COVID -19 update - ANVISA Resolution 584

Hereinbelow is a resumed version in office translated form of a Resolution (RDC 584 dated 08/12/2021) recently published by Port Health Authority ANVISA. The Resolution basically establishes protocols and procedures to be followed, legitimizing ANVISA supervision and application of fines for non-compliance.

Attention is drawn to the necessity to maintain mentioned records on Cleanliness and Disinfection and on Solid Waste Management as well as crew training records containing, at least, the date of the training, names of the participants, and the results of the learning evaluations.

Options are suggested for managing vessels with at least one covid incident on board in what would appear to be an attempt to avoid full suspension of activities, however, ANVISA shall determine when possible risks to public health are identified and whether full quarantine is necessary.

ANVISA – RESOLUTION 584 dated 08/12/2021

In view of the Public Health Emergency of International Importance - PISP and due to the SARS-CoV-2 pandemic, ANVISA, the Brazilian National Health Authority, has recently published a Resolution (RDC 584 dated 08/12/2021) aimed at establishing sanitary measures relative to platforms located in Brazilian jurisdictional waters and cargo vessels, including those with foreign crew members.

BOARDING

Legal representatives are to make sure that access to platforms or vessels by crew, pilots, agents, suppliers, stevedores, other service providers and professionals is conditioned to compliance with the following requirements:

I - presentation of proof of complete vaccination against COVID-19;

II - presentation of a document proving that a laboratory test of nucleic acid amplification of the RT-PCR or RT-LAMP type has been carried out for screening for infection by SARS-CoV-2, with a negative or non-detectable result, carried out within 72 hours prior to boarding, or a non-reactive result from a rapid antigen test carried out within 24 hours prior to boarding; and

III - pre-boarding screening to identify possible symptoms of COVID-19.

§1 Individuals not eligible by the National Immunization Program for vaccination against COVID-19 are exempt from submitting the proof, provided they comply with a 14-day quarantine before boarding.

§2 Public authorities, whose visits cannot be rescheduled, and professionals involved in interventions necessary for the safety of navigation are exempt from complying with clauses I and II of this Article, provided they wear face masks and maintain physical distance.

§3 Professionals involved in urgent and emergency health care are exempt from complying with items I and II above.

§4 The test mentioned for in item II shall be arranged by the person in charge of the vessel or platform.

Access of non-crew members and third parties on board ships and platforms shall be restricted to the execution of activities that are strictly necessary to the loading and unloading operation and measures are to be taken to reduce contact of non-staff and third parties with crew members and with the surfaces of vessels.

DISEMBARKATION

Disembarkation of travellers is subject to the same requisites as listed for entry by air as established in Ordinance 658 dated 05/10/2021, namely, evidence of a negative Covid 19 antigen test done 24 hrs must be shown. Travellers who have had Covid 19 in the last 90 days as from the first symptoms, who are asymptomatic and continue with PCR or antigen test detectable for covid-19 will be allowed entrance upon presentation of the following documents:

a - two detectable RT-PCR results, with an interval of at least fourteen days, the last one being carried out within seventy-two hours prior to the time of boarding;

b - antigen test that reports a negative or non-reactive result after the last detectable RT-PCR result;

c - medical certificate stating that the individual is asymptomatic and able to travel, including the date of travel. The certificate must be issued in Portuguese or Spanish or English and contain the identification and signature of the physician responsible for the declaration.

Crew do not need to fill out the Traveller's Health Declaration mentioned in the Ordinance and those authorized to disembark for urgent medical attention, for quarantine or isolation ashore are not required to present negative covid 19 results.

For off signing crew, a term of responsibility is to be signed by agents for repatriation costs; airline tickets are to be shown and a Term of Traveller Sanitary Control is to be filled in as per RDC 21 dated 28/03/2008.

NON-PHARMACOLOGICAL MEASURES

Face masks are to be used by all; exception given to crew working on deck. 70° GL alcohol is to be made available for hand cleansing in places where people are more likely to be passing through and social distancing measures are to be in place where possible.

Communication as to preventive measures is to be constantly visible to all engaged in operations and air-conditioning on full air renovation capacity, or, doors and windows left open whenever possible.

Cleanliness and Disinfection Plans are to be elaborated to mitigate chances of contamination through surface contact or contaminated objects.

A specific cleanliness and disinfection plan for covid 19 situations identified on board is to be established and drilled by a team periodically.

Crew working on cleaning (including laundry and garbage removal) are to use discardable gloves and aprons. Special attention is to be given to areas used or visited by people suffering from or suspected of having covid 19 and 24 hours are to pass before cleaning cabins that have been used by covid 19 patients.

A specific protocol for cleanliness and disinfection of non-disposable tableware is to be followed by trained personnel under constant supervision.

Formal records are to be kept of the cleanliness and disinfection, signed by those responsible for its application.

A Solid Waste Management Plan is to be in place as well as a record of the execution of the related procedures.

