Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
ENFORCEMENT
Section 120.016 - Enforcement Policy and Procedures

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.016

Current through Register 1531, September 27, 2024

(A) Purpose. The purpose of the enforcement program of the Agency is to promote and protect the radiological health and safety of the public, including employees' health and safety, and the environment by:

* Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

** Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.

(1) Ensuring compliance with regulations and conditions of license;

(2) Obtaining prompt correction of violations that may affect safety;

(3) Deterring future violations; and

(4) Encouraging improvement of licensee, registrant and vendor performance, 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 all persons who do not comply with regulations. In no case will licensees who do not achieve and maintain adequate levels of protection be permitted to conduct licensed activities.

(B) Grounds for Immediate Suspension of a License or Certificate of Registration or Issuance of an Order to Immediately Cease Activity. In accordance with M.G.L. c. 111, § 5O, the Commissioner may summarily suspend a license or certificate of registration or order immediate cessation of an activity, without a prior hearing, whenever the Department finds that public health, safety or the environment would be threatened by delay in issuance of an order. A facility or person may not operate during the period of a suspension of his/its license or certificate of registration and may not conduct a prohibited activity after notification of an order requiring the immediate cessation of an activity. However, upon request by the licensee or registrant, a hearing shall be provided promptly after the issuance of such suspension or order.

(C) Grounds for Denial, Modification, Limitation, Revocation or Refusal to Renew a License or Certificate of Registration.

(1) Specific Grounds. The Department may issue an order denying, revoking, modifying, limiting, or refusing to renew a license or certificate of registration sought or issued under 105 CMR 120.000, or issue an order to cease an activity, for any one of the following reasons:
(a) The applicant, licensee or registrant has failed to submit the information required for licensure or registration under 105 CMR 120.000.

(b) The applicant failed to meet the requirements for licensure or registration as specified in 105 CMR 120.000.

(c) The applicant, licensee or registrant is not suitable and responsible to operate a facility as required or provide the service as licensed or registered.

(d) The applicant, licensee or registrant has obtained or attempted to obtain or maintain a certificate of registration or license by fraud, misrepresentation, or by the submission of incorrect, false or misleading information.

(e) The applicant, licensee or registrant has failed to pay licensure and/or registration fees.

(f) The applicant, licensee or registrant has failed to pay civil penalties or criminal fines levied in accordance with of M.G.L. c. 111, § 5O or 5P and/or 105 CMR 120.000.

(g) The applicant, licensee or registrant has:
1. failed to allow duly authorized agents of the Agency to conduct inspections; or

2. attempted to impede the work of duly authorized representatives of the Agency or the enforcement of any provisions of M.G.L. c. 111 §§ 5N through 5P or 105 CMR 120.000.

(h) The applicant, licensee or registrant has been convicted of, pleaded guilty to, or has, in a judicial proceeding, admitted facts sufficient for a finding that he/she is guilty of, any criminal violation relating directly or indirectly to his/her fitness to be licensed or registered under 105 CMR 120.000.

(i) The applicant, licensee or registrant has been the subject of proceedings which resulted in the suspension, denial, modification, limitation, or revocation of a similar license or certificate of registration or refusal of renewal of a similar license.

(j) The applicant, licensee or registrant has violated 105 CMR 120.000 or a license condition and has a history of non-compliance with the same or similar violation or has received a warning letter from the Department within the last five years for the same or similar violation.

(k) The applicant, licensee or registrant has been disciplined in another jurisdiction in any way by a licensing authority for reasons substantially the same as those set forth in 105 CMR 120.016(C).

(l) The applicant or licensee operated a facility after the expiration of the license.

(m) The applicant, licensee or registrant has failed to remedy or correct a cited violation by the date specified in the written notice from the Department under M.G.L. c. 111, § 5O or by the date specified in the plan of correction accepted or modified by the Department, unless the applicant, licensee or registrant demonstrates to the satisfaction of the Department that such failure was not due to neglect of duty and occurred despite his/her good faith attempt to make corrections by the specified time.

