and adorn-ments may be of marginal benefit. Therefore, the NRC plans to reevaluate the exemption that permits the use of uranium in glass enamel and the use of the glass enamel on an end product such as jewelry.

DRAFT 04/22/83 Enclosure 2

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During the reevaluation period, the NRC believes it prudent to prohibit further increase in the circulation of cloisonne jewelry containing uranium in

~the U.S.- Thus the NRC is suspending the exemption in 10 CFR 40.13(c)(2)(iii) l I

- pertaining to. glass enamel and glass enamel frit containing uranium. The suspension has the effect of prohibiting importation of the cloisonne jewelry containing uranium into the U.S. for. commercial distribution'except for those ordered for importation before the effective suspension date. However, consumers, retailers and others who already have the jewelry on hand or on order will

' continue to be allowed to possess, use, transfer, and sell, the jewelry without-a license. The suspension will be terminated at the' completion of the final Commission action following the reevaluation of the exemption or on June 30, 1985, whichever comes first.

Enclosed also for your information is a copy of an announcement to be releaded to the public.

Sincerely, Robert B. Minogue, Director Office of Nuclear Regulatory Research

Enclosures:

1. Notices of rulemaking

2. Public' announcement DRAFT 06/07/83 Enclosure 2

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-NRC SUSPENDS EXEMPTION.FOR RADI0 ACTIVE; CLOISONNE JEWELRY The Nuclear Regulatory Commission is suspending immediately an. exemption from its regulations that permitted cloisonne-type jewelry containing uranium to be imported into the '

United States without a specific NRC license. Consumers, retailers and others who already have the jewelry on hand will continue to be allowed to possess, sell and transfer it without a license. .

The suspension will maintain the status quo and prevent the amount of radioactive cloisonne j ewelry in circulation

..from increasing'while the NRC reevaluates the exempt use of glass enamel containing uranium.in consumer products such as

~ jewelry.

On January 25, 1983, the New York State Department of Health announced that it had found that some pieces of cloisonne jewelry were radioactive. The radiation was a result of uranium used to produce golden-yellow and beige colors in the brightly colored glass enamel of the jewelry.

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-After the announcement-by the State of.New York, other states and the NRC examined thousar.ds of pieces of cloi'onne s

jewelry. LThe Department of Energy's Radiological and Environmental

-Sciences. Laboratory in-Idaho Falls, Idaho, also performed a radiological analysis of the jewelry. This information '

indicated that about 10 percent of the jewelry is radioactive as a result of the uranium cont.ent in the glass enamel. The uranium content of the enamel of the radioactive pieces was in the range of 3 to.7 percent by weight. The radiation dose' rate at contact with the surface of the enam.el ranged from 3 to 7 millirems.per-hour, but the exposure rate decreased '

rapidly with distance from the surface of the jewelry. (In comparison, the radiation dose from a chest x-ray is about 25 millirems.) No removable radioactivity was detected on any san.ple. '

Based on these findings, the NRC has determined that a piece of cloisonne jewelry worn with the radioactive enameled surfste in direct contact with the skin (such as a ring'or pendant) for a period of 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months per week for a year could deliver a dose of about 2 to 4 rems to a small area of the skin. This corresponds to a skin cancer incidence risk of '

about 2 to 4 in a million. The risk of actual death from these skin cancers is considerably less.

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When the radioactive enameled surface of the-jewelry is not'in' direct contact with the skin, the radiation. dose,and-corresponding. cancer risk are~much lower.

NRC~ regulations permit the use of uranium in glass enamel or glass enamel "frit" (a mixture of sand and other' .

. materials'used to make the glass enamel). On November 17,.

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1964, the Commission's predecessor, the Atomic Energy Commission, published a final regulation'that exempted from licensing requirements the receipt, possession, use, transfer or import of uranium contained in glass enamel and g' ass l enamel frit containing not more than 10 percent by weight of the uranium. The AEC noted the long-standing use of uranium to produce certain colors--dating back at least to the early part of this century--and stated that, "By reason of the low ,

amount of radiation from glass enamel and glass enamel frit and the short period of time a person would use or be near.

such material, resultant external radiation exposure to the user would be only a small fraction of the limits recommended by the Federal Radiation Council or the International Commission on Radiological Protection."

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c However, the AEC's evaluation may not have considered the use of uranium frit in jewelry worn next to the skin. A person might wear a piece of cloisonne jewelry, such as a pendant suspended from a neck chain, in contact with his or her skin for relatively long periods of time. Distribution of the cloisonne jewelry may also be on a wider scale than the AEC had anticipated for products using frit.

Although the use of the radioactive cloisonne jewelry does not constit.ute an immediate or significant health hazard, the NRC believes the,use of the jewelry does con-stitute an unnecesary exposure to radiation. This view is based on the principle that there should not be any man-made radiation exposure without the expectation of benefit resulting from s6ch expouure.

The NRC believes that all radioactive cloisonne jewelry is imported. If such jewelry was imported or ordered for import into the United States before , 1983, it is not subject to the suspension of the exemption.

If there is a manufacturer of the jewelry in this country, the suspension of the e'xemption has the effect of prohibiting him from any commercici distribution of the '

jewelry not made before , 1983.

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ENCLOSURE 4

REGULATORY ANiLYSIS Suspension of Exemption Permitting Use of Glass Enamel and Glass Enamel Frit Conuining Small Amounts of Uranium

1. Statement of the Problem On January 25, 1983 the New York State Department of Health announced that it had found some pieces of cloisonne jewelry to be radioactive. The radiation was a result of the uranium used to produce golden yellow and beige colors in the brightly colored glass enamel of the jewelry. All of the cloisonne jewelry found to contain uranium has been imported. There is no known manu-facturer of this type of jewelry in the United States.

Although the u;e of cloisonne jewelry containing uranium does not constitute an immediate or significant health hazard, the NRC believes the use of the jewelry cotGd constitute an unnecessary exposure to radiation. Therefore, the Commission believes it prudent to reevaluate the exemption that permits the use of uranium in glass enamel and the use of the glass enamel on an end product such as jewelry. The Commission is considering a suspension of the exemption in 10 CFR 40.13(c)(2)(iii) pertaining to glass enamel and glass enamel frit during the reevaluation period.

2. Objective The objective of the amendment is to prohibit further increase in the circulation of cloisonne jewelry containing uranium in the U.S. while the NRC reevaluates the exempt use of glass enamel and glass enamel frit containing uranium. This action could avoid additional public exposure to radiation from l cloisonne jewelry containing uranium which could be imported during the suspension period.

