Ala. Admin. Code r. 420-3-26-.13
2. Any request to appeal an order, determination, or denial shall be filed within 30 days of receiving written notice of such order, determination or denial. Such request should be addressed to:
State Health Officer
Alabama Department of Public Health
Montgomery, Alabama 36130-1701
All appeals should:
(a) A major continuing goal of the Agency is to assure that ionizing radiation source facilities are constructed and operated with the necessary degree of safety and reliability. Similarly, it is the responsibility of the Agency to assure a corresponding degree of management controls and safety in the licensed materials processes and programs.
The nuclear industry generally recognizes the necessity for improvements in safety as well as the economic advantages that are derived by extending the management techniques and philosophy of safety to the operations of plants and processes. It is essential that all registrants and licensees meet these high standards.
While broad sanctions are available to the Agency in the event they are necessary, the objectives of safety and reliability should generally be achievable through augmented internal management programs.
Results of Agency inspections and investigations of licensed activities have shown that registrants and licensees have not in all cases complied with regulatory requirements and it has been necessary to take specific enforcement actions commensurate with the violations. This document sets out the criteria for enforcement actions to be taken with respect to future violations of license conditions relating to health and safety, in accordance with the Alabama Regulations for Control of Radiation and Act 582, Regular Session 1963, Title 22, Chapter 14, Code of Ala. 1975, as amended.
The enforcement actions available to the Agency in the exercise of its regulatory responsibilities may be divided into the following four basic types which are applicable to specific enforcement situations:
1. Noncompliance Letters.
This is a letter describing the proposed violations and request to reply within usually thirty (30) days. In his reply, the registrant or licensee may:
2. Written Notices of Violations.
Enforcement actions may be written notices to registrants or licensees, citing the proposed violations observed during investigations, inspections, or inquiries. This is a formal notice and requires at least a written response.
3. Civil Penalties.
The Agency has authority to assess a civil penalty of radioactive material licensees in cases where the noncompliance is serious or repeated. Appendix A details how and when the civil penalties are determined and how they may be reduced.
4. Orders to Cease and Desist; and Orders for Suspension, Modification or Revocation of a License or to Suspend the Activities of a Registrant.
The Agency has authority to issue orders to "cease and desist," and orders to suspend, modify, or revoke licenses. Such orders are preceded by certain procedural requirements including a written notice of violation to the licensee or registrant providing him with an opportunity to respond as to the corrective measures being taken. In the event the licensee or registrant fails to respond to the notice or to demonstrate that satisfactory corrective action is being taken, an order to show cause may be issued requiring the licensee or registrant to show why the particular order (either of revocation, or modification or suspension) should not be made effective. In those instances where the health, safety, or interest of employees to the public so requires or willful violation of the agency's rules is involved, the notice provision may be dispensed with and, in addition, the particular order may be made immediately effective pending further order. In addition to proceeding by way of order, the Agency may also, pursuant to §22-14-12, request the Attorney General to obtain an injunction or other court order to enjoin licensees or registrants from violating the Act or any rules or order issued thereunder.
APPENDIX A
GENERAL STATEMENT OF POLICY AND PROCEDURE FOR
ENFORCEMENT ACTIONS
The following statement of general policy and procedure explains the enforcement policy and procedures of the Agency and its staff in initiating enforcement actions. This statement is applicable to enforcement in matters involving the public health and safety, and the environment.
(d) Encouraging improvement of licensee or registrant and by example, that of industry, including the prompt identification and reporting of potential safety problems.
Consistent with the purpose of this program, prompt and vigorous enforcement action will be taken when dealing with licensees or registrants who do not achieve the necessary meticulous attention to detail and the high standard of compliance which the Agency expects. Each enforcement action is dependent on the circumstances of the case and requires the exercise of discretion after consideration of these policies and procedures. In no case, however, will licensees or registrants who cannot achieve and maintain adequate levels of protection be permitted to conduct licensed or registered activities.
(2) Procedural Framework. Rule 420-3-26-.13 of these rules sets forth the procedures the Agency uses in exercising its enforcement authority. This rule sets forth the procedures for issuing notices of violation.