(n) The applicant or licensee has engaged in or aided in the falsification of test results or any other records required to be maintained in accordance with 105 CMR 120.000.

(o) The applicant, licensee or registrant receives, possesses, uses, transfers, owns or operates or uses radioactive materials or machines which emit ionizing radiation in a manner which endangers public health, safety, or the environment.

(2) Other Grounds. The Department reserves the right to deny, modify, limit revoke or refuse to renew a license or certificate of registration for any other sufficient reason not listed in 105 CMR 120.016(C)(1) if it reasonably considers such action necessary to protect the public health, safety or the environment. In addition, nothing in 105 CMR 120.000 shall be deemed to limit the Department's authority to establish or recognize further general or specific grounds for discipline through rulemaking, adjudication, the issuance of polices or advisories or other similar means.

(D) Severity of Violations.

(1) Violations of 105 CMR 120.000 are categorized in terms of five levels of severity to show their relative importance within each of the following five activity areas:
(a) Health Physics;

(b) Transportation;

(c) Materials Operations;

(d) Miscellaneous Matters; and,

(e) Emergency Preparedness.

(2) Within each activity area, Severity Level I has been assigned to violations that are the most significant and Severity Level V to those that are the least significant. Severity Level I and II violations are of very significant regulatory concern. In general, violations that are included in these categories involve actual or high potential impact on the public. 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.

(3) 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 Health Physics is not directly comparable to that associated with Severity Level I violations in Emergency Preparedness.

(4) While examples are provided in 105 CMR 120.019: Appendix A 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 of the examples is predicated on a violation of an existing regulatory requirement. Each is designed to illustrate the significance which the Department places on a particular type of violation of regulatory requirements.

(5) 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.

(6) The severity level of a violation may be increased if the circumstances surrounding the matter involve careless disregard of requirements, deception, or other indication of willfulness. The term "willfulness" includes, but is not limited to, the deliberate violation of any provision of M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P or careless disregard of the requirements of M.G.L. c. 111, §§ 3, 5M, 5N, 5O, and 5P. Willfulness does not include acts which do not rise to the level of careless disregard, e.g. 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 or 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.

(7) The Agency expects licensees to provide complete, timely, and accurate information and reports. Accordingly, unless otherwise categorized in 105 CMR 120.019: Appendix A 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 will not normally be cited for a failure to report a condition or event unless the licensee was actually aware of the condition or event which it failed to report or should have been aware of the condition or event. However, the severity level of an untimely report, in contrast to no report, may be reduced depending on the circumstances surrounding the matter.

(E) Enforcement Conference. Whenever the Agency has learned of the existence of a potential violation for which a civil penalty or other escalated enforcement action may be warranted, or recurring nonconformance on the part of a vendor, the Agency may schedule an enforcement conference with the licensee or vendor prior to taking enforcement action. The Agency may also elect to hold an enforcement conference for other violations, e.g. Severity Level IV violation which, if repeated, could lead to escalated enforcement action. The purpose of the enforcement conference is to:

(a) Discuss the violations or nonconformance, their significance and causes, and the licensee's or vendor's corrective actions;

(b) Determine whether there are any aggravating or mitigating circumstances;

(c) Obtain other information which will help determine the appropriate enforcement action; and

(d) Provide an opportunity for the licensee to explain what corrective actions have been taken or will be taken in response to the Notice of Violation. (See 105 CMR 120.016(F).

(F) Enforcement Procedures.

(1)
(a) Notice of Violation. Whenever the Agency finds upon inspection, investigation of a complaint or through information in its possession that an applicant, licensee or registrant is not in compliance with provisions of M.G.L. c. 111, §§ 5N through 5P or a regulation promulgated thereunder, the Agency shall notify the applicant, licensee or registrant of such violation or deficiency. The notice shall include a statement of the violations or deficiencies found, the provision of the law relied upon, and a reasonable period of time for correction. A violation or deficiency may result in denial, suspension, revocation or refusal to renew a license or certificate of registration; a modification or limitation of a license or certificate of registration; a cease and desist order; and/or the imposition of a civil penalty and/or criminal sanctions.