1 Enclosure 4 L - _ _ . _ . - _ _ - - - _ _ _ _ _ _ _ _ _ _ _ _ _ - - _

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3. Alternatives 3.1 -Take no action This alternative would allow the continuing exemption of glass enamel and glass enamel frit containing uranium until the Commission takes final regulatory action following the reevaluation of the exemption. Under this alternative, cloisonne jewelry containing uranium may continue to be imported for commercial distribution.

3.2 Suspend the exemption This alternative would prohibit further importation of cloisonne jewelry containing uranium into the U.S. for commercial distribution. However, a

" grandfather clause" would be included to permit the continuing exemption of.

persons who receive, possess, use or transfer cloisonne jewelry containing uranium imported or ordered for importation before the effective date of the ,

suspension.

4. Consequences 4.1 Take no action Under this alternative, additional importation of the cloisonne jewelry containing uranium for commercial distribution in the U.S. would be permitted.

This additional importation would increase the circulation of the jewelry in the U.S. and thus would increase the public exposure to radiation from this jewelry. There is no economic impact under this alternative.

4.2 Suspend the exemption This alternative would prohibit further importation of the cloisonne jewelry containing uranium into the U.S. for commercial distribution. 'It also would prohibit importation of (1) glass enamel or glass enamel frit containing uranium or (2) products contain glass enamel or glass enamel frit containing uranium.

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This action would prohibit increase in the circulation of the cloisonne jewelry containing uranium within the U.S. Therefore, this action would also prevent an increase in public exposure to radiation from the cloisonne jewelry that could be imported during the period of reevaluation of the exemption by the NRC.

Since the " grandfather clause" in the suspension would permit continuing j the exemption for cloisonne jewelry containing uranium imported or ordered for importation prior to the suspension date, the economic impact to the distribu-tors, retailers and consumers is negligible. ,

There will be some impact to importers who plan to import cloisonne jewelry for commercial distribution during the suspension period. Importers would be prohibited from importing for commercial distribution cloisonne jewelry containing uranium unless they have specific licenses fror.1 the NRC. However, since 90% of cloisonne jewelry does not contain uranium and there are nonradioactive substitute colors available, it is possible for the importers to import nonradioactive cloisonne jewelry. Therefore, even for importers, the economic impact is very small.

5. Decision Rationale The second alternative, suspension of the exemption, appears to have the effect of preventing further increase in public exposure to radiation from cloisonne jewelry containing uranium. In addition, this alternative would impose .

negligible economic impact to distributors, retailers, and consumers, and a very 1

small economic impact to commercial importers. Therefore, the Commission should suspend the exemption pertaining to glass enamel and glass enamel frit containing uranium.

6. Implementation The amendment will be effective upon publication until the completion of final Commission action following reevaluation or June 30, 1985, whichever comes first.

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ENCLOSURE 5 1

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NUCLEAR REGULA' TORY COMMDSSION . -

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Office af Puui= M-:ci o Q* a i.. ,j Weshinston, D.C. F.:.555 No. '83-11 FOR IMMEDIATE RELEASE

.Tel. 301/492-7713 (Tuesday, February 1,1983)

NRC STAFF EVALUATES CLOISONNE-TYPE JEWELRY

.The Nuclear Regulatory Commission staff has concluded a-

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. preliminary evaluation of 'he t us'e of cloisonne-type jewelry which is painted with a-glaze containing small amounts of uranium. ,

The New York. State Department of Health announced on January 25. that it had found some pieces of the slitthtly.

radioactive j ewelry and identi'fied it as being yellow-orange or off-white (beige) in color.' .

. Additional pieces of the jewelry have been found since-the New York State announcement. Based on its preliminary evaluation, the staff has cone.luded that normal use of the

. jewelry does not constitute an immediate or significant

~'hoalth hazard. .

Calculations indicate that contin'ued use of a large piece of the j ewelry--such as a pendant--with the painted .

surface in direct contact with the skin for a period of 50'

. hours per week for a year would result in c radiation dose.

about one quarter of that which would' be allowed for the :

slin of workers in the nuclear industry under current NRC -

regulations. If the painted surfaces are not in direct contact with the skin, the dose would be considerably less. .

The skin is relatively insensitive .to radiation when compared -

. to other organs of_.,the body.

~ The staff has consulted with the Food and Drug Adminis-tration and the Consumer Product Safety Commission on this matter. -

The staff believes, however, that use of the slightly .

radioactive jewelry does constituto an unnecessary exposure ,

to radiation. This view is based on the principle that any exposure to radiation.should be avoided, if possible, uniess there is a resulting benefi..

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l RADIOLOGICAL ASSESSMENT OF CLOISONNE JEWELRY

SUMMARY

The Nuclear Regulatory Commission staff has concluded an assessment of radiation dose and risk associated with the use of cloisonne-style jewelry containing small quantities of uranium in the enamel glaze based upon rad'iological data collected by the Radiological and Environmental Sciences Laboratory (RESL), Idaho Falls.

The dose delivered during one year to the area of .ekin in direct contact with the radioactive enamel if the jewelry is worn 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months / week or 520 hours0.00602 days 0.144 hours 8.597884e-4 weeks 1.9786e-4 months / year was determined to range between 2 to 4 rad. When direct contact between the enamel surface and the skin does not occur, the projected radiation dose will be less than 25 mrem / year. These doses to the skin are within the current Inter-national Commission on Radiological Protection Recommendations for exposure of the public. The maximum dose to the skin from essentially continuous exposure would range between 30 to 40 rad per year. Doses of this magnitude would be in excess of recommarGd limits for individual members of the public for skin of the whole body but are within the limits recommended for radiation workers. The ,

assumptions used to calculate the high values are believed to be extreme over-estimates of actual use patterns.

The tissue at risk has been determined to be the skin. The skin, while exhibiting a relatively high natural incidence of caricinoma's, is relatively insensitive to radiation induced carcinoma. An upper bound estimate of the incidence of radiation induced skin carcinoma risk per rad of exposure was taken from the 1980 report of the National Academy of Sciences Committee on the Biological

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3 This assessment has been limited to th'e risk to individuals. ' The collective dose and risk to the public was not addressed because the amount of jewelry containing ura11um is not presently known, nor .is it likely to be. It is ,

believed that importors and distributors were generally unaware that some jewelry was radioactive, and consequently there are no records which would indicate how much u'ranium bearing jewelry has been distributed.

I. Introduction Some pieces of Cloisonne Jewelry have been found which have measureable levels of radiation at their surfaces. The radiation occurs because of the presence of uraniumi 'n several of the gleze materials. Cl oi sonne style jewelry has been popular in the United States for several years. Its distinguishing characterist.ics are an enameled face which may be of almost any shape or design. Typical pieces include pendants, belt buckles, rings, earrings, and hair combs. The colors which might contain uranium are mainly gold, off-white, and ivory.