The procedure to be used in assessing civil penalties is set forth in 420-3-26-.13(2). This rule provides that the Agency Director or Radiation Control Division Director initiates the civil penalty process by issuing a notice of violation and proposed imposition of a civil penalty. The licensee is provided an opportunity to contest in writing, the proposed imposition of a civil penalty. After evaluation of the licensee's response, the Director may mitigate, remit, or impose the civil penalty. An opportunity is provided for a hearing if a civil penalty is imposed.
The procedure for issuing an order to show cause why a license should not be modified, suspended, or revoked or why such other action should not be taken is set forth in Rule 420-3-26-.13. The mechanism for modifying a license or registration by order is set forth in the same rule. These sections provide an opportunity for a hearing to the affected licensee. However, the Agency is authorized to make orders immediately effective if the public health, safety or interest so requires.
(3) Severity of Violation. Regulatory requirements31 have varying degrees of safety, safeguards, or environmental significance. Therefore, the relative importance of each violation must be identified as the first step in the enforcement process.
Consequently, violations are categorized in terms of five levels of severity to show their relative importance within each of the following five activity areas:
(e) Emergency Preparedness.
Licensed or registered activities not directly covered by one of the above listed areas, e.g., reciprocity license or
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31 The term “requirement” as used in this Appendix means a legally binding requirement such as a statute, rule, regulation, license condition, technical specification, or order.
registered activities, will be placed in the activity area most suitable in light of the particular violation involved. Within each activity area, Severity Level I has been assigned to violations that are the most significant and Severity Level V violations are the least significant. Severity Level I and II violations are of very significant regulatory concern. In general, violations that are included in these severity categories involve actual or high potential impact on the public or an individual. Severity Level III violations are cause for significant concern. Severity Level IV violations are less serious but are of more than minor concern; i.e., if left uncorrected, they could lead to a more serious concern. Severity Level V violations are of minor safety or environmental concern.
Comparisons of significance between activity areas are inappropriate. For example, the immediacy of any hazard to the public associated with Severity Level I violations in nuclear medicine is not directly comparable to that associated with Severity Level I violations in industrial radiography.
While examples are provided in Supplements I through V for determining the appropriate severity level for violations in each of the five activity areas, the examples are neither exhaustive nor controlling. These examples do not create new requirements. Each is designed to illustrate the significance which the Agency places on a particular type of violations of Agency requirements. Each of the examples in the supplements is predicated on a violation of a regulatory requirement.
In each case, the severity of a violation will be characterized at the level best suited to the significance of the particular violation. In some cases, violations may be evaluated in the aggregate and a single severity level assigned for a group of violations.
The severity level of a violation may be increased if the circumstances surrounding the matter involve careless disregard of requirements, deception, or other indications of willfulness. The term "willfulness" as used here embraces a spectrum of violations ranging from deliberate intent to violate or falsify, to and including careless disregard for requirements. Willfulness does not include acts which do not rise to the level of careless disregard, i.e., inadvertent clerical errors in a document submitted to the Agency. In determining the specific severity level of a violation involving willfulness, consideration will be given to such factors as the position of the person involved in the violation (e.g., first-line supervisor or senior manager), the significance of any underlying violation, the intent of the violator (i.e., negligence not amounting to careless disregard, careless disregard, or deliberateness), and the economic advantage, if any, gained as a result of the violation. The relative weight given to each of these factors in arriving at the appropriate severity level will be dependent on the circumstances of the violation.
The Agency expects licensees or registrants to provide full, complete, timely, and accurate information and reports. Accordingly, unless otherwise categorized in the Supplements, the severity level of a violation involving the failure to make a required report to the Agency will be based upon the significance of and the circumstances surrounding the matter that should have been reported. A licensee or registrant will not normally be cited for a failure to report a condition or event unless the licensee or registrant was actually aware of the condition or event which it failed to report. However, the severity level of an untimely report, in contrast to no report, may be reduced depending on the circumstances surrounding the matter.
3. obtain other information which will help determine the appropriate enforcement action.
In addition, during the enforcement conference, the licensee or registrant will be given an opportunity to explain to the Agency what corrective actions (if any) were taken or will be taken following discovery of the potential violation or nonconformance. Licensees or registrants will be told when a meeting is an enforcement conference. Enforcement conferences will not normally be announced to the public.
When needed to protect the public health and safety, escalated enforcement action, such as the issuance of an immediately effective order modifying, suspending, terminating, or revoking a license or registration, will be taken prior to the enforcement conference. In such cases, an enforcement conference may be held after the escalated enforcement action is taken.