Solid waste generated, when there are suspected or confirmed cases of Covid19, shall be treated as infectious, being incinerated on board or collected by a specialized company, holder of a Company Operating Permit for the adequate treatment and final destination of the waste.

All those involved in the operations of ports, vessels and platforms must receive periodic training on the non-pharmacological measures to fight Covid-19 and on its signs and symptoms.

The training records should contain, at least, the date of the training, names of the participants, and the results of the learning evaluations.

CONTINGENCY PLANNING

A covid 19 contingency plan will contain procedures for:

I - boarding, disembarkation and crew change;

II - access control for non-crew members and third parties

III - communication with the local ANVISA unit responsible for the port;

IV - compulsory notification of suspected and confirmed cases of Covid-19 on board and other health events;

V - isolation and quarantine on board;

VI - cleaning and disinfection.

Vessels are to make sure there is sufficient stock of personal protective equipment and records kept of at least:

I - pre-boarding screening procedures;

II - clinical and laboratory assessment of travellers in quarantine and isolation, if applicable;

III - contact tracing;

IV - tests performed on board; and

V - clinical and laboratory health assessments.

Those responsible should be formally appointed and training records maintained. A communication protocol should be implemented between the crew and those responsible for the vessel or platform, for immediate reporting of the identification of signs and symptoms or of suspected cases of COVID-19.

NOTIFICATION

The captain or person responsible for the vessel or platform shall immediately notify the ANVISA unit responsible for the port of the occurrence of cases of COVID-19, influenza syndrome, severe acute respiratory syndrome, acute diarrheal disease, and other diseases of compulsory notification defined by the Ministry of Health.

§1 Vessels shall begin notifying health events at least 24 hours and at most 36 hours prior to their expected arrival in the first Brazilian port, using the fastest means available.

§2 Vessels and platforms should update or supplement notifications already made in the following situations:

I - in the occurrence of atypical behaviour of events on board;

II - increase in the number of cases or severity of the event; and

III - when it is necessary to disembark for health care or death on board.

CONTAMINATION

Confirmed covid 19 patients are to be kept in isolation. Symptomatic crew members with a negative result from the rapid antigen test shall have a new sample collected for testing by RT-PCR or RT-LAMP and even if the tests return negative, should remain in isolation until remission of the symptoms.

A symptomatic crew member with a negative result from the rapid antigen test shall have a new sample collected for testing by RT-PCR or RT-LAMP.

Symptomatic crew members, even if the RT-PCR or RT-LAMP results are negative, should remain in isolation until remission of the symptoms.

Close contacts of suspected or confirmed cases who are not fully vaccinated should be kept in quarantine for 14 days or until infection has been ruled out or confirmed.

Close contacts of suspected or confirmed cases who have been fully vaccinated should monitor themselves for a period of 14 days.

Close contacts must reinforce non-pharmacological measures to prevent transmission of SARS-CoV-2, adding the following measures

I - mandatory use of face masks for professional use, including outdoors;

II - to take their meals, preferably, in their cabins

III - not to frequent collective and recreation areas

IV - not to take part in meetings or any other activity that may bring about a gathering of people;

V - be submitted to a daily health assessment, before starting their daily activities.

All close contacts, regardless of vaccination status, should be tested for the diagnosis of COVID-19.

Samples for the test should be collected between the 5th and the 7th day of the last contact with the confirmed case, without prejudice to the possibility of adoption, by those responsible for the vessel, of complementary tests performed at other times.

The close contacts referred to above, provided they are asymptomatic and present negative or non-detectable results in the tests, are exempt from continuing the measures established above.

ANVISA can determine a quarantine of 14 days for crew members, regardless of vaccination status, if identified:

I - inconsistency in the epidemiological or laboratory investigation;

II - presentation of inconclusive diagnostic reports;

III - negative results with sample collection before the 5th day or after the 7th day of contact with a confirmed or suspected case of Covid-19.

DISEMBARKATION OF PATIENTS

Disembarkation of confirmed and suspected cases and close contacts not vaccinated against Covid-19 is allowed for continued compliance with sanitary measures on land.

The permission referred to must be provided for in the Port's Contingency Plan for Public Health Emergencies and is subject to prior authorization by the local ANVISA unit responsible for the port.

Authorization for quarantine or isolation of crew members on land is subject to the favourable opinion of the municipal health authority, and notification to the competent health authority must be ensured for any suspected and confirmed cases identified after the vessel's operation has been terminated.

The disembarkation provided for may be carried out without the authorisations provided for in cases of urgency and health emergency, provided that the agreed safety protocols and Contingency Plan for Public Health Emergencies of the port are observed.

In the event of emergency disembarkation, the local ANVISA unit responsible for the port of destination or of operation shall be informed within 4 (four) hours of disembarking.

The request for disembarkation shall contain the following information

I - full name of the traveller

II - nationality

III - identification document number

IV - date of birth

V - date and place of boarding

VI - function on board

VII - reason for disembarkation;

VIII - name of the company responsible for removal and transport;

IX - name, address and telephone number of health service of traveller's destination

X - tests performed and results

XI - date of disembarkation

XII - number generated in the individual Compulsory Notification, if relevant.