Nuclear Regulatory Commission regulations (Section 40.13(c)(2) of 10 CFR Part 4C} provide an exemption from licensing for uranium contained in certain consumer products, such as glass enamel f.rit. This exemption applies to concentrations of uranium up to 10 percent by weight.

.The purpose of this paper is to report the restits of radiation measurements I

that have 'been made of cloisonne jewelry containing uranium and to assess the radiation risk to individuals associated with use of these items.

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_.._._..____-____-___-___.__--______._______.-_--.c__. -

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3, 3 . 5 Thermol'uminescent dosimeter (LiF) measurements were employed to ' determine -

the dose rate to the basal layers of the skin (7 mg/cm2 absorber density thickness). Exposure times were 65 hours7.523148e-4 days 0.0181 hours 1.074735e-4 weeks 2.47325e-5 months in the analysis by RESL and 18 hours2.083333e-4 days 0.005 hours 2.97619e-5 weeks 6.849e-6 months at pRC.

Dose rates were determined for both the enameled and non-enameled -

(back) surfaces. In addition, depth' dose estimates were taken at a

. distance of 1 cm by RESL. .

Samples of the enamel glaze were physically removed from the jewelry pieces and subjected to alpha, b' eta, and gamma spectroscopy to determine the isotopes present, beta particle energy and penetration, and the weight percentage of source material.

Alpha and gamma spectroscopy indicated the presence of uranium 238 and 234, thorium 234, protactinium 234, and in one instance radium 226 in the enamel glaze. The ratio of U-238 to U-234 was determined to be about 2.5, indicating depleted uranium source material. Gamma spectroscopy showed photopeaks in the regions typical for thorium-234 and protactinium-234.

Beta spectroscopy and absorber curves were developed to determine the penetrating power of the radiations. A half-value density thickness 2

of 46 mg/cm was found, indicating a beta emitter of g'reater than 1.4 MeV. This corresponds to the known radiological decay scheme of, protactinium 234 The source material content of the glaze was determined by RESL to be variable depending upon the specific ' pigment analyzed. The " gold" pi gment was found to contain 6 to 7 percent uranium, while the "off-white" pigment was found

RADIOLOGICAL ASSESSMENT OF CLOISONNE JEWELRY 3 &3

SUMMARY

The Nuclear Regulatory Commission staff has concluded an assessment of radiation dose and risk associated with the use of cloisonne-style jewelry contLining small quantities of uranium in the enamel glaze based upon rad'iological data collected by the Radiological and Environmental Sciences Laboratory (RESL), Idaho Falls.

The dose delivered during one year to the area of skin in direct contact with the radioactive enamel if the jewelry is worn 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months / week or 520 hours0.00602 days 0.144 hours 8.597884e-4 weeks 1.9786e-4 months / year was determined to range between 2 to 4 rad. When direct contact between the enamel surface and the skin does not occur, the projected radiation dose will be 4

less than 25 mrem / year. These doses to the skin are within the current Inter-national Commission on Radiological Protection Recommendations for exposure of the public. The maximum dose to the skin from essentially continuous exposure would range between 30 to 40 rad per year. Dose.s of this magnitude would ce in excess of recommended limits for individual members of .the public for skin of the whole body but are within the limits recommended for radiation workers. The assumptions used to calculate the high values are believed to be extreme over-estimates of actual use patterns.

The tissue at risk has been determined to be the skin. The skin, while exhibiting a relatively high natural incidence of caricinoma's, is relatively insensitive to radiation induced carcinoma. An upper bound estimate of the incidence of radiation induced skin carcinoma risk per rad of exposure was taken from the 1980 report of the National Academy of Sciences Committee on the Biological l - e ?

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Effects of Ionizing Radiation as 1 X 10-0 . The risk of incidence of a radiation induced skin carcinoma is used in this report rather thr.n the risk of a radiation' induced carcinoma leading to a fatality as ,is normally. the case (ICRP 1977) because treatment is very effective and the fatality rate is unknown.

The staff has concluded that continued moderate use of cloisonne jewelry by members of the public does not constitute a hazard in excess of that commonly accepted in daily activities. The staff does not believe cloisonne pieces presently possessed by members of the public need to be disposed of on the basis of potential risks to health and safety. Further, the dose received by and risk to distributors, children, and other members of the public have been determined to be less than that for someone wearing the j ewel ry. Those individuals wishing to discard jewelry should be directed to use normal refuse means for disposal.

The data collected by RESL indicate that the uranium content of the enamel glaze is within the bounds of the NRC exemption for glass enamel frit (10 CFR 40.13(c)(2)) However, the principle that exposures i to radiation should be avoided, if possible, unless there is a resulting benefit and the Commission policy statement (30 FR 3462) regarding the 'use of source and byproduct material in products intended for )

use by the general public, indicates that the exemption should be reexamined.

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This assessment has been limited to the risk to individuals. The collective dose and risk to the public was not addressed because the amount of jewelry containing uranium is not presently known, nor is it likely to be. It is ,

believed that importors and distributors were generally unaware that some '

jewelry was radioactive, and consequently there are no records which would indicate how much u'ranium bearing jewelry has been distributed.

I. Introduction Some pieces of Cloisonne Jewelry have been found which have measureable

~

levels of radiation at their surfaces. The radiation occurs because of the presence of uranium in several of the glaze materials. Cl oi sonne style jewelry has been oopular in the United States for several years. Its distinguishing characterist.ics are an enameled face which may be of almost any shape or design. Typical pieces include pendants, belt buckles, rings, earrings, and hair combs. The colors which might contain uranium are mainly gold, off-white, and ivory.

Nuclear Regulatory Commission regulations (Section 40.13(c)(2) of 10 CFR Part 40) provide an exemption from licensing for uranium contained in certain consumer products, such as glass enamel frit. This exemption applies to concentrations of uranium up to 10 percent by weight.

The purpose of this paper is to report the results of radiation measurements that have been made of cloisonne jewelry containing uranium and to assess the radiation risk to individuals associated with use of these items.

_____._________________-m.___ _ _ _ . _ _ _ _ _ _ _ _ - -

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II, Samples of. Jewelry i Samples of' cloisonne jewelry have been obtained from various areas of

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the country and analyzed by several laboratories. In particular Nuclear Regulatory Commission offices Region II and V obtained samples. Radiological data on these: samples was collected by the Radiological and Environmental Sciences Laboratory (RESL), U. S. Department of Energy Idaho Operations !

Center, Idaho Falls, Idaho. The samples measured liave cansisted of pendants, belt buckles, and hair clips, some of which were covered with enamel glaze on both the front and back surfaces. In addition to this source, radiological measurements made by the Pacific Radiation Corporation (PRC), Temple City, California of samples obtained from Edmond R. tiansoon Imports were used 'in -

the assessment.

