Regulations and Regulatory Issues

Introduction

Protection Philosophies

International Guidance

ICRP 60 / NCRP 116 and Dose

Federal Regulation of TENORM

U.S. Guidance

CRCPD Suggested State Regulations for Control of Radiation

States Regulation of TENORM

Pre-1978 Byproduct Material

HPS/ANSI Standard for NORM - Guide for Control and Release of NORM

Guidance Documents for TENORM

Recycling and Disposal of TENORM


Regulation, Control, and Management of TENORM


Introduction


In the past, NORM and TENORM has been defined by what is not more than by what it is. A similar quandary exists with regulations of NORM and TENORM. Many States believe NORM and TENORM are regulated under their general regulations on radiation, other States have specific regulations, mostly to address oil field wastes. Internationally, regulations for TENORM are being adopted in various levels. Several regulatory initiatives are being undertaken in the United States with respect to diffuse sources of TENORM.


Note: This section is pretty outdated. It is under revision, but may take some time to get it caught up. For informational purposes only, check with your local regulatory authority!


The Health Physics Society / American National Standards Institute (ANSI) (HPS 2009) have issued Standard N13.53, Control and Release of Technologically Enhanced Naturally Radioactive Material.   The Conference of Radiation Control Program Directors (CRCPD) developed suggested regulations for States to use when developing their rules (CRCPD 2004). The new CRCPD Standard was approved by the CRCPD in 2004. (CRCPD 2004). 

The Environmental Protection Agency (EPA) had proposed changes to the RPG (EPA 1994), which would impact TENORM regulations. The proposed RPG would have adopted the recommendations of ICRP 60 (ICRP 1990), and would recommend regulation of sources as well as limits to individuals. However, after going nowhere for six years because of partisan wrangling at the behest of numerous lobbies, the proposed rule was withdrawn, and a new effort has begun to re-craft a new proposed RPG. The USNRC has a policy on alternate feedstocks and disposal of waste in 11 (e)2 uranium mill tailings disposal sites (USNRC 1995). The NRC also promulgated a final rule for license termination at uranium recovery facilities (FR June 11, 1999).

Canada is considering adopting regulations for handling of NORM based on a previous Canadian guidance document (WCNC 1995). It uses a graded approach to the amount of protection workers would need based on expected exposure (FPTRPC 1999).

Initiatives are also being undertaken in Europe to harmonize its regulations for radioactive materials (including NORM) as part of the European Commission efforts (EURATOM 1996). EU countries were supposed to adopt the basic recommendations as of May 2000 in their respective countries' regulations. The EU recommendations are risk-based, and use ICRP 60 as their basis.

There is concern about the risks of low level radiation growing from all sides of the issue. Industry and professional organizations are openly challenging the validity of the Linear No Threshold Hypothesis (LNT) as being too conservative and costly. Others are pointing to data showing that one alpha particle can cause cancer, and thus radioactive materials and radiation need to be regulated more vigorously than ever.

This is a serious issue. There are implications for everyone. If low levels of radiation turn out to have a threshold below where there really is no risk to speak of, then laws may be loosened. Governments and business are already trying to figure out what to do with millions of tons of radioactive scrap metal left over from the Cold War and from the decommissioning of nuclear power plants that is now underway, as well as TENORM-contaminated scrap metal from industries like oil and gas drilling and refining. Mining companies all over the world generate billions of tons a year of tailings that are often contaminated with TENORM. Some of these tailings are regulated already for their heavy metal content, or for the chemical residues left over from processing the ores. Mine tailings disposal is a huge and costly problem. Industry representatives make up a large portion of the task forces and committees that are drafting these regulations.

If low levels of radiation actually are proven to be carcinogenic, or have mutagenic, teratogenic, or some other detrimental effects, then current regulatory efforts may fall short of protecting the public and workers.

There is growing concern from the environmental community and the public in general that these regulations will not be protective of human health and the environment, but rather:


Numerous national and international bodies provide recommendations on radiation protection, some of which have no regulatory authority, but their recommendations often serve as the basis for many of the regulations on radiation protection adopted by regulatory bodies. Federal and State agencies are tasked with passing laws and implementing regulations based on the recommendations of the advisory organizations, industry, and the public. The following sections address the regulatory aspects of TENORM from a Federal, State and International level. There is a section on the major documents that are used as a basis for the proposed regulations, and a discussion of the current regulatory efforts.