3. the date when full compliance will be achieved.
The Agency may require responses to notices of violation to be under oath. Normally, responses under oath will be required only in connection with civil penalties and orders.
The Agency uses the notice of violation as the standard method for formalizing the existence of a violation. A notice of violation is normally the only enforcement action taken, except in cases where the criteria for civil penalties and orders, as set forth in Sections (5)(b) and (5)(c) respectively, are met. In such cases, the notice of violation will be issued in conjunction with the elevated actions.
Licensees or registrants are not ordinarily cited for violations resulting from matters not within their control, such as equipment failures that were not avoidable by reasonable licensee or registrant quality assurance measures or management controls. Generally, however, licensees or registrants are held responsible for the acts of their employees. Accordingly, this policy should not be construed to excuse personnel errors.
2. any requirement for which a license may be revoked.
Civil penalties are designed to emphasize the need for lasting remedial action and to deter future violations.
Civil penalties are imposed absent mitigating circumstances for Severity Level I and II violations, are considered for Severity Level III violations, and may be imposed for Severity Level IV violations that are similar
321 to previous violations for which the licensee failed to take effective corrective action.
In applying this guidance for Severity Level IV violations, the Agency normally considers civil penalties only for similar Severity Level IV violations that occur after the date of the last inspection or within two years, whichever period is greater.
Civil penalties will normally be assessed for any willful violation of any Agency requirement including those at any severity level.
The Agency imposes different levels of penalties for different severity level violations and different classes of licensees. Tables 1A and 1B show the base civil penalties for various fuel cycle, and materials programs. The structure of these tables generally takes into account the gravity of the violation as a primary consideration and the ability to pay as a secondary consideration. Generally, operations involving greater potential consequences to the public and licensee employees receive higher civil penalties. Regarding the secondary factor of ability of various classes of licensees to pay the civil penalties, it is not the Agency's intention that the economic impact of a civil penalty be such that it puts a licensee out of business (orders, rather than civil penalties, are used when the intent is to terminate licensed activities) or adversely affects a licensee's ability to safely conduct licensed activities. The deterrent effect of civil penalties is best served when the amounts of such penalties take into account a licensee's "ability to pay." In determining the amounts of civil penalties for licensees for whom the tables do not reflect the ability to pay, the Agency will consider as necessary an increase or decrease on a case-by-case basis.
The Agency attaches great importance to comprehensive licensee programs for detection, correction, and reporting of problems that may constitute, or lead to, violation of regulatory requirements. This is emphasized by giving credit for effective licensee audit programs when licensees find, correct, and report problems expeditiously and effectively. To encourage licensee self-identification and correction of
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32 The word “similar” as used in this Rule, refers to those violations which could have been reasonably expected to have been prevented by the licensee’s corrective action.
violations and to avoid potential concealment of problems of safety significance, application of the adjustment factors set forth below may result in no civil penalty being assessed for violations which are identified, reported (if required), and effectively corrected by the licensee.
On the other hand, ineffective licensee programs for problem identification or correction are unacceptable. In cases involving willfulness, flagrant Agency identified violations, repeated poor performance in an area of concern, or serious breakdown in management controls, the Agency intends to apply its full enforcement authority where such action is warranted, including issuing appropriate orders and assessing civil penalties for continuing violations on a per day basis, up to the statutory limit of $10,000331 per violation, per day. In this regard, while management involvement, direct or indirect, in a violation may lead to an increase in the civil penalty, the lack of such involvement may not be used to mitigate a civil penalty.
Allowance of mitigation could encourage lack of management involvement in licensed activities and a decrease in protection of the public health and safety.
The Agency reviews each proposed civil penalty case on its own merits and adjusts the base civil penalty values upward or downward appropriately. Tables 1A and 1B identify the base civil penalty values for different severity levels, activity areas, and classes of licensees. After considering all relevant circumstances adjustments to these values may be made for the factors described in the following table.
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33 $1,000 for qualifying small businesses and nonprofit entities.
