Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 121.000 - To Control The Radiation Hazards Of Lasers, Laser Systems And Optical Fiber Communication Systems Utilizing Laser Diode Or Light Emitting Diode Sources
ENFORCEMENT
Section 121.027 - Enforcement Policy and Procedures

Universal Citation: 105 CMR 121.000 MA Code of Regs 121.027

Current through Register 1531, September 27, 2024

(A) Enforcement Policy. The purpose of the enforcement program of the Radiation Control Program is to promote and protect the health and safety of the public and employees of laser facilities by:

(1) Ensuring compliance with regulations and conditions of the registration;

(2) Obtaining prompt correction of violations and adverse quality conditions which may affect safety;

(3) Deterring future violations and occurrences of conditions adverse to safety; and,

(4) Encouraging improvement of registrant and vendor performance, and by example, that of industry, including the prompt identification 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 registrants who do not achieve and maintain adequate levels of protection be permitted to utilize laser devices.

(B) Grounds for Suspension of A Certificate of Registration or Issuance of an Order to Immediately Cease Activity. The Department may summarily suspend a certificate of registration, or order immediate cessation of an activity, without a prior hearing and with or without an opportunity to correct violations, 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 its/his 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 registrant, a hearing shall be provided promptly after the issuance of such suspension order in accordance with the provisions of 105 CMR 121.027(E)(4)(a).

(1) Specific Grounds. The Department may issue an order denying, revoking, modifying, limiting, or refusing to renew a certificate of registration sought or issued under 105 CMR 121.000 for any one of the following reasons:

(a) The applicant, registrant has failed to submit the information required for registration under 105 CMR 121.000.

(b) The applicant failed to meet the requirements for registration as specified in 105 CMR 121.000.

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

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

(e) The applicant or registrant has failed to pay the registration fee.

(f) The applicant or registrant has failed to pay civil penalties levied in accordance with 105 CMR 121.000.

(g) The applicant or registrant has:

1. failed to allow duly authorized agents of the Radiation Control Program to conduct inspections; or

2. attempted to impede the work of duly authorized representatives of the Radiation Control Program or the enforcement of any provision of 105 CMR 121.000.

(h) The applicant 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 registered under 105 CMR 121.000.

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

(j) The applicant or registrant has been the subject of proceedings which were ultimately resolved by settlement agreement but which were initiated to suspend, deny, modify, limit, or revoke or refuse renewal of a license, unless the Settlement Agreement contained provisions which either:

1. stated that the applicant or registrant was not guilty of the violations he/she/it was charged with or

2. provided that the charges or violations that were the subject of the Settlement Agreement or the Settlement Agreement itself cannot be used in whole or in part as the basis for any future registration or enforcement action by the Department.

(k) The applicant or registrant has been sanctioned and/or disciplined in any manner by a registering or licensing authority in another jurisdiction for substantially one or more of the same reasons set forth herein.

(l) The applicant or registrant operated a facility after the expiration of the certificate of registration.

(m) The applicant or registrant has failed to remedy or correct a cited violation by the date specified in the written notice from the Department under 105 CMR 121.000 or by the date specified in the plan of correction accepted or modified by the Department, unless the applicant 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 registrant has engaged in or aided in the falsification of test results.

(o) The applicant or registrant receives, possesses, uses, transfers, owns or operates or uses a laser device in a manner which endangers public health, safety, or the environment.

(p) The applicant or registrant uses a registered laser for purposes other than those set forth in its application or certificate of registration.

(2) Other Grounds The Department reserves the right to deny, modify, limit revoke or refuse to review a certificate of registration for any other sufficient reason not listed in 105 CMR 121.016(C)(1) if it reasonably considers such action necessary to protect the public health, safety or the environment. In addition, nothing herein 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) Civil Penalties.

(1) If the Department determines, after a notice has been issued and an opportunity for a hearing has been provided, that a registrant, vendor, or other person has not complied with an order issued pursuant to M.G.L. c. 111 § 5I or with any applicable rule, regulation, 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 $500 per violation. Such civil penalty may be assessed whether or not the violation was willful.

(2) Payment of civil penalties imposed under M.G.L. c. 111, § 5I shall be made by check, draft, or money order payable to the Commonwealth of Massachusetts, and mailed to: Radiation Control Program, State Laboratory, 305 South Street, Jamaica Plain, MA 02130.