(b) Confirmatory Action Letters. The Agency may issue Confirmatory Action Letters confirming a licensee's, registrant's, or vendor's agreement to take certain actions to remove significant concerns about health and safety, safeguards, or the environment.

(2) Plan of Correction.
(a) The applicant, licensee or registrant shall within ten days of receipt of the notice, file with the Agency a written plan of correction. The plan shall clearly identify the licensee or registrant, state the date, reference the violation(s) cited, state specific corrective action(s) and timetable(s) and date(s) for completion for each violation cited, and shall be signed by either the applicant, licensee or registrant or his/her designee.

(b) The Agency may re-inspect a facility in order to determine whether the corrections have been made. If upon review of plan of correction and/or reinspection the Agency finds that the applicant, licensee or registrant is in compliance with 105 CMR 120.000 and that the applicant, licensee or registrant has submitted an acceptable plan of correction, the Agency shall notify the applicant, licensee or registrant of its findings of compliance and/or its acceptance or modification of the plan of correction.

(c) If upon review of plan of correction and/or reinspection the Agency finds the plan of correction is unacceptable, the Agency may request that the applicant, licensee or registrant amend and resubmit the plan of correction within five days of the date of notice of the required amendment to the plan of correction or such other time as the Agency may specify for resubmission.

(d) If upon review of the plan of correction and/or reinspection the Agency determines that an applicant, licensee or registrant remains non-compliant with applicable laws and regulations regarding licensure, or the Agency determines that further enforcement action is necessary to ensure compliance with regulatory requirements and deter future non-compliance the Department may initiate enforcement procedures as set forth in 105 CMR 120.016.

(3) Notice of Department's Intent to Issue an Order.
(a) Except as specified in 105 CMR 120.016(F)(4)(b), prior to the Department issuing an order to modify, limit, deny, revoke or refuse to renew a license, and/or to require a person to cease and desist any activity, and/or to impose civil penalties, the applicant, licensee or registrant shall be notified in writing of the Agency's Intent to Issue an Order. The Notice of Intent to Issue an Order shall include the grounds for the Department's action, the provision(s) of law relied upon, the amount of any civil penalty or the requirements of the proposed order, and a right to request an adjudicatory hearing.

(b) If a license or certificate of registration is to be denied, modified, limited, revoked or refused renewal or if an activity is to be ceased or a civil penalty imposed by the Department, then the aggrieved applicant, licensee or registrant may request an adjudicatory hearing within 21 days of receipt of notification of the Department's Intent to Issue an Order. Said request shall be filed in accordance with 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures.

(4) Administrative Hearings: Procedure.
(a) Immediate Suspension of a License or Certificate of Registration or Issuance of an Order to Immediately Cease an Activity:
1. The Department shall give the licensee or registrant written notice stating the reason(s) for the immediate suspension or issuance of an order to immediately cease an activity and the provisions of law relied upon. The immediate suspension or order to immediately cease an activity shall take effect immediately upon issuance of the notice.

2. The Department shall provide for a hearing pursuant to 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures promptly after the issuance of an order of immediate suspension or an order to immediately cease an activity.

3. In cases of immediate suspension of a license or certificate of registration or issuance of an order to immediately cease an activity, the Hearing Officer shall determine whether the Department has proved by a preponderance of the evidence that there existed, immediately prior to or at the time of the immediate suspension or cease and desist order, a threat to public health, safety or the environment.

4. In the event that the Department determines that the violation of state law or of 105 CMR 120.000 which posed a threat to public health, safety or the environment is corrected prior to the decision of the Hearing Officer, the Department may lift the immediate suspension by giving written notice to the licensee or registrant.

(b) Denial, Modification, Limitation, Revocation, or Refusal to Renew a License or Certificate of Registration Based on Failure to File Reports or Pay Fees or Maintain Insurance: In accordance with M.G.L. c. 30A, § 13, no Notice of Intent to Issue an Order shall be required and no hearing shall be offered where denial, modification, limitation, revocation, suspension or refusal to renew is based solely upon failure of the licensee or registrant to file timely reports, schedules or applications or to pay lawfully prescribed fees, or to maintain insurance coverage as required by any law or regulation.