Other jewelry items such as earrings and r.ings have not been subjected !

to-radiological measurement. It is anticipated that analyses based upon the results of the sample types measured provide a conservative estimate when applied to other jewelry items due to their relative size and the low potential for direct contact of the enamel with the skin.

III. Radiological Analyses and Results -

-Samples of Cloisonne jewelry were surveyed by beta / gamma portable survey equipment'to determine those items which contained uranium glaze. These individual pieces were then subjected to several additional tests to determine dose rates, the radiation penetration potential, and, percentage of uranium in the jewelry.

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.- /. 5 Thermol'uminescent dosimeter (LiF). measurements were employed to determine the dose rate to the basal layers of the skin (7 mg/cm2 absorber density thickness). Exposure times were 65 hours7.523148e-4 days 0.0181 hours 1.074735e-4 weeks 2.47325e-5 months in the analysis by RESL and 18 hours2.083333e-4 days 0.005 hours 2.97619e-5 weeks 6.849e-6 months -

at PRC. Dose rates were determined for both the' enameled and non-enameled' (back) surfaces. In addition, depth dose estimates were taken at a distance of 1 cm by RESL.- .

Samples of the enamel glaze were physically removed from the jewelry pieces and subjected to alpha, b~ eta, and gamma spectroscopy to _ determine the isotopes present, beta particle energy and penetration, and the weight percentage of source material.

Alpha and gamma spectroscopy indicated the presence of uranium 238 and 234, therium 234, protactinium 234, and in one instance radium 226 in the enamel glaze. The ratio of U-238 to U-234 was determined to be about 2.5, indicating depleted uranium source material. Gamma spectroscopy showed photopeaks in the regions typical for thorium-234 and protactinium-234.

Beta spectroscopy and absorber curves were developed to determine the penetrating power of the radiations. A half-value density thickness 2

of 46 mg/cm was found, indicating a beta emitter of g'reater than 1.4 MeV. This corresponds to the known. radiological decay scheme of, protactinium 234.

The source material content of the glaze was determined by RESL to be variable

~

depending upon the specific pigment analyzed. The " gold" pigment was found to contain 6 to 7 percent uranium, while the "off-white" pigment was found

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1 to contain roughly 3 percent. A third suspected color, identified as

" ivory" by RESL was found not to contain any uranium. The weight percent values correlate reasonably well with data obtained from the Taiwan AEC which listed light yellow and gold pigments with a total weight percent of uranium in the range of 8 to 9 percent, and an i.vory pigment containing approximately.3 percent. It is presumed that the "off-white" color described by RESL corresponds to the ivory pigment reported by the Taiwan AEC. The uranium content of the jewelry analyzed is sumarized in Tabic 1.

The dose rate delivered through 7 mg/cm2 of absorber was determined for a number of samples by RESL and is summarized for each piece of jewelry in Table 2. In general, thermoluminescent detectors (TLD) which were placed directly over regions containing uranium pigments exhibited relatively high dose readings, while TLD's placed in other areas of the jewelry gave little or no reading. Measurements made on the back surfaces of jewelry pieces which were enameled on only one side revealed very low dose level s. In addition, depth dose values taken from the front and back surfaces were found to be "not detectable" (less than 17 microrad/ hour).

IV. Radiological Dose Assessment

To assess the potential dose to individuals who may wear or distribute cloisonne jewelry, assumptions for realistic and maximum credible scenerios were developed for their exposure history. The scenerios developed, with their associated assumptions, are detailed below. The calculated doses using radiation data presented in Table 2 are given in Table 3.

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7 TABLE 1 Uranium Content of Enamel Glaze Materials As Determined by RESL

" Gold" Color 6-7% (Sample. Contaminated with base metal)

Depletion ratio (U-238/U-234) = 2.5 "Off-White Color 3.3 + 0.2%

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Depletion ratio (U-238/U-234) = 2.4 Approximately 10%'of activity due to Thorium and/or Radium

" Ivory" Color No Source fiaterial Detected As reported by Taiwan AEC - quote from telex

'.'Our analysis are as follows:

Product No. Color U-238 Wt.%- U-235 Wt.% Total Wt.% Sp. Act. Ci/g JG 2815 Ivory 2.97 0.0076 2.98 0.010 JG 302! Lt. Yellow 8.2 0.0156 8.20 0.028 JG 3064 Golden 9.0 -

0.0194 9.00 0.031 L

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l c i Table 2 Thermoluminiscent 0,etector Oose Rate Determinations (Source: Telephone conversations with gr. Dale Olsen, RESL:ID0) {

(All TLD measurements made thru 7 mg/cm absorber unless otherwise noted) J A. Elephant Pendant; Single Side Enameled, Source: Region V Front Surface range 0.1 to 9.9 mrad /hr average 3.1 + 0.2 mrad /hr Rear Surface range 0.0 to 0.1 mrad /hr average 0.032 + 0.027 mrad /hr Depth Dose, 1cm. Front Surface <17u rad /h7 ("not detectable")

Depth Dose, icm. Back Surface <l7u rad /hr ("not detectable")-

B. Square, Pendant, Single Side Enameled, Source: Region V Front Surface, Gold flower 6.8 + 0.5 mrad /hr

- (<10% of area)

Front Surface, Other <l.9 mrad /hr C. Hair Clip, Single Side Enameled, Source: California Front Surface, off-white background 2.7 + 0.2 mrad /hr

, (50% of area)

Front Surface, yellow flower center 1.2 + 0.1 mrad /hr Front Surface, greet-marroon leaf 0.3E0.1 mrad /hr D. Belt Buckle, Single Side Enameled, Source: Region II 2 inches X 1 3/4 inches Front Surface', off-white background 3.7 + 0.3 mrad /hr (50% of area)

Front Surface, gold color 6.9 7 0.5 mrad /hr (5% of area) '

Front Surface, copper color 0.9E0.1 mrad /hr E. . Heart Pendant, Both Sides Enameled, Source: Region 11 Front Surface, gold color 3.7 + 0.3 mrad /hr Front Surface, other 0.15 + 0.1 mrad /hr F. Rectangular Pendant, Single Side Enameled, Source: Region II l

Front Surface, off-white background 5 mrad /hr Front Surface, yellow color 3. 6 .m rad /h r PACIFIC RADIATION CORP. MEASUREMENTS Seven pieces analyzed Front Surface range 4.6 to 5.7 mrad /hr average 5.1 +' O.4 mrad /hr Rear Surface "not detectabTe" NO REMOVABLE ACTIVITY DETECTED ON ANY SAMPLE NO ALPHA ACTIVITY DETECTED AT THE ENAMEL SURFACE c _ _ _ _ _ - - _ _ _ _ _ _ - _ - _ _ _ _ _ _ _ _ _ _ _ - _ - _ _ -

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J 5 Table 3' SKIN DOSE RESULTS ')

Item Type Dose Rate Hours Exposure Total Dose p

. A. Elephan't Pendant .

