Resolution - RDC nº 305, 14 November 2002
(DO dated 11/18/02)

The Collegiate Directorate of the Brazilian Sanitary Surveillance Agency, in the use of the attributions vested in it by article 11, item IV of the ANVISA Regulation approved by Decree nº 3.029 dated 16 April 1999, c/c § 1 of article 111 of the Internal Regulation approved by Administrative Order nº 593, dated 25 August 2000, republished on 22 December 2000, in meeting held 5 November 2002,

WHEREAS that disposed in article 7, Chapter II of Law nº 9.782, dated 26 January 1999;

WHEREAS the occurrence of epizooty of bovine spongiform encephalopathy (BSE) in European countries;

WHEREAS the occurrence of cases of the form of Creutzfeldt-Jakob Disease (CJD) that affects humans found in European countries and the strong suspicion of its connection to bovine spongiform encephalopathy;

WHEREAS the at-risk countries defined by the International Epizooty Organization – OIE;

WHEREAS the criteria defined by the International Zoosanitary Code to determine whether a country or area fits in the restrictions related to bovine spongiform encephalopathy;

WHEREAS various countries adopt restrictive legislation concerning transmissible spongiform encephalopathies (TSEs);

WHEREAS the need to adopt measures to protect the Brazilian population against transmissible spongiform encephalopathies;

WHEREAS the existence of epidemiological evidence that shows the relation of those diseases in humans with the consumption of meat products and derivates elaborated from infected ruminants;

WHEREAS the possibility of transmission of pathogenic substances to humans by products of animal origin used in diagnosis and treatment procedures;

WHEREAS the potential transmission risk of the disease by the use of human organs and tissues of people who live in countries where CJD has been detected;

WHEREAS Brazilian measures adopted to forbid for an undetermined period of time the import for human consumption and/or animal feed of live ruminants of the bovine, ovine, caprine and bubaline species as well as wild ruminants and their derivates, considering the Special Commission instituted by Administrative Order 216, dated 16 February 2001 of the Minister of State of Health;

WHEREAS the need to establish rules and procedures for the import of products subject to sanitary control;

WHEREAS the import of raw materials, semi-elaborated and bulk products used in the production of food for human consumption are foreseen in specific legislation of the Ministry of Agriculture and Food Supply - MAPA,

Adopted the following Resolution of the Collegiate Directorate and I, the Substitute Director-Chairman determine its publication:

Art.1 While conditions that present health risks persist, the following remains forbidden in the national territory: the entry and trade of raw materials and finished, semi-elaborated or bulk products made of the tissues/fluids of ruminant animals for use in human beings including medicines, cosmetics and health products, as specified below:

1 – tissues/fluids of the infectivity I category, according to the classification found in annex 4, of animals coming from countries of geographic risk 2,3 or 4 as established by the "European Commission’s Scientific Steering Geographical BSE Risk Classification", equivalent to the 2, 3, 4 and 5 categories of geographic risk, taking as a reference the assessment of the country or zone as defined by the International Zoosanitary Code for bovine spongiform encephalopathy, as described in Annex 5.

2 - tissues/fluids of the infectivity II and III categories, according to the classification found in annex 4, of animals coming from countries of geographic risk 3 or 4 as established by the "European Commission’s Scientific Steering Geographical BSE Risk Classification", equivalent to the 3, 4 and 5 categories of geographic risk, taking as a reference the assessment of the country or zone as defined by the International Zoosanitary Code for bovine spongiform encephalopathy, as described in Annex 5.

§ 1 The countries not classified by the "European Commission’s Scientific Steering Geographical BSE risk classification" and/or the International Zoosanitary Code are included in this ban, being considered of maximum risk.

§ 2 Pulmonary surfactants remain excluded from the dispositions of this article as long as they present the documentation described in specific legislation.

Art 2 The entry, trade and exposition to the consumption of raw materials and products made of the tissues/fluids of ruminant animals used as components in the production of medicines, cosmetics and health products remain conditioned to the presentation to the sanitary authorities and approval of documentation described in specific legislation, as follows:

1 – raw materials obtained from tissues/fluids of the infectivity IV category, according to classification found in annex 4, of animals coming from countries of geographic risk 1, 2,3 or 4 as established by the "European Commission’s Scientific Steering Geographical BSE Risk Classification", equivalent to the 1, 2, 3, 4 and 5 categories of geographic risk, taking as a reference the assessment of the country or zone as defined by the International Zoosanitary Code for bovine spongiform encephalopathy, as described in Annex 5.