(c) Denial, Modification, Limitation, Revocation or Refusal to Renew a License or Certificate of Registration; Orders to Cease an Activity; Civil Penalties:
1. All adjudicatory proceedings shall be conducted in accordance with M.G.L. c. 30A and 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures.

2. Except for circumstances specified in 105 CMR 120.016(F)(4)(b), if the Department determines that a license or certificate of registration should be denied, modified, limited, revoked, or refused renewal, and/or that a facility should cease an activity, and/or that a civil penalty should be imposed, and if the Department notifies the applicant, licensee or registrant of its intended action, upon receipt of a Notice of Claim for an Adjudicatory Proceeding, the Department shall initiate a hearing pursuant to 801 CMR 1.00: Standard Adjudicatory Rules of Practice and Procedures.

3. The Hearing Officer shall determine whether the Department has proved by a preponderance of the evidence that the license or certificate of registration should be denied, modified, limited, revoked or refused renewal; that an activity should be ceased; and/or that a civil penalty be imposed based on relevant facts as they existed at or prior to the time the Department initiated the hearing procedure.

4. If the Hearing Officer finds any single ground for denial, modification, limitation, revocation, suspension, or refusal to renew a license or certificate of registration; for a cessation of an activity; and/or for imposition of a civil penalty, then the Hearing Officer shall render a recommended decision affirming the issuance of the Department's Order.

(d) Final Agency Decision and Judicial Review:
1. The recommended decision of a Hearing Officer in any adjudicatory proceeding conducted under 105 CMR 120.000 shall be reviewed by the Commissioner. The Commissioner's decision upon this review shall constitute a final agency decision in an adjudicatory proceeding subject to judicial review pursuant to M.G.L. c. 30A, § 14.

2. Any applicant, licensee or registrant that fails to exercise its right to an adjudicatory proceeding under 105 CMR 120.000 waives its right to an adjudicatory hearing, its right to administrative review by the Commissioner and its right to judicial review pursuant to M.G.L. c. 30A, § 14.

(G) Civil Penalties.

(1) If the Department determines, after a notice has been issued and an opportunity for a hearing has been provided, that a licensee, registrant or vendor has not complied with an order issued pursuant to M.G.L. c. 111, § 5O or with any provision of M.G.L. c. 111, §§ 5N through 5P or with any applicable rule, regulation, license or certificate of registration adopted or issued thereunder, the Department, in lieu of, or in addition to suspending, denying, modifying, limiting, revoking, or refusing renewal of a license or certificate of registration, may assess civil penalties in an amount not exceeding $100,000 per violation. Such civil penalty may be assessed whether or not the violation was willful.

(2) The decision whether to issue a civil penalty and the amount of any civil penalty depends on the facts of each case. Generally, civil penalties are most likely to be imposed for Severity Level I violations and if mitigating circumstances are absent, for Severity Level II violations. Civil penalties are considered for Severity Level III violations, and may be imposed for Severity Level IV violations that are similar to previous violations that occurred after the date of the last inspection or within two years, whichever period is greater for which the licensee did not take effective corrective action.

(3) Civil penalties may be assessed for known and conscious violations of the reporting requirements of 105 CMR 120.000 and for any willful violation of any Agency requirement including those at any severity level.

(4) Payment of civil penalties imposed under M.G.L. c. 111, § 5O shall be made by check, draft, or money order payable to the Commonwealth of Massachusetts, and mailed to the Radiation Control Program.

