Consumer Product Policy Statement

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Proposed revision to policy statement; request for public comment.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC or Commission) is proposing to update its policy statement on products intended for use by the general public (consumer products). While the NRC is not making any significant changes to the policy, general updating is needed to reflect the approaches and terminology used in radiation protection that have evolved over time, as well as relevant legislation and regulatory actions.

DATES:

Submit comments by December 28, 2011. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

ADDRESSES:

Please include Docket ID NRC-2010-0292 in the subject line of your comments. For instructions on submitting comments and accessing documents related to this action, see Section I, “Submitting Comments and Accessing Information” in the SUPPLEMENTARY INFORMATION section of this document. You may submit comments by any one of the following methods:

• Federal rulemaking Web site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-2010-0292. Address questions about NRC dockets to Carol Gallagher, telephone: 301-492-3668, e-mail: Carol.Gallagher@nrc.gov.
• Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attn: Rulemakings and Adjudications Staff.
• E-mail comments to: Rulemaking.Comments@nrc.gov. If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at 301-415-1677.
• Hand-deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays (Telephone 301-415-1677).
• Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

FOR FURTHER INFORMATION CONTACT:

Shirley Xu, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-7640; e-mail: Shirley.Xu@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Submitting Comments and Accessing Information

Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov . Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed.

You can access publicly available documents related to this document using the following methods:

• NRC's Public Document Room (PDR): The public may examine and have copied, for a fee, publicly available documents at the NRC's PDR, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland.
• NRC's Agencywide Documents Access and Management System (ADAMS):

Publicly available documents created or received at the NRC are available online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html . From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR reference staff at 1-800-397-4209, or 301-415-4737, or by e-mail to PDR.Resource@nrc.gov.

• Federal Rulemaking Web Site: Public comments and supporting materials related to this proposed policy statement revision can be found at http://www.regulations.gov by searching on Docket ID NRC-2010-0292.

II. Background

On March 16, 1965 (30 FR 3462), the Atomic Energy Commission (AEC), the NRC's predecessor agency, issued its policy statement on products intended for use by the general public (consumer products). Under this policy, the AEC and then the NRC have periodically reevaluated the overall impact to the public of products allowed to be distributed for use by the general public, which are normally used under an exemption from licensing of the consumer-user and from all associated regulatory requirements. The AEC/NRC staff has reevaluated the policy at times and found it to serve the agency well in spite of the passage of considerable time. The policy is written in very general terms and, because of this, has not needed revision. However, the NRC is now proposing to update the policy to include approaches and terminology more consistent with the evolving approach to radiation protection, and to recognize relevant legislative and regulatory actions.

III. Discussion

The 1965 policy used terms consistent with the approach to radiation protection represented primarily in the early documents of the International Commission on Radiation Protection (ICRP). These include “permissible dose to the gonads” and “permissible body burden.” Newer approaches to radiation protection do not include such limits. The recommendations of the ICRP originally included control of dose to the gonads because of concern for potential genetic risks, i.e., risks to future generations. It has been determined that genetic risks are much lower than believed at the time; thus, separate limits for doses to the gonads are no longer used. Also, early approaches to radiation protection included limits on body burden, i.e., the amount of a radionuclide present in a person's body. In newer approaches for controlling cumulative exposure from radionuclides retained in the body, the calculated dose for the year of intake includes doses that will result in the future.

Additional updating is needed due to legislation that has been enacted since 1965. The Energy Reorganization Act of 1974 revised the Atomic Energy Act in a number of ways, primarily to separate the regulatory responsibilities from the AEC and to create the NRC. Relevant AEC policies, such as the subject policy, became NRC policies. Also in 1974, the Commission was given the authority to create exemptions from licensing for special nuclear material in addition to byproduct material and source material. The NRC has not issued any exemptions from licensing for products containing special nuclear material, but the revised policy would recognize the authority to do so.

Another relevant legislative action was the National Environmental Policy Act (NEPA) of 1969. In subparagraph 9(c), the policy addresses the consideration of potential impacts to the environment from the possible dispersion of radioactive material and the uncontrolled disposal of products used under exemption. This is the primary environmental impact to be considered in most instances of evaluating a potential exemption from licensing. Specific procedures for complying with NEPA have been developed, and are addressed in Title 10 of the Code of Federal Regulations (10 CFR) part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” Thus, any rulemaking to add an exemption from licensing requirements would require NRC documentation of environmental considerations in accordance with these procedures. In addition, the responsibilities of the Federal Radiation Council are now performed within the Environmental Protection Agency (EPA).

Since the issuance of the 1965 policy, the NRC has issued class exemptions, under which additional products belonging to an identified class of products can be approved through a licensing action, if an applicant to manufacture or distribute a product demonstrates that the product meets certain safety criteria. This approach to exemptions from licensing should also be recognized in the policy. Also, these safety criteria include more specific criteria for accidents than in the existing policy. The revised policy would better address the level of risks that are acceptable for accident and misuse scenarios. However, the guidance remains relatively general.

In addition, the example products noted in paragraphs 5 and 6 of the policy statement would be revised to be more relevant and up to date. For example, thoriated tungsten welding rods, while available to the public, are used in unique, expensive equipment and are not normally used by the public in the form of consumer products. Likewise, shipping containers constructed with uranium as shielding are not used by the public in the form of consumer products.

IV. Proposed Revised Statement of Policy

Products Intended for Use by General Public (Consumer Products)

Criteria for the approval of products containing radioactive material and intended for use by the general public.