Front 3.1 mrad /hr 520 hrs 1.6 rad 5840' hrs 18 rad

< Rear 0.032 mrad /hr 520 hrs- 17. mrad 5840 hrs 187 mrad

, 8760' hrs 280 mrad

' B. Square Pendant Front 6.8 mrad /hr 520 hrs 3.5 rad 5840 hrs 40 rad C. Hair Clip No contact Depth Dose Not Detectable not calculated

- D. Belt Buckle No contact Depth Dose Not Detectable not calculated E. Heart Pendant Front, gold 3.7 mrad /hr 520 hrs 1.9 rad 5840 22 rad

' Front, other 0.15 mrad /hr 520 hrs 78 mrad 5840 hrs 880 mrad F. Rectangular Pendant Front, off-white 5 mrad /hr 520 hrs .2.6 rad -

5840 hrs 29 rad Front, yellow 3.6 mrad /hr 520 hrs 1.9 rad 5840 hrs 21 rad G. PRC Measurements (Jewelry type not reported)

Front 5.1 mrad /hr 520 hrs 2.6 rad 5840 hrs 30 rad Rear "not detectable" 520 hrs 5840 hrs not calculated 8760 hrs

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10 A. Individuals . Wearing Jewelry To determine a realistic, estimate of the potential exposure and risk for someone owning pieces of c1oisonne, several assumptions were required concerning the use patterns for this type of jewelry. It has j L been assumed that cloisonne is basically a " fashion" type of jewelry l

worn with certain types of clothing and not likel-y, in most situations, to be worn with a high degree of frequency. .The following use patterns.

for vari.ous types of' jewelry were considered.

1

1. Pendant.

In a realistic situation, a necklace or pendant might be worn to work or out evenings with a certain types of clothing. On the days when the pendant is worn, the' t'ime involved was assumed to be 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months . Assuming 1 day per week for this piece of jewelry, the total time of exposure is (10 hrs / day) x (1 day / week) x (52 weeks / year) = 520. hours / year. The pendant is assumed to be in direct contact with the skin, although this is unlikely since most pieces.would be displayed on the ou'tside of the garmet, ii. Ring This type of ring would not constitute an everday use ' item, and would therefore be worn only as an accessory to certain types of clothing, similar;to the pendant above. The same time assumptions were used as described -in A.1. above for a total exposure time of 520 hours0.00602 days 0.144 hours 8.597884e-4 weeks 1.9786e-4 months / year. The enamel surface of a ring would not be in direct contact with the skin, so only dose measurements for the non-enameled (back) surface of the jewelry were considered.

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i. Because the enamel surface is ' typically flat and large in comphrison with the band,-the enamel will tend to remain on the top of the finger. Hence, contact between other fingers and the enamel is unlikely. .

iii . Earring These items would generally be worn to coordinate with other items of jewelry and' hence may be treated as the pendant and .

ring described above. The total exposure time is therefore-taken to be 520 hours0.00602 days 0.144 hours 8.597884e-4 weeks 1.9786e-4 months / year. Again, the enamel surface would not be in direct contact with the skin.

iv. Belt Buckle The buckle is generally kept with one particular belt, hence 4

this item would also be used only once per week on the average with certain types of clothing. The total exposure time may therefore be taken to be the same as for the other items described above at 520 hours0.00602 days 0.144 hours 8.597884e-4 weeks 1.9786e-4 months / year. Again, the enamel surface would not be in contact with the skin. In most circumstances, two layers of belt material, in addition to one layer of cloth would be present between the back surface of the belt buckle and the skin.

Therefore, only depth doses would be appropriate in the deter-mination of doses received from buckles.

For an upper bound estimate of potential exposures, a maximum credible scenerio was developed which considers the maximum exposure conditions which might be experienced by any individual. The likelihood of such exposure is small, since the assumptions are intended to be very conservative.

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1. Pendant The maximum credible exposure would occur when an individual wears the pendant continuously during a day. _ In this case, it is assumed that an individual is awake for 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months per day. During the course of a year a total of- (16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months / day) X (365 days / year.) =

5840 hours0.0676 days 1.622 hours 0.00966 weeks 0.00222 months of -ex,posure could be accumulated. Again, the pendant l

i gla'ze enamel surface is assumed to be in constant contact

l L . with the skin.

i ii. Ring .

A ring is a piece of jewelry which is not necessarily removed during the night. Therefore the maximum credible exposure-is that of continuous contact (8760 hours0.101 days 2.433 hours 0.0145 weeks 0.00333 months ) during the year.

The enamel surface is assumed not to be in contact with the skin.

iii. Earring i These items, like the pendants described above, would generally be removed during the night. Hence a total of 5840 hours0.0676 days 1.622 hours 0.00966 weeks 0.00222 months of exposure would be accumulated during the course of a year.

The enamel surface is assumed not to be in contact with the skin.

iv. Belt Buckle The belt buckle, like the pendant and earrings described previously, would not be worn continuously. Therefore a total of 5840 hours0.0676 days 1.622 hours 0.00966 weeks 0.00222 months of exposure would be accumulated. The enamel is not in contact with the skin, and is assumed to be held away from the skin by the belt material.

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, 13 B. Distributors The distributors constitute the entire supply chain from a small jewelry store to a large importor. In considering the potential for.

exposure, the local jewelry store employee is at greater risk since -

1 l that person would be more likely to handle individual items.

L Two situtation were considered.

I

1. For some realistic estimate of' exposure, the store employee was assumed to work a standard 8 hour9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months day during which he/she handled a piece of cloisonne jewelry containing uranium once every i

30 minutes. The total exposure time per piece of jewelry was assumed to be 1 minute total (showing, packing, etc.). Therefore, over the course of a year the employee would receive (2 minutes /

hour) x (8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months / day) x (5 days / week) x (50 weeks / year) = 4000 minutes per year or roughly 70 hours8.101852e-4 days 0.0194 hours 1.157407e-4 weeks 2.6635e-5 months of exposure. The skin of the fingers nay be assumed to be in direct contact with the glazed surface during this period. For the remainder of the working shift, the jewelry is assumed to be in some type of glass case, which would shield the individual.

^

ii. For a maximum upper-bound on the exposure of employees, the frequency of exposure was assumed to be once every 5 minutes.

