Ministerial Agreement SEN 28-2024

To establish the Procedure for Application of Sanctions, for the purposes of non-compliance with the provisions of Legislative Decree No. 195-2009, which approved the Law on Nuclear Activities and Radiological Safety and Executive Agreement 073-2019 which approved the General Regulation for the Implementation of the Law, Regulations, Safety Guides, Authorization conditions and other requirements issued by the General Directorate of Radiological Safety, with the purpose of:

• 1)

  Supporting the general function of the Regulatory Authority in relation to the protection of health and safety of persons, the protection of property and the environment;

• 2)

  Promoting and fostering a safety culture among authorization holders, service providers and workers of a radioactive and/or nuclear installation;

• 3)

  Deterring non-compliance with regulatory requirements, conditions associated with any authorization and measures resulting from an inspection;

• 4)

  Ensuring that the violator acknowledges non-compliance with safety requirements and leads to designing and implementing effective corrective measures on the causes that provoked the violation;

• 5)

  Ensuring that users of radioactive sources, ionizing radiation-emitting equipment and nuclear material comply with all radiological safety, physical security and safeguards requirements, included in the authorizations, at all stages of the life of the radioactive and/or nuclear installation;

• 6)

  Providing an assurance to the public that radiological safety, physical security and safeguards are maintained. 7. Strengthening compliance with national legislation regarding the application of sanctions for violations in matters of radiological safety, physical security and safeguards.

The application of sanctions is the response to violations committed against legislation, regulations and norms on radiological safety, physical security and safeguards, taking into consideration the technical advice prepared by the General Directorate of Radiological Safety based on current legislation, including:

• 1)

  Law on Nuclear Activities and Radiological Safety, Legislative Decree No. 195-2009;

• 2)

  General Regulation for the Implementation of the Law on Nuclear Activities and Radiological Safety, Executive Agreement No. 073-2019;

• 3)

  Regulation on Authorizations for Radioactive Installations and Ionizing Radiation Generating Equipment, Executive Agreement No. 003-2014;

• 4)

  Radiological Protection Regulation, Executive Agreement No. 004-2014;

• 5)

  Regulation on Safe Transport of Radioactive Materials, Executive Agreement 003-2015;

• 6)

  Regulation for the Management of Radioactive Waste, Executive Agreement 004-2015;

• 7)

  Regulation on Physical Protection of Nuclear and Radioactive Materials, Executive Agreement 005-2015;

• 8)

  Creation of the General Directorate of Radiological Safety (DGSR), as the National Regulatory Authority on Radiological Safety (ARNSR), Executive Agreement 006-2016;

• 9)

  National Registry of Technical Service Providers in Radiological Protection, Ministerial Agreement SEN-015-2021;

• 10)

  Safety Guides; and, 11. Their reforms, updates and new applicable legislation.

The present procedure is mandatory for compliance by personnel involved in the Secretariat of State in the Office of Energy, to establish sanctions for violations of norms on Nuclear Activities, Radiological Safety, Physical Security and Safeguards.

The present procedure applies to all natural and legal persons, applicants and authorized parties or those that are subject to regulation and control by the Regulatory Authority. These include, but are not limited to the following: 1. Authorization holders (Public or Private Legal Persons). 2. Applicants for authorizations, including individual authorizations (natural persons). 3. Service providers authorized by the Regulatory Authority. 4. Persons who have in their possession radiation sources, ionizing radiation generating equipment and nuclear materials without the required authorization. 5. Persons who work with radiation sources, ionizing radiation generating equipment and nuclear materials.

The present procedure applies to all activities carried out in the country related to the peaceful uses of nuclear energy and ionizing radiation in its applications in the fields of medicine, industry, agriculture, research and the generation of electrical energy.

Violations, in accordance with the risk associated with the health of persons, property and the environment, are categorized into three levels of severity: 1. Serious Violations: Those non-compliances that involve a high risk for radiological safety, physical security and safeguards, the health of persons, significant damage to property or the environment, classified in article 94 of Executive Agreement No. 73-2019 are considered serious violations. 2. Less Serious Violations: Those non-compliances that have a moderate impact for radiological safety, physical security and safeguards, so that there is no serious and imminent threat to the safety or health of persons, or provision for significant damage to property or the environment, classified in article 96 of Executive Agreement No. 73-2019 are considered less serious violations. 3. Minor Violations: Those non-compliances that have a low impact or are considered of little significance for radiological safety, physical security and safeguards, classified in article 97 of Executive Agreement No. 73-2019.

The sanctions applied pursuant to this procedure shall be:

• 1)

  Suspension or Revocation of Authorizations;

• 2)

  Closure measures of radioactive installations for a maximum of three (3) months;

• 3)

  Seizure of nuclear or radioactive materials, the cost of which shall be borne by the sanctioned party. 4. Fines established in Annex 1 of the present agreement and classified in Chapter VI of the General Regulation for the Implementation of the Law on Nuclear Activities and Radiological Safety; 5. Reshipment of radioactive material to the country of origin, the cost of which shall be borne by the sanctioned party. For the same non-compliance, a fine sanction may be applied to which another of the sanctions enumerated in this article may be added.