This notice sets forth the essential terms of the Commission's policy with respect to approval of the use of byproduct material, source material, and special nuclear material in products intended for use by the general public (consumer products) without the imposition of regulatory controls on the consumer-user. This is accomplished by the exemption, on a case-by-case basis, of the possession and use of the approved items from the licensing requirements for byproduct, source, or special nuclear material of the Atomic Energy Act of 1954, as amended, and of the Commission's regulations in 10 CFR part 30, “Licensing of Byproduct Material,” 10 CFR part 40, “Licensing of Source Material,” or 10 CFR part 70, “Licensing of Special Nuclear Material.”

1. At the present time it appears unlikely that the total contribution to the exposure of the general public to radiation from the use of radioactivity in consumer products will exceed a fraction of limits recommended for exposure to radiation from all sources. Information as to total quantities of radioactive materials being used in such products and the number of items being distributed will be obtained through recordkeeping and reporting requirements applicable to the manufacture and distribution of such products. Periodically, the NRC staff conducts an overall reevaluation of this information to estimate the range of likely doses to the population. If radioactive materials are used in sufficient quantities in products reaching the public so as to raise any question of the combined exposure from multiple consumer products becoming a significant fraction of the permissible dose to the public, the Commission will, at that time, reconsider its policy on the use of radioactive materials in consumer products.

2. Approval of a proposed consumer product, and adding a new exemption from licensing provision to the regulations, depends upon both associated exposures of persons to radiation and the apparent usefulness of the product. In general, risks of exposure to radiation will be considered to be acceptable if it is shown that in handling, use, and disposal of the product, it is unlikely that individuals in the population will receive more than a small fraction, less than a few hundredths, of individual dose limits in NRC regulations and as recommended by such groups as the ICRP, the National Council on Radiation Protection and Measurements, and the EPA, and that the probability of individual doses exceeding any of the specified limits is low and the probability of individual doses approaching a level that could cause immediate effects is negligible. Otherwise, a decision will be more difficult and will require a careful weighing of all factors, including benefits that will accrue or be denied to the public as a result of the Commission's action. Factors that may be pertinent are listed in paragraphs 9 and 10, below.

3. Products proposed for distribution will be useful to some degree. Normally, the Commission will not attempt an extensive evaluation of the degree of benefit or usefulness of a product to the public. However, in cases where tangible benefits to the public are questionable and approval of such a product may result in widespread use of radioactive material, such as in common household items, the degree of usefulness and benefit that accrues to the public may be a deciding factor. In particular, the Commission considers that the use of radioactive material in toys, novelties, and adornments may be of marginal benefit.

4. Applications for approval of “off-the-shelf” items that are subject to mishandling, especially by children, will be approved only if they are found to combine an unusual degree of utility and safety.

5. The Commission has approved certain long-standing uses of source material, many of which antedate the atomic energy program. These include:

(a) Use of uranium to color glass for certain decorative purposes; and

(b) Thorium in various alloys and products (e.g., gas mantles, optical lenses, tungsten wire in such things as electric lamps and vacuum tubes) to impart desirable physical properties.

6. The Commission also approved the use of tritium as a substitute luminous material for the long-standing use of radium for this purpose on watch and clock dials and hands.

7. The Commission has approved additional uses of byproduct and source material in consumer products. These include the following:

(a) Tritium and other radionuclides in electron tubes;

(b) Americium-241 in smoke detectors; and

(c) Thorium and uranium in piezoelectric ceramic, which is used in many electronic products and other consumer products.

8. In approving uses of byproduct, source, or special nuclear material in consumer products, the Commission establishes limits on quantities or concentrations of radioactive materials and, if appropriate, on radiation emitted. In some cases, other limitations, such as quality control and testing, considered important to health and safety are also specified. In the case of class exemptions, specific safety criteria are included in the regulations, which require the applicant to evaluate many pathways of exposure of the public.

Principal Considerations With Respect to Evaluation of Products

9. In evaluating proposals for the use of radioactive materials in consumer products the principal considerations are:

(a) The potential external and internal exposure of individuals in the population to radiation from the handling, use and disposal of individual products;

(b) The potential total cumulative radiation dose to individuals in the population who may be exposed to radiation from a number of products;

(c) The long-term potential external and internal exposure of the general population from the uncontrolled disposal and dispersal into the environment of radioactive materials from products authorized by the Commission; and

(d) The benefit that will accrue to or be denied the public because of the utility of the product by approval or disapproval of a specific product.

10. The general criteria for approval of individual products are set forth in paragraph 2, above. Detailed evaluation of potential exposures would take into consideration the following factors, together with other considerations, which may appear pertinent in the particular case:

(a) The external radiation levels from the product.

(b) The proximity of the product to human tissue during use.

(c) The area of tissue exposed. A dose to the skin of the whole body would be considered more significant than a similar dose to a small portion of the skin of the body.

(d) Potential of the radionuclides to cause exposures from intakes. Materials that result in lower cumulative exposures when taken into the body would be considered more favorably than materials that result in higher exposures from intakes.

(e) The quantity of radioactive material per individual product. The smaller the quantity the more favorably would the product be considered.

(f) Form of material. Materials with a low solubility in body fluids and the environment will be considered more favorably than those with a high solubility.

(g) Containment of the material. Products which contain the material under very severe environmental conditions will be considered more favorably than those that will not contain the material under such conditions.

(h) Degree of access to product during normal handling and use. Products which are inaccessible to children and other persons during use will be considered more favorably than those that are accessible.