2 - raw materials obtained from tissues/fluids of the infectivity II and III categories, according to classification found in annex 4, of animals coming from countries of geographic risk 1or 2 as established by the "European Commission’s Scientific Steering Geographical BSE Risk Classification", equivalent to the 1or 2 categories of geographic risk, taking as a reference the assessment of the country or zone as defined by the International Zoosanitary Code for bovine spongiform encephalopathy, as described in Annex 5.

3 – raw materials obtained from tissues/fluids of the infectivity I category, according to classification found in annex 4, of animals coming from countries of geographic risk 1 as established by the "European Commission’s Scientific Steering Geographical BSE Risk Classification", equivalent to the 1 category of geographic risk, taking as a reference the assessment of the country or zone as defined by the International Zoosanitary Code for bovine spongiform encephalopathy, as described in Annex 5.

Art 3 The following remains forbidden in the national territory while the conditions that constitute health risks persist: the entry, trade and exposition to the consumption of food additives and of packaged, ready-to-eat foods destined for human consumption made with the tissues/fluids of ruminants coming from countries of geographic risk 3 and 4 as established by the "European Commission’s Scientific Steering Geographical BSE Risk Classification", equivalent to the 1 category of geographic risk, taking as a reference the assessment of the country or zone as defined by the International Zoosanitary Code for bovine spongiform encephalopathy, as described in Annex 5.

Art 4 This Resolution does not apply to finished products for in vitro diagnosis. However, the manufacturer must specify the potential contamination risk with TSEs (transmissible spongiform encephalopathies) and the necessary biosafety procedures in the informative materials of products obtained from the tissues/fluids of ruminant animals, including the expression “Potentially Infectious”.

Art 5 The byproducts of milk and wool obtained from live animals remain excluded from the restrictions foreseen in this Resolution.

Art.6 The entry of human organs and tissues from people that reside in the United Kingdom and the Republic of Ireland remain forbidden while the conditions that present a risk to health persist in the national territory
Sole Paragraph. The following remain included in the prohibition of this article: products derived from human organs and tissues such as hypophisary hormones or any other implantable, injectable or ingestible or applicable to the human body in any other way.

Art. 7 The use of human blood and tissue components obtained from people of any nationality who have lived in the United Kingdom or in the Republic of Ireland for a period equal or superior to six consecutive or intermittent months starting in 1980 remains forbidden, as well as that of people who present clinical disturbances compatible with Creutzfeldt-Jakob Disease (CJD).

Art. 8 The re-use of medical chirurgical supplies or instruments used by people who present clinical conditions indicative of CJD remains conditioned to the adoption of the processing measures contained in Annex 1 of this RDC.

Art. 9 The adoption of precautions for the handling of patients, treatment of articles and surfaces, manipulation and discarding of supplies and samples of tissues contained in Annex 2 and 3 of this RDC is mandatory.

Art. 10 The sanitary requirements contained in this resolution extend to already initiated import procedures and to products in transit in ports, airports and frontiers.

Art. 11 The sanitary authority of ports, airports and frontiers can, at the moment of import of other products not referred to above, demand proof that they are free of substances obtained from the animal species mentioned in article 1.

Art. 12 The Brazilian Sanitary Surveillance Agency will adopt specific measures regarding products not discriminated in this Resolution that are considered to pose a potential risk.

Art. 13 The Resolution of the Collegiate Directorate - RDC nº 213, dated 30 July 2002 and the Resolution of the Collegiate Directorate - RDC nº 251 dated 09 September 2002 are hereby revoked.

Art. 14 This Resolution enters into force on the date of its publication.

RICARDO OLIVA

ANNEXES

ANNEX I: Procedures for the processing of materials used in patients with a clinical suspicion of CJD or vCJD.

ANNEX II: Biosafety procedures for the handling of patients, samples or other materials potentially contaminated with CJD or vCJD.

ANNEX III: Procedures for the handling of corpses.

ANNEX IV: Relative infectivity of body tissues and fluids of animals.