TABLE 1A. - BASE CIVIL PENALTIES1
| Plant | Transportation | ||
| operations const., health | Greater | Type A | |
| physics and | than type A | quantity or | |
| EP | quantity2 | less3 | |
| a. Industrial | $10,000 | $10,000 | $5,000 |
| Processors4 b. Mills & | 10,000 | 5,000 | 2,000 |
| Uranium Conversion Facilities c. Industrial | 10,000 | 5,000 | 2,000 |
| Users of Material5 d. Waste Disposal | 10,000 | 5,000 | 2,000 |
| Licensees e. Academic or | 5,000 | 2,500 | 1,000 |
| Medical Institutions f. Other Material Licensees | 1,000 | 2,500 | 1,000 |
1. Prompt Identification and Reporting. Reduction of up to 50% of the base civil penalty may be given when a licensee identifies the violation and promptly reports the
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1 For qualifying small businesses and nonprofit entities use one-tenth the values listed in the table. Civil penalties only apply to radioactive material licensees.
2 Includes high level waste, unirradiated fissile material, and any other quantities requiring Type B packaging.
3 Includes low specific activity waste (LSA), low level waste, Type A packages, and excepted quantities and articles.
4 Large firms engaged in manufacturing or distribution of byproduct, source, or special nuclear material.
5 Includes industrial radiographers, nuclear pharmacies, and other industrial users.
violation to the Agency. In weighing this factor, consideration will be given to, among other things, the length of time the violation existed prior to discovery, the opportunity available to discover the violation, the ease of discovery and the promptness and completeness of any required report. No consideration will be given to this factor if the licensee does not take immediate action to correct the problem upon discovery.
2. Corrective Action to Prevent Recurrence.
Recognizing that corrective action is always required to meet regulatory requirements, the promptness and extent to which the licensee takes corrective action, including actions to prevent recurrence, may be considered in modifying the civil penalty to be assessed. Unusually prompt and extensive corrective action may result in reducing the proposed civil penalty as much as 50% of the base value shown in Table 1. On the other hand, the civil penalty may be increased as much as 50% of the base value if initiation of corrective action is not prompt or if the corrective action is only minimally acceptable. In weighing this factor, consideration will be given to, among other things, the timeliness of the corrective action, degree of licensee initiative, and comprehensiveness of the corrective action--such as whether the action is focused narrowly to the specific violation or broadly to the general area of concern.
3. Past Performance. Reduction by as much as 100% of the base civil penalty shown in Table 1 may be given for prior good performance in the general area of concern. On the other hand, the base civil penalty may be increased as much as 100% for prior poor performance in the general area of concern.
In weighing this factor, consideration will be given to, among other things, the effectiveness of previous corrective action for similar problems, overall performance such as prior enforcement history including Severity Level IV and V violations in the area of concern. For example, failure to implement previous corrective action for prior similar problems may result in an increase in the civil penalty.
5. Multiple Occurrences. The base civil penalty may be increased as much as 50% where multiple examples of a particular violation are identified during the inspection period.
The above factors are additive. However, in no instance will a civil penalty for any one violation exceed $10,000 per day.
The duration of a violation may also be considered in assessing a civil penalty. A greater civil penalty may be imposed if a violation continues for more than a day. For example:
(iii) Alternatively, whether or not a licensee is aware or should have been aware of a violation that continues for more than one day, the civil penalty imposed for one violation may be increased to reflect the added significance resulting from the duration of the violation.
The Tables and the mitigating factors determine the civil penalties which may be assessed for each violation. However, the focus is on the fundamental underlying causes of a problem for which enforcement action appears to be warranted, the cumulative total for all violations which contributed to or were unavoidable consequences of that problem may be based on the amount shown in the table for a problem of that Severity Level, as adjusted. If an evaluation of such multiple violations shows that more than one fundamental problem is involved, each of which, if viewed independently, could lead to civil penalty action by itself, then separate civil penalties may be assessed for each such fundamental problem. In addition, the failure to make a required report of an event requiring such reporting is considered a separate problem and will normally be assessed a separate civil penalty, if the licensee is aware of the matter that should have been reported.
TABLE 1B. - BASE CIVIL PENALTIES Applies only to Radioactive Material Licensees
| Base civil penalty amount | |
| (percent of amount listed | |
| Severity Level | in Table 1A) |
| I | 100 |
| II | 80 |
| III | 50 |
| IV | 15 |
| V | 5 |
(v) For any reason not mentioned above for which license revocation or registration termination is legally authorized.
Suspensions may apply to all or part of the licensed or registered activity. Ordinarily, a licensed or registered activity is not suspended (nor is a suspension prolonged) for failure to comply with requirements where such failure is not willful and adequate corrective action has been taken.