The total time was therfore taken to be (12 minutes / hour) x (8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months / day) x (5 days / week) x (50 weeks / year) = 24000 min per year or 400 hours0.00463 days 0.111 hours 6.613757e-4 weeks 1.522e-4 months of exposure. -

C. Other Members of the Public Other members of the public could be exposed to cloisonne jewelry by indirect means such as proximity to the piece, or by handling a

9 14 -

4 piece being shown to them. In general, these contacts will be of short duration and highly sporadic in nature, resulting in very small exposure times. Direct contact.will almost never occur, hence only. penetrating radiations would provide a dose to these individuals.

D. Children Under certain circumstances children may be exposed to cloisonne-jewelry in addition to the ways previously described for the individual wearing the jewelry and _ other members of the general population.

These situations involve the "what if" case where a child might be exposed by playing with the jewelry or putting. it into the mouth. In such situations, the tirr,e of_ exposure will be very small compared-with other exposure scenerios developed previously. In addition, the child might swallow the object, resulting in exposure as the item traveled through the GI tract. In general, the hazard in this case is not that of the radioactivity, but rather that of choking from the object itself. The enamel has been demonstrated by RESL to be very hard, hence it is unlikely that pieces of the glaze would be chipped off by the childs teeth. The u.ranium is believed to be very insoluble, therefore the material would not be absorbed into the body if swallowed.

Transit time for material in the GI tract would be on the order of 42 hours4.861111e-4 days 0.0117 hours 6.944444e-5 weeks 1.5981e-5 months , with any one section of GI tissue being exposed for a much q shorter period of time.

V. Dose-Risk Conversion Considerations ' '[ \ . .f. ,. ',{p ,

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The tissue of primary concern when dealing with exposure t6 cloisonie

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jewelry is the skin. The thickness of the skin varies con,siderablIy grom,;

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. e .7 15 part of the body to another. Hence the baral cell' layar of the epidermis, which is taken to be the skin tissue most at risk (ICRP,1977) varies in-depth from 50 to 100 micrometers (um). For practical dose assessment, the International . Commission on Radiological Protection (1977) recommended the use of a depth of 70 pm. This depth constitutes an absorber thickness of approximately 7 mg/cm2 ,

The principal classifications of radiation-induced skin cancer are squamous-cell and basal-cell- carcinomas. According to the Committee on the Biological Effects of Ionizing Radiation (BEIR Committee) (NAS,1980) the basal-cell carcinoma type tends to predominate at icwer overall exposures, with squamous-cell carcinomas occuring after. large radiation exposures associated with severe radiodermatitis and ulceration. In addition, anatomic location is apparently a determining factor with basal-cell carcinoma predominate on the head and neck while squamous-cell carcinoma occurs on the hands (NAS, 1980).

When considering the effects of radiation-induced skin cancer, it is noted that there is generally a low mortality rate associated with the disease (UNSCEAR, 1977). For basal-cell carcinoma the mortality rate is practically zero, since treatment by simple excision or local application of chemothereputic agents is very effective. In addition, there are well documented differences in the natural incidence of skin cancers between various races. In particular, both Blacks and Mongoloids have been shown to have a far lower incidence of skin cancer than Caucasians (NAS,1980).

16 "

Skin cancer as a late radiation effect was first reported in the early 1900's, and many cases have been reported since then. However, the BEIR committee (NAS,1980) concluded that the literature on radiation induced human skin cancer was sufficiently unsystematic that many questions remained essentially unanswered. In particular,' the areas of uncertainty include the shape of the dose-response curve, dose fractionation, and high and low LET radiation effects.

As reported by the BEIR c'ommittee (NAS,1980) two studies of x-ray therapy have yielded positive results'and can be used for estimating partial-body radiation risks. These must be qualified by no, ting that several similar studies did not yield any positive results. Therefore, the following values may represent the upper bound of risk. In the following discussion, all risk estimates are given in terms of incidence (cases per rad). The absolute-risk estimate from Tinea Capitis studie; (NAS,1980) where the average dose was 700 rads is 1 x.10-6 cases per rad with 90 percent confidence limits ranging from 0.7 to 1.5 x 10-6 ,

In the positive Thymus-irradiation study (NAS,1980) where the average ..

dose was 330 rads, the absolute risk was given as 0.4 x 10-6 cases per rad with 90 percent conf'dence values from 0.1 to 1.5 x 10-6 ,

Unputilished data referred to by the BEIR committee (NAS,1980) showed a l j

significant increase in the incidence of skin cancers, primarily basal-cell carcinomas of the face, in a large series of uranium miners. The estimated cumulative alpha-irradiation doses to the basal-cell layer were estimated i l

I

____ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ]

4..

1

.* . ., . 17 at about 100 rads. This is the only available literature concerning high LET radiations. The observed incid'ence yields an absolute risk value of approximately 2.9 X 10-6 cases per rad.

The positive results were bbtained in studies where the dose and dose rate were high. This might lead to an overestimation of the actual dose-response in the areas of concern. In addition, some of.the largest studie.s, such as those on the Japanese atomic bomb survivors, have failed to determine an excess incidence of skin cancers (NAS,1980). Due to the relative insensitivity of the skin, the International Commission of Radiological Protection (ICRP) has remained silent concerning a numerical risk estimate. The only guidance provided by the ICRP (ICRP,1977) is for a dose level of 2,000 rads, at which cosmetically-unacceptable changes may occur.

Given the range of uncertainty associated with these risk estimates for skin cancer, an incidence value of 1 x 10-6 per rad has been adopted as a reasonable mean of the values reported for the purposes of this assessment. This risk estimator is likely to constitute the upper limit of projected effects, in light of the low dose levels, dose rates, and high fractionation involved.

An issue which occurs when evaluating a dose to the skin is the surface area over which the dose would be averaged for use in risk estimation and for compar-ison with appropriate limits. Guidance in this matter may be taken from the ICRP (ICRP,1977) Publication 26, paragraphs 182 and 183. In situations where 2

nonuniform exposure of a transient nature occurs, a surface area of 100 cm is

18 .

recommended. In addition, in situations such as accidents where highly nonuniform irradiation occurs, an estimate should be made of the average-dose equivalent over 1 cm in the region of the highest dose equivalent.

l While exposure to jewelry does not constitute an a'ccident situation, the area'of exposure will be consistent in location, rather than variable. It is therefore appropriate to use the l- cm2 area, which would be similar to the area of contact for a- pendant, as the area for dose computation.

Therefore no effort was made in this . analysis to average the dose rate data over a spe-ified constant area of skin.

An~o ther potential tissue of concern from cloisonne jewelry is the ' female breast. Data on breast cancer suggest that, during reproductive life, the breast may be one of the more radiosensitive tissues of the human body. - The risk value given by the BEIR Committee (NAS,1980) is 5.8 x 10-6 cases per rad for breast cancer induction. .A dose to the breast, in order to be ef"> 'tive, must be delivered to the capillary bed. This means that only the penetrating dose data will be of consequence in evaluations for this organ.