ANNEX V: Assessment of Geographic Risk

ANNEX 1

Procedures for the processing of materials used in patients with a clinical suspicion of CJD or vCJD

1. Preference must be given to disposable materials and instruments that must be incinerated after use;

2. Surgical instruments and other reusable materials must be kept wet or moist until processing;

3. These materials must be visibly identified as being of “BIOLOGICAL RISK” until they are discarded or processed;

4. Cleaning must take place as quickly as possible to avoid the adherence of tissue, liquid or secretion residues;

5. Materials that are potentially contaminated must not be placed in contact with other materials;

6. The surfaces in which these materials are placed must be covered with waterproof fields to be incinerated after use. If this is not possible, the surfaces must be uncontaminated as described in ANNEX 2;

7. Materials resistant to autoclaving must undergo one of the following processes PRIOR TO ROUTINE STERILIZATION:

7.1 Immersion in 1N (one normal) sodium hydroxide (NaOH) * for one hour;
7.2. Sterilization in gravitational autoclave at 132º C for one hour (exposition time).

8. Materials not resistant to autoclaving must be submitted to immersion in 2N NaOH or 5% sodium hypochlorite** for one hour.

9. Electrodes used in electromyography that are inserted percutaneously, cortical or in depth electrodes and other materials used directly in the nervous tissue must be submitted to the procedures described in item 7 or, if this is not possible, incinerated.

10. Such sensitive instruments as fibroscopes, microscopes and devices for intracardiac monitoring must, as much as possible, be covered or wrapped in waterproof and disposable material prior to use. Any parts that enter in contact with the internal tissue of patients must be decontaminated using the most effective procedure applicable ***, through mechanical cleaning for the elimination of adhered residues and, if possible, must be submitted to one of the processes described in items 7 and 8. The same applies to those parts that can be taken apart or disconnected.

11. The following shall not be used to deactivate prionic protein due to their lack of efficacy: Formol, B-propiolactone, Hydrogen peroxide, ethylene oxide, ammonia , peracetic acid, phenols, hydrochloric acid, dry heat<300ºC,ionizing radiation, ultraviolet radiation and microwaves.

12. Automatic processors used to wash materials shall be used before the procedures described above are adopted, and must be activated in an empty cycle before they receive other products.

13. The precautions described herein also apply to dentistry. As a rule NaOH does not corrode stainless steel, but in practice some steel alloys can be damaged. It is recommended to test a sample or consult the manufacturer prior to submitting a large number of instruments to the process. NaOH can be used as a wash for the autoclaving of instruments, but is corrosive for glass and aluminum. Sodium hypochlorite is not corrosive for glass or aluminum, but corrodes stainless steel, including the components of autoclaves, and can therefore not be used as a wash in autoclaving. If hypochlorite is used to clean an instrument, it must be completely rinsed before it is autoclaved.
* The manipulation of solutions must observe adequate protection measures for the workers.
**Sodium hypochlorite solution must be prepared on the same day.
***Exhaustive mechanical cleaning, repeated washing with a detergent/proteinase solution followed by disinfection with 4M glutaraldehyde, guanidinium thiocyanate 4M or 6M urea.

ANNEX 2

Biosafety procedures for the handling of patients, samples and other materials potentially contaminated by CJD or vCJD.

1. The personal precautions adopted in the care of patients suspected of CJD or vCJD in the handling of materials or in cleansing procedures are the same as those recommended for the prevention of hepatitis B and C.

2. Accidental exposure of health professionals:

2.1. In case of exposure of healthy skin to possibly contaminated materials wash the area immediately with warm water without frictioning, rinse and let dry. Apply 0.5% sodium hydrochlorite for one minute;
2.2. Percutaneous exposure must be followed by washing in warm water and soap. Rinse and let dry;
2.3. Contact with the mucous membranes must be followed by washing with warm water (mouth) and saline solution (eyes);
2.4. Any occurrences must be communicated in a manner analogous to other accidental exposures and their registers must be kept for at least twenty years if the diagnosis of the related patient is not subsequently dismissed.

3. Tissue samples of the nervous system extracted for hystopathologic analyses must be sent to the reference laboratories defined by the official epidemiological surveillance system.
Obs.: Precautions with the handling of samples in reference laboratories will be dealt with in a specific document and are not the object of this RDC.

4. Surfaces that have come in contact with potentially contaminated instruments, materials, body tissues or fluids must, after rigorous mechanical cleansing, be inundated with 2N NaOH or 5% sodium hypochlorite for one hour and then completely rinsed with water.

5. Such materials as recipients and drainage tubes used in patients suspected of CJD or vCJD must be discarded like solid residues as described below.

