sexta-feira, 15 de julho de 2011

RDC 72/2009 - ANVISA

Agents for ports of the state of Rio de Janeiro have been informed by the local branch of the Port Health Authority – ANVISA, that, as from the 20th of June 2011, they expect to receive, together with the usual relevant and pertinent documentation required for free pratique purposes, spreadsheets referent to the maintenance and cleanliness of the air conditioning system and an Air Quality Report which is to be issued every six months, based on an evaluation following parameters established in a Technical Directive number RE 09, dated 16th of January 2003.

The above requirement, according to ANVISA – RIO, is in accordance with an order received from their “coordination”; seeks to enhance health and safety at the ports under Sanitary Control in the state of Rio de Janeiro and is in line with article 61 of directive RDC 72 issued in December 2009.


Loosely translated said article states as follows:

"Art. 61. Spreadsheets referent to the maintenance, operation, cleanliness and disinfection of the acclimatization equipment, as well as the result sheets for air quality must be presented to the competent Sanitary Authority, upon request.

Single paragraph. The quality of artificially acclimatized air by means of systems with a capacity of refrigeration the same or superior to 5 TR´s (60.000 BTU´s), must be evaluated every semester and attend to the physical, chemical and biological parameters, as defined in the RE no. 09, of the 16th of January of 2003.

Naturally, as above requirement is not exactly based on any International Convention, most, if not all ships visiting any of the ports of the state of Rio de Janeiro do not have the required “spreadsheets” or air quality reports (issued every semester) demonstrating that the conditioned air breathed on board foreign flagged vessels complies with Brazilian standards.

In the absence of said documents, local PHA accept that the vessel should be visited by a listed air quality control company who, probing in appropriate spaces and charging around USD1500,00, issue a certificate in ten days. Fortunately the vessel is allowed to sail before the certificate is ready.

International Health Regulation 2005, (to which Brazil is party), does not list Air Conditioning Maintenance Records amongst the health documents provided for under said Regulations and neither, it would seem, can they be found specifically mentioned in any IMO or ILO convention to which Brazil is signatory, yet, none the less, ANVISA included, in RDC 72/2009 (which seeks to incorporate relevant IHR 2005 procedures into local legislation), the above mentioned article 61.

Attachment XIII to RDC 72/2009 is a check list with items that may be looked into by visiting Port Health Authorities. In relation to air-conditioning, the list contains the following instruction:

“Air conditioning equipment must be kept in a good maintenance, control, operational and clean condition. Substitution of filters must be done as per manufacturers instructions or every six months. No objects are to be kept in the AC unit. External air intake must be protected. Air quality tests are to be done every six months (for systems over 60.000BTU) and kept within parameters established in RE 09/2003. The reports are to be available for perusal by the Health Authority.

Maintenance, operation, cleanliness and disinfection of the air conditioning system are to be recorded on spreadsheets and also available for perusal”.

Whereas it is probably not too difficult to keep a record of air conditioning maintenance, the ANVISA resolution RE 09/2003 points to parameters (established by the Brazilian Ministry of Health) that are not known to the international community, which makes compliance a rather complicated exercise for non Brazilian vessels.

Thus, unless some form of collective action is taken against the implementation of article 61 of RDC72/2009, the solution shall be to either pay for the services of an air tester in order to be able to produce the required report/certificate or face the consequences. RDC72/2009 states that non compliance shall subject the vessel to a fine – value unknown. Possible delay to the vessel and fighting the fine shall, one would expect, be more expensive than to just have an ANVISA listed company test the air and issue the required document. Local agents, no doubt, shall be able to procure the services of such a company.