4. Cease and Desist Orders are typically used to stop an unauthorized activity that has continued after notification by the Agency that such activity is unauthorized.
Orders are made effective immediately, without prior opportunity for hearing, whenever it is determined that the public health, interest, or safety so requires, or when the order is responding to a violation involving willfulness. Otherwise, a prior opportunity for a hearing on the order is afforded. For cases in which the Agency believes a basis could reasonably exist for not taking the action as proposed, the licensee or registrant will ordinarily be afforded an opportunity to show cause why the order should not be issued in the proposed manner.
(d) Escalation of Enforcement Sanctions. The Agency considers violations of Severity Levels I, II, or III to be serious. If serious violations occur, the Agency will, where necessary, issue orders in conjunction with civil penalties to achieve immediate corrective actions and to deter further recurrence of serious violations. The Agency carefully considers the circumstances of each case in selecting and applying the sanction(s) appropriate to the case in accordance with the criteria described in Sections (5)(b) and (5)(c) above.
Examples or enforcement actions that could be taken for similar Severity Level I, II, or III violations are set forth in Table 2. The actual progression to be used in a particular case will depend on the circumstances. However, enforcement sanctions will normally escalate for recurring similar violations.
Normally the progression of enforcement actions for similar violations will be based on violations under a single license or registration. When more than one facility is covered by a single license or registration, the normal progression will be based on similar violations at an individual facility and not on similar violations under the same license. However, it should be noted that under some circumstances, e.g., where there is common control over some facet of facility operations, similar violations may be charged even though the second violation occurred at a different facility or under a different license or registration. For example, a survey violation at Unit 2 of a multiunit plant that repeats an earlier violation at Unit 1 might be considered similar.
TABLE 2. - EXAMPLES OF PROGRESSION OF ESCALATED ENFORCEMENT ACTIONS FOR SIMILAR VIOLATIONS IN THE SAME ACTIVITY AREA
UNDER THE SAME LICENSE OR REGISTRATIONa
| Number of similar violations | ||
| from the date of the last | ||
| inspection or within the | ||
| Severity | previous two years | |
| violation | (whichever period is greater) | |
| 1st | 2nd 3rd | |
| I | (a + b) | (a + b + c) (d) |
| II | (a) | (a + b) (a + b + c) |
| III | (a) (a + b) |
(e) Enforcement Actions Involving Individuals.
Enforcement actions involving individuals, including licensed users or physicians or registered users, are significant personnel actions, which will be closely controlled and judiciously applied. An enforcement action will normally be taken only when there is little doubt that the individual fully understood, or should have understood, his or her responsibility: knew, or should have known, the required actions: and knowingly, or with careless disregard (i.e., with more than mere negligence), failed to take required actions which have actual or potential safety significance. Most transgressions of individuals at the level of Severity Level III, IV or V violations will be handled by citing only the facility licensee or registrant.
More serious violations, including those involving the integrity of an individual (e.g., lying to the Agency), concerning matters within the scope of the individual's responsibilities, will be considered for enforcement action against the individual. Action against the individual, however, will not be taken if the improper action by the individual was
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a Civil penalty, applies only to radioactive material licensees.
b Suspension of affected operations until the Radiological Health Branch Director is satisfied that there is reasonable assurance that the licensee or registrant can operate in compliance with the applicable requirements; or modification of the license or registration, as appropriate.
c Show cause for modification or revocation of the license or registration, as appropriate.
d Further action, as appropriate.
caused by management failures. The following examples of situations illustrate this concept:
5. Violations resulting from inadequate procedures unless the individual used a faulty procedure knowing it was faulty and had not attempted to get the procedure corrected.
Examples of situations which could result in enforcement actions against individuals include, but are not limited to, violations which involve:
9. Willfully withholding safety significant information rather than making such information known to appropriate supervisory or technical personnel.
Any proposed enforcement action against individuals must be done by the Radiation Control Division Director. The opportunity for an Enforcement Conference with the individual will usually be provided.
Examples of sanctions that may be appropriate against Agency licensed or registered operators are:
3. Suspension for a specified period, modification, or revocation of the license or registration authorization.
The sanctions are listed in escalating order of significance.34 The particular sanction to be used should be determined on a case-by-case basis.
In the case of an unlicensed individual, an Order modifying the facility license to require the removal of the individual from all radioactive material related activities for a specified period of time or indefinitely may be appropriate.