Risk estimates for various areas of the GI tract tend to be very low. The mo.st sensitive tissue, the colon, has been assigned an incidence estimate of 0.6 x 10-6 cases per rad (NAS,1980).

VI. Dose-Risk Assessment Estimates of risk for the skin for the various dose estimates pr.esented in Table 3 are 'shown in Table 4. A risk value of 1 x 10 -6 $3

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. TABLE 4 DOSE VS. RISK OF' INCIDENCE OF RADIATION INDUCED SKIN CARCINOMA Dose / year -Risk / year

17 mrad 1.7 x 10-8 78 mrad 7.8 x 10-0 .

187 mrad' 1.9 x 10~7 280 mrad 2.8 x 10~7 9

880 mrad 8.8 x 10-7 1.6 rad 1.6 x 10-6 ,

1.9 rad' .1.9 x 10-6

'2.6 rad 2.6 x 10-6 3.5 rad 3.5'x 10-6 18 rad - 1.8 x 10-5

. 21 rad 2.1 x 10-5 22 rad 2.2 x 10-5 29 rad 2.9 x 10-5 ,

40 rad 4.0 x 10-5 l

Based upon risk estimator of 1 x 10-6 cases per rad per year

[- .

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l ,

20 * [. ,'

i equivalent to saying I case.in one million individuals each identically /

exposed to 1 - rad. There are several, statements which can be made from the_results presented in Tables 3 and 4. -

tfrst, for situations where pendants are in direct contact with the skin, the total dose in the case of the realistic scenerio, is in the range of 2 to 4 rads per year. This corresponds to a risk of 2 to 4 in one million per year for skin cancer incidence. This dose level per year is within the levels recommended by the International Commission on Radiological Protection for' dose to any individual organ of a member of the public.

For the worst case situation, the dose estimates are approximately 20 to 40 rads per year. The corresponding risk levels are 2 to 4 cases in 100,000 per year. While these levels are an order of magnitude greater than the realistic estimates, they are within the dose limits recommended by the ICRP for individual organ doses'of radiation workers.

The risk estimates presented in this assessment are based upon the incidery of carcinoma induced by radiation. The ICRP dose limitation system is based upon a correspondence between dose and risk of carcinoma leading to fatality.

As mentioned previously, the mortality rate for basal-cell carcinoma (the type most likely to be induced) is very low due to the effective treatment procedures available. Therefore use of an incidence risk value for comparison to ICRP dose limitations is conseryct1/e.

Second, for other cloisonne jewelry containing uranium (such as rings, earrings, belt buckles, and hair combs) there is a much lower level of risk 4

p f, *f ',

H,.. ..,7 21 due to the lack of direct skin contact with the. enamel glaze. Data from RESL and .PRC ~ indicate that the level of rad'.t. tion being emitted from the back of a single sided piece of jewelry is very low. This may be seen

.in the. dose estimates for the realistic scenerio, where a total dose 'of 17 mrad per year w'as obtained. Even the maximum postulated exposure resulted in a skin dose estimate of only 300 mrad per year. . These -levels of dose and risk are wel1 within the range which would normally be considered acceptable for" members of the general public (ICRP,1977) for other activities.

Third, the risk to other organs, such as the female breast, due to the wearing of cloisonne jewelry is essentially zero. This is due to the fac't.

that depth dose measurements at 1 centimeter indicate a level of exposure below that detectable. The sensitive tissues of the breast would be at a distance 'of greater than 1 cm, hence an additional level of safety is incorporated.

Fourth, exposure from swallowing a pendant reading 6.8 mrad / hour could result in a maximum dose to the GI tract of approximately 300 mrem. Given the incidence value of 0.6 x 10-6 cases per rad for excess colon-cancer, the risk of this dose may be conservatively taken as 2 x '10~7 . Again, these levels of dose and risk are well within the range. shich would normally be considered acceptable for members of the general public (ICRP,1977).

Fifth, the uranium content of the enamel glaze is within the bounds of the NRC exemption for glass enamel frit. Only two or three of the

ar,

.. -22 enamel colors have been found to'contain uranium, and most of the cloisonne'will. contain only very small (if any) amounts of the radioactive material.

1 VII.- Conclusions and Recommendations It is concluded'that normal use of cloisonne jewel'ry does not constitute a level or risk in ' excess of. that normally accepted by individuals in their daily activities Excessive use of'such jewelry could result in radiation doses to the skin which might be considered unacceptable by members of the general public.

This assessment has been limited to the risk to individuals. The collective dose and risk to the public was not addressed because the amount of jewelry containing uranium is not presently known, _nor is it likely to be. It is -

believed that importors and distributors were generally unaware that some jewelry was radioac'tive, and that here are therefore no records which would indicate how much uranium bearing jewelry has been distributed.

The staff doeu not believe cloisonne jewelry pieces presently possessed by members of the public need to be disposed of on the barfs of potential 1

risks to health and safety. Further, the dose received by and risk to distributors, children, and other members of the public have been de'termined to be less than that for someone wearing the jewelry. Those individuals' wishing to discard jewelry should be directed to use normal refuse means for disposal.

$. ng' *;*

23 The exemption under which the jewelry was ' distributed (10 CFR 40.13(c)(2)).

should be reexamined in light 'of the ma'rginal benefit obtained from glaze materials containing uranium. This recommendation is in keeping with (1) the principle that exposures to radiation should 'be avoided,'if possible, unless there is a resulting benefit and (ii) ~ the NRC policy statement- (30 FR 3462) regarding the use of source and byproduct material in products intenced for use by the general public. ~

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. REFERENCES l ICRP, 1977 International Commission on Radiological Protection,

" Recommendations of the International Commission on Radiological i' Protection", ICRP Publication No. 26., 1977

UNSCEAR. - 1977 United Nations Scientific Committee on the Effects of Atomic Radiation",_" Sources and Effects of Ionizing Radiation", .

Report to the General Assembly,1977. -

NAS,1980 Committee on the Biological E,ffects of Ionizing Radi.ations, "The Effects on Populations of Exposure to Low Levels of Ionizing Radiation: 1980" National Academy Press, 1980.

Telex to Mr. Yu Sung, Director, Coordination Council for N. A. Affairs, Washington. 0.C., from Chen-Wa Cheng, Secretary General, AEC Taiwan, 1983.

Letter to Edmond R. Mansoon Imports, Los Angeles, CA, from Daniel Gollnick, Pacific Radiation' Corporation, Temple City, CA.1983.