(3) 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;

(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 121.000;

(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, § 5I or any rule or regulation adopted hereunder;

(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.

(E) Enforcement Procedures.

(1) Notice of Violation. Whenever the Radiation Control Program finds upon inspection, investigation of a complaint or through information in its possession that an applicant or registrant is not in compliance with provisions of M.G.L. c. 111, §5I or 5N or a regulation promulgated thereunder, the Radiation Control Program shall notify the applicant 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 certificate of registration; a modification or limitation of a certificate of registration; a cease and desist order; and/or the imposition of a civil penalty and/or criminal sanctions. Nothing in 105 CMR 121.027, however, shall be deemed to limit the Department's right to immediately suspend a certificate of registration or to issue an order to immediately cease an activity in accordance with 105 CMR 121.027(B).

(2) Plan of Correction.

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

(b) The Radiation Control Program 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 Radiation Control Program finds that the applicant or registrant is in compliance with 105 CMR 121.000 and/or that the applicant or registrant has submitted an acceptable plan of correction, the Radiation Control Program shall notify the applicant 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 Radiation Control Program finds the plan of correction is unacceptable, the Radiation Control Program may request that the applicant or registrant amend and resubmit the plan of correction with five days of the date of notice or such other time as the Radiation Control Program may specify for resubmission.

(d) If upon review of the plan of correction and/or reinspection the Radiation Control Program determines that an applicant or registrant remains non-compliant with applicable laws and regulations , the Department may initiate enforcement procedures as set forth below.

(3) Notice of Department's Intent to Issue an Order.

(a) Prior to the Department issuing an order to modify, limit, deny, revoke or refuse to renew a certificate of registration to require a person to cease and desist any activity, and/or to impose civil penalties, the applicant or registrant shall be notified in writing of the grounds for the Department's action, the provision(s) of law relied upon, the amount of any civil penalty, and his/her right to request an adjudicatory proceeding and/or judicial review.

(b) If a 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 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 Standard Adjudicatory Rules of Practice and Procedures, 801 CMR 1.01 et seq.

(4) Administrative Hearings: Procedure.

(a) Suspension of a Certificate of Registration or Issuance of an Order to Immediately Cease an Activity

1. The Department will give the registrant written notice stating the reason(s) for the suspension or issuance of an order to immediately cease an activity and the provisions of law relied upon. The suspension or order to immediately cease an activity shall take effect immediately upon issuance of the notice.

2. The Department will provide for a hearing pursuant to 80l CMR 1.01 et seq. promptly after the issuance of an order of suspension or an order to immediately cease an activity.

3. In cases of suspension of a 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 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 121.000 which posed a threat is corrected prior to the decision of the Hearing Officer, the Department may lift the suspension by giving written notice to the registrant.

(b) Denial, Modification, Limitation, Revocation, or Refusal to Renew a Certificate of Registration Based on Failure to File Reports: No hearing shall be afforded where denial, modification, limitation, revocation, suspension or refusal to review is based solely upon failure of the registrant to file timely reports, schedules or applications, or to pay lawfully prescribed fees as required by any law or regulation.

(c) Denial, Modification, Limitation, Revocation or Refusal to Renew a Certificate of Registration; Orders to Cease an Activity; Civil Penalties:

1. All adjudicatory proceedings will be conducted in accordance with M.G.L. c. 30A and the Standard Adjudicatory Rules of Practice and Procedure, 801 CMR 1.01 et seq.

2. Except for circumstances specified in 105 CMR 121.027(E)(4)(b), if the Department determines that a 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 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 1.01 et seq.

3. The Hearing Officer will determine whether the Department has proved by a preponderance of the evidence that the 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 certificate of registration; for a cessation of an activity; and/or for imposition of a civil penalty, then the Hearing Officer will 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 121.000 shall be reviewed by the Commissioner. The Commissioner's decision upon this review shall constitute a final Radiation Control Program 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 121.000 waives both its right to administrative review by the Commissioner and its right to judicial review pursuant to M.G.L. c. 30A § 14.

(F) Nonexclusivity of Enforcement Procedures. None of the enforcement procedures contained in 105 CMR 121.000 are exclusive. Any combination of enforcement procedures may be invoked simultaneously if the situation so requires.

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