(f) Reopening Closed Enforcement Actions. If significant new information is received or obtained by the
Agency which indicates that an enforcement sanction was incorrectly applied, consideration may be given, dependent on the circumstances, to reopening a closed enforcement action to increase or decrease the severity of a sanction or to correct the record. Reopening decisions will be made on a case-by-case
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34 Except for individuals subject to civil penalties because they are person as defined by Section 22-14 et seq., Code of Ala. 1975, as amended, and are licensed as the named licensee on the licensing document.
basis, are expected to occur rarely, and require the specific approval of the Radiation Control Division Director.
1. Because the Agency wants to encourage and support licensee or registrant initiative for self-identification and correction of problems, the Agency will not generally issue a notice of violation for a violation that meets all of the following criteria:
2. The Agency may also refrain from issuing a Notice of Violation or a proposed civil penalty for violations that meet all of the following criteria:
(i)(I) The Agency has taken significant enforcement action based upon a major safety event contributing to an extended shutdown of a licensee's or registrant's operations or the licensee or registrant is forced into an extended shutdown or work stoppage related to generally poor performance over a long period;
(iv) The non-willful violations would normally not be categorized as higher than Severity Level III violations under the Agency's Enforcement Policy.
Notwithstanding the above, a civil penalty may be proposed in a case where multiple Severity Level III violations are discovered. This action would be taken when judgment warrants it on the circumstances of the individual case.
(h) Related Administrative Actions. In addition to the formal enforcement mechanisms of notices of violation, civil penalties, and orders, the Agency also uses administrative mechanisms, such as bulletins, information notices, generic letters, notices of deviation, notices of nonconformance and confirmatory action letters to supplement its enforcement program. The Agency expects licenses to adhere to any obligations and commitments resulting from these processes and will not hesitate to issue appropriate orders to licensees or registrants to make sure that such commitments are met.
(7) Inaccurate and Incomplete Information. A violation of the regulations on submitting incomplete and inaccurate information, whether or not considered a material false statement, can result in the full range of enforcement sanctions. The labeling of a communication failure as a material false statement will be made on a case-by-case basis and will be reserved for egregious violations. Violations involving inaccurate or incomplete information or the failure to provide significant information identified by a licensee or registrant normally will be categorized based on the guidance herein in (3) of this Appendix, "Severity of Violations," and in Supplement IV.
(g) the reasonableness of the explanation for not providing complete and accurate information.
Absent at least careless disregard, an incomplete or inaccurate unsworn oral statement normally will not be subject to enforcement action unless it involves significant information provided by a licensee or registrant official. However, enforcement action may be taken for an unintentionally incomplete or inaccurate oral statement provided to the Agency by a licensee or registrant official or others on behalf of a licensee or registrant, if a record was made of the oral informantor, and provided to the licensee or registrant thereby permitting an opportunity to correct the oral informantor, such as if a transcript of the communication or meeting summary containing the error was made available to the licensee or registrant and was not subsequently corrected in a timely manner.
When a licensee or registrant has corrected inaccurate or incomplete information, the decision to issue a citation for the initial inaccurate or incomplete information normally will be dependent on the circumstances, including the case of detection of the error, the timeliness of the correction, whether the
Agency or the licensee or registrant identified the problem with the communication, and whether the Agency relied on the information prior to the correction. Generally, if the matter was promptly identified and corrected by the licensee or registrant prior to reliance by the Agency, or before the Agency raised a question about the information, no enforcement action will be taken for the initial inaccurate or incomplete information. On the other hand, if the misinformation is identified after the Agency relies on it, or after some question is raised regarding the accuracy of the information, then some enforcement action normally will be taken even if it is in fact corrected. However, if the initial submittal was accurate when made but later turns out to be erroneous because of newly discovered information or advance in technology, a citation normally would not be appropriate if, when the new information or advance in technology, a citation normally would not be appropriate if, when the new information became available, the initial submittal was corrected.