Disembarkation is subject to prior protocol, with the local unit of ANVISA responsible for the port of disembarkation, of detailed procedures on

I - the safe transportation of travellers to the facilities where they will complete the quarantine or isolation period, the use of public transport and app-based passenger transport services being prohibited;

II - the continuity of the fulfilment of the quarantine or isolation period in a designated facility on land approved by the municipal or state health authority

III - the commitment by the company responsible for the vessel to provide logistics and bear the costs of the unloading operation;

IV - the commitment of the company responsible for the vessel to ensure health support infrastructure and the presentation of a plan for the return of travellers to their destinations, when necessary;

V - the presentation of the completed Traveller's Health Control Declaration - TCSV, in accordance with Annex IV of the Collegiate Directive Resolution - RDC No 21, of 28 March 2008, or any other that may replace it.

A clinical monitoring report of the traveller in hospitalization must be sent to the Anvisa unit whenever there are updates on the clinical status of the traveller.

FREE PRATIQUE AND NOTICE OF ARRIVAL

For the concession of Free Pratique and consent to the Notice of Arrival, the responsible parties for the vessel must, apart from usual documents, present the On Board Medical Book containing the records of health occurrences on board for the last 30 days at the time of application. Should there be no record of health occurrences on board in the last 30 days, the master or a crew member appointed by him shall certify in the On Board Medical Book the date of the last record.

Those responsible for the vessel shall inform if the vessel operates under the management rules for vessels with one or more cases of COVID-19 provided for in the attachment to this Resolution.

The granting of Free Pratique is conditioned to the completion of all fields in the form and the signature of the Maritime Declaration of Health (DMS) by the master or designated officer.

The local unit of ANVISA responsible for the port may grant authorization for berthing of the vessel in cases where there is a health event on board, recording the impediment to operation and undocking in the Single Virtual Document (DUV) with a view to ensuring prior communication to all those indicated in the Contingency Plan for Public Health Emergencies of the Port and the decision for berthing or anchoring of the vessel shall follow what is established in the Contingency Plan for Public Health Emergencies of the Port.

OPTIONS FOR MANAGING VESSELS WITH ONE OR MORE CASES OF COVID-19

The presence on board a vessel with a suspected or confirmed case of Covid-19 implies the adoption of one of the measures provided for below.

The choice for the option provided for is at the discretion of the vessel's legal representative, who shall take into consideration the port location, itinerary, availability of alternative crew, and operational and logistic capacity necessary for the operation of the chosen option.

The choice provided for must be previously approved by the ANVISA unit responsible for the port, which, upon considering the epidemiological scenario of the vessel and the information submitted by the person responsible for the vessel, may decide for another of the options provided for.

Vessels with one hundred percent (100%) of the crew fully vaccinated are exempt from adopting the measures provided for above, provided that all measures provided for are adopted for the management of suspected, confirmed cases and close contacts.

The local ANVISA unit responsible for the port may impose option 3 provided for, regardless of the vaccination status of the crew, when possible risks to public health are identified or if there is evidence of cases on board related to a variant of concern (VOC) or of interest (VOI) of SARS-CoV-2 that is not in sustained transmission in the national territory.

The quarantined vessel, in the terms of option 3, if moored in the port, shall remain in an isolated area with the access ladder raised, and access by persons shall not be permitted without the express consent of the local ANVISA unit responsible for the port.

The person in charge of the vessel is exempt from complying with the foregoing in emergency situations essential to the safety of navigation and human life, provided that the correct use of PPE is observed.

The period for compliance with the quarantine of vessels (option 3) starts on the date of onset of symptoms of the suspected case or on the date of collection of material for the diagnostic examination of the last case confirmed on board.

The identification of a new laboratory-confirmed case implies the need for a new choice of option. The loading and unloading operation of the vessel shall be approved by the local ANVISA unit responsible for the port, which shall consider, in making its decision, the levels of exposure of port workers and crew members affected during the operation.

The control measures to be adopted during the operation shall be in accordance with the Contingency Plan of the terminal and the ship owning company, considering the precautionary recommendations against COVID-19 and the type of operation.

Records must be generated of the cleaning and disinfection provided for in the attachment, which should minimally contain the date, sanitizing agents used and those responsible for the activity.

Operations for the supply of water, food, removal of solid waste and sanitary effluents may occur normally, provided they are authorized by the local ANVISA unit responsible for the port, upon presentation of an operational plan that points out flows of operation that ensure the application of non-pharmacological measures.

The termination of the measures provided for shall be determined by the local unit of ANVISA responsible for the port, upon request of the person in charge of the vessel.

Activities of vessels, platforms and ports may be suspended, by determination of ANVISA, due to the identification of risks to public health or noncompliance with the sanitary rules in force.

Non-compliance constitutes a sanitary infraction, without prejudice to the applicable civil, administrative and criminal responsibilities.

OPTIONS TO MANAGE VESSELS WITH ONE OR MORE COVID-19 CASES