The sanctions applied shall be graduated in accordance with the severity of the non-compliances and violations, taking into account the following conditions: 8.1 - MITIGATING FACTORS: 1. Authorization holders and/or users subject to regulation who have a record of compliance with all technical-legal requirements established in current legislation on Radiological Safety, Physical Security and Safeguards. 2. Authorization holders and/or users subject to regulation who demonstrate delay due to lack of financial resources, when carrying out activities of social interest without profit; 3. Authorization holders and/or users subject to regulation who declare in writing about the error committed and remedy the violation at the same time immediately; 4. Authorization holders and/or users subject to regulation who make verifiable efforts to mitigate or reverse the effects of a violation; 5. Authorization holders and/or users subject to regulation who take corrective measures on their own; 6. Authorization holders and/or users subject to regulation who take corrective measures quickly and completely; 7. Authorization holders and/or users subject to regulation who detect and report the violation. 8.2 - AGGRAVATING FACTORS:

• 1)

  Authorization holders and/or users subject to regulation who have a record of non-compliance with technical-legal requirements established in current legislation on Radiological Safety, Physical Security and Safeguards;

• 2)

  Authorization holders and/or users subject to regulation who commit a violation as a result of negligent conduct;

• 3)

  The damage caused by the violation;

• 4)

  Authorization holders and/or users subject to regulation who with the violation committed obtain a competitive or economic benefit to the detriment of safety;

• 5)

  Operations involving high-activity radioactive sources and/or high inventories of radioactive materials. 6. The potentially greater consequences for the public, exposed workers and the environment. 7. The importance of the violation for safety and the complexity of the correction necessary; 8. Recidivism in a violation within the period of validity of the authorization; 9. The deliberate or intentional violation of the limits and conditions specified in the authorization or in the regulations. 10. The existence of multiple violations simultaneously. Recidivism in the commission of a violation shall increase the level of severity of the sanction.

The imposition of sanctions applicable to violations considered Serious, Less Serious and Minor with direct impact to health and the environment shall be carried out according to the following steps:

• a)

  Investigation process;

• b)

  Identification and Evaluation of violations through review of documents of the parties involved and others that the General Directorate of Radiological Safety deems appropriate to technically substantiate the violation and the sanction to be applied;

• c)

  Selection of appropriate technical corrective measures to remedy the violation;

• d)

  Notification of possible violations and sanctions to the violator;

• e)

  Determine the sanction to be applied or the possibility of exempting from liability;

• f)

  Application of the sanction and notification to the violator;

• g)

  Compliance and cessation of sanctionary measures;

• h)

  Referral to the competent Judicial Body if applicable.

The investigation process for sanctions shall be initiated by the Secretariat of State in the Office of Energy as Regulatory Authority, through the General Directorate of Radiological Safety, ex officio or by complaint, for action or omission committed by the holder of an authorization and/or users subject to regulation. If the process were initiated by a complaint, the General Directorate of Radiological Safety shall arrange the measures and actions aimed at clarifying the facts reported, provided that they are credible.

In order to proceed to clarify the circumstances and gather evidence aimed at clarifying the commission of alleged non-compliances with applicable regulations, the investigation stage shall be initiated and shall be conducted by the inspector who identified the violation(s), and the Director of the General Directorate of Radiological Safety may designate another inspector who shall participate as support in this stage of the process. To that effect the designated inspector must:

• 1)

  Proceed to investigate the facts and circumstances under which the alleged violation occurred;

• 2)

  Gather all evidence such as records, witness statements, expert reports, documentary evidence, complaints, etc., which in their judgment are conducive to clarifying the investigation;

• 3)

  Frame the fault when there is one, in accordance with the regulations that could be applicable;

• 4)

  Identify the potential responsible parties; and 5. Recommend the measures to be applied.

In parallel with the administrative sanctions application procedure, violators must submit, within a period of thirty (30) business days, an action plan that shall include: An investigation that determines the causes that generated the violation, the corrective actions, the preventive measures to avoid recurrence of the violation and the implementation timeline of the corrective measures; with the designation of the person responsible for its compliance. Said Action Plan must be authorized by the Regulatory Authority.

The inspector in charge of the investigation shall forward to the General Secretariat for legal analysis and notification to the natural or legal persons involved, who within ten (10) business days of the notification of the identified violation, may proceed with the defense regarding the alleged violation and offer the evidentiary measures they deem appropriate. This period may be extended by the inspector of the General Directorate of Radiological Safety at the request of the persons involved when the complexity of the violation requires it.