6. Garments and materials (gloves, brushes, tissues, lab coats, etc.) used for cleaning the surfaces described in item 4 or for the manipulation of materials potentially contaminated, including residues, must be incinerated after use.

7. Solid residues resulting from the care of patients suspected of CJD or vCJD must be conditioned in milky white, leak-proof, resistant double bags identified as BIOLOGIC RESIDUE. Appropriate puncture-resistant, leak-proof, waste disposal containers must be provided for discharge of perforating or cutting material.

8. The residues referred to in items 5, 6 and 7 must be incinerated.

ANNEX 3

Procedures for the handling of corpses

1. The usual measures adopted for the control of infection in the handling of cadavers apply to the removal of corpses of patients that died of CJD or vCJD or are suspected of it.

2. The corpse must be placed in a sealed bag before removal. If there is fluid leakage, especially in case of solution of continuity of the skull or in case of cephalo-rachidian liquid leakage, the bag must be lined with absorbent material.

3. The presence in the area of people other than those needed to perform the necropsy must be avoided. All those involved must be informed of the diagnostic possibility, risks and precautions to be observed.

4. The necropsy team must be adequately attired, including full surgical scrubs, surgical caps, double surgical gloves and full face shield.

5. Preference shall be given to the use of disposable instruments. If this is not possible, the precautions described in ANNEX 1, items 7 and 8 shall be taken.

6. The use of manual saws is recommended to avoid the generation of particles and aerosols. Electrical saws will only be allowed if operated in specific bags for the contention of aerosols or if the professionals use powered air purifying respirators containing adequate filters.

7. Post mortem examinations must be restricted to the brain, avoiding a full necropsy, unless facilities with special safety characteristics are available. Before the skull is opened, plastic linings protected with absorbent material shall be placed under the head to ensure the contention of liquids and residues.

8. The precautions referred to in ANNEX 2, including those that deal with waste disposal, also apply to necropsy procedures.

ANNEX 4

Relative infectivity of body tissues and fluids of animals.

Category I – High infectivity
Brain, spinal marrow, eyes
Category II – Medium infectivity
Ileum, lymph nodes, proximal colon, spleen, tonsils, dura-mater, pineal gland, placenta, liquor, hypophisis, adrenal.
Category III – Low infectivity
Distal colon, nasal mucous membranes, peripheric nerves, bone marrow, liver, lungs, pancreas, thymus
< Category IV – Infectivity not detected

Blood, feces, heart kidneys, mammary glands, milk, ovary, saliva, salivary glands, seminal vesicle, skeletal muscle, testicles, thyroid gland, uterus, foetal tissue, bile, cartilage, bone (except skull and spine) conjunctive tissue, fur, skin, urine.

ANNEX 5
GEOGRAPHIC RISK ASSESSMENT

Bibliography:

JARVIS, W.R. Precautions for Creutzfeldt-Jakob Disease. Infection Control, 3 (3): 238-9, 1982.
Committee on Health Care Issues, American Neurological
Association. Precautions in Handling Tissues, Fluids, and Other
Contaminated Materials from Patients with Documented or Suspected
Creutzfeldt-Jakob Disease. Ann. Neurol, 19 (1): 75-77, 1986.
BROWN,P et al. A simple and effective method for
inactivating virus infectivity in formalin-fixed tissue samples from patients with Creutzfeldt-Jakob disease. Neurology, 40: 887-890, 1990.
European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medicinal Products. Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via medicinal products, Revision September 2000 (CPMP/BWP/1230/98/Rev.1).
Infection Control Guidelines for Transmissible Spongiform Encephalopathies. Geneva: World Health Organization, 1999. WHO/CDS/CSR/APH/2000.3.
Healthcare Infection Control Practices Advisory Committee (HICPAC). Draft Guideline for Environmental Infection Control in Healthcare Facilities. Atlanta: Centers for Disease Control and Prevention, 2001.
<http://www.oie.int/esp/normes/mcode/E_00066.htm> . Access in: 14 December. 2001.
<http://www.bsereview.org.uk/data/eumap/non-eu-risks.htm> Access in: 14 December. 2001.
SCHATZMAYR, H.G. Príons e sua Importância em Biossegurança in: Teixeira, P. (org.) e Valle, S. (org.), Biossegurança: uma abordagem multidsciplinar pp. 273-93. Rio de Janeiro: FIOCRUZ, 1996.