4 I

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1 i

ENCLOSURE 7 e

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. N' U. S. ATOMIC ENERGY COM311SSION' . I I

sReprtnt frorn Federal Registern 30 F.R. 3460. March 16.1965 4

l l questionable and approval of auch a product tal ""be external radiation levels frorn the nlp Ultil(u gll )LI1Lnu l[3j{ g f pf]llpjQQ) g may result in widespread use of radioactive product.

uUltl:111991U n

'"**"** '"'h " '" ' * * " ""* '"'

P'**'**D *I 'h' P#* * "*

L USE OF BYPRODUCT MATERIAL AND Items, the degree of usefulness and beneht man tiuue during use.

SOURCE MATERIAL that accrues to the pub!!c may be a riccid. tes The area of tissue crimed. A dose ing factor. In particular, the Commluion to the skin of the whole tsody would be Products Inlended for Use 7 General considers that the use of rntlicactive ma- considered more signihcant than a similar 8

Public (Consumer Products) terial in toys. novelties, and adornments may dose to a small poruon of the skin of the be of marginal benent. body.

Crticrio for the approval of prodsets 4. Applications for approval of "off-the- id) Radiotoxicity of the f adionuc!! des.

inicaded for use by the pencral ;mblic shelf" Items that are subject to mishandling The less toxic materials with a high permis-c:ntrenana byproduct material and soerce especially by children will be approved only sible body burden, high concentration limit m terial. This notice arts forth the essenual if they are found to combine an unusual in air and water, would be considered more terms of the Commission's policy with re- degree of utility and safety. favorably than materials with a high radio-spect to approval of the use 01 byproduct 6. The Commission has approved certain toxicity, mitIrlal and source material in products in- long standing uses of source matertal most (e) The quantity of radioactive material tendId for use by the general public (con- of which antedate the atomic energy pro- per individual product. The amaller the quan.

sumer products) without the imposition of gram. These include: tity the more favorably would the product regulatory controls on the consumer-user. (1) Use of uranium to color glass and be considered.

This is accomplished by the exemption. on a glazes for certain decorative purposes: (f) Form of material. Materials with a case-by case basis, of the posseaston and use (2) Thorium in various alloys and prod- low solub111ty in body fluids w1!! be con-cf the approved items from the !! censing re- ucts (gas mantles, tungsten wire, melding sidered more favorably than those with a quirsments for byproduct and source ma- rods, optical lenses, etc.) to impart desirable high solubility, terid of the Atomic Energy Act of 1954, as physleal properues; and .

(g) Containment of the material. Products sminded, and of the Commission's regu:a- (3) Urantum and thorium in photographic which contain the material under very sev-tions "!icensing of Byproduct Material".10 Alm and prints. era environmental conditions will be con-CTR Part 30 and " Licensing of Source Ma- 6. The Commission has also approved the sidered more favorably than those that will trrill" 10 CFR Part 40. use of tritium as a substitute luminous ma- not contain the material under such condi-

1. At the present time it appears un!!kely terial for the long standing use of ndium tions, that the total contribution to the exposure for this purpose on watch and clock d!als th) Degree of access '.o product during cf the general public to radiation from the and hands. normal handling and use. Products which use of radioactivity in consumer products 7.The Commission has approved add!- are inaccessible to children and other per-vill exceed small fractions of limits recom- tional uses of byproduct and source material sons during use will be considered more minded for exposure to radiation from all in consumer products. These include the favorably than those that are acerssible, sources. Information as to total quantitles of following:

radioactive materists being used in such (1) Tritium in automobile lock illumi- ministrative (Sec.161, 68 Stat. 948: 42 U S.C. 22DI. Ad.

prtducts and the number of items being nators; Proredure Act, sec. 3. 60 Stat.

distributed will be obtained through record- (2) 'Iritium in balances of preetston: 238; $ U.S.C. 2002) kssping and reporting requirements applica- (3) Urantum as shielding in shipping con-Dated at Washington. D.C., this 8th day ble to Lhe manufacture and distribution of tainers: and such products. If radioactive materials are (4) Urantum in fire detection unita. of March 1965.

used in suff.clent quantitles in products 8. In approving uses of byproduct and rziching the public so as to raise any ques- source materials in consumer products, the For the Atomic Energy Commission.

tion of population exposure becerning a sig- Commission establishes limits on quantitles nincant fraction of the permissible dose or concentrations of radioactive materials W. B. McCooL.

Secretary.

to the gonads, the Commission will, at that and. If appropriate, on radiation emitted. In tune. teconsider its polley on the use of sorr.e cases other limitations, such as quality radioactive materials in consumer producta, control and testing, considered important to IF.It. Doc. 6 M 616: f iled, star. 13. 2983; health and safety are also spec 1 Sed. 8 45 a.m.)

2. Approval of a proposed consumer prod-uct will depend upon both associated ex.

posures of persons to radiation and the PnNcreatErattfArloN Cows:staarlows Wrru Rcseter to or PaoDUcts epparent usefulness of the product. In gen.

tral, rists of exposure to radiation w111 be 9. In evaluating proposals for the use of considered to be acceptable if it is shown radioacttre materials in consumer products that in handling, use and di:posal of the the principal considerations are:

product it is un!!Lely that individuals in (a) The potential external and internal th* population will recette more than a smtla exposure of individuals in the population to fraction. less than a few hundredths. of radiation from the handling, use and dis-Individual dose limits recommended by such posal of individual products; groups ha the International Commission on (b) The potential total accumulative radt-Radiological Protection (ICRP). the National ation dose to individuals in the population Counc11 on Radiation Protection and Meas- who may be exposed to radiation from a vrements (NCRPl. and the Federal Radia- number of products; tion Counell (TRC), and that the probability tc! The inng. term potential external and Ef indindual doses approaching any of the internal exposure of the generni population spreined limits la ner!!cibly small. Other. from the ur.rontrolled disposal and dispersal rise, a decision will be more di.*5 cult and into the environment of radioactive mate-will require a careful weghing of all factors. rials from prcduers authorir.ed by the Com. '

meluding beneSts that will accrue or be massion; and denied to the public as a result of the Com- (d) The benent that will accrue to or be mission's actior.. Tactors that may be perti- denied the public because of the ut1hty of nent are lis'ed in paragraphs 9 and 10. the product t y approval or disapproval of a below. spec 1Sc prnetuct.

3. It is considered that as a general rule 10. The general criteria for approval of products pMposed for distribution will be individual products are set forth in pars-useful to some degree. Normally the Commis- graph 2. nbove. Dein11cd evaluation of po-slon util not attempt an extenstre evaluatiJn tential expnaures would inke into considers-of the cegree of benent or usefulness of a tion the followmg factors together with other product to the pub!!c. However. In cases considerMtuns which may appent pertinent where targtble benents to the public are in the particular case

M

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-_ _ __ -__ _________________-_ - ____-_______ _ __-____ -

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