(5) Factors in Determining the Amount of Penalty. In determining the amount of the civil penalty, the Department shall consider the following:
(a) The willfulness of the violation;

(b) The actual and potential danger to the public health or the environment;

(c) The actual or potential costs of such danger to the public health or the environment;

(d) The actual or potential damage or injury to the public health or environment;

(e) The actual and potential cost of such damage or injury;

(f) The actual or potential cost to the Commonwealth of enforcing provisions of 105 CMR 120.000;

(g) Whether the person being assessed the civil penalty did everything reasonable to prevent failure to, to come into compliance promptly, and to remedy and mitigate whatever harm might have been done as a result of the failure to comply;

(h) Whether the person being assessed the civil penalty has previously failed to comply with any order issued pursuant to M.G.L. c. 111, §§ 5N through 5P;

(i) Whether imposition of a civil penalty is likely to deter future non-compliance;

(j) The financial condition of the person being assessed the civil penalty; and

(k) The public interest.

(H) Escalation of Enforcement Sanctions.

(1) The Department considers violations of Severity Levels I, II or III to be of significant regulatory concern. When Severity Level I, II or III violations occur, the Department will, where necessary, issue orders in conjunction with civil penalties to achieve immediate corrective actions and to deter further recurrence of serious violations. The Department 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 105 CMR 120.016(D).

(2) The progression of enforcement actions for similar violations will usually be based on similar violations at an individual facility and not on similar violations under the same license. However, 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. For example, a health physics violation at one division of a dual unit hospital that repeats an earlier violation of the other division might be considered similar.

(I) Criminal Enforcement. The Department may elect to enforce any section of 105 CMR 120.000 or provision of M.G.L. c. 111, § 5P by seeking to have criminal sanctions imposed. Any person who violates M.G.L. c. 111, § 5N or § 5O or any rule, regulation, license, registration, or order adopted or issued under said M.G.L. c. 111, § 5N or § 5O shall be fined not less than $100 nor more than $2,000, or be imprisoned for a period of not more than two years, or both. Any person who continues to violate the provisions of the aforementioned laws after due notice by the Department shall be fined not less than $1,000 nor more than $20,000 or be imprisoned for a period of not more than 20 years, or both. After due notice has been issued by the Department, each day of such violation shall constitute a separate offense.

(J) Judicial Enforcement. The Department may apply directly to the Supreme Judicial Court or Superior Court to enforce any provision of M.G.L. c. 111, §§ 5N through 5P and/or any rule or regulation, license, registration, or order adopted and issued thereunder by the Department. When a person is engaged in or about to engage in any act or practice which constitutes or will constitute a violation of such provision, rule, regulation, license, registration, or order, the Department may seek to restrain such act or practice or the use or occupation of premises or parts thereof or such other equitable relief as public health and safety requires.

(K) Nonexclusivity of Enforcement Procedures. None of the enforcement procedures contained in 105 CMR 120.000 are mutually exclusive. Any enforcement procedures may be invoked simultaneously if the situation so requires.

(L) Deliberate Misconduct.

(1) Any licensee; certificate of registration holder; quality assurance program approval holder; applicant for a license or certificate of registration or quality assurance program approval; employee of a licensee, certificate of registration holder, quality assurance program approval holder or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or certificate of registration holder, quality assurance program approval holder or applicant for a license or certificate of registration or quality assurance program approval, who knowingly provides to any licensee, applicant, certificate holder, quality assurance program approval holder, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's, certificate holder's, quality assurance program approval holder's or applicant's activities in this part, may not:
(a) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, certificate of registration holder, quality assurance program approval holder or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license or certificate of registration or quality assurance program approval issued by the Agency; or

(b) Deliberately submit to the Agency, a licensee, certificate of registration holder, quality assurance program approval holder, an applicant, or a licensee's, certificate holder's, quality assurance program approval holder's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the Agency.

(2) A person who violates 105 CMR 120.016(L)(1)(a) or (b) may be subject to enforcement action in accordance with the procedures in 105 CMR 120.016.

(3) For the purposes of 105 CMR 120.016(L)(1)(a), deliberate misconduct by a person means an intentional act or omission that the person knows:
(a) Would cause a licensee, certificate of registration holder, quality assurance program approval holder or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Agency; or

(b) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, quality assurance program approval holder, applicant, contractor, or subcontractor.

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