Protection Philosophies


The underlying philosophies of radiation protection and definition of dose have evolved over time:

Early protection philosophies were based on individual protection from acute doses (such as the tolerance dose), after nuclear weapons testing and civilian power reactors were built, protection philosophies were expanded to encompass chronic exposures to populations (collective dose) notably with respect to genetic doses. Finally, regulations addressing sources of radiation were promulgated to mitigate doses to receptors (such as the NESHAPS). As these concepts expanded and more "stuff" came under control, it was put forth that some practices and small amounts/volumes of radioactivity or radiation could be excluded from regulation. Thus, the exemption and clearance issues came into being.


Exclusion

Exclusion covers activity sources not amenable to control, such as 40K in the human body, cosmic radiation, etc. It has been used interchangeably with exemption, but there are differences. Items or practices that are excluded from control never enter the regulatory arena, they are not examined and then determined to be exempted.

 

Exemption

Exemption had earlier been used to denote all radioactive material placed outside regulatory control because of the low risk they give rise to and because control would be a waste of resources. Later this term has been restricted to cover radioactive sources which never enter the regulatory regime, typically small sources such as tracers used in research, calibration tracers, and some consumer products containing small sources or low levels of activity per unit mass. Exemption can be carried out for entire practices or for sources within a practice. It is always linked to specific regulatory controls. The exemption may be from all of these controls or only some of them, and may have conditions attached.

 

Clearance

Clearance can be carried out for materials which, by their nature or location or both, have been subject to regulatory controls. In its most general form (unconditional clearance) it allows the unrestricted disposal, re-use or recycling of material, with no further control once the material leaves the originating facility or practice being regulated.

 

Practice

Any human activity that introduces additional sources of exposure or exposure pathways or extends exposure to additional people or modifies the network of exposure pathways from existing sources, so as to increase the exposure or the likelihood of exposure of people or the number of people exposed. Another definition is: a human activity that can increase the exposure of individuals to radiation from an artificial source, or from natural source where natural radionuclides are processed for their radioactive, fissile or fertile properties, except in the case of an emergency exposure.



The radiation protection principles for practices are:

The concept of intervention (distinct from other practices) is based on general principles of:


International Guidance

Check out Nick Tsurikov's extensive Listing of International Regulations

ICRP 60

The International Commission on Radiation Protection (ICRP) is an association of scientists from many countries, including the U.S. that develops recommendations on all aspects of radiation protection. It is an advisory organization with no regulatory authority, but its recommendations greatly influence the development of standards around the world. The primary document outlining the system of radiation protection being adopted world-wide is ICRP Publication 60 (ICRP 1990). This document outlines the system to regulation of sources as well as individuals. It is based on general principles with respect to practices: justification, optimization of protection, and limitation (individual dose limits). The concept of intervention (distinct from other practices) is based on general principles that: the intervention should do more good than harm; and the form, scale, and duration of the intervention should be optimized. For the public, an annual limit on effective dose of 1 mSv (100 mrem), with a subsidiary limit in some years, provided the average over five years does not exceed 5 mSv (500 mrem). It also recommends treatment of potential exposures, e.g., practices which may lead to interventions.


ICRP 65 addresses indoor radon, both for the public and in occupational settings, and gives recommendations for practices and interventions (ICRP 1994). Buckley, et.al., (Buckley 1997) identifies provisions ICRP 60 has that are of particular relevance to current initiatives in the U.S. and for the EU countries:


IAEA

The International Atomic Energy Agency (IAEA) published standards based on the recommendations of the ICRP and other organizations. The Euratom treaty of 1957 prescribes that uniform basic safety standards (BSS) shall be prescribed. The first Directive was issued in 1959, and was revised over the years. The current revision to the Basic Safety Series was issued as Principles for Exemption of Radiation Sources and Practices from Radiological Control, Safety Series 89 (IAEA 1988). A draft revision, International basic safety standards for protection against ionising radiation and the safety of radiation sources was published in 1994. It introduces the distinction between practices and intervention and the concepts of dose constraint and potential exposure.

There are two basic criteria that can determine whether or not a practice can be a candidate for exemption from the BSS:

The guide states that an individual effective dose of 10 - 100 µSv (1 to 10 mrem) per year would result in insignificant risks. Based on the possibility of multiple exposure from several exempted practices, the guidance recommends an annual de minimis dose of 10 µSv (1 mrem). The proposed HPS/ANSI 13.12 recommendations have some similarities to the Safety Series 89 limits. The EC issued a similar council directive in 1996. Current revisions to the EC BSS were due by May 2000. Additional BSS documents have been published that give measurable quantities to the dose limits in Safety Series 89 (IAEA 1992).