The failure to correct inaccurate or incomplete information which the licensee or registrant does not identify as significant normally will not constitute a separate violation. However, the circumstances surrounding the failure to correct may be considered relevant to the determination of enforcement action for the initial inaccurate or incomplete statement. For example, an unintentionally inaccurate or incomplete submission may be treated as a more severe matter if the licensee or registrant later determines that the initial submittal was in error and does not correct it or if there were clear opportunities to identify the error. If information not corrected was recognized by a licensee or registrant as significant, a separate citation may be made for the failure to provide significant information. In any event, in serious cases where the licensee's or registrant's actions in not correcting or providing information raise questions about its commitment to safety or its fundamental trustworthiness, the Agency may exercise its authority to issue orders modifying, suspending, or revoking the license or registration. The Agency recognizes that enforcement determinations must be made on a case-by-case basis taking into consideration the issues described above.
The Agency recognizes that oral information may in some situations be inherently less reliable than written submittals because of the absence of an opportunity for reflection and management review. However, the Agency must be able to rely on oral communications from licensee officials concerning significant information. A licensor registrantee or registrant official for purposes of application of the Enforcement Policy means a first line supervisor or above as well as a licensed individual or registered activity, radiation safety officer, or a person listed on a license or registration as an authorized user of licensed material or registered equipment or activity. Therefore, in determining whether to take enforcement action for an oral statement, consideration may be given to such factors as:
(9) Responsibilities. The Director, Division of Radiation Control, as the principal enforcement officer of the Agency, has been delegated the authority to issue notices of violations, civil penalties, and orders. In recognition that the regulation of radiation related activities in many cases does not lend itself to a mechanistic treatment, the Director, Radiological Health Branch must exercise judgment and discretion in determining the severity levels of the violations and the appropriate enforcement sanctions, including the decision to impose a civil penalty and the amount of such penalty, after considering the general principles of this statement of policy and the technical significance of the violations and the surrounding circumstances.
The State Committee of Public Health will be provided written notification of all enforcement actions involving civil penalties or orders.
SUPPLEMENT I - SEVERITY CATEGORIES
Health Physics 420-3-26-.0335
(2) Severity II. - Violations involving for example:
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35 Personnel overexposures and associated violations, incurred during a life-saving effort, will be treated on a case-by-case basis.
(5) Severity V. - Violations that have minor safety or environmental significance.
SUPPLEMENT II - SEVERITY CATEGORIES
Transportation36
(c) Any noncompliance with labeling, placarding, shipping paper, packaging, loading, or other requirements that could reasonably result in the following:
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36 Some transportation requirements are applied to more than one licensee involved in the same activity such as a shipper and a carrier. When a violation of such a requirement occurs, enforcement action will be directed against the responsible licensee which, under the circumstances of the case, may be one or more of the licensees involved.
(5) Severity V. - Violations that have minor safety or environmental significance.
SUPPLEMENT III - SEVERITY CATEGORIES
Radioactive Materials Operations
(5) Severity V. - Violations that have minor safety or environmental significance.
SUPPLEMENT IV - SEVERITY CATEGORIES
Miscellaneous Matters
1. by a licensee or registrant official because of careless disregard for the completeness or accuracy of the information, or
____________
37 In applying the examples in this supplement regarding inaccurate or incomplete information and records, reference also should be made to the information in (6) of this Appendix.
(b) Information which the Agency requires be kept by a licensee or registrant which is incomplete or inaccurate and the incompleteness or inaccuracy is of minor significance.
SUPPLEMENT V - SEVERITY CATEGORIES
Emergency Preparedness
(1) Severity I. - Violations involving for example:
In a general emergency, licensee failure to promptly
(c) respond to the event (e.g., assess actual or potential offsite consequences, activate emergency response facilities, and augment shift staff).
Severity II. - Violations involving for example:
(4) Severity IV. - Violations involving for example:
Licensee or registrant's failure to meet or implement any emergency planning standard or requirement not directly related to assessment and notification.
(5)Severity V. - Violations that have minor safetyor environmental significance.
Statutory Authority: Code of Ala. 1975, §§22-14-4, 22-14-6, 22-14-7, 22-14-8, 22-14-11, 22-14-12, 22-14-13, 41-22-4, 41-22-5, 41-22-6, 41-22-7, 41-22-9, 41-22-11, 41-22-12, 41-22-13, 41-22-14, 41-22-15, 41-22-16, 41-22-17, 41-22-18, 41-22-19.
Editor’s Note: Filed September 1, 1982. Readopted with amendments filed October 24, 1983. Amended: Filed December 19, 1986. Amended: Filed January 19, 1990.
History: Adopted effective December 31, 1983. Revised and Repromulgated effective January 31, 1990.