Once the defense submitted by the investigated user is received, the inspector in charge of the investigation may request the presentation before the General Directorate of Radiological Safety of new evidence that clarifies the violations under investigation.

Once the investigation stage is concluded, the inspector in charge of the investigation shall prepare a technical report, in which shall describe what has been done, evaluating the evidence, the analysis of the defenses, the mitigating and aggravating factors to be considered, specifying the non-compliances found, recommending the applicable sanction and exempting from liability those involved in the investigation in the cases that apply.

The inspector in charge of the investigation shall transfer to the Director of the General Directorate of Radiological Safety the file of sanctions with the technical report for consideration and issuance of the Technical Opinion.

The General Directorate of Radiological Safety (DGSR) shall transfer the file to the General Secretariat together with the technical opinion for the issuance of the corresponding pronouncement, which shall forward it to the Legal Services Directorate, which shall issue the respective Legal Opinion.

Once the legal opinion is issued, the General Secretariat shall prepare the corresponding resolution in order to impose the sanction or exempt those involved from liability. Subsequently, it transfers the file together with the resolution for consideration and signature by the Supreme Executive Authority.

Once the resolution is signed, the General Secretariat notifies the legal representative or the natural persons involved in the investigation process in accordance with what the Administrative Procedure Law establishes.

If the resolution imposes one or more sanctionary measures, the mechanism for monitoring the imposed measures is initiated, which shall comprise:

• 1)

  Keep the registration system updated to monitor the commitments of the holders of authorization and/or users subject to regulation;

• 2)

  Review the action plans of the corrective measures presented by the violator;

• 3)

  Maintain control and monitoring over the dates imposed for the fulfillment of corrective measures and sanctions;

• 4)

  Establish and execute a graduated process to declare the applied sanctions as fulfilled, and;

• 5)

  Verify the completion of corrective actions.

The General Directorate of Radiological Safety shall declare the cessation or fulfillment of the applied sanctions in accordance with the imposed sanction: 1. Fine: once the sanction is paid and corrective measures are fulfilled, if applicable. 2. Suspension of authorization, temporary seizure of nuclear or radioactive materials, and closure of radioactive and nuclear installations: after the period for which the sanction was imposed has elapsed and when radiological safety, physical security, and safeguard conditions prior to the commission of the infraction have been recovered.

Once the periods of the sanctions have elapsed, if the causes that motivated their application persist, the General Directorate of Radiological Safety shall begin a new investigation carrying out the pertinent actions and, if appropriate, shall request an extension of the applied sanction or, as the case may be, shall propose the revocation of the pertinent authorization. In any case (Serious, Less Serious, and Minor Infractions), the Regulatory Authority may additionally request any information it considers necessary to determine compliance with the corrective measures.

The sanction of revocation of authorization and the definitive seizure of nuclear or radioactive materials are sanctions of a permanent character, taking into account the severity of the infraction that motivated their application.

Compliance with technical corrective measures related to minor infractions shall be accredited by the authorization holder with documentary evidence and may be verified on-site through field inspection at the discretion of the DGSR.

Compliance with technical corrective measures related to serious and less serious infractions shall be accredited by the authorization holder with documentary evidence and must in all cases be verified on-site through field inspection by the General Directorate of Radiological Safety.

The commission of crimes classified in the Penal Code and its amendments regarding Radiological Safety "Crimes Related to Nuclear Energy and Ionizing Radiation" may be sanctioned, in addition to the penalties established in the Penal Code, with the sanctions established in the Law on Nuclear Activities and Radiological Safety and the General Regulation for the Implementation of the Law on Nuclear Activities and Radiological Safety, in accordance with this procedure.

Matters not provided for in this procedure shall be governed supplementarily by what is established in the Administrative Procedure Law, the Law on Administrative Contentious Jurisdiction, the Penal Code, the Criminal Procedure Code, and other applicable laws.

Resolutions imposing administrative sanctions shall be executed in the manner provided by the Administrative Procedure Law. Once the administrative remedy is exhausted, the administrative contentious action shall proceed and shall be conducted in accordance with the applicable regulations.

The General Directorate of Radiological Safety shall issue the Internal Procedure for the Application of Sanctions for Infractions within ninety (90) days from the date of publication of this agreement.

This Agreement shall enter into force as of its publication in the Official Journal "LA GACETA". Done in the city of Tegucigalpa, municipality of the Central District on the twentieth day of the month of March of the year two thousand twenty-four (2024). COMMUNICATE AND PUBLISH.- ENG. TOMÁS ANTONIO RODRÍGUEZ SÁNCHEZ UNDERSECRETARY OF RENEWABLE ENERGY AND ELECTRICITY SECRETARIAT OF STATE IN THE OFFICE OF ENERGY DELEGATION AGREEMENT NO. SEN-115-2022 ERICKA LORENA MOLINA AGUILAR GENERAL SECRETARY