European Commission

The Draft Euratom Basic Ssafety Standards Directive,Version 24 February, 2010 affect TENORM in the EU.
The draft is not complete; not all limits and values have been set. Many carry forward from the 1996 draft discussed below.
Supporting guidance will be developed based on the latest BSS. It is up to the individual Countries to adopt the standards into their statutes and regulations.
"The subject matter and general purpose of this Directive is the health protection of the public, patients and workers against the dangers of ionising radiation; this Directive also applies to the protection of the environment as a pathway from environmental sources to the exposure of man, complemented where appropriate with specific consideration of the exposure of biota in the environment as a whole; in addition to the general purpose of health and environmental protection this Directive also aims at ensuring adequate control of the safety and security of sources and the provision of appropriate information in an emergency exposure situation." ... "It shall apply to any planned, existing or emergency exposure situation which involves a risk from exposure to ionising radiation which cannot be disregarded from the radiation protection point of view with regard to the health protection of workers, members of the public, or patients and other individuals subject to medical exposure or with regard to the protection of the environment.
This Directive shall apply to all planned exposure situations involving radiation sources,namely:
(a) the production, processing, handling, use, storage, holding, transport, shipment, import to, and export from the Community and the disposal of radioactive material;
(b) the operation of electrical equipment emitting ionising radiation;
(c) exposure situations which involve the presence of natural radiation sources that lead to a significant increase in the exposure of workers or members of the public, in particular:
(i) the operation of aircraft and spacecraft
(ii) exposure to radon in workplaces
(iii) the activities in industries processing materials with naturally occurring radionuclides, or activities related to such processing,
(d) any other activity specified by the Member State.
4. This Directive applies to existing exposure situations other than those involving exposures excluded under Article 3; it applies in particular to the exposure of the public to indoor radon and to external exposure from building materials; cases of lasting exposure resulting from the after-effects of an emergency or a past activity shall be dealt with as an existing exposure situation.

The draft replaces the 1996 draft (Euratom 1996 ). The document is entitled "Council Directive 96/29Euratom (OJ L159 29th June 1996)" which are just called the "Basic Standards Directive". It is similar in many ways to the IAEA BSS. The EC BSS list of exemption values covers only practices (Menem 1998).

Note emphasis on building materials, indoor radon, and specific call out of NORM. This is not seen in US regulations.


List of industrial sectors involving naturally occurring radioactive material When applying Article 50 the following list of industrial sectors involving naturally occurring radioactive material, including relevant secondary processes, shall be taken into account:



Annex 14 Indicative list of types of building materials considered for control measures with regard to their emitted gamma radiation
1. Natural materials
2. Materials incorporating residues from industries processing naturally occurring radioactive material, such as:

The 1996 Directive:

The Directive provides the following exposure limits:

Table 5. EC Clearance levels

 Radionuclide  Quantity  Concentration
 40K  106 Bq (27 mCi)  100 Bq/g (2.7 nCi/g)
 226Ra and progeny  10,000 Bq (270 nCi)  10 Bq/g (270 pCi/g)
232Th (secular equilibrium) 1,000 Bq (27 nCi) 1 Bq/g (27 pCi/g)
238U (secular equilibrium) 1,000 Bq (27 nCi) 1 Bq/g (27 pCi/g)

There is concern about the clearance levels, and exemption levels among the EC members.

TITLE VII Significant Increase In Exposure Due To Natural Radiation Sources. This section addresses occupational exposure to NORM:

This section is the subject of much debate, and may be the basis for guidance or regulation in the US someday. This section is one of the reasons that the EU countries are slow to adopt the BSS.

Work Activities:

"… within which the presence of natural radiation sources leads to a significant increase in the exposure of workers or of members of the public which cannot be disregarded from the radiation protection point of view."

 

It requires each Member State shall ensure the identification…of work activities which may be of concern. These include, in particular:

 

The sections addressing protection from exposure from terrestrial natural radiation sources and protection of air crews shall apply to the extent that the Member States have declared that exposure to natural radiation sources due to work activities identified in accordance with paragraph 2 [the first two bullets under "Work Activities]" of this Article needed attention and had to be subject to control.

Protection against exposure from terrestrial natural radiation sources:

Protection of Air Crew:

Each Member State shall make arrangements for undertakings operating aircraft to take account of exposure to cosmic radiation of air crew who are liable to be subject to exposure to more than 1 mSv per year. The undertakings shall take appropriate measures, in particular: